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Study identifies risk factors for infection after transbronchial biopsy

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Wed, 04/15/2020 - 15:44

Among patients who undergo endobronchial ultrasound-guided transbronchial biopsy using a guide sheath (EBUS-GS-TBB) for diagnosing lung cancer, cavitation and low-density areas inside the target lesion on CT and stenosis of the responsible bronchus are risk factors for infection after the procedure, according to a study published in CHEST.

“Infectious complications after [transbronchial biopsy] constitute a serious clinical problem because they might delay the start of treatment or cause the intended treatment to be modified to a milder one,” said Tomohide Souma, MD, of the department of respiratory medicine at Fujita Health University in Toyoake, Japan, and colleagues. “The precise mechanism of such complications is still unclear, and effective prophylaxis procedures have not been established. ... Thus, it is very important to identify the risk factors for infectious complications after TBB if and when these complications are to be avoided.”

To evaluate potential risk factors for infectious complications after EBUS-GS-TBB in a large sample of patients, Dr. Souma and colleagues retrospectively studied the medical records of 1,045 consecutive patients (median age, 72; 68% male) who underwent EBUS-GS-TBB between January 2013 and December 2017 at Fujita Health University Hospital.

In all, 47 patients developed infections, a cumulative incidence of about 4.5%. Infections included pneumonia (51.1%), intratumoral infection (29.8%), and three cases each of lung abscess, pleurisy, and empyema. Three patients, two with empyema and one with lung abscess, died within 1 month before administration of anticancer treatment. “In total, more than 40% of patients with post–EBUS-GS-TBB infection were unable to receive preplanned anticancer treatment,” the researchers said.

On multivariate analysis, cavitation in the lesion (odds ratio, 3.63), low-density areas in the lesion (OR, 13.26), and bronchoscopic findings of responsible bronchus stenosis (OR, 7.82) were significantly associated with development of infections post biopsy.

An analysis that matched 89 patients who received prophylactic antibiotics with controls who did not receive prophylactic antibiotics did not find that prophylactic antibiotics significantly reduced the likelihood of post–EBUS-GS-TBB infection.

“Notably, three risk factors found in our study indicate that the inflammation-prone status of lesions may be the most important factor for developing post–EBUS-TBB infection,” Dr. Souma and colleagues said. “Although our study does not rebuff the role of antibiotics in postbronchoscopy infection therapy, clinicians should notify patients that post-TBB infection may occur despite the use of prophylactic antibiotics. We recommend that careful and frequent follow-up be applied to patients undergoing diagnostic EBUS-GS-TBB with reference to the risk factors identified in our study.”

A. Christine Argento, MD, FCCP, assistant professor of medicine and thoracic surgery and director of the interventional pulmonary fellowship program at Northwestern University, Chicago, noted that this is an important study on a topic that has not been well described in the past.

Dr. A. Christine Argento


“This paper ... identifies three factors that were associated with infectious complications – namely, cavitation, low density areas, and a visibly stenosed bronchus leading to the lesion,” she said. “When planning bronchoscopy to sample lesions that fit one of these three criteria, I will likely be more cautious in the future meaning that in these cases, I would limit biopsies to 6-8 pieces which is typically sufficient and I would minimize any trauma to the bronchus leading to the lesion, as if the bronchus is already stenosed on bronchoscopic inspection it is likely inflamed and will only be exacerbated by repeated manipulation and insertions with the bronchoscope and guide sheath leading to a postobstructive phenomenon that was observed in this cohort.

“As far as pleurisy and empyema, it is not described if [the investigators] used fluoroscopy, but this would be an important aspect,” she added. “Ideally, one would not cause disruption of the pleural surface as contamination from the lung to the pleural space can have serious and prolonged infectious consequences as was reported in this study. Fluoroscopy would help the operator to avoid taking samples that would be too close to the pleural surface and could potentially decrease this complication.

“In the United States, it is not always standard practice to see patients 5-7 days following bronchoscopy to assess for complications. Although some of these patients would have presented for evaluation with symptoms, presumably several of these patients would not have. Also pre- and postbronchoscopy labs are not commonly drawn in the United States and so a rise in white blood cells or C-reactive protein would not be known.

“Finally, [the investigators] point out that prophylactic antibiotics do not seem to be effective, and I would agree based on their results. I would only consider using antibiotics as a directed measure if the patient develops infectious complications and the antibiotic choice and duration of therapy would be tailored to the specific complication encountered,” she said.

The researchers had no disclosures.

SOURCE: Souma T et al. CHEST. 2020 Mar 4. doi: 10.1016/j.chest.2020.02.025.

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Among patients who undergo endobronchial ultrasound-guided transbronchial biopsy using a guide sheath (EBUS-GS-TBB) for diagnosing lung cancer, cavitation and low-density areas inside the target lesion on CT and stenosis of the responsible bronchus are risk factors for infection after the procedure, according to a study published in CHEST.

“Infectious complications after [transbronchial biopsy] constitute a serious clinical problem because they might delay the start of treatment or cause the intended treatment to be modified to a milder one,” said Tomohide Souma, MD, of the department of respiratory medicine at Fujita Health University in Toyoake, Japan, and colleagues. “The precise mechanism of such complications is still unclear, and effective prophylaxis procedures have not been established. ... Thus, it is very important to identify the risk factors for infectious complications after TBB if and when these complications are to be avoided.”

To evaluate potential risk factors for infectious complications after EBUS-GS-TBB in a large sample of patients, Dr. Souma and colleagues retrospectively studied the medical records of 1,045 consecutive patients (median age, 72; 68% male) who underwent EBUS-GS-TBB between January 2013 and December 2017 at Fujita Health University Hospital.

In all, 47 patients developed infections, a cumulative incidence of about 4.5%. Infections included pneumonia (51.1%), intratumoral infection (29.8%), and three cases each of lung abscess, pleurisy, and empyema. Three patients, two with empyema and one with lung abscess, died within 1 month before administration of anticancer treatment. “In total, more than 40% of patients with post–EBUS-GS-TBB infection were unable to receive preplanned anticancer treatment,” the researchers said.

On multivariate analysis, cavitation in the lesion (odds ratio, 3.63), low-density areas in the lesion (OR, 13.26), and bronchoscopic findings of responsible bronchus stenosis (OR, 7.82) were significantly associated with development of infections post biopsy.

An analysis that matched 89 patients who received prophylactic antibiotics with controls who did not receive prophylactic antibiotics did not find that prophylactic antibiotics significantly reduced the likelihood of post–EBUS-GS-TBB infection.

“Notably, three risk factors found in our study indicate that the inflammation-prone status of lesions may be the most important factor for developing post–EBUS-TBB infection,” Dr. Souma and colleagues said. “Although our study does not rebuff the role of antibiotics in postbronchoscopy infection therapy, clinicians should notify patients that post-TBB infection may occur despite the use of prophylactic antibiotics. We recommend that careful and frequent follow-up be applied to patients undergoing diagnostic EBUS-GS-TBB with reference to the risk factors identified in our study.”

A. Christine Argento, MD, FCCP, assistant professor of medicine and thoracic surgery and director of the interventional pulmonary fellowship program at Northwestern University, Chicago, noted that this is an important study on a topic that has not been well described in the past.

Dr. A. Christine Argento


“This paper ... identifies three factors that were associated with infectious complications – namely, cavitation, low density areas, and a visibly stenosed bronchus leading to the lesion,” she said. “When planning bronchoscopy to sample lesions that fit one of these three criteria, I will likely be more cautious in the future meaning that in these cases, I would limit biopsies to 6-8 pieces which is typically sufficient and I would minimize any trauma to the bronchus leading to the lesion, as if the bronchus is already stenosed on bronchoscopic inspection it is likely inflamed and will only be exacerbated by repeated manipulation and insertions with the bronchoscope and guide sheath leading to a postobstructive phenomenon that was observed in this cohort.

“As far as pleurisy and empyema, it is not described if [the investigators] used fluoroscopy, but this would be an important aspect,” she added. “Ideally, one would not cause disruption of the pleural surface as contamination from the lung to the pleural space can have serious and prolonged infectious consequences as was reported in this study. Fluoroscopy would help the operator to avoid taking samples that would be too close to the pleural surface and could potentially decrease this complication.

“In the United States, it is not always standard practice to see patients 5-7 days following bronchoscopy to assess for complications. Although some of these patients would have presented for evaluation with symptoms, presumably several of these patients would not have. Also pre- and postbronchoscopy labs are not commonly drawn in the United States and so a rise in white blood cells or C-reactive protein would not be known.

“Finally, [the investigators] point out that prophylactic antibiotics do not seem to be effective, and I would agree based on their results. I would only consider using antibiotics as a directed measure if the patient develops infectious complications and the antibiotic choice and duration of therapy would be tailored to the specific complication encountered,” she said.

The researchers had no disclosures.

SOURCE: Souma T et al. CHEST. 2020 Mar 4. doi: 10.1016/j.chest.2020.02.025.

Among patients who undergo endobronchial ultrasound-guided transbronchial biopsy using a guide sheath (EBUS-GS-TBB) for diagnosing lung cancer, cavitation and low-density areas inside the target lesion on CT and stenosis of the responsible bronchus are risk factors for infection after the procedure, according to a study published in CHEST.

“Infectious complications after [transbronchial biopsy] constitute a serious clinical problem because they might delay the start of treatment or cause the intended treatment to be modified to a milder one,” said Tomohide Souma, MD, of the department of respiratory medicine at Fujita Health University in Toyoake, Japan, and colleagues. “The precise mechanism of such complications is still unclear, and effective prophylaxis procedures have not been established. ... Thus, it is very important to identify the risk factors for infectious complications after TBB if and when these complications are to be avoided.”

To evaluate potential risk factors for infectious complications after EBUS-GS-TBB in a large sample of patients, Dr. Souma and colleagues retrospectively studied the medical records of 1,045 consecutive patients (median age, 72; 68% male) who underwent EBUS-GS-TBB between January 2013 and December 2017 at Fujita Health University Hospital.

In all, 47 patients developed infections, a cumulative incidence of about 4.5%. Infections included pneumonia (51.1%), intratumoral infection (29.8%), and three cases each of lung abscess, pleurisy, and empyema. Three patients, two with empyema and one with lung abscess, died within 1 month before administration of anticancer treatment. “In total, more than 40% of patients with post–EBUS-GS-TBB infection were unable to receive preplanned anticancer treatment,” the researchers said.

On multivariate analysis, cavitation in the lesion (odds ratio, 3.63), low-density areas in the lesion (OR, 13.26), and bronchoscopic findings of responsible bronchus stenosis (OR, 7.82) were significantly associated with development of infections post biopsy.

An analysis that matched 89 patients who received prophylactic antibiotics with controls who did not receive prophylactic antibiotics did not find that prophylactic antibiotics significantly reduced the likelihood of post–EBUS-GS-TBB infection.

“Notably, three risk factors found in our study indicate that the inflammation-prone status of lesions may be the most important factor for developing post–EBUS-TBB infection,” Dr. Souma and colleagues said. “Although our study does not rebuff the role of antibiotics in postbronchoscopy infection therapy, clinicians should notify patients that post-TBB infection may occur despite the use of prophylactic antibiotics. We recommend that careful and frequent follow-up be applied to patients undergoing diagnostic EBUS-GS-TBB with reference to the risk factors identified in our study.”

A. Christine Argento, MD, FCCP, assistant professor of medicine and thoracic surgery and director of the interventional pulmonary fellowship program at Northwestern University, Chicago, noted that this is an important study on a topic that has not been well described in the past.

Dr. A. Christine Argento


“This paper ... identifies three factors that were associated with infectious complications – namely, cavitation, low density areas, and a visibly stenosed bronchus leading to the lesion,” she said. “When planning bronchoscopy to sample lesions that fit one of these three criteria, I will likely be more cautious in the future meaning that in these cases, I would limit biopsies to 6-8 pieces which is typically sufficient and I would minimize any trauma to the bronchus leading to the lesion, as if the bronchus is already stenosed on bronchoscopic inspection it is likely inflamed and will only be exacerbated by repeated manipulation and insertions with the bronchoscope and guide sheath leading to a postobstructive phenomenon that was observed in this cohort.

“As far as pleurisy and empyema, it is not described if [the investigators] used fluoroscopy, but this would be an important aspect,” she added. “Ideally, one would not cause disruption of the pleural surface as contamination from the lung to the pleural space can have serious and prolonged infectious consequences as was reported in this study. Fluoroscopy would help the operator to avoid taking samples that would be too close to the pleural surface and could potentially decrease this complication.

“In the United States, it is not always standard practice to see patients 5-7 days following bronchoscopy to assess for complications. Although some of these patients would have presented for evaluation with symptoms, presumably several of these patients would not have. Also pre- and postbronchoscopy labs are not commonly drawn in the United States and so a rise in white blood cells or C-reactive protein would not be known.

“Finally, [the investigators] point out that prophylactic antibiotics do not seem to be effective, and I would agree based on their results. I would only consider using antibiotics as a directed measure if the patient develops infectious complications and the antibiotic choice and duration of therapy would be tailored to the specific complication encountered,” she said.

The researchers had no disclosures.

SOURCE: Souma T et al. CHEST. 2020 Mar 4. doi: 10.1016/j.chest.2020.02.025.

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In rectal cancer, fragmented care linked to lower survival

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Wed, 05/26/2021 - 13:46

 

– In locally advanced rectal cancer, fragmentation of radiotherapy and surgery comes at a cost, even at academic medical centers, according to a new analysis of data from the National Cancer Center Database. Researchers found that survival was higher when care was integrated – that is, both the surgery and the radiotherapy were performed at the same location.

The study paints a complex picture. Academic settings had a higher frequency of fragmented care than comprehensive community and community hospitals, but treatment in them was associated with better overall survival. However, patients who received fragmented care at academic hospitals had no survival advantage over the other institutions, according to Kyle Freischlag, MD, an intern at the University of Iowa, Iowa City, who presented the study at the annual clinical congress of the American College of Surgeons. The study was conducted at Duke University, Durham, N.C., during Dr. Freischlag’s time there.

Cancer care is becoming more centralized, with the expectation that patients will travel to specialty centers for treatment. But this isn’t possible for all patients, so some may get surgery at one locale, and radiation therapy at a closer, more convenient center.

The push for centralization of cancer care is embodied by the National Accreditation Program for Rectal Cancer, which accredits hospitals to be centers of excellence for rectal cancer surgery. “It’s a great program, it’s very comprehensive. But it is resource intensive to become accredited, so realistically, I think it will be mostly larger-volume hospitals that will apply for accreditation,” said Elise Lawson, MD, in an interview. Dr. Lawson is assistant professor of surgery at University of Wisconsin–Madison, and moderated the session where the research was presented.

“It is a great first step to improving the quality of rectal cancer care, but this study highlights that accreditation of large-volume centers may not be enough, and that we have to be careful that we aren’t going to exacerbate existing disparities in access and quality of care for patients who live in rural settings,” Dr. Lawson added.

In an analysis of 28,227 patients between 2006 and 2015, 17,663 of whom had integrated care, the researchers found that integrated care patients had a lower likelihood of 30-day unplanned readmissions (6.2% vs. 7.0%; P =.01), and those with fragmented care experienced higher mortality (hazard ratio, 1.07; 95% confidence interval, 1.01-1.12). Treatment in an academic center was associated with lower mortality overall than treatment in community centers (HR, 0.881; P =.005).

Fragmented care was more common in academic centers (40% vs. 36% in comprehensive community centers vs. 37% in community centers, P less than .001). Within academic centers, 5-year overall survival was worse with fragmented versus integrated care (70% vs. 74%; P =.00016).

The researchers found that performance of surgery at an academic center was itself a predictor of better survival (odd ratio, 0.88; 95% CI, 0.81-0.96). Integrated care at an academic center was associated with lower 30-day mortality (0.5% vs. 0.6% in integrated comprehensive community centers vs. 1.1% in integrated community centers; P = .038) and better 5-year overall survival (73% vs. 71% vs. 66%; HR, 0.85; 95% CI, 0.75-0.98; P less than .0001). “However, that survival benefit seen in academic hospitals disappeared when they had fragmented care,” Dr. Freischlag noted.

The study is limited by its retrospective nature, though the researchers did adjust for clinical and demographic characteristics, and selection bias for fragmented care should be generalizable across hospital types.

Dr. Freischlag believes that centralization has created additional financial and emotional burdens on patients, reduced the chances of patients receiving adjuvant therapy and completing radiation therapy, and led to increased stage at diagnosis, all factors that might explain the survival difference. He called for efforts to reduce fragmentation, and to conduct surgery at academic centers whenever possible, since that is associated with a survival advantage.

Dr. Lawson agreed, and called for a greater focus on improving care across centers. “It’s a problem if we’re only improving the large volume centers and not thinking about the burden that travel places on patients that live far away from these centers. This study is further showing that it matters not just where you get surgery, but also chemotherapy and radiation – so we need to think about how to coordinate comprehensive care for patients with rectal cancer better.”

The study received no external funding. Dr. Freischlag and Dr. Lawson reported no relevant conflicts of interest.

SOURCE: Freischlag K et al. J Am Coll Surg. 2019 Oct;229(4):Suppl 1, S52.

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– In locally advanced rectal cancer, fragmentation of radiotherapy and surgery comes at a cost, even at academic medical centers, according to a new analysis of data from the National Cancer Center Database. Researchers found that survival was higher when care was integrated – that is, both the surgery and the radiotherapy were performed at the same location.

The study paints a complex picture. Academic settings had a higher frequency of fragmented care than comprehensive community and community hospitals, but treatment in them was associated with better overall survival. However, patients who received fragmented care at academic hospitals had no survival advantage over the other institutions, according to Kyle Freischlag, MD, an intern at the University of Iowa, Iowa City, who presented the study at the annual clinical congress of the American College of Surgeons. The study was conducted at Duke University, Durham, N.C., during Dr. Freischlag’s time there.

Cancer care is becoming more centralized, with the expectation that patients will travel to specialty centers for treatment. But this isn’t possible for all patients, so some may get surgery at one locale, and radiation therapy at a closer, more convenient center.

The push for centralization of cancer care is embodied by the National Accreditation Program for Rectal Cancer, which accredits hospitals to be centers of excellence for rectal cancer surgery. “It’s a great program, it’s very comprehensive. But it is resource intensive to become accredited, so realistically, I think it will be mostly larger-volume hospitals that will apply for accreditation,” said Elise Lawson, MD, in an interview. Dr. Lawson is assistant professor of surgery at University of Wisconsin–Madison, and moderated the session where the research was presented.

“It is a great first step to improving the quality of rectal cancer care, but this study highlights that accreditation of large-volume centers may not be enough, and that we have to be careful that we aren’t going to exacerbate existing disparities in access and quality of care for patients who live in rural settings,” Dr. Lawson added.

In an analysis of 28,227 patients between 2006 and 2015, 17,663 of whom had integrated care, the researchers found that integrated care patients had a lower likelihood of 30-day unplanned readmissions (6.2% vs. 7.0%; P =.01), and those with fragmented care experienced higher mortality (hazard ratio, 1.07; 95% confidence interval, 1.01-1.12). Treatment in an academic center was associated with lower mortality overall than treatment in community centers (HR, 0.881; P =.005).

Fragmented care was more common in academic centers (40% vs. 36% in comprehensive community centers vs. 37% in community centers, P less than .001). Within academic centers, 5-year overall survival was worse with fragmented versus integrated care (70% vs. 74%; P =.00016).

The researchers found that performance of surgery at an academic center was itself a predictor of better survival (odd ratio, 0.88; 95% CI, 0.81-0.96). Integrated care at an academic center was associated with lower 30-day mortality (0.5% vs. 0.6% in integrated comprehensive community centers vs. 1.1% in integrated community centers; P = .038) and better 5-year overall survival (73% vs. 71% vs. 66%; HR, 0.85; 95% CI, 0.75-0.98; P less than .0001). “However, that survival benefit seen in academic hospitals disappeared when they had fragmented care,” Dr. Freischlag noted.

The study is limited by its retrospective nature, though the researchers did adjust for clinical and demographic characteristics, and selection bias for fragmented care should be generalizable across hospital types.

Dr. Freischlag believes that centralization has created additional financial and emotional burdens on patients, reduced the chances of patients receiving adjuvant therapy and completing radiation therapy, and led to increased stage at diagnosis, all factors that might explain the survival difference. He called for efforts to reduce fragmentation, and to conduct surgery at academic centers whenever possible, since that is associated with a survival advantage.

Dr. Lawson agreed, and called for a greater focus on improving care across centers. “It’s a problem if we’re only improving the large volume centers and not thinking about the burden that travel places on patients that live far away from these centers. This study is further showing that it matters not just where you get surgery, but also chemotherapy and radiation – so we need to think about how to coordinate comprehensive care for patients with rectal cancer better.”

The study received no external funding. Dr. Freischlag and Dr. Lawson reported no relevant conflicts of interest.

SOURCE: Freischlag K et al. J Am Coll Surg. 2019 Oct;229(4):Suppl 1, S52.

 

– In locally advanced rectal cancer, fragmentation of radiotherapy and surgery comes at a cost, even at academic medical centers, according to a new analysis of data from the National Cancer Center Database. Researchers found that survival was higher when care was integrated – that is, both the surgery and the radiotherapy were performed at the same location.

The study paints a complex picture. Academic settings had a higher frequency of fragmented care than comprehensive community and community hospitals, but treatment in them was associated with better overall survival. However, patients who received fragmented care at academic hospitals had no survival advantage over the other institutions, according to Kyle Freischlag, MD, an intern at the University of Iowa, Iowa City, who presented the study at the annual clinical congress of the American College of Surgeons. The study was conducted at Duke University, Durham, N.C., during Dr. Freischlag’s time there.

Cancer care is becoming more centralized, with the expectation that patients will travel to specialty centers for treatment. But this isn’t possible for all patients, so some may get surgery at one locale, and radiation therapy at a closer, more convenient center.

The push for centralization of cancer care is embodied by the National Accreditation Program for Rectal Cancer, which accredits hospitals to be centers of excellence for rectal cancer surgery. “It’s a great program, it’s very comprehensive. But it is resource intensive to become accredited, so realistically, I think it will be mostly larger-volume hospitals that will apply for accreditation,” said Elise Lawson, MD, in an interview. Dr. Lawson is assistant professor of surgery at University of Wisconsin–Madison, and moderated the session where the research was presented.

“It is a great first step to improving the quality of rectal cancer care, but this study highlights that accreditation of large-volume centers may not be enough, and that we have to be careful that we aren’t going to exacerbate existing disparities in access and quality of care for patients who live in rural settings,” Dr. Lawson added.

In an analysis of 28,227 patients between 2006 and 2015, 17,663 of whom had integrated care, the researchers found that integrated care patients had a lower likelihood of 30-day unplanned readmissions (6.2% vs. 7.0%; P =.01), and those with fragmented care experienced higher mortality (hazard ratio, 1.07; 95% confidence interval, 1.01-1.12). Treatment in an academic center was associated with lower mortality overall than treatment in community centers (HR, 0.881; P =.005).

Fragmented care was more common in academic centers (40% vs. 36% in comprehensive community centers vs. 37% in community centers, P less than .001). Within academic centers, 5-year overall survival was worse with fragmented versus integrated care (70% vs. 74%; P =.00016).

The researchers found that performance of surgery at an academic center was itself a predictor of better survival (odd ratio, 0.88; 95% CI, 0.81-0.96). Integrated care at an academic center was associated with lower 30-day mortality (0.5% vs. 0.6% in integrated comprehensive community centers vs. 1.1% in integrated community centers; P = .038) and better 5-year overall survival (73% vs. 71% vs. 66%; HR, 0.85; 95% CI, 0.75-0.98; P less than .0001). “However, that survival benefit seen in academic hospitals disappeared when they had fragmented care,” Dr. Freischlag noted.

The study is limited by its retrospective nature, though the researchers did adjust for clinical and demographic characteristics, and selection bias for fragmented care should be generalizable across hospital types.

Dr. Freischlag believes that centralization has created additional financial and emotional burdens on patients, reduced the chances of patients receiving adjuvant therapy and completing radiation therapy, and led to increased stage at diagnosis, all factors that might explain the survival difference. He called for efforts to reduce fragmentation, and to conduct surgery at academic centers whenever possible, since that is associated with a survival advantage.

Dr. Lawson agreed, and called for a greater focus on improving care across centers. “It’s a problem if we’re only improving the large volume centers and not thinking about the burden that travel places on patients that live far away from these centers. This study is further showing that it matters not just where you get surgery, but also chemotherapy and radiation – so we need to think about how to coordinate comprehensive care for patients with rectal cancer better.”

The study received no external funding. Dr. Freischlag and Dr. Lawson reported no relevant conflicts of interest.

SOURCE: Freischlag K et al. J Am Coll Surg. 2019 Oct;229(4):Suppl 1, S52.

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In duodenal neuroendocrine tumors, resection technique matters

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Fri, 06/11/2021 - 11:45

Endoscopic resection technique matters for patients with duodenal neuroendocrine tumors, according to a study presented at the annual Digestive Disease Week.

In a retrospective case series of 20 patients, local recurrence was seen primarily in patients who had cold forceps, rather than deeper, excision techniques. However, most patients who had cold forceps resections also remained recurrence-free, said Jonathan Ragheb, MD, a resident physician at the Cleveland Clinic.

Duodenal neuroendocrine tumors are becoming increasingly prevalent, so Dr. Ragheb and colleagues were interested in “seeing what we should do with them when we encounter them in clinical practice – whether it be surgery or endoscopic intervention,” he said.

In an interview, Dr. Ragheb said that he and his colleagues structured the study to answer the question: “What is the impact of the margin status on the recurrence of the tumor?” This relationship is important in guiding neuroendocrine tumor (NET) management, he said. The technique used for NET removal may also have effects on recurrence rates, so Dr. Ragheb and his collaborators were also interested in answering that question.

The investigators looked at patients at two facilities with a histopathologic diagnosis of duodenal NET who had endoscopic tumor resection during 2004-2018. They excluded patients who had cold forceps endoscopic resection (ER) and clear margins, patients who had further surgical therapy, and those who were lost to endoscopic follow-up.

Assessment of resection margin status was performed independently by pathologists at each study center.

“We found that people with clear margins tend not to have any recurrence, and this is over the course of a year to a year and a half of follow-up,” said Dr. Ragheb, adding, “Those patients who did have some positive margins – whether lateral margins or vertical margins – the majority of them did not have recurrence over that time period.” However, 4 of the patients in the 20-patient cohort did have some tumor recurrence, and all of these patients had an incomplete initial resection.

The investigators took a closer look at which resection techniques were most likely to result in clear margins and no recurrences, and they found that deeper techniques were associated with fewer recurrences. These included endoscopic submucosal or mucosal resection and en bloc snare polypectomy; all were associated with fewer recurrences than resections performed with cold forceps biopsy.

In all, 7 patients had clear (R0) margins, while 13 patients had an incomplete (R1) resection from the biopsy. Of the patients who had R1 margins with local recurrence, three had received a cold forceps biopsy. The other recurrence was in a patient who had endoscopic mucosal resection.

“Margin status is not the sole contributor to recurrence rates of these duodenal neuroendocrine tumors,” said Dr. Ragheb, noting that previous work has identified other possible factors, including tumor grade and biology, that can affect recurrence.

Knowledge gaps still exist regarding best practices for biopsy and decision of duodenal NETs, acknowledged Dr. Ragheb. The present study only followed patients for about a year and a half, so longer-term recurrence patterns and their relationship with various resection techniques aren’t known.

“Larger studies considering tumor grading and ER [endoscopic resection] technique are needed to fully elucidate the risk of local recurrences after ER,” wrote Dr. Ragheb and colleagues.

Dr. Ragheb reported no outside sources of funding and no conflicts of interest.

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Endoscopic resection technique matters for patients with duodenal neuroendocrine tumors, according to a study presented at the annual Digestive Disease Week.

In a retrospective case series of 20 patients, local recurrence was seen primarily in patients who had cold forceps, rather than deeper, excision techniques. However, most patients who had cold forceps resections also remained recurrence-free, said Jonathan Ragheb, MD, a resident physician at the Cleveland Clinic.

Duodenal neuroendocrine tumors are becoming increasingly prevalent, so Dr. Ragheb and colleagues were interested in “seeing what we should do with them when we encounter them in clinical practice – whether it be surgery or endoscopic intervention,” he said.

In an interview, Dr. Ragheb said that he and his colleagues structured the study to answer the question: “What is the impact of the margin status on the recurrence of the tumor?” This relationship is important in guiding neuroendocrine tumor (NET) management, he said. The technique used for NET removal may also have effects on recurrence rates, so Dr. Ragheb and his collaborators were also interested in answering that question.

The investigators looked at patients at two facilities with a histopathologic diagnosis of duodenal NET who had endoscopic tumor resection during 2004-2018. They excluded patients who had cold forceps endoscopic resection (ER) and clear margins, patients who had further surgical therapy, and those who were lost to endoscopic follow-up.

Assessment of resection margin status was performed independently by pathologists at each study center.

“We found that people with clear margins tend not to have any recurrence, and this is over the course of a year to a year and a half of follow-up,” said Dr. Ragheb, adding, “Those patients who did have some positive margins – whether lateral margins or vertical margins – the majority of them did not have recurrence over that time period.” However, 4 of the patients in the 20-patient cohort did have some tumor recurrence, and all of these patients had an incomplete initial resection.

The investigators took a closer look at which resection techniques were most likely to result in clear margins and no recurrences, and they found that deeper techniques were associated with fewer recurrences. These included endoscopic submucosal or mucosal resection and en bloc snare polypectomy; all were associated with fewer recurrences than resections performed with cold forceps biopsy.

In all, 7 patients had clear (R0) margins, while 13 patients had an incomplete (R1) resection from the biopsy. Of the patients who had R1 margins with local recurrence, three had received a cold forceps biopsy. The other recurrence was in a patient who had endoscopic mucosal resection.

“Margin status is not the sole contributor to recurrence rates of these duodenal neuroendocrine tumors,” said Dr. Ragheb, noting that previous work has identified other possible factors, including tumor grade and biology, that can affect recurrence.

Knowledge gaps still exist regarding best practices for biopsy and decision of duodenal NETs, acknowledged Dr. Ragheb. The present study only followed patients for about a year and a half, so longer-term recurrence patterns and their relationship with various resection techniques aren’t known.

“Larger studies considering tumor grading and ER [endoscopic resection] technique are needed to fully elucidate the risk of local recurrences after ER,” wrote Dr. Ragheb and colleagues.

Dr. Ragheb reported no outside sources of funding and no conflicts of interest.

Endoscopic resection technique matters for patients with duodenal neuroendocrine tumors, according to a study presented at the annual Digestive Disease Week.

In a retrospective case series of 20 patients, local recurrence was seen primarily in patients who had cold forceps, rather than deeper, excision techniques. However, most patients who had cold forceps resections also remained recurrence-free, said Jonathan Ragheb, MD, a resident physician at the Cleveland Clinic.

Duodenal neuroendocrine tumors are becoming increasingly prevalent, so Dr. Ragheb and colleagues were interested in “seeing what we should do with them when we encounter them in clinical practice – whether it be surgery or endoscopic intervention,” he said.

In an interview, Dr. Ragheb said that he and his colleagues structured the study to answer the question: “What is the impact of the margin status on the recurrence of the tumor?” This relationship is important in guiding neuroendocrine tumor (NET) management, he said. The technique used for NET removal may also have effects on recurrence rates, so Dr. Ragheb and his collaborators were also interested in answering that question.

The investigators looked at patients at two facilities with a histopathologic diagnosis of duodenal NET who had endoscopic tumor resection during 2004-2018. They excluded patients who had cold forceps endoscopic resection (ER) and clear margins, patients who had further surgical therapy, and those who were lost to endoscopic follow-up.

Assessment of resection margin status was performed independently by pathologists at each study center.

“We found that people with clear margins tend not to have any recurrence, and this is over the course of a year to a year and a half of follow-up,” said Dr. Ragheb, adding, “Those patients who did have some positive margins – whether lateral margins or vertical margins – the majority of them did not have recurrence over that time period.” However, 4 of the patients in the 20-patient cohort did have some tumor recurrence, and all of these patients had an incomplete initial resection.

The investigators took a closer look at which resection techniques were most likely to result in clear margins and no recurrences, and they found that deeper techniques were associated with fewer recurrences. These included endoscopic submucosal or mucosal resection and en bloc snare polypectomy; all were associated with fewer recurrences than resections performed with cold forceps biopsy.

In all, 7 patients had clear (R0) margins, while 13 patients had an incomplete (R1) resection from the biopsy. Of the patients who had R1 margins with local recurrence, three had received a cold forceps biopsy. The other recurrence was in a patient who had endoscopic mucosal resection.

“Margin status is not the sole contributor to recurrence rates of these duodenal neuroendocrine tumors,” said Dr. Ragheb, noting that previous work has identified other possible factors, including tumor grade and biology, that can affect recurrence.

Knowledge gaps still exist regarding best practices for biopsy and decision of duodenal NETs, acknowledged Dr. Ragheb. The present study only followed patients for about a year and a half, so longer-term recurrence patterns and their relationship with various resection techniques aren’t known.

“Larger studies considering tumor grading and ER [endoscopic resection] technique are needed to fully elucidate the risk of local recurrences after ER,” wrote Dr. Ragheb and colleagues.

Dr. Ragheb reported no outside sources of funding and no conflicts of interest.

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Skip metastasis rate low in node-negative oral cancers

Actually, doctors should include neck level IV in these scenarios
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Tue, 05/28/2019 - 18:32

 

In patients with clinically node-negative oral cavity cancers, the rate of skip metastasis to neck level IV is extremely low, according to authors of a recent meta-analysis.

The rate of level IV involvement was about 2.5%, and the rate of skip metastasis was 0.5% in the analysis, which comprised 11 retrospective studies and 2 randomized clinical trials including a total of 1,359 patients with clinically node-negative oral cavity squamous cell carcinomas.

Encountering a suspected positive lymph node during neck dissection does not appear to be an indicator of high rates of level IV involvement, according to Anton Warshavsky, MD, and colleagues in the department of otolaryngology–head and neck surgery and maxillofacial surgery at Tel Aviv Sourasky Medical Center, Israel.

“Supraomohyoid neck dissection [SOHND] is adequate for this subset of patients,” Dr. Warshavsky and coauthors wrote in a report on the study that appears in JAMA Otolaryngology–Head & Neck Surgery.

SOHND, a type of selective neck dissection, refers to removal of lymph nodes in levels I-III. This approach is now frequently used in managing clinically node-negative oral cavity squamous cell carcinoma and provides control rates similar to those associated with more extensive neck dissections, Dr. Warshavsky and colleagues wrote.

However, concern regarding the risk of skip metastases, or involvement of neck level IV without involvement of lower levels, has stirred controversy. SOHND might not be adequate in these patients because of the possibility of occult metastasis to neck level IV.

Accordingly, Dr. Warshavsky and colleagues combed the available medical literature to find relevant articles for a meta-analysis to better characterize the rate of skip metastasis to level IV in patients who had undergone neck dissection.

Level IV involvement rates in clinically node-negative patients ranged from 0% to 11.4% in the 13 included studies. Based on fixed-effects modeling, the rate of involvement was 2.53% (95% CI, 1.64-3.55%), according to the published report.

The rate of skip metastasis was “extremely low,” wrote Dr. Warshavsky and coauthors. Rates ranged from 0% to 5.50%, with a fixed-effects model of 0.50% (95% CI, 0.09%-1.11%).

Cases involving higher levels of the neck did not impact the rate of level IV metastasis, results of a subgroup analysis found. Likewise, an analysis based on T stage showed that rates of level 4 involvement were comparable and low for T stages I-II and III-IV.

These findings are limited, however, not only by the retrospective nature of this study, but also by the fact that many studies reported limited data, hampering the investigators’ ability to run statistics and perform subgroup analyses.

“Unfortunately, data in almost all of the analyzed articles failed to report the relations between the primary tumor site and the neck levels involved by metastatic tumor,” they wrote. “Only primary lesions of the tongue could be accurately assessed.”

Dr. Warshavsky and coauthors reported no conflicts of interest related to the research.

SOURCE: Warshavsky A et al. JAMA Otolaryngol Head Neck Surg. 2019 May 9. doi: 10.1001/jamaoto.2019.0784.

Body

 

Although this meta-analysis shows that the risk of level IV involvement is less than 5% in patients with clinically node-negative (cN0) oral cavity cancers, going beyond standard supraomohyoid neck dissection (SOHND) may still be warranted for specific patients.

While the authors conclude that elective treatment of level IV is not required in patients with cN0 oral cavity cancer, there are two situations in which clinicians should consider adding level IV to standard SOHND.

The first is when a patient has gross macroscopic disease in upper levels, particularly level III. Most studies in the meta-analysis had insufficient data to determine whether involvement of upper levels increased risk of level IV involvement. When encountering gross disease during an elective neck dissection, some researchers have recommended including level IV and V.

The second scenario is when a posterolateral oral tongue cancer is near or at the tongue base, since oropharyngeal cancers are known to drain to levels II-IV.

The decision to make exceptions in these two situations should be based on the combination of clinical judgment and evidence-based medicine in certain situations. That said, for most patients with cNO oral cavity cancer, SOHND is enough.

Arun Sharma, MD, MS , is with the division of otolaryngology–head and neck surgery at Southern Illinois University, Springfield. He had no conflict of interest related to his editorial, which appears in JAMA Otolaryngology–Head & Neck Surgery .

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Although this meta-analysis shows that the risk of level IV involvement is less than 5% in patients with clinically node-negative (cN0) oral cavity cancers, going beyond standard supraomohyoid neck dissection (SOHND) may still be warranted for specific patients.

While the authors conclude that elective treatment of level IV is not required in patients with cN0 oral cavity cancer, there are two situations in which clinicians should consider adding level IV to standard SOHND.

The first is when a patient has gross macroscopic disease in upper levels, particularly level III. Most studies in the meta-analysis had insufficient data to determine whether involvement of upper levels increased risk of level IV involvement. When encountering gross disease during an elective neck dissection, some researchers have recommended including level IV and V.

The second scenario is when a posterolateral oral tongue cancer is near or at the tongue base, since oropharyngeal cancers are known to drain to levels II-IV.

The decision to make exceptions in these two situations should be based on the combination of clinical judgment and evidence-based medicine in certain situations. That said, for most patients with cNO oral cavity cancer, SOHND is enough.

Arun Sharma, MD, MS , is with the division of otolaryngology–head and neck surgery at Southern Illinois University, Springfield. He had no conflict of interest related to his editorial, which appears in JAMA Otolaryngology–Head & Neck Surgery .

Body

 

Although this meta-analysis shows that the risk of level IV involvement is less than 5% in patients with clinically node-negative (cN0) oral cavity cancers, going beyond standard supraomohyoid neck dissection (SOHND) may still be warranted for specific patients.

While the authors conclude that elective treatment of level IV is not required in patients with cN0 oral cavity cancer, there are two situations in which clinicians should consider adding level IV to standard SOHND.

The first is when a patient has gross macroscopic disease in upper levels, particularly level III. Most studies in the meta-analysis had insufficient data to determine whether involvement of upper levels increased risk of level IV involvement. When encountering gross disease during an elective neck dissection, some researchers have recommended including level IV and V.

The second scenario is when a posterolateral oral tongue cancer is near or at the tongue base, since oropharyngeal cancers are known to drain to levels II-IV.

The decision to make exceptions in these two situations should be based on the combination of clinical judgment and evidence-based medicine in certain situations. That said, for most patients with cNO oral cavity cancer, SOHND is enough.

Arun Sharma, MD, MS , is with the division of otolaryngology–head and neck surgery at Southern Illinois University, Springfield. He had no conflict of interest related to his editorial, which appears in JAMA Otolaryngology–Head & Neck Surgery .

Title
Actually, doctors should include neck level IV in these scenarios
Actually, doctors should include neck level IV in these scenarios

 

In patients with clinically node-negative oral cavity cancers, the rate of skip metastasis to neck level IV is extremely low, according to authors of a recent meta-analysis.

The rate of level IV involvement was about 2.5%, and the rate of skip metastasis was 0.5% in the analysis, which comprised 11 retrospective studies and 2 randomized clinical trials including a total of 1,359 patients with clinically node-negative oral cavity squamous cell carcinomas.

Encountering a suspected positive lymph node during neck dissection does not appear to be an indicator of high rates of level IV involvement, according to Anton Warshavsky, MD, and colleagues in the department of otolaryngology–head and neck surgery and maxillofacial surgery at Tel Aviv Sourasky Medical Center, Israel.

“Supraomohyoid neck dissection [SOHND] is adequate for this subset of patients,” Dr. Warshavsky and coauthors wrote in a report on the study that appears in JAMA Otolaryngology–Head & Neck Surgery.

SOHND, a type of selective neck dissection, refers to removal of lymph nodes in levels I-III. This approach is now frequently used in managing clinically node-negative oral cavity squamous cell carcinoma and provides control rates similar to those associated with more extensive neck dissections, Dr. Warshavsky and colleagues wrote.

However, concern regarding the risk of skip metastases, or involvement of neck level IV without involvement of lower levels, has stirred controversy. SOHND might not be adequate in these patients because of the possibility of occult metastasis to neck level IV.

Accordingly, Dr. Warshavsky and colleagues combed the available medical literature to find relevant articles for a meta-analysis to better characterize the rate of skip metastasis to level IV in patients who had undergone neck dissection.

Level IV involvement rates in clinically node-negative patients ranged from 0% to 11.4% in the 13 included studies. Based on fixed-effects modeling, the rate of involvement was 2.53% (95% CI, 1.64-3.55%), according to the published report.

The rate of skip metastasis was “extremely low,” wrote Dr. Warshavsky and coauthors. Rates ranged from 0% to 5.50%, with a fixed-effects model of 0.50% (95% CI, 0.09%-1.11%).

Cases involving higher levels of the neck did not impact the rate of level IV metastasis, results of a subgroup analysis found. Likewise, an analysis based on T stage showed that rates of level 4 involvement were comparable and low for T stages I-II and III-IV.

These findings are limited, however, not only by the retrospective nature of this study, but also by the fact that many studies reported limited data, hampering the investigators’ ability to run statistics and perform subgroup analyses.

“Unfortunately, data in almost all of the analyzed articles failed to report the relations between the primary tumor site and the neck levels involved by metastatic tumor,” they wrote. “Only primary lesions of the tongue could be accurately assessed.”

Dr. Warshavsky and coauthors reported no conflicts of interest related to the research.

SOURCE: Warshavsky A et al. JAMA Otolaryngol Head Neck Surg. 2019 May 9. doi: 10.1001/jamaoto.2019.0784.

 

In patients with clinically node-negative oral cavity cancers, the rate of skip metastasis to neck level IV is extremely low, according to authors of a recent meta-analysis.

The rate of level IV involvement was about 2.5%, and the rate of skip metastasis was 0.5% in the analysis, which comprised 11 retrospective studies and 2 randomized clinical trials including a total of 1,359 patients with clinically node-negative oral cavity squamous cell carcinomas.

Encountering a suspected positive lymph node during neck dissection does not appear to be an indicator of high rates of level IV involvement, according to Anton Warshavsky, MD, and colleagues in the department of otolaryngology–head and neck surgery and maxillofacial surgery at Tel Aviv Sourasky Medical Center, Israel.

“Supraomohyoid neck dissection [SOHND] is adequate for this subset of patients,” Dr. Warshavsky and coauthors wrote in a report on the study that appears in JAMA Otolaryngology–Head & Neck Surgery.

SOHND, a type of selective neck dissection, refers to removal of lymph nodes in levels I-III. This approach is now frequently used in managing clinically node-negative oral cavity squamous cell carcinoma and provides control rates similar to those associated with more extensive neck dissections, Dr. Warshavsky and colleagues wrote.

However, concern regarding the risk of skip metastases, or involvement of neck level IV without involvement of lower levels, has stirred controversy. SOHND might not be adequate in these patients because of the possibility of occult metastasis to neck level IV.

Accordingly, Dr. Warshavsky and colleagues combed the available medical literature to find relevant articles for a meta-analysis to better characterize the rate of skip metastasis to level IV in patients who had undergone neck dissection.

Level IV involvement rates in clinically node-negative patients ranged from 0% to 11.4% in the 13 included studies. Based on fixed-effects modeling, the rate of involvement was 2.53% (95% CI, 1.64-3.55%), according to the published report.

The rate of skip metastasis was “extremely low,” wrote Dr. Warshavsky and coauthors. Rates ranged from 0% to 5.50%, with a fixed-effects model of 0.50% (95% CI, 0.09%-1.11%).

Cases involving higher levels of the neck did not impact the rate of level IV metastasis, results of a subgroup analysis found. Likewise, an analysis based on T stage showed that rates of level 4 involvement were comparable and low for T stages I-II and III-IV.

These findings are limited, however, not only by the retrospective nature of this study, but also by the fact that many studies reported limited data, hampering the investigators’ ability to run statistics and perform subgroup analyses.

“Unfortunately, data in almost all of the analyzed articles failed to report the relations between the primary tumor site and the neck levels involved by metastatic tumor,” they wrote. “Only primary lesions of the tongue could be accurately assessed.”

Dr. Warshavsky and coauthors reported no conflicts of interest related to the research.

SOURCE: Warshavsky A et al. JAMA Otolaryngol Head Neck Surg. 2019 May 9. doi: 10.1001/jamaoto.2019.0784.

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Key clinical point: In patients with clinically node-negative oral cavity cancers, rates of skip metastasis to neck level IV are extremely low, meaning that supraomohyoid neck dissection is likely sufficient for most cases.

Major finding: The rate of level IV involvement was about 2.5%, and the rate of skip metastasis was 0.5%.

Study details: A meta-analysis of 11 retrospective studies and 2 randomized clinical trials, including a total of 1,359 patients who had undergone neck dissection.

Disclosures: The study authors reported no conflicts of interest.

Source: Warshavsky A et al. JAMA Otolaryngol Head Neck Surg. 2019 May 9. doi: 10.1001/jamaoto.2019.0784.

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Laparoscopic distal gastrectomy safe alternative to open surgery

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When experienced surgeons are involved, laparoscopic distal gastrectomy is a safe alternative to open surgery in patients with early-stage gastric cancer, results of a randomized trial suggest.

Five-year overall survival exceeded 93% for both laparoscopic and open surgery groups in the multicenter trial, which included 1,416 patients with stage I gastric cancer treated by 15 surgeons who each had performed at least 100 gastrectomies.

Cancer-specific survival and recurrence were not significantly different between groups, while an intent-to-treat analysis confirmed the noninferiority of laparoscopic gastrectomy versus the open procedure, said investigators, led by Hyung-Ho Kim MD, PhD, of the Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS) group.

“Our trial supports the use of laparoscopic distal gastrectomy as a standard treatment option for clinical stage I distal gastric cancer when it can be performed by surgeons with sufficient experience,” Dr. Kim and his coauthors wrote in JAMA Oncology.

Some had doubted the oncologic safety of the laparoscopic approach because of the potential for inadequate lymphadenectomy leading to an increased risk of locoregional recurrence, said Dr. Kim and his coauthors in the KLASS group, “which includes 15 surgeons from 13 institutes.” However, among patients in this phase 3 randomized trial, known as KLASS-01, the mean number of retrieved lymph nodes was similar for the laparoscopic and open surgery groups, and there was no surgical margin involvement in any patient, investigators reported.

“We thus anticipated comparable long-term oncologic outcomes for overall and cancer-specific survival because these early outcomes indicated the oncologic safety of the laparoscopic procedure,” they said. Moreover, they said, earlier publications on the KLASS-01 study demonstrated that the laparoscopic approach was associated with less blood loss, fewer wound complications, and shorter hospital stays, compared with open distal gastrectomy.

In the current study, Dr. Kim and his coauthors reported that, with a median follow-up of about 100 months, the 5-year overall survival rate was 94.2% for the laparoscopic group and 93.3% for the open group (P = .64), while further statistical analysis confirmed that the laparoscopic approach was noninferior to the open approach. Similarly, the 5-year cancer-specific survival rates were 97.1% and 97.2% for the laparoscopic and open approach, respectively (P = .91), while recurrence was not significantly different at 5.6% and 4.8% (P = .49).

The investigators cited several limitations. One is that the investigators looked only at patients with stage I cancer “suitable for distal subtotal gastrectomy. Applying laparoscopic surgery for more advanced cancers and different operations, such as total gastrectomy, needs to be verified through other clinical trials,” they said.

Nevertheless, they wrote, “These long-term oncologic outcomes of [laparoscopy-assisted distal gastrectomy] support the adoption of this procedure as a standard treatment for clinical stage I gastric cancer.”

Dr. Kim and his coauthors reported no conflicts of interest related to the study, which was supported by a grant from the Ministry of Health & Welfare, Republic of Korea.

SOURCE: Kim HH et al. JAMA Oncol. 2019 Feb 7. doi: 10.1001/jamaoncol.2018.6727.

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When experienced surgeons are involved, laparoscopic distal gastrectomy is a safe alternative to open surgery in patients with early-stage gastric cancer, results of a randomized trial suggest.

Five-year overall survival exceeded 93% for both laparoscopic and open surgery groups in the multicenter trial, which included 1,416 patients with stage I gastric cancer treated by 15 surgeons who each had performed at least 100 gastrectomies.

Cancer-specific survival and recurrence were not significantly different between groups, while an intent-to-treat analysis confirmed the noninferiority of laparoscopic gastrectomy versus the open procedure, said investigators, led by Hyung-Ho Kim MD, PhD, of the Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS) group.

“Our trial supports the use of laparoscopic distal gastrectomy as a standard treatment option for clinical stage I distal gastric cancer when it can be performed by surgeons with sufficient experience,” Dr. Kim and his coauthors wrote in JAMA Oncology.

Some had doubted the oncologic safety of the laparoscopic approach because of the potential for inadequate lymphadenectomy leading to an increased risk of locoregional recurrence, said Dr. Kim and his coauthors in the KLASS group, “which includes 15 surgeons from 13 institutes.” However, among patients in this phase 3 randomized trial, known as KLASS-01, the mean number of retrieved lymph nodes was similar for the laparoscopic and open surgery groups, and there was no surgical margin involvement in any patient, investigators reported.

“We thus anticipated comparable long-term oncologic outcomes for overall and cancer-specific survival because these early outcomes indicated the oncologic safety of the laparoscopic procedure,” they said. Moreover, they said, earlier publications on the KLASS-01 study demonstrated that the laparoscopic approach was associated with less blood loss, fewer wound complications, and shorter hospital stays, compared with open distal gastrectomy.

In the current study, Dr. Kim and his coauthors reported that, with a median follow-up of about 100 months, the 5-year overall survival rate was 94.2% for the laparoscopic group and 93.3% for the open group (P = .64), while further statistical analysis confirmed that the laparoscopic approach was noninferior to the open approach. Similarly, the 5-year cancer-specific survival rates were 97.1% and 97.2% for the laparoscopic and open approach, respectively (P = .91), while recurrence was not significantly different at 5.6% and 4.8% (P = .49).

The investigators cited several limitations. One is that the investigators looked only at patients with stage I cancer “suitable for distal subtotal gastrectomy. Applying laparoscopic surgery for more advanced cancers and different operations, such as total gastrectomy, needs to be verified through other clinical trials,” they said.

Nevertheless, they wrote, “These long-term oncologic outcomes of [laparoscopy-assisted distal gastrectomy] support the adoption of this procedure as a standard treatment for clinical stage I gastric cancer.”

Dr. Kim and his coauthors reported no conflicts of interest related to the study, which was supported by a grant from the Ministry of Health & Welfare, Republic of Korea.

SOURCE: Kim HH et al. JAMA Oncol. 2019 Feb 7. doi: 10.1001/jamaoncol.2018.6727.

 

When experienced surgeons are involved, laparoscopic distal gastrectomy is a safe alternative to open surgery in patients with early-stage gastric cancer, results of a randomized trial suggest.

Five-year overall survival exceeded 93% for both laparoscopic and open surgery groups in the multicenter trial, which included 1,416 patients with stage I gastric cancer treated by 15 surgeons who each had performed at least 100 gastrectomies.

Cancer-specific survival and recurrence were not significantly different between groups, while an intent-to-treat analysis confirmed the noninferiority of laparoscopic gastrectomy versus the open procedure, said investigators, led by Hyung-Ho Kim MD, PhD, of the Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS) group.

“Our trial supports the use of laparoscopic distal gastrectomy as a standard treatment option for clinical stage I distal gastric cancer when it can be performed by surgeons with sufficient experience,” Dr. Kim and his coauthors wrote in JAMA Oncology.

Some had doubted the oncologic safety of the laparoscopic approach because of the potential for inadequate lymphadenectomy leading to an increased risk of locoregional recurrence, said Dr. Kim and his coauthors in the KLASS group, “which includes 15 surgeons from 13 institutes.” However, among patients in this phase 3 randomized trial, known as KLASS-01, the mean number of retrieved lymph nodes was similar for the laparoscopic and open surgery groups, and there was no surgical margin involvement in any patient, investigators reported.

“We thus anticipated comparable long-term oncologic outcomes for overall and cancer-specific survival because these early outcomes indicated the oncologic safety of the laparoscopic procedure,” they said. Moreover, they said, earlier publications on the KLASS-01 study demonstrated that the laparoscopic approach was associated with less blood loss, fewer wound complications, and shorter hospital stays, compared with open distal gastrectomy.

In the current study, Dr. Kim and his coauthors reported that, with a median follow-up of about 100 months, the 5-year overall survival rate was 94.2% for the laparoscopic group and 93.3% for the open group (P = .64), while further statistical analysis confirmed that the laparoscopic approach was noninferior to the open approach. Similarly, the 5-year cancer-specific survival rates were 97.1% and 97.2% for the laparoscopic and open approach, respectively (P = .91), while recurrence was not significantly different at 5.6% and 4.8% (P = .49).

The investigators cited several limitations. One is that the investigators looked only at patients with stage I cancer “suitable for distal subtotal gastrectomy. Applying laparoscopic surgery for more advanced cancers and different operations, such as total gastrectomy, needs to be verified through other clinical trials,” they said.

Nevertheless, they wrote, “These long-term oncologic outcomes of [laparoscopy-assisted distal gastrectomy] support the adoption of this procedure as a standard treatment for clinical stage I gastric cancer.”

Dr. Kim and his coauthors reported no conflicts of interest related to the study, which was supported by a grant from the Ministry of Health & Welfare, Republic of Korea.

SOURCE: Kim HH et al. JAMA Oncol. 2019 Feb 7. doi: 10.1001/jamaoncol.2018.6727.

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Key clinical point: Laparoscopic distal gastrectomy performed by experienced surgeons is a safe alternative to open surgery in patient with early-stage gastric cancer.

Major finding: The 5-year overall survival rate was 94.2% for the laparoscopic group and 93.3% for the open group (P = .64).

Study details: The KLASS-01 trial, which included 1,416 patients with stage I gastric cancer treated by 15 experienced surgeons.

Disclosures: The coauthors reported no conflicts of interest related to the study, which was supported by a grant from the Ministry of Health &Welfare, Republic of Korea.

Source: Kim HH et al. JAMA Oncol. 2019 Feb 7. doi: 10.1001/jamaoncol.2018.6727.

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Characteristics of mucinous adenocarcinoma highlighted

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– Head and neck mucinous adenocarcinoma is commonly diagnosed at a low tumor stage with no nodal involvement but with the potential for distant metastases.

The findings come from the largest study of its kind to date, which was presented by Neel R. Sangal at the Triological Society’s Combined Sections Meeting.

“Mucinous carcinoma was previously classified as colloid carcinoma, which leads to increased confusion in the nomenclature,” said Mr. Sangal, a 4th-year student at New Jersey Medical School, Newark.

“This changed in the 1980s, which led to difficulty in characterizing the disease over time. This histology is well studied in the GI system, in the lungs, and in the breast, but the head and neck presentation is extremely rare, and it lacks comprehensive study.

“It commonly presents as a slow-growing, painless, nonulcerated nodule. From case reports, it’s typically low-grade and indolent, but it commonly recurs, and it does have metastatic potential,” he said. “Histologically, it’s characterized by nets of aggressive epithelial cells that are accompanied by significant extracellular mucin.”

In an effort to understand the demographic, clinicopathologic, treatment, and survival characteristics of mucinous adenocarcinoma, the researchers evaluated cases from the Surveillance, Epidemiology, and End Results Program (SEER) database between 1973 and 2014. They selected patients based on their International Classification of Diseases morphological code specific for mucinous adenocarcinoma and ICD primary site code consistent for cancers of the head and neck.

In all, 583 cases met criteria, “which highlights how rare this disease is,” Mr. Sangal said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons.



The mean age at diagnosis was 64.8 years; 55.2% of cases were male, 64.5% were white, 15.4% were black, 8.7% were Hispanic, 6.7% were Asian, and the remaining 5% were from other ethnicities. The four most frequent primary sites were the eyelid (29.8%), followed by skin of the face (22.6%), skin of the scalp and neck (12.2%), and the parotid gland (8.7%). Most of the lesions lacked nodal involvement and metastasis (94.1% and 96.2%, respectively). Histology presented mainly at lower stages. Specifically, 68% had T0-1 disease, 21.5% had T2-3 disease, and 10.5% had T4 disease.

When the researchers stratified treatment frequency by various clinical pathologic characteristics, they found large differences in the type of treatment received by the primary site. “Those on the salivary gland tended to receive radiation at a much higher percentage than those of the skin, which mostly received surgery alone,” Mr. Sangal said. “We also found a linear correlation between T stage and increased use of radiation alongside surgery. Similarly, those with nodal involvement and distant metastasis had increased rates of radiation with surgery.”

Disease-specific survival and overall survival rates were 92.2% and 80.5%, respectively. Advanced age at diagnosis was a significant predictor of survival. In addition, Hispanics had the highest rates of survival, while the white and black patients had similar survival curves. “Tumors of the parotid gland had significantly worse survival outcomes than those of the skin,” Mr. Sangal added. “We also found a linear correlation between T stage and survival. Similarly, those with nodal involvement and distant metastasis also had decreased survival.”

He acknowledged certain limitations of the study, including the potential for inconsistent coding in the SEER database.

Samer T. Elsamna was lead author on the study. None of the researchers reported having financial disclosures.

SOURCE: Elsamna ST et al. Triological CSM 2019, Abstracts.

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– Head and neck mucinous adenocarcinoma is commonly diagnosed at a low tumor stage with no nodal involvement but with the potential for distant metastases.

The findings come from the largest study of its kind to date, which was presented by Neel R. Sangal at the Triological Society’s Combined Sections Meeting.

“Mucinous carcinoma was previously classified as colloid carcinoma, which leads to increased confusion in the nomenclature,” said Mr. Sangal, a 4th-year student at New Jersey Medical School, Newark.

“This changed in the 1980s, which led to difficulty in characterizing the disease over time. This histology is well studied in the GI system, in the lungs, and in the breast, but the head and neck presentation is extremely rare, and it lacks comprehensive study.

“It commonly presents as a slow-growing, painless, nonulcerated nodule. From case reports, it’s typically low-grade and indolent, but it commonly recurs, and it does have metastatic potential,” he said. “Histologically, it’s characterized by nets of aggressive epithelial cells that are accompanied by significant extracellular mucin.”

In an effort to understand the demographic, clinicopathologic, treatment, and survival characteristics of mucinous adenocarcinoma, the researchers evaluated cases from the Surveillance, Epidemiology, and End Results Program (SEER) database between 1973 and 2014. They selected patients based on their International Classification of Diseases morphological code specific for mucinous adenocarcinoma and ICD primary site code consistent for cancers of the head and neck.

In all, 583 cases met criteria, “which highlights how rare this disease is,” Mr. Sangal said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons.



The mean age at diagnosis was 64.8 years; 55.2% of cases were male, 64.5% were white, 15.4% were black, 8.7% were Hispanic, 6.7% were Asian, and the remaining 5% were from other ethnicities. The four most frequent primary sites were the eyelid (29.8%), followed by skin of the face (22.6%), skin of the scalp and neck (12.2%), and the parotid gland (8.7%). Most of the lesions lacked nodal involvement and metastasis (94.1% and 96.2%, respectively). Histology presented mainly at lower stages. Specifically, 68% had T0-1 disease, 21.5% had T2-3 disease, and 10.5% had T4 disease.

When the researchers stratified treatment frequency by various clinical pathologic characteristics, they found large differences in the type of treatment received by the primary site. “Those on the salivary gland tended to receive radiation at a much higher percentage than those of the skin, which mostly received surgery alone,” Mr. Sangal said. “We also found a linear correlation between T stage and increased use of radiation alongside surgery. Similarly, those with nodal involvement and distant metastasis had increased rates of radiation with surgery.”

Disease-specific survival and overall survival rates were 92.2% and 80.5%, respectively. Advanced age at diagnosis was a significant predictor of survival. In addition, Hispanics had the highest rates of survival, while the white and black patients had similar survival curves. “Tumors of the parotid gland had significantly worse survival outcomes than those of the skin,” Mr. Sangal added. “We also found a linear correlation between T stage and survival. Similarly, those with nodal involvement and distant metastasis also had decreased survival.”

He acknowledged certain limitations of the study, including the potential for inconsistent coding in the SEER database.

Samer T. Elsamna was lead author on the study. None of the researchers reported having financial disclosures.

SOURCE: Elsamna ST et al. Triological CSM 2019, Abstracts.

 

– Head and neck mucinous adenocarcinoma is commonly diagnosed at a low tumor stage with no nodal involvement but with the potential for distant metastases.

The findings come from the largest study of its kind to date, which was presented by Neel R. Sangal at the Triological Society’s Combined Sections Meeting.

“Mucinous carcinoma was previously classified as colloid carcinoma, which leads to increased confusion in the nomenclature,” said Mr. Sangal, a 4th-year student at New Jersey Medical School, Newark.

“This changed in the 1980s, which led to difficulty in characterizing the disease over time. This histology is well studied in the GI system, in the lungs, and in the breast, but the head and neck presentation is extremely rare, and it lacks comprehensive study.

“It commonly presents as a slow-growing, painless, nonulcerated nodule. From case reports, it’s typically low-grade and indolent, but it commonly recurs, and it does have metastatic potential,” he said. “Histologically, it’s characterized by nets of aggressive epithelial cells that are accompanied by significant extracellular mucin.”

In an effort to understand the demographic, clinicopathologic, treatment, and survival characteristics of mucinous adenocarcinoma, the researchers evaluated cases from the Surveillance, Epidemiology, and End Results Program (SEER) database between 1973 and 2014. They selected patients based on their International Classification of Diseases morphological code specific for mucinous adenocarcinoma and ICD primary site code consistent for cancers of the head and neck.

In all, 583 cases met criteria, “which highlights how rare this disease is,” Mr. Sangal said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons.



The mean age at diagnosis was 64.8 years; 55.2% of cases were male, 64.5% were white, 15.4% were black, 8.7% were Hispanic, 6.7% were Asian, and the remaining 5% were from other ethnicities. The four most frequent primary sites were the eyelid (29.8%), followed by skin of the face (22.6%), skin of the scalp and neck (12.2%), and the parotid gland (8.7%). Most of the lesions lacked nodal involvement and metastasis (94.1% and 96.2%, respectively). Histology presented mainly at lower stages. Specifically, 68% had T0-1 disease, 21.5% had T2-3 disease, and 10.5% had T4 disease.

When the researchers stratified treatment frequency by various clinical pathologic characteristics, they found large differences in the type of treatment received by the primary site. “Those on the salivary gland tended to receive radiation at a much higher percentage than those of the skin, which mostly received surgery alone,” Mr. Sangal said. “We also found a linear correlation between T stage and increased use of radiation alongside surgery. Similarly, those with nodal involvement and distant metastasis had increased rates of radiation with surgery.”

Disease-specific survival and overall survival rates were 92.2% and 80.5%, respectively. Advanced age at diagnosis was a significant predictor of survival. In addition, Hispanics had the highest rates of survival, while the white and black patients had similar survival curves. “Tumors of the parotid gland had significantly worse survival outcomes than those of the skin,” Mr. Sangal added. “We also found a linear correlation between T stage and survival. Similarly, those with nodal involvement and distant metastasis also had decreased survival.”

He acknowledged certain limitations of the study, including the potential for inconsistent coding in the SEER database.

Samer T. Elsamna was lead author on the study. None of the researchers reported having financial disclosures.

SOURCE: Elsamna ST et al. Triological CSM 2019, Abstracts.

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Key clinical point: Head and neck adenocarcinoma is mostly indolent with a favorable outcome.

Major finding: Disease-specific survival and overall survival rates were 92.2% and 80.5%, respectively.

Study details: An evaluation of 583 head and neck mucinous adenocarcinoma cases from the Surveillance, Epidemiology, and End Results (SEER) database between 1973 and 2014.

Disclosures: The researchers reported having no financial disclosures.

Source: Elsamna ST et al. Triological CSM 2019, Abstracts.

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Don’t leave vaginal hysterectomies behind, surgeon urges

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Mon, 01/07/2019 - 17:10

LAS VEGAS – While vaginal hysterectomies are becoming less common, a gynecologic surgeon urges colleagues to reconsider the value of the procedure.

Courtesy Cashman Photo
Dr. Roseanne M. Kho

While “younger trainees are seeing fewer vaginal procedures being done and have less confidence to do the procedure,” research suggests that the vaginal approach can offer major benefits, compared with the alternatives, Rosanne M. Kho, MD, of the Cleveland Clinic, said at the Pelvic Anatomy and Gynecologic Surgery Symposium.

Dr. Kho pointed to several studies suggesting a decline in vaginal hysterectomies as laparoscopic and robot procedures become more common. One study compared hysterectomy surgery approaches during 2007-2010 and found a sharp rise in robotic procedures (0.5% to 10%) and a big decrease in abdominal procedures (from 54% to 40%). The rate of laparoscopic procedures grew (from 24% to 30%), while vaginal procedures dipped slightly (22% to 20%) (JAMA. 2013 Feb 20;309[7]:689-98). Another study tracked hysterectomy strategies at Pittsburgh’s Magee-Womens Hospital in almost 14,000 women during 2000-2010. It found that vaginal hysterectomy rates fell from 22% to 17% while laparoscopic rates grew remarkably from 3% to 43%. Open procedures fell dramatically from 75% to 36% (Am J Obstet Gynecol. 2013 Apr. doi: 10.1016/j.ajog.2013.01.022).

These findings are “telling me that surgeons are steering away from the vaginal approach because the laparoscopic and robotic approach are much more appealing,” Dr. Koh said at the meeting, which was jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.

Specifically, it appears that surgeons think the vaginal hysterectomy is more “challenging” and “cumbersome,” Dr. Kho said, and they lack inadequate training.

Why should vaginal hysterectomy still be considered? Dr. Kho pointed to two pieces of evidence:

  • Expert opinion. A 2017 committee opinion from the American College of Obstetricians and Gynecologists examined routes of hysterectomy in benign disease and declared that, despite the decrease in its use, “evidence supports the opinion that [when feasible] vaginal hysterectomy is associated with better outcomes” than are laparoscopic or abdominal hysterectomy. Also, the decision to perform a salpingo-oophorectomy is not necessarily a contraindication to performing a vaginal hysterectomy, according to the committee opinion (Obstet Gynecol. 2017 Jun;129[6]:e155-e9).The opinion also says, “the vaginal approach is preferred among the minimally invasive approaches. Laparoscopic hysterectomy is a preferable alternative to open abdominal hysterectomy for those patients in whom a vaginal hysterectomy is not indicated or feasible. Although minimally invasive approaches to hysterectomy are the preferred route, open abdominal hysterectomy remains an important surgical option for some patients.”
  • Randomized, controlled studies. A 2015 Cochrane Library systematic review examined 47 randomized, controlled trials and found that “vaginal hysterectomy should be performed whenever possible. Where vaginal hysterectomy is not possible, both a laparoscopic approach and abdominal hysterectomy have their pros and cons, and these should be incorporated in the decision-making process” (Cochrane Database Syst Rev. 2015 Aug 12. doi: 10.1002/14651858.CD003677.pub5).

What if a patient has an enlarged uterus? Dr. Kho coauthored a 2017 review that suggested that vaginal hysterectomy may be appropriate in this case. Her report found that in women with large uteri, “vaginal hysterectomy is preferred over laparoscopic and laparoscopic assistance with less operative time and hospital cost. In morbidly obese patients with large uteri, total laparoscopic hysterectomy is superior to vaginal hysterectomy with lesser odds of blood transfusion and lower length of hospital stay” (Clin Obstet Gynecol. 2017 Jun;60[2]:286-95).

What about the removal of fallopian tubes – salpingectomy – during vaginal hysterectomy? Dr. Kho highlighted a 2017 decision analysis that said these procedures are frequently performed for cancer prevention during laparoscopic and open hysterectomies “but [fallopian tubes] are not routinely removed during vaginal hysterectomy because of perceptions of increased morbidity, difficulty, or inadequate surgical training.”

The analysis, however, determined that “salpingectomy should routinely be performed with vaginal hysterectomy because it was the dominant and therefore cost-effective strategy. Complications are minimally increased, but the trade-off with cancer prevention is highly favorable.” (Am J Obstet Gynecol. 2017 Nov;217[5]:603.e1-603.e6).

Dr. Kho reported consulting for AbbVie, Olympus, and Applied Medical.

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LAS VEGAS – While vaginal hysterectomies are becoming less common, a gynecologic surgeon urges colleagues to reconsider the value of the procedure.

Courtesy Cashman Photo
Dr. Roseanne M. Kho

While “younger trainees are seeing fewer vaginal procedures being done and have less confidence to do the procedure,” research suggests that the vaginal approach can offer major benefits, compared with the alternatives, Rosanne M. Kho, MD, of the Cleveland Clinic, said at the Pelvic Anatomy and Gynecologic Surgery Symposium.

Dr. Kho pointed to several studies suggesting a decline in vaginal hysterectomies as laparoscopic and robot procedures become more common. One study compared hysterectomy surgery approaches during 2007-2010 and found a sharp rise in robotic procedures (0.5% to 10%) and a big decrease in abdominal procedures (from 54% to 40%). The rate of laparoscopic procedures grew (from 24% to 30%), while vaginal procedures dipped slightly (22% to 20%) (JAMA. 2013 Feb 20;309[7]:689-98). Another study tracked hysterectomy strategies at Pittsburgh’s Magee-Womens Hospital in almost 14,000 women during 2000-2010. It found that vaginal hysterectomy rates fell from 22% to 17% while laparoscopic rates grew remarkably from 3% to 43%. Open procedures fell dramatically from 75% to 36% (Am J Obstet Gynecol. 2013 Apr. doi: 10.1016/j.ajog.2013.01.022).

These findings are “telling me that surgeons are steering away from the vaginal approach because the laparoscopic and robotic approach are much more appealing,” Dr. Koh said at the meeting, which was jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.

Specifically, it appears that surgeons think the vaginal hysterectomy is more “challenging” and “cumbersome,” Dr. Kho said, and they lack inadequate training.

Why should vaginal hysterectomy still be considered? Dr. Kho pointed to two pieces of evidence:

  • Expert opinion. A 2017 committee opinion from the American College of Obstetricians and Gynecologists examined routes of hysterectomy in benign disease and declared that, despite the decrease in its use, “evidence supports the opinion that [when feasible] vaginal hysterectomy is associated with better outcomes” than are laparoscopic or abdominal hysterectomy. Also, the decision to perform a salpingo-oophorectomy is not necessarily a contraindication to performing a vaginal hysterectomy, according to the committee opinion (Obstet Gynecol. 2017 Jun;129[6]:e155-e9).The opinion also says, “the vaginal approach is preferred among the minimally invasive approaches. Laparoscopic hysterectomy is a preferable alternative to open abdominal hysterectomy for those patients in whom a vaginal hysterectomy is not indicated or feasible. Although minimally invasive approaches to hysterectomy are the preferred route, open abdominal hysterectomy remains an important surgical option for some patients.”
  • Randomized, controlled studies. A 2015 Cochrane Library systematic review examined 47 randomized, controlled trials and found that “vaginal hysterectomy should be performed whenever possible. Where vaginal hysterectomy is not possible, both a laparoscopic approach and abdominal hysterectomy have their pros and cons, and these should be incorporated in the decision-making process” (Cochrane Database Syst Rev. 2015 Aug 12. doi: 10.1002/14651858.CD003677.pub5).

What if a patient has an enlarged uterus? Dr. Kho coauthored a 2017 review that suggested that vaginal hysterectomy may be appropriate in this case. Her report found that in women with large uteri, “vaginal hysterectomy is preferred over laparoscopic and laparoscopic assistance with less operative time and hospital cost. In morbidly obese patients with large uteri, total laparoscopic hysterectomy is superior to vaginal hysterectomy with lesser odds of blood transfusion and lower length of hospital stay” (Clin Obstet Gynecol. 2017 Jun;60[2]:286-95).

What about the removal of fallopian tubes – salpingectomy – during vaginal hysterectomy? Dr. Kho highlighted a 2017 decision analysis that said these procedures are frequently performed for cancer prevention during laparoscopic and open hysterectomies “but [fallopian tubes] are not routinely removed during vaginal hysterectomy because of perceptions of increased morbidity, difficulty, or inadequate surgical training.”

The analysis, however, determined that “salpingectomy should routinely be performed with vaginal hysterectomy because it was the dominant and therefore cost-effective strategy. Complications are minimally increased, but the trade-off with cancer prevention is highly favorable.” (Am J Obstet Gynecol. 2017 Nov;217[5]:603.e1-603.e6).

Dr. Kho reported consulting for AbbVie, Olympus, and Applied Medical.

LAS VEGAS – While vaginal hysterectomies are becoming less common, a gynecologic surgeon urges colleagues to reconsider the value of the procedure.

Courtesy Cashman Photo
Dr. Roseanne M. Kho

While “younger trainees are seeing fewer vaginal procedures being done and have less confidence to do the procedure,” research suggests that the vaginal approach can offer major benefits, compared with the alternatives, Rosanne M. Kho, MD, of the Cleveland Clinic, said at the Pelvic Anatomy and Gynecologic Surgery Symposium.

Dr. Kho pointed to several studies suggesting a decline in vaginal hysterectomies as laparoscopic and robot procedures become more common. One study compared hysterectomy surgery approaches during 2007-2010 and found a sharp rise in robotic procedures (0.5% to 10%) and a big decrease in abdominal procedures (from 54% to 40%). The rate of laparoscopic procedures grew (from 24% to 30%), while vaginal procedures dipped slightly (22% to 20%) (JAMA. 2013 Feb 20;309[7]:689-98). Another study tracked hysterectomy strategies at Pittsburgh’s Magee-Womens Hospital in almost 14,000 women during 2000-2010. It found that vaginal hysterectomy rates fell from 22% to 17% while laparoscopic rates grew remarkably from 3% to 43%. Open procedures fell dramatically from 75% to 36% (Am J Obstet Gynecol. 2013 Apr. doi: 10.1016/j.ajog.2013.01.022).

These findings are “telling me that surgeons are steering away from the vaginal approach because the laparoscopic and robotic approach are much more appealing,” Dr. Koh said at the meeting, which was jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.

Specifically, it appears that surgeons think the vaginal hysterectomy is more “challenging” and “cumbersome,” Dr. Kho said, and they lack inadequate training.

Why should vaginal hysterectomy still be considered? Dr. Kho pointed to two pieces of evidence:

  • Expert opinion. A 2017 committee opinion from the American College of Obstetricians and Gynecologists examined routes of hysterectomy in benign disease and declared that, despite the decrease in its use, “evidence supports the opinion that [when feasible] vaginal hysterectomy is associated with better outcomes” than are laparoscopic or abdominal hysterectomy. Also, the decision to perform a salpingo-oophorectomy is not necessarily a contraindication to performing a vaginal hysterectomy, according to the committee opinion (Obstet Gynecol. 2017 Jun;129[6]:e155-e9).The opinion also says, “the vaginal approach is preferred among the minimally invasive approaches. Laparoscopic hysterectomy is a preferable alternative to open abdominal hysterectomy for those patients in whom a vaginal hysterectomy is not indicated or feasible. Although minimally invasive approaches to hysterectomy are the preferred route, open abdominal hysterectomy remains an important surgical option for some patients.”
  • Randomized, controlled studies. A 2015 Cochrane Library systematic review examined 47 randomized, controlled trials and found that “vaginal hysterectomy should be performed whenever possible. Where vaginal hysterectomy is not possible, both a laparoscopic approach and abdominal hysterectomy have their pros and cons, and these should be incorporated in the decision-making process” (Cochrane Database Syst Rev. 2015 Aug 12. doi: 10.1002/14651858.CD003677.pub5).

What if a patient has an enlarged uterus? Dr. Kho coauthored a 2017 review that suggested that vaginal hysterectomy may be appropriate in this case. Her report found that in women with large uteri, “vaginal hysterectomy is preferred over laparoscopic and laparoscopic assistance with less operative time and hospital cost. In morbidly obese patients with large uteri, total laparoscopic hysterectomy is superior to vaginal hysterectomy with lesser odds of blood transfusion and lower length of hospital stay” (Clin Obstet Gynecol. 2017 Jun;60[2]:286-95).

What about the removal of fallopian tubes – salpingectomy – during vaginal hysterectomy? Dr. Kho highlighted a 2017 decision analysis that said these procedures are frequently performed for cancer prevention during laparoscopic and open hysterectomies “but [fallopian tubes] are not routinely removed during vaginal hysterectomy because of perceptions of increased morbidity, difficulty, or inadequate surgical training.”

The analysis, however, determined that “salpingectomy should routinely be performed with vaginal hysterectomy because it was the dominant and therefore cost-effective strategy. Complications are minimally increased, but the trade-off with cancer prevention is highly favorable.” (Am J Obstet Gynecol. 2017 Nov;217[5]:603.e1-603.e6).

Dr. Kho reported consulting for AbbVie, Olympus, and Applied Medical.

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Moderate approach best for NET liver mets

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– Even partial reduction of liver metastases from malignant small bowel neuroendocrine tumors will help symptoms and improve survival, according to James Howe, MD, director of surgical oncology and endocrine surgery at the University of Iowa, Iowa City.

M. Alexander Otto/MDedge News
Dr. James Howe

“Hepatic cytoreduction is not just to cut down on hormone production” to relieve carcinoid syndrome symptoms, but also “there seems to be a survival benefit,” he said at the annual clinical congress of the American College of Surgeons.

There was a time when it was thought that at least 90% of liver metastases needed to be removed for patients benefit, but it’s become clear that even clearing 70% will help.

It’s important, however, to use parenchymal sparing techniques such as wedge excision, enucleation, and ablation. “We don’t do a lot of right and left hepatectomies anymore,” because patients often live a long time with the disease, many past 10 years, so the goal is management without undo side effects from aggressive treatment. “The key thing with all patients is to avoid morbidity. These patients are going to live a long time if you do not do very much,” Dr. Howe said.

The general surgical approach is to remove the primary neuroendocrine tumor (NET) plus regional lymph nodes; debulk peritoneal disease; cytoreduce liver metastases, and remove the gallbladder, because many patients go on to somatostatin analogs; in 2 years or so, they’ll develop gallstones.

CT is overall the most useful imaging tool for workup. The terminal ileum is the most common location of small bowel NETs, but often “the primary will not be seen,” so “the main thing I look for is mesenteric lymphadenopathy. Liver metastases are even more suspicious.” PET imaging with gallium-labeled somatostatin analogues is also “very good for determining if a lesion is indeed a NET and to determine sites of distant metastases,” Dr. Howe said.

Suspicious findings are followed by surgical exploration, which he usually does by midline incision, the size of which depends on if hepatic cytoreduction is planned. “It’s critically important to palpate the entire small bowel, or you are going to miss lesions. You can feel them quite easily even if they are just 1 or 2 mm,” he said.

Laparoscopy is an option for quicker recovery and other benefits, but the downside is “you are going to miss multifocal disease if you are using metal graspers to feel the small bowel,” and challenging node resection is impossible. One compromise is to do a small incision of a few inches; “you can actually palpate the small bowel through a small incision, and resect a section of bowel through it,” he said.

He saves systemic therapy for patients who progress despite surgery and somatostatin analogues. Everolimus is an option, but the most promising option is lutetium Lu 177 dotatate (Lutathera), approved by the Food and Drug Administration in early 2018 for pancreatic and gastrointestinal NETs.

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– Even partial reduction of liver metastases from malignant small bowel neuroendocrine tumors will help symptoms and improve survival, according to James Howe, MD, director of surgical oncology and endocrine surgery at the University of Iowa, Iowa City.

M. Alexander Otto/MDedge News
Dr. James Howe

“Hepatic cytoreduction is not just to cut down on hormone production” to relieve carcinoid syndrome symptoms, but also “there seems to be a survival benefit,” he said at the annual clinical congress of the American College of Surgeons.

There was a time when it was thought that at least 90% of liver metastases needed to be removed for patients benefit, but it’s become clear that even clearing 70% will help.

It’s important, however, to use parenchymal sparing techniques such as wedge excision, enucleation, and ablation. “We don’t do a lot of right and left hepatectomies anymore,” because patients often live a long time with the disease, many past 10 years, so the goal is management without undo side effects from aggressive treatment. “The key thing with all patients is to avoid morbidity. These patients are going to live a long time if you do not do very much,” Dr. Howe said.

The general surgical approach is to remove the primary neuroendocrine tumor (NET) plus regional lymph nodes; debulk peritoneal disease; cytoreduce liver metastases, and remove the gallbladder, because many patients go on to somatostatin analogs; in 2 years or so, they’ll develop gallstones.

CT is overall the most useful imaging tool for workup. The terminal ileum is the most common location of small bowel NETs, but often “the primary will not be seen,” so “the main thing I look for is mesenteric lymphadenopathy. Liver metastases are even more suspicious.” PET imaging with gallium-labeled somatostatin analogues is also “very good for determining if a lesion is indeed a NET and to determine sites of distant metastases,” Dr. Howe said.

Suspicious findings are followed by surgical exploration, which he usually does by midline incision, the size of which depends on if hepatic cytoreduction is planned. “It’s critically important to palpate the entire small bowel, or you are going to miss lesions. You can feel them quite easily even if they are just 1 or 2 mm,” he said.

Laparoscopy is an option for quicker recovery and other benefits, but the downside is “you are going to miss multifocal disease if you are using metal graspers to feel the small bowel,” and challenging node resection is impossible. One compromise is to do a small incision of a few inches; “you can actually palpate the small bowel through a small incision, and resect a section of bowel through it,” he said.

He saves systemic therapy for patients who progress despite surgery and somatostatin analogues. Everolimus is an option, but the most promising option is lutetium Lu 177 dotatate (Lutathera), approved by the Food and Drug Administration in early 2018 for pancreatic and gastrointestinal NETs.

– Even partial reduction of liver metastases from malignant small bowel neuroendocrine tumors will help symptoms and improve survival, according to James Howe, MD, director of surgical oncology and endocrine surgery at the University of Iowa, Iowa City.

M. Alexander Otto/MDedge News
Dr. James Howe

“Hepatic cytoreduction is not just to cut down on hormone production” to relieve carcinoid syndrome symptoms, but also “there seems to be a survival benefit,” he said at the annual clinical congress of the American College of Surgeons.

There was a time when it was thought that at least 90% of liver metastases needed to be removed for patients benefit, but it’s become clear that even clearing 70% will help.

It’s important, however, to use parenchymal sparing techniques such as wedge excision, enucleation, and ablation. “We don’t do a lot of right and left hepatectomies anymore,” because patients often live a long time with the disease, many past 10 years, so the goal is management without undo side effects from aggressive treatment. “The key thing with all patients is to avoid morbidity. These patients are going to live a long time if you do not do very much,” Dr. Howe said.

The general surgical approach is to remove the primary neuroendocrine tumor (NET) plus regional lymph nodes; debulk peritoneal disease; cytoreduce liver metastases, and remove the gallbladder, because many patients go on to somatostatin analogs; in 2 years or so, they’ll develop gallstones.

CT is overall the most useful imaging tool for workup. The terminal ileum is the most common location of small bowel NETs, but often “the primary will not be seen,” so “the main thing I look for is mesenteric lymphadenopathy. Liver metastases are even more suspicious.” PET imaging with gallium-labeled somatostatin analogues is also “very good for determining if a lesion is indeed a NET and to determine sites of distant metastases,” Dr. Howe said.

Suspicious findings are followed by surgical exploration, which he usually does by midline incision, the size of which depends on if hepatic cytoreduction is planned. “It’s critically important to palpate the entire small bowel, or you are going to miss lesions. You can feel them quite easily even if they are just 1 or 2 mm,” he said.

Laparoscopy is an option for quicker recovery and other benefits, but the downside is “you are going to miss multifocal disease if you are using metal graspers to feel the small bowel,” and challenging node resection is impossible. One compromise is to do a small incision of a few inches; “you can actually palpate the small bowel through a small incision, and resect a section of bowel through it,” he said.

He saves systemic therapy for patients who progress despite surgery and somatostatin analogues. Everolimus is an option, but the most promising option is lutetium Lu 177 dotatate (Lutathera), approved by the Food and Drug Administration in early 2018 for pancreatic and gastrointestinal NETs.

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QOL is poorer for young women after mastectomy than BCS

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Young women with early breast cancer who undergo mastectomy instead of breast-conserving surgery have poorer quality of life in the longer term, according to investigators for a multicenter cross-sectional cohort study reported at the San Antonio Breast Cancer Symposium.

Dr. Laura S. Dominici

Women aged 40 or younger make up about 7% of all newly diagnosed cases of breast cancer in the United States, according to lead author, Laura S. Dominici, MD, of Dana-Farber/Brigham and Women’s Cancer Center and Harvard Medical School, Boston.

“Despite the fact that there is equivalent local-regional control with breast conservation and mastectomy, the rates of mastectomy and particularly bilateral mastectomy are increasing in young women, with a 10-fold increase seen from 1998 to 2011,” she noted in a press conference. “Young women are at particular risk for poorer psychosocial outcomes following a breast cancer diagnosis and in survivorship. However, little is known about the impact of surgery, particularly in the era of increasing bilateral mastectomy, on the quality of life of young survivors.”

Nearly three-fourths of the 560 young breast cancer survivors studied had undergone mastectomy, usually with some kind of reconstruction. Roughly 6 years later, compared with peers who had undergone breast-conserving surgery, women who had undergone unilateral or bilateral mastectomy had significantly poorer adjusted BREAST-Q scores for satisfaction with the appearance and feel of their breasts (beta, –8.7 and –9.3 points) and psychosocial well-being (–8.3 and –10.5 points). The latter also had poorer adjusted scores for sexual well-being (–8.1 points). Physical well-being, which captures aspects such as pain and range of motion, did not differ significantly by type of surgery.

“Local therapy decisions are associated with a persistent impact on quality of life in young breast cancer survivors,” Dr. Dominici concluded. “Knowledge of the potential long-term impact of surgery and quality of life is of critical importance for counseling young women about surgical decisions.”
 

Moving away from mastectomy

“The data are, to me anyway, more disconcerting when you consider the high mastectomy rate in this country relative to Europe, and this urge to have bilateral mastectomies, which, pardon the expression, is ridiculous in some cases because it doesn’t improve your outcome. And yet, it does have deleterious effects that last for years psychologically,” commented SABCS codirector and press conference moderator C. Kent Osborne, MD, who is director of the Dan L. Duncan Cancer Center at Baylor College of Medicine, Houston. “What can we do about that?” he asked.

“It’s a really challenging problem,” Dr. Dominici replied. “Part of what we are missing in the conversation that we have with our patients is this kind of information. We can certainly tell patients that the outcomes are equivalent, but if they don’t know that the long-term [quality of life] impact is potentially worse, then that may not affect their decision. The more prospective data that we generate to help us figure out which patients are going to have better or worse outcomes with these different types of surgery, the better we will be able to counsel patients with things that will be meaningful to them in the long run.”

The study was not designed to tease out the specific role of anxiety about a recurrence or a new breast cancer, which is a major driver of the decision to have mastectomy and also needs to be addressed during counseling, Dr. Dominici and Dr. Osborne agreed. “I think I spend more time talking patients out of bilateral mastectomy or mastectomy at all than anything,” he commented.
 

 

 

Study details

The women studied were participants in the prospective Young Women’s Breast Cancer Study (YWS) and had a mean age of 37 years at diagnosis. Most (86%) had stage 0-2 breast cancer. (Those with metastatic disease at diagnosis or a recurrence during follow-up were excluded.)

Overall, 52% of the women underwent bilateral mastectomy, 20% underwent unilateral mastectomy, and 28% underwent breast-conserving surgery, Dr. Dominici reported. Within the mastectomy group, most underwent implant-based reconstruction (69%) or flap reconstruction (12%), while some opted for no reconstruction (11%).

Multivariate analyses showed that, in addition to mastectomy, other significant predictors of poorer breast satisfaction were receipt of radiation therapy (beta, –7.5 points) and having a financially uncomfortable status as compared with a comfortable one (–5.4 points).

Additional significant predictors of poorer psychosocial well-being were receiving radiation (beta, –6.0 points), being financially uncomfortable (–7 points), and being overweight or obese (–4.2 points), and additional significant predictors of poorer sexual well-being were being financially uncomfortable (–6.8 points), being overweight or obese (–5.3 points), and having lymphedema a year after diagnosis (–3.8 points).

The only significant predictors of poorer physical health were financially uncomfortable status (beta, –4.8 points) and lymphedema (–6.4 points), whereas longer time since surgery (more than 5 years) predicted better physical health (+6.0 points), according to Dr. Dominici.

Age, race, marital status, work status, education level, disease stage, chemotherapy, and endocrine therapy did not significantly predict any of the outcomes studied.

“This was a one-time survey of women who were enrolled in an observational cohort study, and we know that preoperative quality of life likely drives surgical choices,” she commented, addressing the study’s limitations. “Our findings may have limited generalizability to a more diverse population in that the majority of our participants were white and of high socioeconomic status.”

Dr. Dominici disclosed that she had no conflicts of interest. The study was funded by the Agency for Healthcare Research and Quality, Susan G. Komen, the Breast Cancer Research Foundation, and The Pink Agenda.

SOURCE: Dominici LS et al. SABCS 2018, Abstract GS6-06,

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Young women with early breast cancer who undergo mastectomy instead of breast-conserving surgery have poorer quality of life in the longer term, according to investigators for a multicenter cross-sectional cohort study reported at the San Antonio Breast Cancer Symposium.

Dr. Laura S. Dominici

Women aged 40 or younger make up about 7% of all newly diagnosed cases of breast cancer in the United States, according to lead author, Laura S. Dominici, MD, of Dana-Farber/Brigham and Women’s Cancer Center and Harvard Medical School, Boston.

“Despite the fact that there is equivalent local-regional control with breast conservation and mastectomy, the rates of mastectomy and particularly bilateral mastectomy are increasing in young women, with a 10-fold increase seen from 1998 to 2011,” she noted in a press conference. “Young women are at particular risk for poorer psychosocial outcomes following a breast cancer diagnosis and in survivorship. However, little is known about the impact of surgery, particularly in the era of increasing bilateral mastectomy, on the quality of life of young survivors.”

Nearly three-fourths of the 560 young breast cancer survivors studied had undergone mastectomy, usually with some kind of reconstruction. Roughly 6 years later, compared with peers who had undergone breast-conserving surgery, women who had undergone unilateral or bilateral mastectomy had significantly poorer adjusted BREAST-Q scores for satisfaction with the appearance and feel of their breasts (beta, –8.7 and –9.3 points) and psychosocial well-being (–8.3 and –10.5 points). The latter also had poorer adjusted scores for sexual well-being (–8.1 points). Physical well-being, which captures aspects such as pain and range of motion, did not differ significantly by type of surgery.

“Local therapy decisions are associated with a persistent impact on quality of life in young breast cancer survivors,” Dr. Dominici concluded. “Knowledge of the potential long-term impact of surgery and quality of life is of critical importance for counseling young women about surgical decisions.”
 

Moving away from mastectomy

“The data are, to me anyway, more disconcerting when you consider the high mastectomy rate in this country relative to Europe, and this urge to have bilateral mastectomies, which, pardon the expression, is ridiculous in some cases because it doesn’t improve your outcome. And yet, it does have deleterious effects that last for years psychologically,” commented SABCS codirector and press conference moderator C. Kent Osborne, MD, who is director of the Dan L. Duncan Cancer Center at Baylor College of Medicine, Houston. “What can we do about that?” he asked.

“It’s a really challenging problem,” Dr. Dominici replied. “Part of what we are missing in the conversation that we have with our patients is this kind of information. We can certainly tell patients that the outcomes are equivalent, but if they don’t know that the long-term [quality of life] impact is potentially worse, then that may not affect their decision. The more prospective data that we generate to help us figure out which patients are going to have better or worse outcomes with these different types of surgery, the better we will be able to counsel patients with things that will be meaningful to them in the long run.”

The study was not designed to tease out the specific role of anxiety about a recurrence or a new breast cancer, which is a major driver of the decision to have mastectomy and also needs to be addressed during counseling, Dr. Dominici and Dr. Osborne agreed. “I think I spend more time talking patients out of bilateral mastectomy or mastectomy at all than anything,” he commented.
 

 

 

Study details

The women studied were participants in the prospective Young Women’s Breast Cancer Study (YWS) and had a mean age of 37 years at diagnosis. Most (86%) had stage 0-2 breast cancer. (Those with metastatic disease at diagnosis or a recurrence during follow-up were excluded.)

Overall, 52% of the women underwent bilateral mastectomy, 20% underwent unilateral mastectomy, and 28% underwent breast-conserving surgery, Dr. Dominici reported. Within the mastectomy group, most underwent implant-based reconstruction (69%) or flap reconstruction (12%), while some opted for no reconstruction (11%).

Multivariate analyses showed that, in addition to mastectomy, other significant predictors of poorer breast satisfaction were receipt of radiation therapy (beta, –7.5 points) and having a financially uncomfortable status as compared with a comfortable one (–5.4 points).

Additional significant predictors of poorer psychosocial well-being were receiving radiation (beta, –6.0 points), being financially uncomfortable (–7 points), and being overweight or obese (–4.2 points), and additional significant predictors of poorer sexual well-being were being financially uncomfortable (–6.8 points), being overweight or obese (–5.3 points), and having lymphedema a year after diagnosis (–3.8 points).

The only significant predictors of poorer physical health were financially uncomfortable status (beta, –4.8 points) and lymphedema (–6.4 points), whereas longer time since surgery (more than 5 years) predicted better physical health (+6.0 points), according to Dr. Dominici.

Age, race, marital status, work status, education level, disease stage, chemotherapy, and endocrine therapy did not significantly predict any of the outcomes studied.

“This was a one-time survey of women who were enrolled in an observational cohort study, and we know that preoperative quality of life likely drives surgical choices,” she commented, addressing the study’s limitations. “Our findings may have limited generalizability to a more diverse population in that the majority of our participants were white and of high socioeconomic status.”

Dr. Dominici disclosed that she had no conflicts of interest. The study was funded by the Agency for Healthcare Research and Quality, Susan G. Komen, the Breast Cancer Research Foundation, and The Pink Agenda.

SOURCE: Dominici LS et al. SABCS 2018, Abstract GS6-06,

 

Young women with early breast cancer who undergo mastectomy instead of breast-conserving surgery have poorer quality of life in the longer term, according to investigators for a multicenter cross-sectional cohort study reported at the San Antonio Breast Cancer Symposium.

Dr. Laura S. Dominici

Women aged 40 or younger make up about 7% of all newly diagnosed cases of breast cancer in the United States, according to lead author, Laura S. Dominici, MD, of Dana-Farber/Brigham and Women’s Cancer Center and Harvard Medical School, Boston.

“Despite the fact that there is equivalent local-regional control with breast conservation and mastectomy, the rates of mastectomy and particularly bilateral mastectomy are increasing in young women, with a 10-fold increase seen from 1998 to 2011,” she noted in a press conference. “Young women are at particular risk for poorer psychosocial outcomes following a breast cancer diagnosis and in survivorship. However, little is known about the impact of surgery, particularly in the era of increasing bilateral mastectomy, on the quality of life of young survivors.”

Nearly three-fourths of the 560 young breast cancer survivors studied had undergone mastectomy, usually with some kind of reconstruction. Roughly 6 years later, compared with peers who had undergone breast-conserving surgery, women who had undergone unilateral or bilateral mastectomy had significantly poorer adjusted BREAST-Q scores for satisfaction with the appearance and feel of their breasts (beta, –8.7 and –9.3 points) and psychosocial well-being (–8.3 and –10.5 points). The latter also had poorer adjusted scores for sexual well-being (–8.1 points). Physical well-being, which captures aspects such as pain and range of motion, did not differ significantly by type of surgery.

“Local therapy decisions are associated with a persistent impact on quality of life in young breast cancer survivors,” Dr. Dominici concluded. “Knowledge of the potential long-term impact of surgery and quality of life is of critical importance for counseling young women about surgical decisions.”
 

Moving away from mastectomy

“The data are, to me anyway, more disconcerting when you consider the high mastectomy rate in this country relative to Europe, and this urge to have bilateral mastectomies, which, pardon the expression, is ridiculous in some cases because it doesn’t improve your outcome. And yet, it does have deleterious effects that last for years psychologically,” commented SABCS codirector and press conference moderator C. Kent Osborne, MD, who is director of the Dan L. Duncan Cancer Center at Baylor College of Medicine, Houston. “What can we do about that?” he asked.

“It’s a really challenging problem,” Dr. Dominici replied. “Part of what we are missing in the conversation that we have with our patients is this kind of information. We can certainly tell patients that the outcomes are equivalent, but if they don’t know that the long-term [quality of life] impact is potentially worse, then that may not affect their decision. The more prospective data that we generate to help us figure out which patients are going to have better or worse outcomes with these different types of surgery, the better we will be able to counsel patients with things that will be meaningful to them in the long run.”

The study was not designed to tease out the specific role of anxiety about a recurrence or a new breast cancer, which is a major driver of the decision to have mastectomy and also needs to be addressed during counseling, Dr. Dominici and Dr. Osborne agreed. “I think I spend more time talking patients out of bilateral mastectomy or mastectomy at all than anything,” he commented.
 

 

 

Study details

The women studied were participants in the prospective Young Women’s Breast Cancer Study (YWS) and had a mean age of 37 years at diagnosis. Most (86%) had stage 0-2 breast cancer. (Those with metastatic disease at diagnosis or a recurrence during follow-up were excluded.)

Overall, 52% of the women underwent bilateral mastectomy, 20% underwent unilateral mastectomy, and 28% underwent breast-conserving surgery, Dr. Dominici reported. Within the mastectomy group, most underwent implant-based reconstruction (69%) or flap reconstruction (12%), while some opted for no reconstruction (11%).

Multivariate analyses showed that, in addition to mastectomy, other significant predictors of poorer breast satisfaction were receipt of radiation therapy (beta, –7.5 points) and having a financially uncomfortable status as compared with a comfortable one (–5.4 points).

Additional significant predictors of poorer psychosocial well-being were receiving radiation (beta, –6.0 points), being financially uncomfortable (–7 points), and being overweight or obese (–4.2 points), and additional significant predictors of poorer sexual well-being were being financially uncomfortable (–6.8 points), being overweight or obese (–5.3 points), and having lymphedema a year after diagnosis (–3.8 points).

The only significant predictors of poorer physical health were financially uncomfortable status (beta, –4.8 points) and lymphedema (–6.4 points), whereas longer time since surgery (more than 5 years) predicted better physical health (+6.0 points), according to Dr. Dominici.

Age, race, marital status, work status, education level, disease stage, chemotherapy, and endocrine therapy did not significantly predict any of the outcomes studied.

“This was a one-time survey of women who were enrolled in an observational cohort study, and we know that preoperative quality of life likely drives surgical choices,” she commented, addressing the study’s limitations. “Our findings may have limited generalizability to a more diverse population in that the majority of our participants were white and of high socioeconomic status.”

Dr. Dominici disclosed that she had no conflicts of interest. The study was funded by the Agency for Healthcare Research and Quality, Susan G. Komen, the Breast Cancer Research Foundation, and The Pink Agenda.

SOURCE: Dominici LS et al. SABCS 2018, Abstract GS6-06,

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Key clinical point: More extensive breast surgery has a long-term negative impact on QOL for young breast cancer survivors.

Major finding: Compared with peers who underwent breast-conserving surgery, young women who underwent unilateral or bilateral mastectomy had significantly poorer adjusted scores for breast satisfaction (beta, –8.7 and –9.3 points) and psychosocial well-being (beta, –8.3 and –10.5 points).

Study details: A multicenter cross-sectional cohort study of 560 women with a mean age of 37 years at breast cancer diagnosis who completed the BREAST-Q questionnaire a median of 5.8 years later.

Disclosures: Dr. Dominici disclosed that she had no conflicts of interest. The study was funded by the Agency for Healthcare Research and Quality, Susan G. Komen, the Breast Cancer Research Foundation, and The Pink Agenda.

Source: Dominici LS et al. SABCS 2018, Abstract GS6-06.

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Perioperative M&M similar for lobar, sublobar surgeries in early lung cancer

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Though lobectomy is the long-held standard of care for people with early stage non–small cell lung cancer, a noninferiority study shows little difference in perioperative morbidity and mortality outcomes when sublobar resections are performed instead.

The study, published online in The Lancet Respiratory Medicine, compared results from 697 functionally and physically fit patients with stage I cancer randomized over a 10-year period to lobar resection (n = 357) or sublobar resection (n = 340). Patients were analyzed for morbidity and mortality outcomes at 30 and 90 days post surgery. Nasser K. Altorki, MD, of Weill Cornell Medicine–New York Presbyterian Hospital, led the study as a post hoc, exploratory analysis of CALGB/Alliance 140503, a multinational phase 3 trial whose primary outcome – still pending – is disease-free survival associated with the two different surgeries.

Dr. Altorki and his colleagues found 30- and 90-day survival to be comparable between surgery types. At 30 days, six patients in the study had died; four in the lobar resection group and two in the sublobar group (1.1% and 0.6%). At 90 days, 10 patients had died, or 1.4% of the cohort; 6 following lobar resection and 4 following sublobar resection. The between-group difference at 30 days was 0.5% (95% confidence interval, –1.1 to 2.3) and at 90 days remained 0.5% (95% CI, –1.5 to 2.6).

Similar rates of serious (grade 3 or worse) adverse advents were seen between surgery groups at 15% and 14%, respectively, and no differences were seen for cardiac or pulmonary complications. In the study, the type of sublobar approach was left to the surgeon’s discretion, and a majority of the sublobar procedures (59%) were found to comprise wedge resections, with the rest segmentectomies. Dr. Altorki and colleagues noted the high rate of wedge resections as striking, because “conventional wisdom … holds that an anatomical segmentectomy, involving individual ligation of segmental vessels and bronchi and wider parenchymal resection, is oncologically superior to nonanatomical wedge resections.” In their analysis the researchers conceded that a three-arm trial allocating patients to lobectomy, segmentectomy, or wedge resection “would have answered more precisely the posited research question,” but said that the sample size needed would have been too large.

The study was funded by the National Cancer Institute. Dr. Altorki reported a research grant from AstraZeneca unrelated to the study; two more coauthors disclosed funding from pharmaceutical or device manufacturers, and an additional 17 coauthors listed no competing interests.

SOURCE: Altorki NK et al. Lancet Respir Med. 2018 Nov 12. doi: 10.1016/S2213-2600(18)30411-9 .

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Though lobectomy is the long-held standard of care for people with early stage non–small cell lung cancer, a noninferiority study shows little difference in perioperative morbidity and mortality outcomes when sublobar resections are performed instead.

The study, published online in The Lancet Respiratory Medicine, compared results from 697 functionally and physically fit patients with stage I cancer randomized over a 10-year period to lobar resection (n = 357) or sublobar resection (n = 340). Patients were analyzed for morbidity and mortality outcomes at 30 and 90 days post surgery. Nasser K. Altorki, MD, of Weill Cornell Medicine–New York Presbyterian Hospital, led the study as a post hoc, exploratory analysis of CALGB/Alliance 140503, a multinational phase 3 trial whose primary outcome – still pending – is disease-free survival associated with the two different surgeries.

Dr. Altorki and his colleagues found 30- and 90-day survival to be comparable between surgery types. At 30 days, six patients in the study had died; four in the lobar resection group and two in the sublobar group (1.1% and 0.6%). At 90 days, 10 patients had died, or 1.4% of the cohort; 6 following lobar resection and 4 following sublobar resection. The between-group difference at 30 days was 0.5% (95% confidence interval, –1.1 to 2.3) and at 90 days remained 0.5% (95% CI, –1.5 to 2.6).

Similar rates of serious (grade 3 or worse) adverse advents were seen between surgery groups at 15% and 14%, respectively, and no differences were seen for cardiac or pulmonary complications. In the study, the type of sublobar approach was left to the surgeon’s discretion, and a majority of the sublobar procedures (59%) were found to comprise wedge resections, with the rest segmentectomies. Dr. Altorki and colleagues noted the high rate of wedge resections as striking, because “conventional wisdom … holds that an anatomical segmentectomy, involving individual ligation of segmental vessels and bronchi and wider parenchymal resection, is oncologically superior to nonanatomical wedge resections.” In their analysis the researchers conceded that a three-arm trial allocating patients to lobectomy, segmentectomy, or wedge resection “would have answered more precisely the posited research question,” but said that the sample size needed would have been too large.

The study was funded by the National Cancer Institute. Dr. Altorki reported a research grant from AstraZeneca unrelated to the study; two more coauthors disclosed funding from pharmaceutical or device manufacturers, and an additional 17 coauthors listed no competing interests.

SOURCE: Altorki NK et al. Lancet Respir Med. 2018 Nov 12. doi: 10.1016/S2213-2600(18)30411-9 .

 

Though lobectomy is the long-held standard of care for people with early stage non–small cell lung cancer, a noninferiority study shows little difference in perioperative morbidity and mortality outcomes when sublobar resections are performed instead.

The study, published online in The Lancet Respiratory Medicine, compared results from 697 functionally and physically fit patients with stage I cancer randomized over a 10-year period to lobar resection (n = 357) or sublobar resection (n = 340). Patients were analyzed for morbidity and mortality outcomes at 30 and 90 days post surgery. Nasser K. Altorki, MD, of Weill Cornell Medicine–New York Presbyterian Hospital, led the study as a post hoc, exploratory analysis of CALGB/Alliance 140503, a multinational phase 3 trial whose primary outcome – still pending – is disease-free survival associated with the two different surgeries.

Dr. Altorki and his colleagues found 30- and 90-day survival to be comparable between surgery types. At 30 days, six patients in the study had died; four in the lobar resection group and two in the sublobar group (1.1% and 0.6%). At 90 days, 10 patients had died, or 1.4% of the cohort; 6 following lobar resection and 4 following sublobar resection. The between-group difference at 30 days was 0.5% (95% confidence interval, –1.1 to 2.3) and at 90 days remained 0.5% (95% CI, –1.5 to 2.6).

Similar rates of serious (grade 3 or worse) adverse advents were seen between surgery groups at 15% and 14%, respectively, and no differences were seen for cardiac or pulmonary complications. In the study, the type of sublobar approach was left to the surgeon’s discretion, and a majority of the sublobar procedures (59%) were found to comprise wedge resections, with the rest segmentectomies. Dr. Altorki and colleagues noted the high rate of wedge resections as striking, because “conventional wisdom … holds that an anatomical segmentectomy, involving individual ligation of segmental vessels and bronchi and wider parenchymal resection, is oncologically superior to nonanatomical wedge resections.” In their analysis the researchers conceded that a three-arm trial allocating patients to lobectomy, segmentectomy, or wedge resection “would have answered more precisely the posited research question,” but said that the sample size needed would have been too large.

The study was funded by the National Cancer Institute. Dr. Altorki reported a research grant from AstraZeneca unrelated to the study; two more coauthors disclosed funding from pharmaceutical or device manufacturers, and an additional 17 coauthors listed no competing interests.

SOURCE: Altorki NK et al. Lancet Respir Med. 2018 Nov 12. doi: 10.1016/S2213-2600(18)30411-9 .

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FROM THE LANCET RESPIRATORY MEDICINE

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Key clinical point: Patients with early-stage lung cancer randomized to lobar or sublobar surgeries fared similarly 30 and 90 days post surgery.

Major finding: Mortality at 30 days and 90 days was 0.5% for both trial groups and serious adverse advents were similar between groups.

Study details: A post hoc analysis from a multinational trial randomizing about 700 stage I NSCLC patients to lobar or sublobar surgery

Disclosures: National Cancer Institute sponsored the study; three authors including the lead author reported financial ties to manufacturers.

Source: Altorki et al. Lancet Respir Med. 2018 Nov 12. doi: 10.1016/S2213-2600(18)30411-9.

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