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Social support needs among patients with advanced breast cancer: sensitivity trumps substance
Background The importance of social support for cancer patients has been established in previous studies. However, much of the existing research has identified associations between general measures of social support and various health indicators. Nevertheless, some research has begun to suggest the utility of more nuanced understandings of how patients receive and use social support.
Objective To examine the roles of nondirective (ie, support that accepts recipients’ feelings and is cooperative with their plans) and directive support (ie, support that prescribes “correct” choices and feelings) as well as social support needs and desires among patients with advanced breast cancer.
Methods We conducted semi-structured interviews (qualitative method) with 8 patients with stage IV breast cancer to collect qualitative information about the disease-related challenges they faced, the support they received from their families and medical teams, and the appropriateness of directive and nondirective support. In addition, we used the 14-item Hospital Anxiety and Depression Scale (HADS) to assess clinically relevant cut-offs for anxiety and depression and the 16-item Social Support Inventory to assess the provision of nondirective and directive social support to the patients (quantitative method).
Results Qualitative findings suggested that there was considerable variability among patients’ reports of social support provided by family, friends, and the medical team. From the qualitative data, patients reported directive support as more useful in times of acute need and emphasized the importance of supportive systems rather than supportive persons in providing emotional support. From the quantitative data, patients reported nondirective support as more typical of support received from both family and medical teams than directive support. On the HADS, 1 patient had a score of 9 on the anxiety subscale, above the score of 7 that is for mild anxiety. No patients scored above the criterion for mild depression, also a score of 7.
Limitations Very small sample limits the ability to generalize findings.
Conclusions The right type of support for patients with advanced breast cancer is contingent on a range of variables, which suggests that the key characteristic of support may not be any particular feature, but the nuanced adjustment of its content and style of delivery to the patient’s circumstances.
Funding Peers for Progress
Click on the PDF icon at the top of this introduction to read the full article.
Background The importance of social support for cancer patients has been established in previous studies. However, much of the existing research has identified associations between general measures of social support and various health indicators. Nevertheless, some research has begun to suggest the utility of more nuanced understandings of how patients receive and use social support.
Objective To examine the roles of nondirective (ie, support that accepts recipients’ feelings and is cooperative with their plans) and directive support (ie, support that prescribes “correct” choices and feelings) as well as social support needs and desires among patients with advanced breast cancer.
Methods We conducted semi-structured interviews (qualitative method) with 8 patients with stage IV breast cancer to collect qualitative information about the disease-related challenges they faced, the support they received from their families and medical teams, and the appropriateness of directive and nondirective support. In addition, we used the 14-item Hospital Anxiety and Depression Scale (HADS) to assess clinically relevant cut-offs for anxiety and depression and the 16-item Social Support Inventory to assess the provision of nondirective and directive social support to the patients (quantitative method).
Results Qualitative findings suggested that there was considerable variability among patients’ reports of social support provided by family, friends, and the medical team. From the qualitative data, patients reported directive support as more useful in times of acute need and emphasized the importance of supportive systems rather than supportive persons in providing emotional support. From the quantitative data, patients reported nondirective support as more typical of support received from both family and medical teams than directive support. On the HADS, 1 patient had a score of 9 on the anxiety subscale, above the score of 7 that is for mild anxiety. No patients scored above the criterion for mild depression, also a score of 7.
Limitations Very small sample limits the ability to generalize findings.
Conclusions The right type of support for patients with advanced breast cancer is contingent on a range of variables, which suggests that the key characteristic of support may not be any particular feature, but the nuanced adjustment of its content and style of delivery to the patient’s circumstances.
Funding Peers for Progress
Click on the PDF icon at the top of this introduction to read the full article.
Background The importance of social support for cancer patients has been established in previous studies. However, much of the existing research has identified associations between general measures of social support and various health indicators. Nevertheless, some research has begun to suggest the utility of more nuanced understandings of how patients receive and use social support.
Objective To examine the roles of nondirective (ie, support that accepts recipients’ feelings and is cooperative with their plans) and directive support (ie, support that prescribes “correct” choices and feelings) as well as social support needs and desires among patients with advanced breast cancer.
Methods We conducted semi-structured interviews (qualitative method) with 8 patients with stage IV breast cancer to collect qualitative information about the disease-related challenges they faced, the support they received from their families and medical teams, and the appropriateness of directive and nondirective support. In addition, we used the 14-item Hospital Anxiety and Depression Scale (HADS) to assess clinically relevant cut-offs for anxiety and depression and the 16-item Social Support Inventory to assess the provision of nondirective and directive social support to the patients (quantitative method).
Results Qualitative findings suggested that there was considerable variability among patients’ reports of social support provided by family, friends, and the medical team. From the qualitative data, patients reported directive support as more useful in times of acute need and emphasized the importance of supportive systems rather than supportive persons in providing emotional support. From the quantitative data, patients reported nondirective support as more typical of support received from both family and medical teams than directive support. On the HADS, 1 patient had a score of 9 on the anxiety subscale, above the score of 7 that is for mild anxiety. No patients scored above the criterion for mild depression, also a score of 7.
Limitations Very small sample limits the ability to generalize findings.
Conclusions The right type of support for patients with advanced breast cancer is contingent on a range of variables, which suggests that the key characteristic of support may not be any particular feature, but the nuanced adjustment of its content and style of delivery to the patient’s circumstances.
Funding Peers for Progress
Click on the PDF icon at the top of this introduction to read the full article.
Patients’ retrospective assessment of palliative chemotherapy for lung or gastrointestinal cancers
Background Decision-making about palliative chemotherapy is complex because treatment goals include increased survival, symptom control, and functional improvement.
Objective To examine whether retrospective assessment by chemotherapy-experienced patients could inform decision-making support for future patients.
Methods 51 patients with thoracic or gastrointestinal malignancy, with no further systemic treatment options, completed the Functional Assessment of Chronic Illness Therapy–Treatment Satisfaction (FACIT-TS) survey and answered free-text questions about their past decisions about therapy.
Results FACIT-TS subscale of treatment effectiveness showed 36% of 49 eligible patients rating effectiveness as being worse than expected, 25% as expected, 37% better. 51% found side effects worse than expected, 19% as expected, and 28% better than expected. Textual analysis of survey responses indicated the majority of patients stood by their decision to take chemotherapy but wished they’d had more information about what to expect. Overall, 55% found chemotherapy to have been worthwhile, 37% not, 8% were undecided.
Limitations Accrual was slower than expected, in part because of a lack of awareness by patients that there were no further chemotherapy options available to them. Selection bias may have favored enrolment from teams open to soliciting patient feedback.
Conclusions Although the majority of patients stood by their decisions about palliative chemotherapy based on their understanding of the therapy at the time of making their decisions, there is a discrepancy between initial expectations about chemotherapy and retrospective assessment of chemotherapy effectiveness and side effects. The introduction of end-of-treatment feedback surveys as a routine quality assurance procedure should be considered.
Click on the PDF icon at the top of this introduction to read the full article.
Background Decision-making about palliative chemotherapy is complex because treatment goals include increased survival, symptom control, and functional improvement.
Objective To examine whether retrospective assessment by chemotherapy-experienced patients could inform decision-making support for future patients.
Methods 51 patients with thoracic or gastrointestinal malignancy, with no further systemic treatment options, completed the Functional Assessment of Chronic Illness Therapy–Treatment Satisfaction (FACIT-TS) survey and answered free-text questions about their past decisions about therapy.
Results FACIT-TS subscale of treatment effectiveness showed 36% of 49 eligible patients rating effectiveness as being worse than expected, 25% as expected, 37% better. 51% found side effects worse than expected, 19% as expected, and 28% better than expected. Textual analysis of survey responses indicated the majority of patients stood by their decision to take chemotherapy but wished they’d had more information about what to expect. Overall, 55% found chemotherapy to have been worthwhile, 37% not, 8% were undecided.
Limitations Accrual was slower than expected, in part because of a lack of awareness by patients that there were no further chemotherapy options available to them. Selection bias may have favored enrolment from teams open to soliciting patient feedback.
Conclusions Although the majority of patients stood by their decisions about palliative chemotherapy based on their understanding of the therapy at the time of making their decisions, there is a discrepancy between initial expectations about chemotherapy and retrospective assessment of chemotherapy effectiveness and side effects. The introduction of end-of-treatment feedback surveys as a routine quality assurance procedure should be considered.
Click on the PDF icon at the top of this introduction to read the full article.
Background Decision-making about palliative chemotherapy is complex because treatment goals include increased survival, symptom control, and functional improvement.
Objective To examine whether retrospective assessment by chemotherapy-experienced patients could inform decision-making support for future patients.
Methods 51 patients with thoracic or gastrointestinal malignancy, with no further systemic treatment options, completed the Functional Assessment of Chronic Illness Therapy–Treatment Satisfaction (FACIT-TS) survey and answered free-text questions about their past decisions about therapy.
Results FACIT-TS subscale of treatment effectiveness showed 36% of 49 eligible patients rating effectiveness as being worse than expected, 25% as expected, 37% better. 51% found side effects worse than expected, 19% as expected, and 28% better than expected. Textual analysis of survey responses indicated the majority of patients stood by their decision to take chemotherapy but wished they’d had more information about what to expect. Overall, 55% found chemotherapy to have been worthwhile, 37% not, 8% were undecided.
Limitations Accrual was slower than expected, in part because of a lack of awareness by patients that there were no further chemotherapy options available to them. Selection bias may have favored enrolment from teams open to soliciting patient feedback.
Conclusions Although the majority of patients stood by their decisions about palliative chemotherapy based on their understanding of the therapy at the time of making their decisions, there is a discrepancy between initial expectations about chemotherapy and retrospective assessment of chemotherapy effectiveness and side effects. The introduction of end-of-treatment feedback surveys as a routine quality assurance procedure should be considered.
Click on the PDF icon at the top of this introduction to read the full article.
Options narrow for acute decompensated heart failure
Acute decompensated heart failure is a condition that clinicians want to prevent rather than treat.
The idea that patients hospitalized with acute decompensated heart failure can have a substantial change in their prognosis from an acute intervention given in the hospital seemed to finally hit a brick wall in November at the American Heart Association scientific sessions.
Treatment of acute heart failure patients with the vasodilating natriuretic peptide ularitide failed to cut long-term cardiovascular mortality or improve several other acute and mid-term outcomes in the TRUE-AHF trial. In a second report, ATHENA-HF, acute treatment with high-dose spironolactone during acute heart failure hospitalizations failed to improve a marker of heart failure severity, N-terminal pro B-type natriuretic peptide.
What alternative interventions are left? Dr. Yancy, as well as Milton Packer, MD, the cardiologist who led TRUE-HF, had somewhat similar answers.
In his discussion of TRUE-AHF, Dr. Yancy cited two possibilities: greater use of the relatively new drug formulation sacubitril plus valsartan (Entresto), which showed strong benefit treating patients with chronic heart failure with reduced ejection fraction (HFrEF); and expanded use of pulmonary-artery pressure (PAP) monitoring using an implanted device that gives clinicians early warning when a heart failure patient’s fluid volume moves into the danger zone that precedes by days or weeks the acute decompensation that produces dyspnea and drives a patient to the hospital.
Increasing experience with PAP monitoring “continues to endorse the notion that having early warning [of fluid overload] is important,” Dr. Yancy said in an interview. “The point of acuity in acute decompensated heart failure predates hospital admission, and this monitoring system allows us to catch this before it causes an emergency department visit. The data are very persuasive.”
“PAP usually rises 2-4 weeks before a heart failure hospitalization. Perhaps we need to focus more on long-term treatment rather than treatment in the hospital.” That’s especially true for patients with heart failure with preserved ejection fraction (HFpEF) because right now no treatment is clearly proven to improve HFpEF outcomes (although several experts make a persuasive case for spironolactone).
“Tight regulation of volume status is our best chance to improve outcomes in HFpEF,” said Dr. Stevenson, who helped pioneer the idea of PAP monitoring for heart failure patients. “Maintaining good volume is very important for HFpEF patients.”
But success with PAP monitoring requires more than gathering the pressure data. Producing benefit for patients “is predicated on having an infrastructure to accommodate the influx of PAP data, being nimble enough to respond to the data and being very precise about which patients you use this in,” cautioned Dr. Yancy. “The tool is not beneficial if the infrastructure is not there,”
The idea is still so new (the first implanted PAP monitor received U.S. approval in 2014) that at his institution, Northwestern Medicine in Chicago, about a dozen patients now have a monitor, he said.
“We’re looking to use it in patients with HFpEF, whom we can’t offer anything else. I’m intrigued by what I see,” in this first wave of Northwestern patients. Dr. Yancy’s anecdotal experience with PAP monitoring so far “helps endorse what the trial results suggested” about providing incremental benefit to heart failure patients.
“The solution is to prevent hospitalization in the first place with the medications we already have, but they’re not used. The medications we already have are enough, but they need to be used,” Dr. Packer told me in an interview during the meeting. He speculated that perhaps 10%-15% of HFrEF patients currently receive the full guideline-directed regimen of heart failure drugs. “That’s unbelievable,” he exclaimed. If clinicians diligently treated advanced HFrEF patients with these four agents, “you’d see a 60%, 70% drop in hospitalizations,” he suggested.
Dr. Packer put some of the blame for underuse of guideline-directed medications on the low financial incentive physicians have to vigorously apply this strategy.
He backed PAP monitoring as a good additional step for selected patients with unstable heart failure. “But as a general approach to managing patients with class III HFrEF, first put them on optimal medical therapy; then we can talk about an invasive procedure to place a PAP monitoring device.”
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
Acute decompensated heart failure is a condition that clinicians want to prevent rather than treat.
The idea that patients hospitalized with acute decompensated heart failure can have a substantial change in their prognosis from an acute intervention given in the hospital seemed to finally hit a brick wall in November at the American Heart Association scientific sessions.
Treatment of acute heart failure patients with the vasodilating natriuretic peptide ularitide failed to cut long-term cardiovascular mortality or improve several other acute and mid-term outcomes in the TRUE-AHF trial. In a second report, ATHENA-HF, acute treatment with high-dose spironolactone during acute heart failure hospitalizations failed to improve a marker of heart failure severity, N-terminal pro B-type natriuretic peptide.
What alternative interventions are left? Dr. Yancy, as well as Milton Packer, MD, the cardiologist who led TRUE-HF, had somewhat similar answers.
In his discussion of TRUE-AHF, Dr. Yancy cited two possibilities: greater use of the relatively new drug formulation sacubitril plus valsartan (Entresto), which showed strong benefit treating patients with chronic heart failure with reduced ejection fraction (HFrEF); and expanded use of pulmonary-artery pressure (PAP) monitoring using an implanted device that gives clinicians early warning when a heart failure patient’s fluid volume moves into the danger zone that precedes by days or weeks the acute decompensation that produces dyspnea and drives a patient to the hospital.
Increasing experience with PAP monitoring “continues to endorse the notion that having early warning [of fluid overload] is important,” Dr. Yancy said in an interview. “The point of acuity in acute decompensated heart failure predates hospital admission, and this monitoring system allows us to catch this before it causes an emergency department visit. The data are very persuasive.”
“PAP usually rises 2-4 weeks before a heart failure hospitalization. Perhaps we need to focus more on long-term treatment rather than treatment in the hospital.” That’s especially true for patients with heart failure with preserved ejection fraction (HFpEF) because right now no treatment is clearly proven to improve HFpEF outcomes (although several experts make a persuasive case for spironolactone).
“Tight regulation of volume status is our best chance to improve outcomes in HFpEF,” said Dr. Stevenson, who helped pioneer the idea of PAP monitoring for heart failure patients. “Maintaining good volume is very important for HFpEF patients.”
But success with PAP monitoring requires more than gathering the pressure data. Producing benefit for patients “is predicated on having an infrastructure to accommodate the influx of PAP data, being nimble enough to respond to the data and being very precise about which patients you use this in,” cautioned Dr. Yancy. “The tool is not beneficial if the infrastructure is not there,”
The idea is still so new (the first implanted PAP monitor received U.S. approval in 2014) that at his institution, Northwestern Medicine in Chicago, about a dozen patients now have a monitor, he said.
“We’re looking to use it in patients with HFpEF, whom we can’t offer anything else. I’m intrigued by what I see,” in this first wave of Northwestern patients. Dr. Yancy’s anecdotal experience with PAP monitoring so far “helps endorse what the trial results suggested” about providing incremental benefit to heart failure patients.
“The solution is to prevent hospitalization in the first place with the medications we already have, but they’re not used. The medications we already have are enough, but they need to be used,” Dr. Packer told me in an interview during the meeting. He speculated that perhaps 10%-15% of HFrEF patients currently receive the full guideline-directed regimen of heart failure drugs. “That’s unbelievable,” he exclaimed. If clinicians diligently treated advanced HFrEF patients with these four agents, “you’d see a 60%, 70% drop in hospitalizations,” he suggested.
Dr. Packer put some of the blame for underuse of guideline-directed medications on the low financial incentive physicians have to vigorously apply this strategy.
He backed PAP monitoring as a good additional step for selected patients with unstable heart failure. “But as a general approach to managing patients with class III HFrEF, first put them on optimal medical therapy; then we can talk about an invasive procedure to place a PAP monitoring device.”
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
Acute decompensated heart failure is a condition that clinicians want to prevent rather than treat.
The idea that patients hospitalized with acute decompensated heart failure can have a substantial change in their prognosis from an acute intervention given in the hospital seemed to finally hit a brick wall in November at the American Heart Association scientific sessions.
Treatment of acute heart failure patients with the vasodilating natriuretic peptide ularitide failed to cut long-term cardiovascular mortality or improve several other acute and mid-term outcomes in the TRUE-AHF trial. In a second report, ATHENA-HF, acute treatment with high-dose spironolactone during acute heart failure hospitalizations failed to improve a marker of heart failure severity, N-terminal pro B-type natriuretic peptide.
What alternative interventions are left? Dr. Yancy, as well as Milton Packer, MD, the cardiologist who led TRUE-HF, had somewhat similar answers.
In his discussion of TRUE-AHF, Dr. Yancy cited two possibilities: greater use of the relatively new drug formulation sacubitril plus valsartan (Entresto), which showed strong benefit treating patients with chronic heart failure with reduced ejection fraction (HFrEF); and expanded use of pulmonary-artery pressure (PAP) monitoring using an implanted device that gives clinicians early warning when a heart failure patient’s fluid volume moves into the danger zone that precedes by days or weeks the acute decompensation that produces dyspnea and drives a patient to the hospital.
Increasing experience with PAP monitoring “continues to endorse the notion that having early warning [of fluid overload] is important,” Dr. Yancy said in an interview. “The point of acuity in acute decompensated heart failure predates hospital admission, and this monitoring system allows us to catch this before it causes an emergency department visit. The data are very persuasive.”
“PAP usually rises 2-4 weeks before a heart failure hospitalization. Perhaps we need to focus more on long-term treatment rather than treatment in the hospital.” That’s especially true for patients with heart failure with preserved ejection fraction (HFpEF) because right now no treatment is clearly proven to improve HFpEF outcomes (although several experts make a persuasive case for spironolactone).
“Tight regulation of volume status is our best chance to improve outcomes in HFpEF,” said Dr. Stevenson, who helped pioneer the idea of PAP monitoring for heart failure patients. “Maintaining good volume is very important for HFpEF patients.”
But success with PAP monitoring requires more than gathering the pressure data. Producing benefit for patients “is predicated on having an infrastructure to accommodate the influx of PAP data, being nimble enough to respond to the data and being very precise about which patients you use this in,” cautioned Dr. Yancy. “The tool is not beneficial if the infrastructure is not there,”
The idea is still so new (the first implanted PAP monitor received U.S. approval in 2014) that at his institution, Northwestern Medicine in Chicago, about a dozen patients now have a monitor, he said.
“We’re looking to use it in patients with HFpEF, whom we can’t offer anything else. I’m intrigued by what I see,” in this first wave of Northwestern patients. Dr. Yancy’s anecdotal experience with PAP monitoring so far “helps endorse what the trial results suggested” about providing incremental benefit to heart failure patients.
“The solution is to prevent hospitalization in the first place with the medications we already have, but they’re not used. The medications we already have are enough, but they need to be used,” Dr. Packer told me in an interview during the meeting. He speculated that perhaps 10%-15% of HFrEF patients currently receive the full guideline-directed regimen of heart failure drugs. “That’s unbelievable,” he exclaimed. If clinicians diligently treated advanced HFrEF patients with these four agents, “you’d see a 60%, 70% drop in hospitalizations,” he suggested.
Dr. Packer put some of the blame for underuse of guideline-directed medications on the low financial incentive physicians have to vigorously apply this strategy.
He backed PAP monitoring as a good additional step for selected patients with unstable heart failure. “But as a general approach to managing patients with class III HFrEF, first put them on optimal medical therapy; then we can talk about an invasive procedure to place a PAP monitoring device.”
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
Stronger together: how to implement oncology and palliative care co-management
Outpatient palliative care is increasingly delivered through co-management, a collaborative model of care that enables palliative care clinicians and oncologists to coordinate efforts. Here, we offer a distillation of our experience with co-management at a large teaching hospital. We describe three strategies to implement co-management: a shared understanding of each subspecialty, a shared framework to help patients cultivate prognostic awareness, and a shared vision for the clinical goals. We hope that this synthesis will foster the development of co-management.
Click on the PDF icon at the top of this introduction to read the full article.
Outpatient palliative care is increasingly delivered through co-management, a collaborative model of care that enables palliative care clinicians and oncologists to coordinate efforts. Here, we offer a distillation of our experience with co-management at a large teaching hospital. We describe three strategies to implement co-management: a shared understanding of each subspecialty, a shared framework to help patients cultivate prognostic awareness, and a shared vision for the clinical goals. We hope that this synthesis will foster the development of co-management.
Click on the PDF icon at the top of this introduction to read the full article.
Outpatient palliative care is increasingly delivered through co-management, a collaborative model of care that enables palliative care clinicians and oncologists to coordinate efforts. Here, we offer a distillation of our experience with co-management at a large teaching hospital. We describe three strategies to implement co-management: a shared understanding of each subspecialty, a shared framework to help patients cultivate prognostic awareness, and a shared vision for the clinical goals. We hope that this synthesis will foster the development of co-management.
Click on the PDF icon at the top of this introduction to read the full article.
‘Negative’ appendectomy = longer LOS, higher morbidity
Among adults, “negative” appendectomy, or appendectomy in which the surgeon discovers there is no appendicitis, is associated with a prolonged hospital stay, greater morbidity, and higher costs than is curative nonperforated appendectomy, according to a report in the American Journal of Surgery.
“Many argue that negative appendectomy is justified to decrease the risk of perforated appendicitis, as it has been accepted that an inverse relationship exists between the rates of negative appendectomy and perforated appendicitis. However, with the increasing prevalence of preoperative imaging, the rate of negative appendectomy has been decreasing, whereas the rate of perforated appendicitis has remained largely the same,” said Kyle Mock, MD, of the department of surgery, Harbor-University of California Los Angeles Medical Center, and his associates (Am J Surg. 2016;212[6]:1076-82). The study found that the prevalence of negative appendectomy decreased from 4.5% to 2.8% in California from 2005 to 2011, while the prevalence of perforated appendicitis decreased from 23.1% to 21.7%
To examine this issue, Dr. Mock and his associates analyzed information from a statewide California inpatient database, focusing on 180,958 adult appendectomy admissions during a 6-year period. Compared with nonperforated appendectomy, negative appendectomy required an additional 0.8 days in length of stay, was associated with greater morbidity, and cost approximately $1,063 more per patient. Rates of negative appendectomy also did not correlate with rates of appendiceal perforation, so negative appendectomy cannot be said to prevent what otherwise would have been a ruptured appendix.
“Consequently, negative appendectomy should no longer be thought of as a benign procedure,” the investigators said.
It is important to note that patients who undergo negative appendectomy likely have other disease processes underlying their signs and symptoms, and they likely require longer hospitalization and incur greater morbidity and costs to identify and treat these alternative disorders. In contrast, patients who undergo routine appendectomy usually are discharged home the same day, Dr. Mock and his associates added.
This researchers had no financial relationships or sources of support in the form of grants, equipment, or drugs. Dr. Mock and his associates reported having no relevant conflicts of interest.
Among adults, “negative” appendectomy, or appendectomy in which the surgeon discovers there is no appendicitis, is associated with a prolonged hospital stay, greater morbidity, and higher costs than is curative nonperforated appendectomy, according to a report in the American Journal of Surgery.
“Many argue that negative appendectomy is justified to decrease the risk of perforated appendicitis, as it has been accepted that an inverse relationship exists between the rates of negative appendectomy and perforated appendicitis. However, with the increasing prevalence of preoperative imaging, the rate of negative appendectomy has been decreasing, whereas the rate of perforated appendicitis has remained largely the same,” said Kyle Mock, MD, of the department of surgery, Harbor-University of California Los Angeles Medical Center, and his associates (Am J Surg. 2016;212[6]:1076-82). The study found that the prevalence of negative appendectomy decreased from 4.5% to 2.8% in California from 2005 to 2011, while the prevalence of perforated appendicitis decreased from 23.1% to 21.7%
To examine this issue, Dr. Mock and his associates analyzed information from a statewide California inpatient database, focusing on 180,958 adult appendectomy admissions during a 6-year period. Compared with nonperforated appendectomy, negative appendectomy required an additional 0.8 days in length of stay, was associated with greater morbidity, and cost approximately $1,063 more per patient. Rates of negative appendectomy also did not correlate with rates of appendiceal perforation, so negative appendectomy cannot be said to prevent what otherwise would have been a ruptured appendix.
“Consequently, negative appendectomy should no longer be thought of as a benign procedure,” the investigators said.
It is important to note that patients who undergo negative appendectomy likely have other disease processes underlying their signs and symptoms, and they likely require longer hospitalization and incur greater morbidity and costs to identify and treat these alternative disorders. In contrast, patients who undergo routine appendectomy usually are discharged home the same day, Dr. Mock and his associates added.
This researchers had no financial relationships or sources of support in the form of grants, equipment, or drugs. Dr. Mock and his associates reported having no relevant conflicts of interest.
Among adults, “negative” appendectomy, or appendectomy in which the surgeon discovers there is no appendicitis, is associated with a prolonged hospital stay, greater morbidity, and higher costs than is curative nonperforated appendectomy, according to a report in the American Journal of Surgery.
“Many argue that negative appendectomy is justified to decrease the risk of perforated appendicitis, as it has been accepted that an inverse relationship exists between the rates of negative appendectomy and perforated appendicitis. However, with the increasing prevalence of preoperative imaging, the rate of negative appendectomy has been decreasing, whereas the rate of perforated appendicitis has remained largely the same,” said Kyle Mock, MD, of the department of surgery, Harbor-University of California Los Angeles Medical Center, and his associates (Am J Surg. 2016;212[6]:1076-82). The study found that the prevalence of negative appendectomy decreased from 4.5% to 2.8% in California from 2005 to 2011, while the prevalence of perforated appendicitis decreased from 23.1% to 21.7%
To examine this issue, Dr. Mock and his associates analyzed information from a statewide California inpatient database, focusing on 180,958 adult appendectomy admissions during a 6-year period. Compared with nonperforated appendectomy, negative appendectomy required an additional 0.8 days in length of stay, was associated with greater morbidity, and cost approximately $1,063 more per patient. Rates of negative appendectomy also did not correlate with rates of appendiceal perforation, so negative appendectomy cannot be said to prevent what otherwise would have been a ruptured appendix.
“Consequently, negative appendectomy should no longer be thought of as a benign procedure,” the investigators said.
It is important to note that patients who undergo negative appendectomy likely have other disease processes underlying their signs and symptoms, and they likely require longer hospitalization and incur greater morbidity and costs to identify and treat these alternative disorders. In contrast, patients who undergo routine appendectomy usually are discharged home the same day, Dr. Mock and his associates added.
This researchers had no financial relationships or sources of support in the form of grants, equipment, or drugs. Dr. Mock and his associates reported having no relevant conflicts of interest.
Key clinical point: In adults, “negative” appendectomy – appendectomy in which the surgeon discovers there is no appendicitis – is associated with longer length of stay, higher morbidity, and higher costs than curative appendectomy.
Major finding: Compared with nonperforated appendectomy, negative appendectomy required an additional 0.8 days in length of stay, was associated with greater morbidity, and cost approximately $1,063 more per patient.
Data source: An analysis of information regarding 180,958 appendectomies performed during a 6-year period and detailed in a state (California) inpatient database.
Disclosures: The researchers had no financial relationships or sources of support in the form of grants, equipment, or drugs. Dr. Mock and his associates reported having no relevant conflicts of interest.
Clinical, practice, and policy trends: a round-up and review of the 2016 oncology landscape
We end this year with yet another encouraging list from the US Food and Drug Administration (FDA) of new drugs or expanded uses for some previously approved drugs for patients with life-threatening cancers. As clinicians focused on delivering quality, cost-effective care to our patients, that is exciting, but the overarching issues of dosing specificity, increasingly specific gene mutation testing, and complex therapy sequencing requirements explain another major trend of 2016: the increasing adoption of standardized pathways. In addition, given the continued explosion in drug pricing and the expanding use of high-cost drugs in more common diseases and in more lines of therapy, payers and providers are working to incorporate expanded decision support tools such as pathways to guide and optimally monitor therapies for patients.
Click on the PDF icon below to read the full article.
We end this year with yet another encouraging list from the US Food and Drug Administration (FDA) of new drugs or expanded uses for some previously approved drugs for patients with life-threatening cancers. As clinicians focused on delivering quality, cost-effective care to our patients, that is exciting, but the overarching issues of dosing specificity, increasingly specific gene mutation testing, and complex therapy sequencing requirements explain another major trend of 2016: the increasing adoption of standardized pathways. In addition, given the continued explosion in drug pricing and the expanding use of high-cost drugs in more common diseases and in more lines of therapy, payers and providers are working to incorporate expanded decision support tools such as pathways to guide and optimally monitor therapies for patients.
Click on the PDF icon below to read the full article.
We end this year with yet another encouraging list from the US Food and Drug Administration (FDA) of new drugs or expanded uses for some previously approved drugs for patients with life-threatening cancers. As clinicians focused on delivering quality, cost-effective care to our patients, that is exciting, but the overarching issues of dosing specificity, increasingly specific gene mutation testing, and complex therapy sequencing requirements explain another major trend of 2016: the increasing adoption of standardized pathways. In addition, given the continued explosion in drug pricing and the expanding use of high-cost drugs in more common diseases and in more lines of therapy, payers and providers are working to incorporate expanded decision support tools such as pathways to guide and optimally monitor therapies for patients.
Click on the PDF icon below to read the full article.
Unless it is diagnosed, obesity won’t be treated
NEW ORLEANS – Obesity has been formally diagnosed in less than half of patients with a body-mass index of 30 kg/m2 or higher in the Cleveland Clinic’s large multispecialty database, and Bartolome Burguera, MD, believes it’s the same story elsewhere.
“I think pretty much all over the country obesity is really not well diagnosed,” Dr. Burguera, director of obesity programs at the Cleveland Clinic, said at Obesity Week 2016.
And that which hasn’t been diagnosed doesn’t get treated.
The diagnosis rate went up with higher BMIs; still, of the 25,137 patients with obesity class 3 as defined by a BMI of 40 kg/m2 or higher, only 75% had a formal diagnosis of obesity in their record, the endocrinologist said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
“For many years, physicians thought that obesity is not a disease. And even though it was considered a disease by some, they didn’t feel they had the tools, the knowledge, the support, the medications, or the time to take care of obesity, especially when they thought of it as a self-inflicted disease,” Dr. Burguera explained in an interview. He believes physician attitudes are slowly changing.
“In our clinic we’ve taken measures to change attitudes, for sure. Now, when we look in the electronic health record we get an automatic alert if the patient has a BMI of 30 or more,” he said.
“I think, in general, many more people now think of obesity as a disease. But it’s a chronic disease and you have to have chronic therapy. We have to make sure we make the diagnosis, and once you make the diagnosis you have to discuss treatment with the patient. If you don’t feel comfortable for whatever reason, I think you have to refer the patient to a colleague to take care of the obesity. Because when you take care of the obesity all the comorbidities get better: the diabetes, the blood pressure, the cholesterol. Obesity is the primary problem in so many other comorbidities. We have put little effort to this point in taking care of the obesity. We’ve put more effort into treating the diabetes and the other comorbidities,” Dr. Burguera said.
The Medicare obesity benefit provides reimbursement in primary care settings for intensive behavioral therapy with face-to-face counseling and motivational interviewing. The billing code is G0447. Coverage is provided for 22 visits over the course of a year, each lasting 15 minutes.
Dr. Batsis presented highlights of his published serial cross-sectional analysis of fee-for-service Medicare claims data for 2012 and 2013. Among Medicare beneficiaries eligible for the obesity benefit because they had a BMI of 30 kg/m2 or above, only 0.35% used the benefit in 2012. There was a tiny uptick to 0.6% in 2013, but even in the tiny fraction of eligible patients who availed themselves of the benefit, the average number of behavioral therapy sessions was just 2.1 visits out of the 22 for which physician reimbursement is available (Obesity. 2016 Sep;24[9]:1983-8).
“Let’s hope the 2014 data look a little better,” commented Dr. Batsis of the Dartmouth Institute for Health Policy and Clinical Practice in Lebanon, N.H.
There was marked regional variation in utilization of the Medicare obesity benefit across the U.S. in 2013. Rates were highest in Colorado – the state with the lowest obesity rate in the country – as well as Nebraska, Wisconsin, Vermont, and New Hampshire. Rates were lowest across the Southwest.
Dr. Burguera’s study was funded by Novo Nordisk. Dr. Batsis reported having no financial conflicts of interest.
NEW ORLEANS – Obesity has been formally diagnosed in less than half of patients with a body-mass index of 30 kg/m2 or higher in the Cleveland Clinic’s large multispecialty database, and Bartolome Burguera, MD, believes it’s the same story elsewhere.
“I think pretty much all over the country obesity is really not well diagnosed,” Dr. Burguera, director of obesity programs at the Cleveland Clinic, said at Obesity Week 2016.
And that which hasn’t been diagnosed doesn’t get treated.
The diagnosis rate went up with higher BMIs; still, of the 25,137 patients with obesity class 3 as defined by a BMI of 40 kg/m2 or higher, only 75% had a formal diagnosis of obesity in their record, the endocrinologist said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
“For many years, physicians thought that obesity is not a disease. And even though it was considered a disease by some, they didn’t feel they had the tools, the knowledge, the support, the medications, or the time to take care of obesity, especially when they thought of it as a self-inflicted disease,” Dr. Burguera explained in an interview. He believes physician attitudes are slowly changing.
“In our clinic we’ve taken measures to change attitudes, for sure. Now, when we look in the electronic health record we get an automatic alert if the patient has a BMI of 30 or more,” he said.
“I think, in general, many more people now think of obesity as a disease. But it’s a chronic disease and you have to have chronic therapy. We have to make sure we make the diagnosis, and once you make the diagnosis you have to discuss treatment with the patient. If you don’t feel comfortable for whatever reason, I think you have to refer the patient to a colleague to take care of the obesity. Because when you take care of the obesity all the comorbidities get better: the diabetes, the blood pressure, the cholesterol. Obesity is the primary problem in so many other comorbidities. We have put little effort to this point in taking care of the obesity. We’ve put more effort into treating the diabetes and the other comorbidities,” Dr. Burguera said.
The Medicare obesity benefit provides reimbursement in primary care settings for intensive behavioral therapy with face-to-face counseling and motivational interviewing. The billing code is G0447. Coverage is provided for 22 visits over the course of a year, each lasting 15 minutes.
Dr. Batsis presented highlights of his published serial cross-sectional analysis of fee-for-service Medicare claims data for 2012 and 2013. Among Medicare beneficiaries eligible for the obesity benefit because they had a BMI of 30 kg/m2 or above, only 0.35% used the benefit in 2012. There was a tiny uptick to 0.6% in 2013, but even in the tiny fraction of eligible patients who availed themselves of the benefit, the average number of behavioral therapy sessions was just 2.1 visits out of the 22 for which physician reimbursement is available (Obesity. 2016 Sep;24[9]:1983-8).
“Let’s hope the 2014 data look a little better,” commented Dr. Batsis of the Dartmouth Institute for Health Policy and Clinical Practice in Lebanon, N.H.
There was marked regional variation in utilization of the Medicare obesity benefit across the U.S. in 2013. Rates were highest in Colorado – the state with the lowest obesity rate in the country – as well as Nebraska, Wisconsin, Vermont, and New Hampshire. Rates were lowest across the Southwest.
Dr. Burguera’s study was funded by Novo Nordisk. Dr. Batsis reported having no financial conflicts of interest.
NEW ORLEANS – Obesity has been formally diagnosed in less than half of patients with a body-mass index of 30 kg/m2 or higher in the Cleveland Clinic’s large multispecialty database, and Bartolome Burguera, MD, believes it’s the same story elsewhere.
“I think pretty much all over the country obesity is really not well diagnosed,” Dr. Burguera, director of obesity programs at the Cleveland Clinic, said at Obesity Week 2016.
And that which hasn’t been diagnosed doesn’t get treated.
The diagnosis rate went up with higher BMIs; still, of the 25,137 patients with obesity class 3 as defined by a BMI of 40 kg/m2 or higher, only 75% had a formal diagnosis of obesity in their record, the endocrinologist said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
“For many years, physicians thought that obesity is not a disease. And even though it was considered a disease by some, they didn’t feel they had the tools, the knowledge, the support, the medications, or the time to take care of obesity, especially when they thought of it as a self-inflicted disease,” Dr. Burguera explained in an interview. He believes physician attitudes are slowly changing.
“In our clinic we’ve taken measures to change attitudes, for sure. Now, when we look in the electronic health record we get an automatic alert if the patient has a BMI of 30 or more,” he said.
“I think, in general, many more people now think of obesity as a disease. But it’s a chronic disease and you have to have chronic therapy. We have to make sure we make the diagnosis, and once you make the diagnosis you have to discuss treatment with the patient. If you don’t feel comfortable for whatever reason, I think you have to refer the patient to a colleague to take care of the obesity. Because when you take care of the obesity all the comorbidities get better: the diabetes, the blood pressure, the cholesterol. Obesity is the primary problem in so many other comorbidities. We have put little effort to this point in taking care of the obesity. We’ve put more effort into treating the diabetes and the other comorbidities,” Dr. Burguera said.
The Medicare obesity benefit provides reimbursement in primary care settings for intensive behavioral therapy with face-to-face counseling and motivational interviewing. The billing code is G0447. Coverage is provided for 22 visits over the course of a year, each lasting 15 minutes.
Dr. Batsis presented highlights of his published serial cross-sectional analysis of fee-for-service Medicare claims data for 2012 and 2013. Among Medicare beneficiaries eligible for the obesity benefit because they had a BMI of 30 kg/m2 or above, only 0.35% used the benefit in 2012. There was a tiny uptick to 0.6% in 2013, but even in the tiny fraction of eligible patients who availed themselves of the benefit, the average number of behavioral therapy sessions was just 2.1 visits out of the 22 for which physician reimbursement is available (Obesity. 2016 Sep;24[9]:1983-8).
“Let’s hope the 2014 data look a little better,” commented Dr. Batsis of the Dartmouth Institute for Health Policy and Clinical Practice in Lebanon, N.H.
There was marked regional variation in utilization of the Medicare obesity benefit across the U.S. in 2013. Rates were highest in Colorado – the state with the lowest obesity rate in the country – as well as Nebraska, Wisconsin, Vermont, and New Hampshire. Rates were lowest across the Southwest.
Dr. Burguera’s study was funded by Novo Nordisk. Dr. Batsis reported having no financial conflicts of interest.
AT OBESITY WEEK 2016
Key clinical point:
Major finding: Only 48% of a large group of patients with a BMI of 30 kg/m2 or higher had a formal diagnosis of obesity in their medical record.
Data source: This was a cross-sectional study of the electronic health records of nearly 325,000 active patients in the Cleveland Clinic database, 41.5% of whom had a BMI of 30 kg/m2 or higher.
Disclosures: The study was funded by Novo Nordisk.
How Can VA Expand Best Practices in Cancer Care?
What are the clinical best practices and how can the VA expand these specialty care innovations and patient care advances across the entire health care system? To understand the progress being made by the VA, Federal Practitioner sat down with Assistant Deputy Under Secretary for Health, for Quality, Safety, and Value Shereef M. Elnahal, MD, MBA, at the Launch Pad: Pathways to Cancer Innovation summit to discuss the Diffusion of Excellence program he is currently leading.
Dr. Elnahal discusses the development of virtual tumor, clinical pharmacy specialists, and the more than 400 other programs under consideration as well as the many programs already being replicated across multiple sites.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
What are the clinical best practices and how can the VA expand these specialty care innovations and patient care advances across the entire health care system? To understand the progress being made by the VA, Federal Practitioner sat down with Assistant Deputy Under Secretary for Health, for Quality, Safety, and Value Shereef M. Elnahal, MD, MBA, at the Launch Pad: Pathways to Cancer Innovation summit to discuss the Diffusion of Excellence program he is currently leading.
Dr. Elnahal discusses the development of virtual tumor, clinical pharmacy specialists, and the more than 400 other programs under consideration as well as the many programs already being replicated across multiple sites.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
What are the clinical best practices and how can the VA expand these specialty care innovations and patient care advances across the entire health care system? To understand the progress being made by the VA, Federal Practitioner sat down with Assistant Deputy Under Secretary for Health, for Quality, Safety, and Value Shereef M. Elnahal, MD, MBA, at the Launch Pad: Pathways to Cancer Innovation summit to discuss the Diffusion of Excellence program he is currently leading.
Dr. Elnahal discusses the development of virtual tumor, clinical pharmacy specialists, and the more than 400 other programs under consideration as well as the many programs already being replicated across multiple sites.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Assay could make blood supply safer, groups say
Photo by Alex Luster
with The Storyhive
Two groups of researchers have reported that an assay can accurately diagnose patients with variant Creutzfeldt-Jakob disease (vCJD), and this could allow for effective detection of prion contamination in donated blood.
The groups both said they were able to detect vCJD with 100% sensitivity and specificity.
One group even detected abnormal prion proteins in the blood of 2 subjects before the individuals exhibited any signs of vCJD.
The researchers said this work paves the way to a noninvasive, early diagnostic screen for vCJD and possibly other conditions involving protein misfolding.
Both studies were published in Science Translational Medicine.
“Our findings, which need to be confirmed in further studies, suggest that our method of detection could be useful for the noninvasive diagnosis of this disease in pre-symptomatic individuals,” said Claudio Soto, MD, author of one of the studies and a professor at the University of Texas Medical School in Houston.
“Early diagnosis would allow any potential therapy to be given before substantial brain damage has occurred. In the case of the blood supply, availability of a procedure to efficiently detect small quantities of the infectious agent would allow removal of blood units contaminated with prions so that new cases can be minimized substantially.”
For their study, Dr Soto and his colleagues used a protein misfolding cyclic amplification assay (PMCA) they developed, which mimics the prion replication process in vitro that occurs in prion disease.
The team used the assay to screen for abnormal prion proteins in blood from 14 individuals with vCJD and 153 control subjects.
In another study, Daisy Bougard, PhD, of Etablissement Français du Sang, INSERM, Université de Montpellier in France, and her colleagues tested a similar technique on blood samples from 18 individuals with vCJD and 238 without vCJD.
Dr Bougard’s group used the same PMCA as Dr Soto’s group. But Dr Bougard and her colleagues first captured prions from blood using plasminogen-coated beads.
In both studies, the PMCA diagnosed vCJD with 100% sensitivity and 100% specificity.
Dr Bougard and her colleagues were able to detect small amounts of prions in 2 blood donors more than a year before the onset of symptoms.
The researchers stressed that these results will need to be confirmed in a larger number of blood samples. 
Photo by Alex Luster
with The Storyhive
Two groups of researchers have reported that an assay can accurately diagnose patients with variant Creutzfeldt-Jakob disease (vCJD), and this could allow for effective detection of prion contamination in donated blood.
The groups both said they were able to detect vCJD with 100% sensitivity and specificity.
One group even detected abnormal prion proteins in the blood of 2 subjects before the individuals exhibited any signs of vCJD.
The researchers said this work paves the way to a noninvasive, early diagnostic screen for vCJD and possibly other conditions involving protein misfolding.
Both studies were published in Science Translational Medicine.
“Our findings, which need to be confirmed in further studies, suggest that our method of detection could be useful for the noninvasive diagnosis of this disease in pre-symptomatic individuals,” said Claudio Soto, MD, author of one of the studies and a professor at the University of Texas Medical School in Houston.
“Early diagnosis would allow any potential therapy to be given before substantial brain damage has occurred. In the case of the blood supply, availability of a procedure to efficiently detect small quantities of the infectious agent would allow removal of blood units contaminated with prions so that new cases can be minimized substantially.”
For their study, Dr Soto and his colleagues used a protein misfolding cyclic amplification assay (PMCA) they developed, which mimics the prion replication process in vitro that occurs in prion disease.
The team used the assay to screen for abnormal prion proteins in blood from 14 individuals with vCJD and 153 control subjects.
In another study, Daisy Bougard, PhD, of Etablissement Français du Sang, INSERM, Université de Montpellier in France, and her colleagues tested a similar technique on blood samples from 18 individuals with vCJD and 238 without vCJD.
Dr Bougard’s group used the same PMCA as Dr Soto’s group. But Dr Bougard and her colleagues first captured prions from blood using plasminogen-coated beads.
In both studies, the PMCA diagnosed vCJD with 100% sensitivity and 100% specificity.
Dr Bougard and her colleagues were able to detect small amounts of prions in 2 blood donors more than a year before the onset of symptoms.
The researchers stressed that these results will need to be confirmed in a larger number of blood samples.
Photo by Alex Luster
with The Storyhive
Two groups of researchers have reported that an assay can accurately diagnose patients with variant Creutzfeldt-Jakob disease (vCJD), and this could allow for effective detection of prion contamination in donated blood.
The groups both said they were able to detect vCJD with 100% sensitivity and specificity.
One group even detected abnormal prion proteins in the blood of 2 subjects before the individuals exhibited any signs of vCJD.
The researchers said this work paves the way to a noninvasive, early diagnostic screen for vCJD and possibly other conditions involving protein misfolding.
Both studies were published in Science Translational Medicine.
“Our findings, which need to be confirmed in further studies, suggest that our method of detection could be useful for the noninvasive diagnosis of this disease in pre-symptomatic individuals,” said Claudio Soto, MD, author of one of the studies and a professor at the University of Texas Medical School in Houston.
“Early diagnosis would allow any potential therapy to be given before substantial brain damage has occurred. In the case of the blood supply, availability of a procedure to efficiently detect small quantities of the infectious agent would allow removal of blood units contaminated with prions so that new cases can be minimized substantially.”
For their study, Dr Soto and his colleagues used a protein misfolding cyclic amplification assay (PMCA) they developed, which mimics the prion replication process in vitro that occurs in prion disease.
The team used the assay to screen for abnormal prion proteins in blood from 14 individuals with vCJD and 153 control subjects.
In another study, Daisy Bougard, PhD, of Etablissement Français du Sang, INSERM, Université de Montpellier in France, and her colleagues tested a similar technique on blood samples from 18 individuals with vCJD and 238 without vCJD.
Dr Bougard’s group used the same PMCA as Dr Soto’s group. But Dr Bougard and her colleagues first captured prions from blood using plasminogen-coated beads.
In both studies, the PMCA diagnosed vCJD with 100% sensitivity and 100% specificity.
Dr Bougard and her colleagues were able to detect small amounts of prions in 2 blood donors more than a year before the onset of symptoms.
The researchers stressed that these results will need to be confirmed in a larger number of blood samples.
G-CHOP no better than R-CHOP in previously untreated DLBCL
SAN DIEGO—Substituting obinutuzumab for rituximab in combination with CHOP chemotherapy does not improve outcomes in patients with previously untreated diffuse large B-cell lymphoma (DLBCL), according to a study presented at the 2016 ASH Annual Meeting.
In this phase 3 trial, known as GOYA, researchers compared obinutuzumab plus CHOP (G-CHOP) to rituximab plus CHOP (R-CHOP) in patients with previously untreated DLBCL.
There were no significant differences between the treatment arms with regard to response rates, progression-free survival (PFS), or overall survival (OS).
In addition, grade 3-5 adverse events (AEs) and serious AEs were more common with G-CHOP than with R-CHOP.
“Rituximab plus CHOP remains the standard of care in this setting,” said study investigator Umberto Vitolo, MD, of the Universitaria Città della Salute e della Scienza di Torino in Torino, Italy.
“Further analyses of the data from this trial will inform and shape the direction of future research activities in DLBCL.”
Dr Vitolo presented results from GOYA at ASH as abstract 470.
Obinutuzumab is a glycoengineered, type II, anti-CD20 monoclonal antibody said to have greater direct cell death induction and antibody-dependent cellular cytotoxicity/phagocytosis activity than rituximab.
In the phase 2 GATHER trial, G-CHOP demonstrated manageable toxicity and promising preliminary efficacy in patients with advanced, untreated DLBCL.
So with the phase 3 GOYA trial, researchers wanted to compare G-CHOP to R-CHOP in DLBCL. The trial enrolled 1418 patients (median age 62) with previously untreated DLBCL.
Patients from 207 centers around the world were randomized to receive eight 21-day cycles of obinutuzumab at 1000 mg intravenously on days 1, 8, and 15 in cycle 1 and day 1 in cycles 2 to 8 (n=706) or rituximab at 375 mg/m2 intravenously on day 1 (n=712) in combination with 6 or 8 cycles of CHOP. Preplanned radiotherapy was allowed for bulky or extranodal disease.
Dr Vitolo said baseline characteristics were well balanced between the 2 treatment arms. Cell-of-origin distribution, as assessed by gene-expression profiling, was similar in both arms.
Virtually all (88%) of the patients received more than 90% of the planned cumulative dose of chemotherapy. Antibody dose delays were more common in the G-CHOP arm.
Efficacy
The median follow-up was 29 months.
For the primary endpoint of investigator-assessed PFS, there was no significant difference between the G-CHOP and R-CHOP arms. The 3-year PFS was 69.6% for G-CHOP and 66.9% for R-CHOP (hazard ratio [HR]=0.92, P=0.3868).
There were no clinically meaningful differences observed between the treatment arms in terms of secondary endpoints, including OS, end-of-treatment overall response rate, and complete response rate, with or without PET scanning.
At the end of treatment, the overall response rates, according to CT and PET, were 77.9% in the R-CHOP arm and 77.4% in the G-CHOP arm. The complete response rates were 59.5% and 56.7%, respectively.
The 3-year OS rate was 81.4% in the R-CHOP arm and 81.2% in the G-CHOP arm (HR=1.00, P=0.9982).
In a pre-specified subgroup analysis of investigator-assessed PFS, there was a slight trend toward improved PFS in favor of G-CHOP for patients with GCB DLBCL, with a 3-year PFS of 79% vs 70% for R-CHOP (HR=0.72).
Safety
No new safety signals were identified. Grade 3 or higher AEs and serious AEs were more common in the G-CHOP arm than the R-CHOP arm. The incidence of grade 3-5 AEs was 73.7% and 64.7%, respectively. The incidence of serious AEs was 42.6% and 37.6%, respectively.
Certain grade 3-5 AEs were more common with G-CHOP than R-CHOP, including neutropenia (46.2% vs 38.1%), infusion-related reactions (2.8% vs 0.6%), infections (19.2% vs 15.5%), and thrombocytopenia 4.4% vs 1.4%).
AEs resulting in withdrawal from treatment and AEs with fatal outcomes were slightly more common with G-CHOP than with R-CHOP. AEs leading to withdrawal occurred in 11.9% and 8.5% of patients, respectively.
Fatal AEs (listed by preferred term) in the G-CHOP arm included septic shock (n=6, 0.9%), pneumonia (n=5, 0.7%), death (n=3, 0.4%), pulmonary embolism (n=2, 1.3%), and cerebrovascular accident (n=2, 0.3%).
Fatal AEs in the R-CHOP arm included pneumonia (n=6, 0.9%), sepsis (n=3, 0.4%), cerebrovascular accident (n=2, 0.3%), and death (n=2, 0.3%).
SAN DIEGO—Substituting obinutuzumab for rituximab in combination with CHOP chemotherapy does not improve outcomes in patients with previously untreated diffuse large B-cell lymphoma (DLBCL), according to a study presented at the 2016 ASH Annual Meeting.
In this phase 3 trial, known as GOYA, researchers compared obinutuzumab plus CHOP (G-CHOP) to rituximab plus CHOP (R-CHOP) in patients with previously untreated DLBCL.
There were no significant differences between the treatment arms with regard to response rates, progression-free survival (PFS), or overall survival (OS).
In addition, grade 3-5 adverse events (AEs) and serious AEs were more common with G-CHOP than with R-CHOP.
“Rituximab plus CHOP remains the standard of care in this setting,” said study investigator Umberto Vitolo, MD, of the Universitaria Città della Salute e della Scienza di Torino in Torino, Italy.
“Further analyses of the data from this trial will inform and shape the direction of future research activities in DLBCL.”
Dr Vitolo presented results from GOYA at ASH as abstract 470.
Obinutuzumab is a glycoengineered, type II, anti-CD20 monoclonal antibody said to have greater direct cell death induction and antibody-dependent cellular cytotoxicity/phagocytosis activity than rituximab.
In the phase 2 GATHER trial, G-CHOP demonstrated manageable toxicity and promising preliminary efficacy in patients with advanced, untreated DLBCL.
So with the phase 3 GOYA trial, researchers wanted to compare G-CHOP to R-CHOP in DLBCL. The trial enrolled 1418 patients (median age 62) with previously untreated DLBCL.
Patients from 207 centers around the world were randomized to receive eight 21-day cycles of obinutuzumab at 1000 mg intravenously on days 1, 8, and 15 in cycle 1 and day 1 in cycles 2 to 8 (n=706) or rituximab at 375 mg/m2 intravenously on day 1 (n=712) in combination with 6 or 8 cycles of CHOP. Preplanned radiotherapy was allowed for bulky or extranodal disease.
Dr Vitolo said baseline characteristics were well balanced between the 2 treatment arms. Cell-of-origin distribution, as assessed by gene-expression profiling, was similar in both arms.
Virtually all (88%) of the patients received more than 90% of the planned cumulative dose of chemotherapy. Antibody dose delays were more common in the G-CHOP arm.
Efficacy
The median follow-up was 29 months.
For the primary endpoint of investigator-assessed PFS, there was no significant difference between the G-CHOP and R-CHOP arms. The 3-year PFS was 69.6% for G-CHOP and 66.9% for R-CHOP (hazard ratio [HR]=0.92, P=0.3868).
There were no clinically meaningful differences observed between the treatment arms in terms of secondary endpoints, including OS, end-of-treatment overall response rate, and complete response rate, with or without PET scanning.
At the end of treatment, the overall response rates, according to CT and PET, were 77.9% in the R-CHOP arm and 77.4% in the G-CHOP arm. The complete response rates were 59.5% and 56.7%, respectively.
The 3-year OS rate was 81.4% in the R-CHOP arm and 81.2% in the G-CHOP arm (HR=1.00, P=0.9982).
In a pre-specified subgroup analysis of investigator-assessed PFS, there was a slight trend toward improved PFS in favor of G-CHOP for patients with GCB DLBCL, with a 3-year PFS of 79% vs 70% for R-CHOP (HR=0.72).
Safety
No new safety signals were identified. Grade 3 or higher AEs and serious AEs were more common in the G-CHOP arm than the R-CHOP arm. The incidence of grade 3-5 AEs was 73.7% and 64.7%, respectively. The incidence of serious AEs was 42.6% and 37.6%, respectively.
Certain grade 3-5 AEs were more common with G-CHOP than R-CHOP, including neutropenia (46.2% vs 38.1%), infusion-related reactions (2.8% vs 0.6%), infections (19.2% vs 15.5%), and thrombocytopenia 4.4% vs 1.4%).
AEs resulting in withdrawal from treatment and AEs with fatal outcomes were slightly more common with G-CHOP than with R-CHOP. AEs leading to withdrawal occurred in 11.9% and 8.5% of patients, respectively.
Fatal AEs (listed by preferred term) in the G-CHOP arm included septic shock (n=6, 0.9%), pneumonia (n=5, 0.7%), death (n=3, 0.4%), pulmonary embolism (n=2, 1.3%), and cerebrovascular accident (n=2, 0.3%).
Fatal AEs in the R-CHOP arm included pneumonia (n=6, 0.9%), sepsis (n=3, 0.4%), cerebrovascular accident (n=2, 0.3%), and death (n=2, 0.3%).
SAN DIEGO—Substituting obinutuzumab for rituximab in combination with CHOP chemotherapy does not improve outcomes in patients with previously untreated diffuse large B-cell lymphoma (DLBCL), according to a study presented at the 2016 ASH Annual Meeting.
In this phase 3 trial, known as GOYA, researchers compared obinutuzumab plus CHOP (G-CHOP) to rituximab plus CHOP (R-CHOP) in patients with previously untreated DLBCL.
There were no significant differences between the treatment arms with regard to response rates, progression-free survival (PFS), or overall survival (OS).
In addition, grade 3-5 adverse events (AEs) and serious AEs were more common with G-CHOP than with R-CHOP.
“Rituximab plus CHOP remains the standard of care in this setting,” said study investigator Umberto Vitolo, MD, of the Universitaria Città della Salute e della Scienza di Torino in Torino, Italy.
“Further analyses of the data from this trial will inform and shape the direction of future research activities in DLBCL.”
Dr Vitolo presented results from GOYA at ASH as abstract 470.
Obinutuzumab is a glycoengineered, type II, anti-CD20 monoclonal antibody said to have greater direct cell death induction and antibody-dependent cellular cytotoxicity/phagocytosis activity than rituximab.
In the phase 2 GATHER trial, G-CHOP demonstrated manageable toxicity and promising preliminary efficacy in patients with advanced, untreated DLBCL.
So with the phase 3 GOYA trial, researchers wanted to compare G-CHOP to R-CHOP in DLBCL. The trial enrolled 1418 patients (median age 62) with previously untreated DLBCL.
Patients from 207 centers around the world were randomized to receive eight 21-day cycles of obinutuzumab at 1000 mg intravenously on days 1, 8, and 15 in cycle 1 and day 1 in cycles 2 to 8 (n=706) or rituximab at 375 mg/m2 intravenously on day 1 (n=712) in combination with 6 or 8 cycles of CHOP. Preplanned radiotherapy was allowed for bulky or extranodal disease.
Dr Vitolo said baseline characteristics were well balanced between the 2 treatment arms. Cell-of-origin distribution, as assessed by gene-expression profiling, was similar in both arms.
Virtually all (88%) of the patients received more than 90% of the planned cumulative dose of chemotherapy. Antibody dose delays were more common in the G-CHOP arm.
Efficacy
The median follow-up was 29 months.
For the primary endpoint of investigator-assessed PFS, there was no significant difference between the G-CHOP and R-CHOP arms. The 3-year PFS was 69.6% for G-CHOP and 66.9% for R-CHOP (hazard ratio [HR]=0.92, P=0.3868).
There were no clinically meaningful differences observed between the treatment arms in terms of secondary endpoints, including OS, end-of-treatment overall response rate, and complete response rate, with or without PET scanning.
At the end of treatment, the overall response rates, according to CT and PET, were 77.9% in the R-CHOP arm and 77.4% in the G-CHOP arm. The complete response rates were 59.5% and 56.7%, respectively.
The 3-year OS rate was 81.4% in the R-CHOP arm and 81.2% in the G-CHOP arm (HR=1.00, P=0.9982).
In a pre-specified subgroup analysis of investigator-assessed PFS, there was a slight trend toward improved PFS in favor of G-CHOP for patients with GCB DLBCL, with a 3-year PFS of 79% vs 70% for R-CHOP (HR=0.72).
Safety
No new safety signals were identified. Grade 3 or higher AEs and serious AEs were more common in the G-CHOP arm than the R-CHOP arm. The incidence of grade 3-5 AEs was 73.7% and 64.7%, respectively. The incidence of serious AEs was 42.6% and 37.6%, respectively.
Certain grade 3-5 AEs were more common with G-CHOP than R-CHOP, including neutropenia (46.2% vs 38.1%), infusion-related reactions (2.8% vs 0.6%), infections (19.2% vs 15.5%), and thrombocytopenia 4.4% vs 1.4%).
AEs resulting in withdrawal from treatment and AEs with fatal outcomes were slightly more common with G-CHOP than with R-CHOP. AEs leading to withdrawal occurred in 11.9% and 8.5% of patients, respectively.
Fatal AEs (listed by preferred term) in the G-CHOP arm included septic shock (n=6, 0.9%), pneumonia (n=5, 0.7%), death (n=3, 0.4%), pulmonary embolism (n=2, 1.3%), and cerebrovascular accident (n=2, 0.3%).
Fatal AEs in the R-CHOP arm included pneumonia (n=6, 0.9%), sepsis (n=3, 0.4%), cerebrovascular accident (n=2, 0.3%), and death (n=2, 0.3%).