Breast Cancer

Indocyanine green dye caused no major side effects and was almost 99% concordant with radioisotope technetium for sentinel lymph node detection in early-stage breast cancer, according to researchers.

The results extend promising findings from an earlier meta-analysis of the tracer in a variety of tumor types, said Dr. Domenico Samorani of Santarcangelo di Romagna Hospital, Rimini, Italy.

“The method seems reproducible, safe, eliminates exposure to ionizing radiation, and is potentially cost-saving, despite requiring specialist training. [Also,] it could be an option for breast cancer centers with no nuclear medicine supply,” wrote Dr. Samorani and colleagues.

Sentinel lymph node biopsy has largely replaced axillary lymph node dissection for staging breast cancer, as it causes much less morbidity and is associated with similar rates of survival and locoregional recurrence. Vital blue dyes and radioisotope technetium (99mTc) are the most commonly used enhancers, but the blue dyes can cause allergic reactions and skin necrosis, and 99mTc is costly and requires special logistics and handling because of its radioactivity, the investigators noted. For these reasons, there has been renewed interest in indocyanine green dye (ICG) as an alternative, they said (Eur. J. Surg. Oncol. 2015;41:64-70).

For the study, the investigators evaluated 589 lymph nodes from 301 patients with clinically node-negative, invasive or microinvasive early breast cancer confirmed by core biopsy. All patients underwent 99mTc-guided sentinel node detection, which served as the gold standard for comparison. To perform ICG-guided detection, the researchers diluted 25 mg of ICG PULSION with 5 mL distilled water and then injected empirical doses of 0.4 to 1.2 mL of the solution subcutaneously above the tumor site for unicentric cancers, or around the areola for multicentric disease. Then the researchers used an infrared-emitting camera (Photodynamic Eye, Hamamatsu Photonics, Hamamatsu, Japan) to visualize the lymphatic drainage pathway and localize sentinel nodes for removal.

Overall, 98.7% of sentinel nodes that were 99mTc positive also were ICG positive (95% confidence interval, 97.1%-99.5%), a high degree of concordance that reflected past study results, the investigators said. Notably, the ICG-guided technique identified at least one sentinel node for 297 patients (98.7%), compared with 287 patients (95.4%) for the 99mTc method (P < .05). Thus, the use of ICG prevented removal of the entire axilla for 10 patients, the researchers wrote.

For six patients, the ICG method identified a metastatic node that 99mTc failed to identify. Therefore, ICG provided an advantage for 16 cases (5.3%). No patients experienced allergic reactions, 3.2% developed seromas, and 2.5% developed paresthesia, the researchers added.

Use of ICG instead of 99mTc for sentinel lymph node detection has several advantages: It does not require involving a nuclear medicine department, uses less radioactive material, minimizes issues around waste disposal, and can be performed in the operating room immediately after the induction of general anesthesia, said the researchers. And if combined with radio-guided occult lesion localization (ROLL), it avoids placing two radioactive tracings at the injection site, thereby facilitating tumor detection, the researchers noted.

Clinicians who are implementing ICG-guided sentinel node detection should consider combining it with 99mTc to avoid missing nodes during the learning process, the researchers emphasized.

They reported no funding sources and no conflicts of interest.

Indocyanine green dye caused no major side effects and was almost 99% concordant with radioisotope technetium for sentinel lymph node detection in early-stage breast cancer, according to researchers.

The results extend promising findings from an earlier meta-analysis of the tracer in a variety of tumor types, said Dr. Domenico Samorani of Santarcangelo di Romagna Hospital, Rimini, Italy.

“The method seems reproducible, safe, eliminates exposure to ionizing radiation, and is potentially cost-saving, despite requiring specialist training. [Also,] it could be an option for breast cancer centers with no nuclear medicine supply,” wrote Dr. Samorani and colleagues.

Sentinel lymph node biopsy has largely replaced axillary lymph node dissection for staging breast cancer, as it causes much less morbidity and is associated with similar rates of survival and locoregional recurrence. Vital blue dyes and radioisotope technetium (99mTc) are the most commonly used enhancers, but the blue dyes can cause allergic reactions and skin necrosis, and 99mTc is costly and requires special logistics and handling because of its radioactivity, the investigators noted. For these reasons, there has been renewed interest in indocyanine green dye (ICG) as an alternative, they said (Eur. J. Surg. Oncol. 2015;41:64-70).

For the study, the investigators evaluated 589 lymph nodes from 301 patients with clinically node-negative, invasive or microinvasive early breast cancer confirmed by core biopsy. All patients underwent 99mTc-guided sentinel node detection, which served as the gold standard for comparison. To perform ICG-guided detection, the researchers diluted 25 mg of ICG PULSION with 5 mL distilled water and then injected empirical doses of 0.4 to 1.2 mL of the solution subcutaneously above the tumor site for unicentric cancers, or around the areola for multicentric disease. Then the researchers used an infrared-emitting camera (Photodynamic Eye, Hamamatsu Photonics, Hamamatsu, Japan) to visualize the lymphatic drainage pathway and localize sentinel nodes for removal.

Overall, 98.7% of sentinel nodes that were 99mTc positive also were ICG positive (95% confidence interval, 97.1%-99.5%), a high degree of concordance that reflected past study results, the investigators said. Notably, the ICG-guided technique identified at least one sentinel node for 297 patients (98.7%), compared with 287 patients (95.4%) for the 99mTc method (P < .05). Thus, the use of ICG prevented removal of the entire axilla for 10 patients, the researchers wrote.

For six patients, the ICG method identified a metastatic node that 99mTc failed to identify. Therefore, ICG provided an advantage for 16 cases (5.3%). No patients experienced allergic reactions, 3.2% developed seromas, and 2.5% developed paresthesia, the researchers added.

Use of ICG instead of 99mTc for sentinel lymph node detection has several advantages: It does not require involving a nuclear medicine department, uses less radioactive material, minimizes issues around waste disposal, and can be performed in the operating room immediately after the induction of general anesthesia, said the researchers. And if combined with radio-guided occult lesion localization (ROLL), it avoids placing two radioactive tracings at the injection site, thereby facilitating tumor detection, the researchers noted.

Clinicians who are implementing ICG-guided sentinel node detection should consider combining it with 99mTc to avoid missing nodes during the learning process, the researchers emphasized.

They reported no funding sources and no conflicts of interest.

Indocyanine green dye caused no major side effects and was almost 99% concordant with radioisotope technetium for sentinel lymph node detection in early-stage breast cancer, according to researchers.

The results extend promising findings from an earlier meta-analysis of the tracer in a variety of tumor types, said Dr. Domenico Samorani of Santarcangelo di Romagna Hospital, Rimini, Italy.

“The method seems reproducible, safe, eliminates exposure to ionizing radiation, and is potentially cost-saving, despite requiring specialist training. [Also,] it could be an option for breast cancer centers with no nuclear medicine supply,” wrote Dr. Samorani and colleagues.

Sentinel lymph node biopsy has largely replaced axillary lymph node dissection for staging breast cancer, as it causes much less morbidity and is associated with similar rates of survival and locoregional recurrence. Vital blue dyes and radioisotope technetium (99mTc) are the most commonly used enhancers, but the blue dyes can cause allergic reactions and skin necrosis, and 99mTc is costly and requires special logistics and handling because of its radioactivity, the investigators noted. For these reasons, there has been renewed interest in indocyanine green dye (ICG) as an alternative, they said (Eur. J. Surg. Oncol. 2015;41:64-70).

For the study, the investigators evaluated 589 lymph nodes from 301 patients with clinically node-negative, invasive or microinvasive early breast cancer confirmed by core biopsy. All patients underwent 99mTc-guided sentinel node detection, which served as the gold standard for comparison. To perform ICG-guided detection, the researchers diluted 25 mg of ICG PULSION with 5 mL distilled water and then injected empirical doses of 0.4 to 1.2 mL of the solution subcutaneously above the tumor site for unicentric cancers, or around the areola for multicentric disease. Then the researchers used an infrared-emitting camera (Photodynamic Eye, Hamamatsu Photonics, Hamamatsu, Japan) to visualize the lymphatic drainage pathway and localize sentinel nodes for removal.

Overall, 98.7% of sentinel nodes that were 99mTc positive also were ICG positive (95% confidence interval, 97.1%-99.5%), a high degree of concordance that reflected past study results, the investigators said. Notably, the ICG-guided technique identified at least one sentinel node for 297 patients (98.7%), compared with 287 patients (95.4%) for the 99mTc method (P < .05). Thus, the use of ICG prevented removal of the entire axilla for 10 patients, the researchers wrote.

For six patients, the ICG method identified a metastatic node that 99mTc failed to identify. Therefore, ICG provided an advantage for 16 cases (5.3%). No patients experienced allergic reactions, 3.2% developed seromas, and 2.5% developed paresthesia, the researchers added.

Use of ICG instead of 99mTc for sentinel lymph node detection has several advantages: It does not require involving a nuclear medicine department, uses less radioactive material, minimizes issues around waste disposal, and can be performed in the operating room immediately after the induction of general anesthesia, said the researchers. And if combined with radio-guided occult lesion localization (ROLL), it avoids placing two radioactive tracings at the injection site, thereby facilitating tumor detection, the researchers noted.

Clinicians who are implementing ICG-guided sentinel node detection should consider combining it with 99mTc to avoid missing nodes during the learning process, the researchers emphasized.

They reported no funding sources and no conflicts of interest.

BALTIMORE – While prognostic tests tied to specific chemotherapy agents may offer a clear benefit in guiding treatment and improving outcomes for certain malignancies, applying the tests more broadly may not offer information that is clinically relevant.

Members of the Medicare Evidence Development & Coverage Advisory Committee were asked to examine prognostic tests for three types of cancers – adenocarcinoma of the colon and rectum, breast cancer (both invasive duct and lobular cancers), and non–small cell lung cancers – in a preliminary effort to determine how Medicare should pay for the use of such tests. They found little evidence on how these tests could lead to better outcomes, despite evidence showing the tests did confirm the analytic and clinical validity of the biomarkers.

vitanovski/Thinkstock.com

Turning to the usefulness of such tests in aiding clinical decision making by physicians and patients, data on “the downstream effects of these tests ... got very thin very quickly,” according to advisory committee member Dr. Beverly A. Guadagnolo of the department of radiation oncology at M.D. Anderson Cancer Center, Houston.

At its March 24 meeting, the committee found that only three tests – microsatellite instability tests in adenocarcinoma of the colon and rectum, and MammaPrint and Oncotype DX Breast – showed evidence of some level of utility in managing patients and improving outcomes; however, none reached an average of 3 (intermediate confidence) on the committee’s 5-point scale of evaluating the strength of the evidence. Oncotype DX Breast was the highest, with a 2.875 average vote across the eight voting members.

Dr. Mitchell Kamrava of the department of radiation oncology at the University of California, Los Angeles, also noted that physicians are doing their best to understand what the different biomarkers actually mean when it comes to treating patients, “but the data are just not quite there yet.”

For Medicare officials, the emphasis going forward will be how useful these tests will be for improving care.

“We approached various lab vendors and they are able to show us plenty of information in terms of analytic validity as well as clinical validity,” Dr. James Rollins, director of the Division of Items and Devices in CMS’ Coverage & Analysis Group, said. “Some of them feel that demonstrating clinical utility is something that they don’t need to provide commercial insurers. I don’t know why they feel that way. But as I said, as time goes on, we will be using more and more clinical utility.”

CMS currently does not have any open national coverage analysis decisions that relate to prognostic cancer tests.

Dr. Rollins said the agency is defining clinical utility as information that leads to improved health outcomes either due to increased benefit or reduction in harm.

gtwachtman@frontlinemedcom.com

BALTIMORE – While prognostic tests tied to specific chemotherapy agents may offer a clear benefit in guiding treatment and improving outcomes for certain malignancies, applying the tests more broadly may not offer information that is clinically relevant.

Members of the Medicare Evidence Development & Coverage Advisory Committee were asked to examine prognostic tests for three types of cancers – adenocarcinoma of the colon and rectum, breast cancer (both invasive duct and lobular cancers), and non–small cell lung cancers – in a preliminary effort to determine how Medicare should pay for the use of such tests. They found little evidence on how these tests could lead to better outcomes, despite evidence showing the tests did confirm the analytic and clinical validity of the biomarkers.

vitanovski/Thinkstock.com

Turning to the usefulness of such tests in aiding clinical decision making by physicians and patients, data on “the downstream effects of these tests ... got very thin very quickly,” according to advisory committee member Dr. Beverly A. Guadagnolo of the department of radiation oncology at M.D. Anderson Cancer Center, Houston.

At its March 24 meeting, the committee found that only three tests – microsatellite instability tests in adenocarcinoma of the colon and rectum, and MammaPrint and Oncotype DX Breast – showed evidence of some level of utility in managing patients and improving outcomes; however, none reached an average of 3 (intermediate confidence) on the committee’s 5-point scale of evaluating the strength of the evidence. Oncotype DX Breast was the highest, with a 2.875 average vote across the eight voting members.

Dr. Mitchell Kamrava of the department of radiation oncology at the University of California, Los Angeles, also noted that physicians are doing their best to understand what the different biomarkers actually mean when it comes to treating patients, “but the data are just not quite there yet.”

For Medicare officials, the emphasis going forward will be how useful these tests will be for improving care.

“We approached various lab vendors and they are able to show us plenty of information in terms of analytic validity as well as clinical validity,” Dr. James Rollins, director of the Division of Items and Devices in CMS’ Coverage & Analysis Group, said. “Some of them feel that demonstrating clinical utility is something that they don’t need to provide commercial insurers. I don’t know why they feel that way. But as I said, as time goes on, we will be using more and more clinical utility.”

CMS currently does not have any open national coverage analysis decisions that relate to prognostic cancer tests.

Dr. Rollins said the agency is defining clinical utility as information that leads to improved health outcomes either due to increased benefit or reduction in harm.

gtwachtman@frontlinemedcom.com

BALTIMORE – While prognostic tests tied to specific chemotherapy agents may offer a clear benefit in guiding treatment and improving outcomes for certain malignancies, applying the tests more broadly may not offer information that is clinically relevant.

Members of the Medicare Evidence Development & Coverage Advisory Committee were asked to examine prognostic tests for three types of cancers – adenocarcinoma of the colon and rectum, breast cancer (both invasive duct and lobular cancers), and non–small cell lung cancers – in a preliminary effort to determine how Medicare should pay for the use of such tests. They found little evidence on how these tests could lead to better outcomes, despite evidence showing the tests did confirm the analytic and clinical validity of the biomarkers.

vitanovski/Thinkstock.com

Turning to the usefulness of such tests in aiding clinical decision making by physicians and patients, data on “the downstream effects of these tests ... got very thin very quickly,” according to advisory committee member Dr. Beverly A. Guadagnolo of the department of radiation oncology at M.D. Anderson Cancer Center, Houston.

At its March 24 meeting, the committee found that only three tests – microsatellite instability tests in adenocarcinoma of the colon and rectum, and MammaPrint and Oncotype DX Breast – showed evidence of some level of utility in managing patients and improving outcomes; however, none reached an average of 3 (intermediate confidence) on the committee’s 5-point scale of evaluating the strength of the evidence. Oncotype DX Breast was the highest, with a 2.875 average vote across the eight voting members.

Dr. Mitchell Kamrava of the department of radiation oncology at the University of California, Los Angeles, also noted that physicians are doing their best to understand what the different biomarkers actually mean when it comes to treating patients, “but the data are just not quite there yet.”

For Medicare officials, the emphasis going forward will be how useful these tests will be for improving care.

“We approached various lab vendors and they are able to show us plenty of information in terms of analytic validity as well as clinical validity,” Dr. James Rollins, director of the Division of Items and Devices in CMS’ Coverage & Analysis Group, said. “Some of them feel that demonstrating clinical utility is something that they don’t need to provide commercial insurers. I don’t know why they feel that way. But as I said, as time goes on, we will be using more and more clinical utility.”

CMS currently does not have any open national coverage analysis decisions that relate to prognostic cancer tests.

Dr. Rollins said the agency is defining clinical utility as information that leads to improved health outcomes either due to increased benefit or reduction in harm.

gtwachtman@frontlinemedcom.com

SAN ANTONIO – In a roundtable at the 2014 San Antonio Breast Cancer Symposium, Dr. Jame Abraham, Dr. Linda Bosserman, and Dr. Debra Patt discussed their top selections from the meeting’s presentations.

Among the topics were the promising findings in a small study involving the novel immune checkpoint inhibitor pembrolizumab in advanced triple-negative breast cancer; the SOFT trial, which looked at ovarian suppression with either tamoxifen or an aromatase inhibitor in premenopausal women with hormone receptor–positive disease; and the negative findings on the use of erythropoietin in patients with metastatic breast cancer.

The editors also highlighted findings showing no difference in disease-free survival between node-negative patients receiving six cycles of 5-fluorouracil, epirubicin, and cyclophosphamide and those receiving four cycles of Adriamycin and cyclophosphamide; and data from the Women’s Intervention Nutrition Study, which showed that lifestyle and dietary changes can have a notable impact on outcomes in women with early-stage, treated breast cancer.

Management of therapy side effects, fertility concerns in younger patients, patient quality of life, and the cost effectiveness of treatment were a subtext to the editors’ discussions of the clinical findings, as they highlighted the importance of looking closely at the risk-benefit relationship in delivering quality, affordable, personalized care to patients with breast cancer.

Dr. Abraham is director of the breast medical oncology at the Cleveland Clinic. Dr. Bosserman is clinical assistant professor at City of Hope Cancer Center, Duarte, Calif. Dr. Patt is a partner at Texas Oncology, Austin, and director of health care informatics at McKesson Specialty Health.

rmatthews@frontlinemedcom.com

SAN ANTONIO – In a roundtable at the 2014 San Antonio Breast Cancer Symposium, Dr. Jame Abraham, Dr. Linda Bosserman, and Dr. Debra Patt discussed their top selections from the meeting’s presentations.

Among the topics were the promising findings in a small study involving the novel immune checkpoint inhibitor pembrolizumab in advanced triple-negative breast cancer; the SOFT trial, which looked at ovarian suppression with either tamoxifen or an aromatase inhibitor in premenopausal women with hormone receptor–positive disease; and the negative findings on the use of erythropoietin in patients with metastatic breast cancer.

The editors also highlighted findings showing no difference in disease-free survival between node-negative patients receiving six cycles of 5-fluorouracil, epirubicin, and cyclophosphamide and those receiving four cycles of Adriamycin and cyclophosphamide; and data from the Women’s Intervention Nutrition Study, which showed that lifestyle and dietary changes can have a notable impact on outcomes in women with early-stage, treated breast cancer.

Management of therapy side effects, fertility concerns in younger patients, patient quality of life, and the cost effectiveness of treatment were a subtext to the editors’ discussions of the clinical findings, as they highlighted the importance of looking closely at the risk-benefit relationship in delivering quality, affordable, personalized care to patients with breast cancer.

Dr. Abraham is director of the breast medical oncology at the Cleveland Clinic. Dr. Bosserman is clinical assistant professor at City of Hope Cancer Center, Duarte, Calif. Dr. Patt is a partner at Texas Oncology, Austin, and director of health care informatics at McKesson Specialty Health.

rmatthews@frontlinemedcom.com

SAN ANTONIO – In a roundtable at the 2014 San Antonio Breast Cancer Symposium, Dr. Jame Abraham, Dr. Linda Bosserman, and Dr. Debra Patt discussed their top selections from the meeting’s presentations.

Among the topics were the promising findings in a small study involving the novel immune checkpoint inhibitor pembrolizumab in advanced triple-negative breast cancer; the SOFT trial, which looked at ovarian suppression with either tamoxifen or an aromatase inhibitor in premenopausal women with hormone receptor–positive disease; and the negative findings on the use of erythropoietin in patients with metastatic breast cancer.

The editors also highlighted findings showing no difference in disease-free survival between node-negative patients receiving six cycles of 5-fluorouracil, epirubicin, and cyclophosphamide and those receiving four cycles of Adriamycin and cyclophosphamide; and data from the Women’s Intervention Nutrition Study, which showed that lifestyle and dietary changes can have a notable impact on outcomes in women with early-stage, treated breast cancer.

Management of therapy side effects, fertility concerns in younger patients, patient quality of life, and the cost effectiveness of treatment were a subtext to the editors’ discussions of the clinical findings, as they highlighted the importance of looking closely at the risk-benefit relationship in delivering quality, affordable, personalized care to patients with breast cancer.

Dr. Abraham is director of the breast medical oncology at the Cleveland Clinic. Dr. Bosserman is clinical assistant professor at City of Hope Cancer Center, Duarte, Calif. Dr. Patt is a partner at Texas Oncology, Austin, and director of health care informatics at McKesson Specialty Health.

rmatthews@frontlinemedcom.com

Background Problems with sexual functioning are common following therapy for breast and gynecologic cancers, although there are few effective treatments.

Objective To assess the impact of ArginMax, a nutritional supplement comprised of extracts of L-arginine, ginseng, gingko, and damiana, as well as multivitamins and minerals, on sexual functioning and quality of life in female cancer survivors.

Methods This was a 12-week, randomized, placebo-controlled trial of eligible patients who were 6 months or more from active treatment and reporting problems with sexual interest, satisfaction, and functioning after therapy. The participants took 3 capsules of ArginMax or placebo twice daily. Outcome measures were the Female Sexual Function Inventory (FSFI) and the Functional Assessment of Cancer Therapy - General (FACT-G). Assessments were done at baseline, 4, 8, and 12 weeks.

Results 186 patients with a median age of 50 years were accrued between May 10, 2007 and March 24, 2010. 76% of the patients were non-Hispanic white. Most had breast or a gynecologic cancer (78% and 12%, respectively). At 12 weeks, there were no differences between the ArginMax group (n = 96) and placebo (n = 92) group in sexual desire, arousal, lubrication, orgasm, satisfaction or pain. However, FACT-G total scores were significantly better for participants who took ArginMax compared with those who took placebo (least squares [LS] means, 87.5 vs 82.9, respectively; P = .009). The Fact-G subscales that were most affected were Physical (25.37 vs. 23.51, P = .001) and Functional Well-Being (22.46 vs. 20.72, P = .007). Toxicities were similar for both groups.

Limitations Study results are limited by a lack of data on the participants’ psychological and physical symptoms and sexual partner variables.

Conclusions ArginMax had no significant impact on sexual functioning, but patient quality of life was significantly better at 12 weeks in participants who received ArginMax.

Funding Sponsored by NCI 3 U10 CA081851-12 and The Daily Wellness Company

Click on the PDF icon at the top of this introduction to read the full article.​

Background Problems with sexual functioning are common following therapy for breast and gynecologic cancers, although there are few effective treatments.

Objective To assess the impact of ArginMax, a nutritional supplement comprised of extracts of L-arginine, ginseng, gingko, and damiana, as well as multivitamins and minerals, on sexual functioning and quality of life in female cancer survivors.

Methods This was a 12-week, randomized, placebo-controlled trial of eligible patients who were 6 months or more from active treatment and reporting problems with sexual interest, satisfaction, and functioning after therapy. The participants took 3 capsules of ArginMax or placebo twice daily. Outcome measures were the Female Sexual Function Inventory (FSFI) and the Functional Assessment of Cancer Therapy - General (FACT-G). Assessments were done at baseline, 4, 8, and 12 weeks.

Results 186 patients with a median age of 50 years were accrued between May 10, 2007 and March 24, 2010. 76% of the patients were non-Hispanic white. Most had breast or a gynecologic cancer (78% and 12%, respectively). At 12 weeks, there were no differences between the ArginMax group (n = 96) and placebo (n = 92) group in sexual desire, arousal, lubrication, orgasm, satisfaction or pain. However, FACT-G total scores were significantly better for participants who took ArginMax compared with those who took placebo (least squares [LS] means, 87.5 vs 82.9, respectively; P = .009). The Fact-G subscales that were most affected were Physical (25.37 vs. 23.51, P = .001) and Functional Well-Being (22.46 vs. 20.72, P = .007). Toxicities were similar for both groups.

Limitations Study results are limited by a lack of data on the participants’ psychological and physical symptoms and sexual partner variables.

Conclusions ArginMax had no significant impact on sexual functioning, but patient quality of life was significantly better at 12 weeks in participants who received ArginMax.

Funding Sponsored by NCI 3 U10 CA081851-12 and The Daily Wellness Company

Click on the PDF icon at the top of this introduction to read the full article.​

Background Problems with sexual functioning are common following therapy for breast and gynecologic cancers, although there are few effective treatments.

Objective To assess the impact of ArginMax, a nutritional supplement comprised of extracts of L-arginine, ginseng, gingko, and damiana, as well as multivitamins and minerals, on sexual functioning and quality of life in female cancer survivors.

Methods This was a 12-week, randomized, placebo-controlled trial of eligible patients who were 6 months or more from active treatment and reporting problems with sexual interest, satisfaction, and functioning after therapy. The participants took 3 capsules of ArginMax or placebo twice daily. Outcome measures were the Female Sexual Function Inventory (FSFI) and the Functional Assessment of Cancer Therapy - General (FACT-G). Assessments were done at baseline, 4, 8, and 12 weeks.

Results 186 patients with a median age of 50 years were accrued between May 10, 2007 and March 24, 2010. 76% of the patients were non-Hispanic white. Most had breast or a gynecologic cancer (78% and 12%, respectively). At 12 weeks, there were no differences between the ArginMax group (n = 96) and placebo (n = 92) group in sexual desire, arousal, lubrication, orgasm, satisfaction or pain. However, FACT-G total scores were significantly better for participants who took ArginMax compared with those who took placebo (least squares [LS] means, 87.5 vs 82.9, respectively; P = .009). The Fact-G subscales that were most affected were Physical (25.37 vs. 23.51, P = .001) and Functional Well-Being (22.46 vs. 20.72, P = .007). Toxicities were similar for both groups.

Limitations Study results are limited by a lack of data on the participants’ psychological and physical symptoms and sexual partner variables.

Conclusions ArginMax had no significant impact on sexual functioning, but patient quality of life was significantly better at 12 weeks in participants who received ArginMax.

Funding Sponsored by NCI 3 U10 CA081851-12 and The Daily Wellness Company

Click on the PDF icon at the top of this introduction to read the full article.​

In patients with human epidermal growth factor receptor 2–positive advanced breast cancer, the combination of lapatinib plus taxane resulted in poorer progression-free survival and more toxicity than trastuzumab plus taxane, according to final clinical trial results reported online March 16 in the Journal of Clinical Oncology.

“Our results support the use of trastuzumab over lapatinib in the HER2 treatment-naive first-line metastatic setting,” wrote Dr. Karen A. Gelmon of the BC Cancer Agency, Vancouver, and her colleagues (J. Clin. Oncol. 2015 Mar. 16 doi:10.1200/JCO.2014.56.9590]).

For patients taking lapatinib plus taxane, the median progression-free survival was 9.0 months vs. 11.3 months for those taking trastuzumab plus taxane (hazard ratio, 1.37; 95% CI, 1.13-1.65; P = .001). Among patients with centrally confirmed HER2-positive disease, those receiving lapatinib had worse overall survival (HR, 1.47; 95% CI, 1.03-2.09; P = .03), the investigators reported.

From 2008 to 2011 the NCIC Clinical Trials Group MA.31 enrolled patients in 21 countries, and evaluated 537 patients with centrally confirmed HER2-postive disease; 61% had an Eastern Cooperative Oncology Group performance status of 0, 82% had no prior anti-HER2 therapy, 70% had no prior taxane therapy, 65% were estrogen-receptor positive, and 42% had metastatic disease at diagnosis. The median follow up was 21.5 months.

Treatment discontinuation because of toxicity was more frequent with lapatinib (15%) than trastuzumab (8%). Grade 3 or 4 rash occurred in 8% of patients in the lapatinib arm, compared with 0% in the trastuzumab group (P < .001). Grade 3 or 4 diarrhea occurred in 19% vs. 1% of the lapatinib and trastuzumab arms, respectively (P < .001).

The authors noted that these results “have implications for the treatment of patients with advanced HER2-positive breast cancer, where dual therapy or newer agents are not available but where the older agents or biosimilars may be available and affordable.”

In patients with human epidermal growth factor receptor 2–positive advanced breast cancer, the combination of lapatinib plus taxane resulted in poorer progression-free survival and more toxicity than trastuzumab plus taxane, according to final clinical trial results reported online March 16 in the Journal of Clinical Oncology.

“Our results support the use of trastuzumab over lapatinib in the HER2 treatment-naive first-line metastatic setting,” wrote Dr. Karen A. Gelmon of the BC Cancer Agency, Vancouver, and her colleagues (J. Clin. Oncol. 2015 Mar. 16 doi:10.1200/JCO.2014.56.9590]).

For patients taking lapatinib plus taxane, the median progression-free survival was 9.0 months vs. 11.3 months for those taking trastuzumab plus taxane (hazard ratio, 1.37; 95% CI, 1.13-1.65; P = .001). Among patients with centrally confirmed HER2-positive disease, those receiving lapatinib had worse overall survival (HR, 1.47; 95% CI, 1.03-2.09; P = .03), the investigators reported.

From 2008 to 2011 the NCIC Clinical Trials Group MA.31 enrolled patients in 21 countries, and evaluated 537 patients with centrally confirmed HER2-postive disease; 61% had an Eastern Cooperative Oncology Group performance status of 0, 82% had no prior anti-HER2 therapy, 70% had no prior taxane therapy, 65% were estrogen-receptor positive, and 42% had metastatic disease at diagnosis. The median follow up was 21.5 months.

Treatment discontinuation because of toxicity was more frequent with lapatinib (15%) than trastuzumab (8%). Grade 3 or 4 rash occurred in 8% of patients in the lapatinib arm, compared with 0% in the trastuzumab group (P < .001). Grade 3 or 4 diarrhea occurred in 19% vs. 1% of the lapatinib and trastuzumab arms, respectively (P < .001).

The authors noted that these results “have implications for the treatment of patients with advanced HER2-positive breast cancer, where dual therapy or newer agents are not available but where the older agents or biosimilars may be available and affordable.”

In patients with human epidermal growth factor receptor 2–positive advanced breast cancer, the combination of lapatinib plus taxane resulted in poorer progression-free survival and more toxicity than trastuzumab plus taxane, according to final clinical trial results reported online March 16 in the Journal of Clinical Oncology.

“Our results support the use of trastuzumab over lapatinib in the HER2 treatment-naive first-line metastatic setting,” wrote Dr. Karen A. Gelmon of the BC Cancer Agency, Vancouver, and her colleagues (J. Clin. Oncol. 2015 Mar. 16 doi:10.1200/JCO.2014.56.9590]).

For patients taking lapatinib plus taxane, the median progression-free survival was 9.0 months vs. 11.3 months for those taking trastuzumab plus taxane (hazard ratio, 1.37; 95% CI, 1.13-1.65; P = .001). Among patients with centrally confirmed HER2-positive disease, those receiving lapatinib had worse overall survival (HR, 1.47; 95% CI, 1.03-2.09; P = .03), the investigators reported.

From 2008 to 2011 the NCIC Clinical Trials Group MA.31 enrolled patients in 21 countries, and evaluated 537 patients with centrally confirmed HER2-postive disease; 61% had an Eastern Cooperative Oncology Group performance status of 0, 82% had no prior anti-HER2 therapy, 70% had no prior taxane therapy, 65% were estrogen-receptor positive, and 42% had metastatic disease at diagnosis. The median follow up was 21.5 months.

Treatment discontinuation because of toxicity was more frequent with lapatinib (15%) than trastuzumab (8%). Grade 3 or 4 rash occurred in 8% of patients in the lapatinib arm, compared with 0% in the trastuzumab group (P < .001). Grade 3 or 4 diarrhea occurred in 19% vs. 1% of the lapatinib and trastuzumab arms, respectively (P < .001).

The authors noted that these results “have implications for the treatment of patients with advanced HER2-positive breast cancer, where dual therapy or newer agents are not available but where the older agents or biosimilars may be available and affordable.”

Although it is generally accepted that women given a diagnosis of breast cancer are vulnerable to depression, studies investigating this association have been hampered by cross-sectional design, a short duration of follow-up, or a lack of clinical detail. In a new study from Denmark, Suppli and colleagues used the national health database to identify almost 2 million women with no history of cancer or inpatient care for depression whom they followed from 1988 to 2011. They identified incident cases of breast cancer in this population, as well as prescriptions for antidepressants and inpatient care for depression during the follow-up period.¹

What they found may surprise you: Not only were women given a diagnosis of breast cancer three times more likely to fill a prescription for an antidepressant in the first year after diagnosis (rate ratio, 3.09; 95% confidence interval [CI], 2.95–3.22), but the rate ratio remained significantly elevated as far out as 8 years after diagnosis.

Suppli and colleagues also found that the rate ratio for hospitalization for depression was 1.70 in the first year (95% CI, 1.41–2.05). It, too, remained significantly elevated as far out as 5 years after diagnosis.

Women who were age 70 or older at the time of diagnosis were more likely to be treated for depression and to be hospitalized. Other risk factors for depression included comorbidity, node-positive disease, basic and vocational educational levels, and living alone.

The type of cancer treatment the women underwent appeared to have no bearing on the risk of depression.

What we can do about the risk of depression in cancer patients
The finding that breast cancer is associated with depression is not new, but the magnitude of the association documented in this large study from a Danish national registry clarifies the role of women’s health providers: We need to be mindful of the long-term impact this disease can have on our patients’ mental health so that we are better able to recognize and proactively address mood disorders in this vulnerable population.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Although it is generally accepted that women given a diagnosis of breast cancer are vulnerable to depression, studies investigating this association have been hampered by cross-sectional design, a short duration of follow-up, or a lack of clinical detail. In a new study from Denmark, Suppli and colleagues used the national health database to identify almost 2 million women with no history of cancer or inpatient care for depression whom they followed from 1988 to 2011. They identified incident cases of breast cancer in this population, as well as prescriptions for antidepressants and inpatient care for depression during the follow-up period.¹

What they found may surprise you: Not only were women given a diagnosis of breast cancer three times more likely to fill a prescription for an antidepressant in the first year after diagnosis (rate ratio, 3.09; 95% confidence interval [CI], 2.95–3.22), but the rate ratio remained significantly elevated as far out as 8 years after diagnosis.

Suppli and colleagues also found that the rate ratio for hospitalization for depression was 1.70 in the first year (95% CI, 1.41–2.05). It, too, remained significantly elevated as far out as 5 years after diagnosis.

Women who were age 70 or older at the time of diagnosis were more likely to be treated for depression and to be hospitalized. Other risk factors for depression included comorbidity, node-positive disease, basic and vocational educational levels, and living alone.

The type of cancer treatment the women underwent appeared to have no bearing on the risk of depression.

What we can do about the risk of depression in cancer patients
The finding that breast cancer is associated with depression is not new, but the magnitude of the association documented in this large study from a Danish national registry clarifies the role of women’s health providers: We need to be mindful of the long-term impact this disease can have on our patients’ mental health so that we are better able to recognize and proactively address mood disorders in this vulnerable population.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Although it is generally accepted that women given a diagnosis of breast cancer are vulnerable to depression, studies investigating this association have been hampered by cross-sectional design, a short duration of follow-up, or a lack of clinical detail. In a new study from Denmark, Suppli and colleagues used the national health database to identify almost 2 million women with no history of cancer or inpatient care for depression whom they followed from 1988 to 2011. They identified incident cases of breast cancer in this population, as well as prescriptions for antidepressants and inpatient care for depression during the follow-up period.¹

What they found may surprise you: Not only were women given a diagnosis of breast cancer three times more likely to fill a prescription for an antidepressant in the first year after diagnosis (rate ratio, 3.09; 95% confidence interval [CI], 2.95–3.22), but the rate ratio remained significantly elevated as far out as 8 years after diagnosis.

Suppli and colleagues also found that the rate ratio for hospitalization for depression was 1.70 in the first year (95% CI, 1.41–2.05). It, too, remained significantly elevated as far out as 5 years after diagnosis.

Women who were age 70 or older at the time of diagnosis were more likely to be treated for depression and to be hospitalized. Other risk factors for depression included comorbidity, node-positive disease, basic and vocational educational levels, and living alone.

The type of cancer treatment the women underwent appeared to have no bearing on the risk of depression.

What we can do about the risk of depression in cancer patients
The finding that breast cancer is associated with depression is not new, but the magnitude of the association documented in this large study from a Danish national registry clarifies the role of women’s health providers: We need to be mindful of the long-term impact this disease can have on our patients’ mental health so that we are better able to recognize and proactively address mood disorders in this vulnerable population.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.