Video

SAN ANTONIO – Phase 2 neoadjuvant endocrine therapy breast cancer trials can and should serve as a testing platform to inform the design of phase 3 trials with the ability to change practice, according to Ingrid A. Mayer, MD.

Correlating outcomes such as the Preoperative Endocrine Prognostic Index and Ki67 blood levels from phase 2 trials to larger, similarly designed trials could reduce costs, time, and the need for large numbers of patients, thereby promoting more efficient development of effective breast cancer therapies, she said during a plenary lecture at the San Antonio Breast Cancer Symposium.

In this video interview, Dr. Mayer, director of breast medical oncology at Vanderbilt University, Nashville, Tenn., explained that while neoadjuvant endocrine therapy is suitable for down-staging tumors in women with stage I-III breast cancer, it is not commonly used, as those patients are also good surgery candidates.

However, neoadjuvant endocrine therapy can be “an incredible platform” to test novel combinations of endocrine therapy agents with or without targeted treatments, validate new biomarkers, discover mechanisms of resistance, and predict the best combinations for moving forward in phase 3 trials, she said, adding that “this is something that all academic institutions potentially should be doing.”

Although the direct clinical benefit for patients who participate in such trials is not tremendous, participation has the potential to ultimately improve outcomes for participants and for “their friends and families and daughters,” and to help propel the science forward, Dr. Meyer noted.

“I would argue that we really should be moving forward to designing trials in the neoadjuvant endocrine setting more and more, and really utilizing this platform for that end,” she said.

Dr. Mayer reported having no relevant disclosures.

[email protected]

SAN ANTONIO – Phase 2 neoadjuvant endocrine therapy breast cancer trials can and should serve as a testing platform to inform the design of phase 3 trials with the ability to change practice, according to Ingrid A. Mayer, MD.

Correlating outcomes such as the Preoperative Endocrine Prognostic Index and Ki67 blood levels from phase 2 trials to larger, similarly designed trials could reduce costs, time, and the need for large numbers of patients, thereby promoting more efficient development of effective breast cancer therapies, she said during a plenary lecture at the San Antonio Breast Cancer Symposium.

In this video interview, Dr. Mayer, director of breast medical oncology at Vanderbilt University, Nashville, Tenn., explained that while neoadjuvant endocrine therapy is suitable for down-staging tumors in women with stage I-III breast cancer, it is not commonly used, as those patients are also good surgery candidates.

However, neoadjuvant endocrine therapy can be “an incredible platform” to test novel combinations of endocrine therapy agents with or without targeted treatments, validate new biomarkers, discover mechanisms of resistance, and predict the best combinations for moving forward in phase 3 trials, she said, adding that “this is something that all academic institutions potentially should be doing.”

Although the direct clinical benefit for patients who participate in such trials is not tremendous, participation has the potential to ultimately improve outcomes for participants and for “their friends and families and daughters,” and to help propel the science forward, Dr. Meyer noted.

“I would argue that we really should be moving forward to designing trials in the neoadjuvant endocrine setting more and more, and really utilizing this platform for that end,” she said.

Dr. Mayer reported having no relevant disclosures.

[email protected]

SAN ANTONIO – Phase 2 neoadjuvant endocrine therapy breast cancer trials can and should serve as a testing platform to inform the design of phase 3 trials with the ability to change practice, according to Ingrid A. Mayer, MD.

Correlating outcomes such as the Preoperative Endocrine Prognostic Index and Ki67 blood levels from phase 2 trials to larger, similarly designed trials could reduce costs, time, and the need for large numbers of patients, thereby promoting more efficient development of effective breast cancer therapies, she said during a plenary lecture at the San Antonio Breast Cancer Symposium.

In this video interview, Dr. Mayer, director of breast medical oncology at Vanderbilt University, Nashville, Tenn., explained that while neoadjuvant endocrine therapy is suitable for down-staging tumors in women with stage I-III breast cancer, it is not commonly used, as those patients are also good surgery candidates.

However, neoadjuvant endocrine therapy can be “an incredible platform” to test novel combinations of endocrine therapy agents with or without targeted treatments, validate new biomarkers, discover mechanisms of resistance, and predict the best combinations for moving forward in phase 3 trials, she said, adding that “this is something that all academic institutions potentially should be doing.”

Although the direct clinical benefit for patients who participate in such trials is not tremendous, participation has the potential to ultimately improve outcomes for participants and for “their friends and families and daughters,” and to help propel the science forward, Dr. Meyer noted.

“I would argue that we really should be moving forward to designing trials in the neoadjuvant endocrine setting more and more, and really utilizing this platform for that end,” she said.

Dr. Mayer reported having no relevant disclosures.

[email protected]

SAN ANTONIO – A tailored 12-month exercise program during adjuvant breast cancer treatment appears to protect cardiovascular function, particularly in patients receiving chemotherapy, according to findings from the randomized EBBA-II trial.
 

The overall change in VO_2max at 12 months was +0.3% in 271 patients randomized to the intervention group, compared with –8.9% in 274 patients in the “usual care” control group, Inger Thune, MD, PhD, said at the San Antonio Breast Cancer Symposium.

Among patients receiving chemotherapy, the VO_2max change at 12 months was +1.6% in 120 patients in the intervention group, compared with –2.76% in 122 patients in the control group, said Dr. Thune of the Cancer Center at Oslo University Hospital.

Study participants were women aged 18-75 years (mean of 55 years at diagnosis) with stage I-II breast cancer, mean body mass index of 25 kg/m², and a mean VO_2max before surgery of 31.5 mL/kg per minute. The intervention group entered a 12-month individualized exercise program 2-3 weeks after surgery based on their own VO_2max at baseline.


They met for training sessions in groups of 10-12 women for 60 minutes twice weekly over the 12-month study period, and were also told to perform at least 120 minutes of exercise at home for a total of 240 minutes of exercise weekly.

Of note, the adherence rate among participants was encouragingly high at about 90%, she said, adding that the findings strongly support tailored exercise during adjuvant breast cancer treatment, as such an intervention appears to counteract declines in cardiovascular function – particularly in those receiving chemotherapy.

In this video interview, Dr. Thune further discussed the study design, implications of the findings, and future directions.

“Cardiovascular morbidity is so important for our breast cancer patients that I think that it’s time to have physical activity [and] physical function as a main interest for all clinicians dealing with breast cancer patients,” she said.

Dr. Thune reported having no disclosures.

SAN ANTONIO – A tailored 12-month exercise program during adjuvant breast cancer treatment appears to protect cardiovascular function, particularly in patients receiving chemotherapy, according to findings from the randomized EBBA-II trial.
 

The overall change in VO_2max at 12 months was +0.3% in 271 patients randomized to the intervention group, compared with –8.9% in 274 patients in the “usual care” control group, Inger Thune, MD, PhD, said at the San Antonio Breast Cancer Symposium.

Among patients receiving chemotherapy, the VO_2max change at 12 months was +1.6% in 120 patients in the intervention group, compared with –2.76% in 122 patients in the control group, said Dr. Thune of the Cancer Center at Oslo University Hospital.

Study participants were women aged 18-75 years (mean of 55 years at diagnosis) with stage I-II breast cancer, mean body mass index of 25 kg/m², and a mean VO_2max before surgery of 31.5 mL/kg per minute. The intervention group entered a 12-month individualized exercise program 2-3 weeks after surgery based on their own VO_2max at baseline.


They met for training sessions in groups of 10-12 women for 60 minutes twice weekly over the 12-month study period, and were also told to perform at least 120 minutes of exercise at home for a total of 240 minutes of exercise weekly.

Of note, the adherence rate among participants was encouragingly high at about 90%, she said, adding that the findings strongly support tailored exercise during adjuvant breast cancer treatment, as such an intervention appears to counteract declines in cardiovascular function – particularly in those receiving chemotherapy.

In this video interview, Dr. Thune further discussed the study design, implications of the findings, and future directions.

“Cardiovascular morbidity is so important for our breast cancer patients that I think that it’s time to have physical activity [and] physical function as a main interest for all clinicians dealing with breast cancer patients,” she said.

Dr. Thune reported having no disclosures.

SAN ANTONIO – A tailored 12-month exercise program during adjuvant breast cancer treatment appears to protect cardiovascular function, particularly in patients receiving chemotherapy, according to findings from the randomized EBBA-II trial.
 

The overall change in VO_2max at 12 months was +0.3% in 271 patients randomized to the intervention group, compared with –8.9% in 274 patients in the “usual care” control group, Inger Thune, MD, PhD, said at the San Antonio Breast Cancer Symposium.

Among patients receiving chemotherapy, the VO_2max change at 12 months was +1.6% in 120 patients in the intervention group, compared with –2.76% in 122 patients in the control group, said Dr. Thune of the Cancer Center at Oslo University Hospital.

Study participants were women aged 18-75 years (mean of 55 years at diagnosis) with stage I-II breast cancer, mean body mass index of 25 kg/m², and a mean VO_2max before surgery of 31.5 mL/kg per minute. The intervention group entered a 12-month individualized exercise program 2-3 weeks after surgery based on their own VO_2max at baseline.


They met for training sessions in groups of 10-12 women for 60 minutes twice weekly over the 12-month study period, and were also told to perform at least 120 minutes of exercise at home for a total of 240 minutes of exercise weekly.

Of note, the adherence rate among participants was encouragingly high at about 90%, she said, adding that the findings strongly support tailored exercise during adjuvant breast cancer treatment, as such an intervention appears to counteract declines in cardiovascular function – particularly in those receiving chemotherapy.

In this video interview, Dr. Thune further discussed the study design, implications of the findings, and future directions.

“Cardiovascular morbidity is so important for our breast cancer patients that I think that it’s time to have physical activity [and] physical function as a main interest for all clinicians dealing with breast cancer patients,” she said.

Dr. Thune reported having no disclosures.

SAN ANTONIO – Oxybutynin (Ditropan), a drug approved to treat overactive bladder, is highly efficacious and well tolerated when used to alleviate hot flashes, according to results of a randomized, controlled trial of 150 women reported by lead author Roberto A. Leon-Ferre, MD.

The women, about two-thirds of whom were breast cancer survivors taking tamoxifen or aromatase inhibitors, were having at least 28 hot flashes weekly at baseline. Results of the trial showed that the 6-week reduction in a hot flash score capturing both frequency and severity was about 30% with placebo, 65% with oxybutynin 2.5 mg b.i.d., and 80% with oxybutynin 5 mg b.i.d. (P less than .01 across groups).

There also was a significant difference in quality of life in favor of the drug and, in the higher-dose group, significantly better scores for mood and life enjoyment. In a video interview, Dr. Leon-Ferre discussed how oxybutynin compares with other available treatment options, which women are good or poor candidates for this drug, and how the findings have influenced his own practice.

Dr. Leon-Ferre of the Mayo Clinic, Rochester, Minn., disclosed that he had no relevant conflicts of interest. The study was funded by the Breast Cancer Research Foundation.

SAN ANTONIO – Oxybutynin (Ditropan), a drug approved to treat overactive bladder, is highly efficacious and well tolerated when used to alleviate hot flashes, according to results of a randomized, controlled trial of 150 women reported by lead author Roberto A. Leon-Ferre, MD.

The women, about two-thirds of whom were breast cancer survivors taking tamoxifen or aromatase inhibitors, were having at least 28 hot flashes weekly at baseline. Results of the trial showed that the 6-week reduction in a hot flash score capturing both frequency and severity was about 30% with placebo, 65% with oxybutynin 2.5 mg b.i.d., and 80% with oxybutynin 5 mg b.i.d. (P less than .01 across groups).

There also was a significant difference in quality of life in favor of the drug and, in the higher-dose group, significantly better scores for mood and life enjoyment. In a video interview, Dr. Leon-Ferre discussed how oxybutynin compares with other available treatment options, which women are good or poor candidates for this drug, and how the findings have influenced his own practice.

Dr. Leon-Ferre of the Mayo Clinic, Rochester, Minn., disclosed that he had no relevant conflicts of interest. The study was funded by the Breast Cancer Research Foundation.

SAN ANTONIO – Oxybutynin (Ditropan), a drug approved to treat overactive bladder, is highly efficacious and well tolerated when used to alleviate hot flashes, according to results of a randomized, controlled trial of 150 women reported by lead author Roberto A. Leon-Ferre, MD.

The women, about two-thirds of whom were breast cancer survivors taking tamoxifen or aromatase inhibitors, were having at least 28 hot flashes weekly at baseline. Results of the trial showed that the 6-week reduction in a hot flash score capturing both frequency and severity was about 30% with placebo, 65% with oxybutynin 2.5 mg b.i.d., and 80% with oxybutynin 5 mg b.i.d. (P less than .01 across groups).

There also was a significant difference in quality of life in favor of the drug and, in the higher-dose group, significantly better scores for mood and life enjoyment. In a video interview, Dr. Leon-Ferre discussed how oxybutynin compares with other available treatment options, which women are good or poor candidates for this drug, and how the findings have influenced his own practice.

Dr. Leon-Ferre of the Mayo Clinic, Rochester, Minn., disclosed that he had no relevant conflicts of interest. The study was funded by the Breast Cancer Research Foundation.

SAN ANTONIO – Younger breast cancer patients who undergo unilateral or bilateral mastectomy report lower breast satisfaction and poorer psychosocial and sexual well-being than counterparts who undergo breast-conserving surgery, finds a cross-sectional cohort study presented by lead investigator Laura S. Dominici, MD, FACS, at the San Antonio Breast Cancer Symposium.

The 560 women studied had a mean age of 37 years and had completed the BREAST-Q questionnaire a median of 5.8 years after their breast cancer diagnosis. Results showed that the mean score for satisfaction with breasts was 65.5 with breast-conserving surgery, 59.3 with unilateral mastectomy, and 60.4 with bilateral mastectomy (P = .008). The mastectomy groups also had poorer scores for psychosocial well-being (P less than .001) and sexual well-being (P less than .001), but not physical well-being. Most of the differences remained significant in meta-analysis. In a video interview, Dr. Dominici, of Dana-Farber Cancer Institute, Boston, discussed worry and anxiety about recurrence and second cancers as drivers of choosing mastectomy, generalizability of the study’s findings, and strategies for incorporating this new information into counseling and shared decision making.

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

SAN ANTONIO – Younger breast cancer patients who undergo unilateral or bilateral mastectomy report lower breast satisfaction and poorer psychosocial and sexual well-being than counterparts who undergo breast-conserving surgery, finds a cross-sectional cohort study presented by lead investigator Laura S. Dominici, MD, FACS, at the San Antonio Breast Cancer Symposium.

The 560 women studied had a mean age of 37 years and had completed the BREAST-Q questionnaire a median of 5.8 years after their breast cancer diagnosis. Results showed that the mean score for satisfaction with breasts was 65.5 with breast-conserving surgery, 59.3 with unilateral mastectomy, and 60.4 with bilateral mastectomy (P = .008). The mastectomy groups also had poorer scores for psychosocial well-being (P less than .001) and sexual well-being (P less than .001), but not physical well-being. Most of the differences remained significant in meta-analysis. In a video interview, Dr. Dominici, of Dana-Farber Cancer Institute, Boston, discussed worry and anxiety about recurrence and second cancers as drivers of choosing mastectomy, generalizability of the study’s findings, and strategies for incorporating this new information into counseling and shared decision making.

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

SAN ANTONIO – Younger breast cancer patients who undergo unilateral or bilateral mastectomy report lower breast satisfaction and poorer psychosocial and sexual well-being than counterparts who undergo breast-conserving surgery, finds a cross-sectional cohort study presented by lead investigator Laura S. Dominici, MD, FACS, at the San Antonio Breast Cancer Symposium.

The 560 women studied had a mean age of 37 years and had completed the BREAST-Q questionnaire a median of 5.8 years after their breast cancer diagnosis. Results showed that the mean score for satisfaction with breasts was 65.5 with breast-conserving surgery, 59.3 with unilateral mastectomy, and 60.4 with bilateral mastectomy (P = .008). The mastectomy groups also had poorer scores for psychosocial well-being (P less than .001) and sexual well-being (P less than .001), but not physical well-being. Most of the differences remained significant in meta-analysis. In a video interview, Dr. Dominici, of Dana-Farber Cancer Institute, Boston, discussed worry and anxiety about recurrence and second cancers as drivers of choosing mastectomy, generalizability of the study’s findings, and strategies for incorporating this new information into counseling and shared decision making.

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

SAN DIEGO – Prophylaxis with rivaroxaban significantly reduced the rate of venous thromboembolism and associated death in high-risk ambulatory cancer patients receiving systemic therapy, results of a randomized trial show.

The reduction in venous thromboembolism (VTE) or VTE-related death was not statistically significant in the primary analysis, in part because a large proportion of patients stopped taking the direct oral anticoagulant, according to investigator Alok A. Khorana, MD, of the Cleveland Clinic.

However, the reduction in events was significant in a prespecified secondary analysis limited to the on-treatment period, Dr. Khorana reported at the annual meeting of the American Society of Hematology, adding that rates of major and nonmajor bleeding were low.

Results are “eagerly awaited” from a different prophylaxis trial – the AVERT study – looking at another direct oral anticoagulant in high-risk cancer patients, Dr. Khorana said in a late-breaking abstracts session.

“If the findings of that trial are consistent with ours, then we certainly hope that these findings should inform future recommendations regarding thromboprophylaxis for high-risk ambulatory cancer patients, and then the landscape of anticoagulation in the cancer population should start to shift from management of events to primary prevention,” he said.

In the study by Dr. Khorana and his colleagues, known as CASSINI, 841 patients with various solid tumors and lymphomas were randomized to either rivaroxaban 10 mg or placebo once daily. The patients, enrolled at 143 study centers in 11 countries, all had a Khorana risk score of 2 or greater.

In the primary analysis period of 180 days, the composite endpoint of VTE or VTE-related death occurred in 5.95% of the rivaroxaban-treated group and 8.79% of the placebo group (hazard ratio, 0.66; 95% confidence interval, 0.40-1.09; P = .101). However, a total of 177 patients (43.7%) stopped rivaroxaban earlier than 180 days, and likewise, 203 patients (50.2%) stopped placebo early.

In a prespecified secondary analysis looking just at the period of time when patients were actually taking rivaroxaban or placebo, rivaroxaban did significantly reduce risk of VTE or VTE-related death, Dr. Khorana said. The composite endpoint occurred in 2.62% of the rivaroxaban patients and 6.41% of placebo patients in that on-treatment analysis (HR, 0.40; 95% CI, 0.20-0.80; P = .007).

Rates of major bleeding and clinically relevant nonmajor bleeding were not significantly different between groups, according to results of a safety analysis. Major bleeding occurred in eight rivaroxaban patients and four placebo patients, or 1.98% and 0.99%, respectively (P = .265).

CASSINI was sponsored by Bayer and Janssen. Dr. Khorana reported disclosures related to Janssen, Bayer, PAREXEL, Sanofi, Pfizer, TriSalus Life Sciences, Halozyme, Seattle Genetics, AngioDynamics, and others.

SAN DIEGO – Prophylaxis with rivaroxaban significantly reduced the rate of venous thromboembolism and associated death in high-risk ambulatory cancer patients receiving systemic therapy, results of a randomized trial show.

The reduction in venous thromboembolism (VTE) or VTE-related death was not statistically significant in the primary analysis, in part because a large proportion of patients stopped taking the direct oral anticoagulant, according to investigator Alok A. Khorana, MD, of the Cleveland Clinic.

However, the reduction in events was significant in a prespecified secondary analysis limited to the on-treatment period, Dr. Khorana reported at the annual meeting of the American Society of Hematology, adding that rates of major and nonmajor bleeding were low.

Results are “eagerly awaited” from a different prophylaxis trial – the AVERT study – looking at another direct oral anticoagulant in high-risk cancer patients, Dr. Khorana said in a late-breaking abstracts session.

“If the findings of that trial are consistent with ours, then we certainly hope that these findings should inform future recommendations regarding thromboprophylaxis for high-risk ambulatory cancer patients, and then the landscape of anticoagulation in the cancer population should start to shift from management of events to primary prevention,” he said.

In the study by Dr. Khorana and his colleagues, known as CASSINI, 841 patients with various solid tumors and lymphomas were randomized to either rivaroxaban 10 mg or placebo once daily. The patients, enrolled at 143 study centers in 11 countries, all had a Khorana risk score of 2 or greater.

In the primary analysis period of 180 days, the composite endpoint of VTE or VTE-related death occurred in 5.95% of the rivaroxaban-treated group and 8.79% of the placebo group (hazard ratio, 0.66; 95% confidence interval, 0.40-1.09; P = .101). However, a total of 177 patients (43.7%) stopped rivaroxaban earlier than 180 days, and likewise, 203 patients (50.2%) stopped placebo early.

In a prespecified secondary analysis looking just at the period of time when patients were actually taking rivaroxaban or placebo, rivaroxaban did significantly reduce risk of VTE or VTE-related death, Dr. Khorana said. The composite endpoint occurred in 2.62% of the rivaroxaban patients and 6.41% of placebo patients in that on-treatment analysis (HR, 0.40; 95% CI, 0.20-0.80; P = .007).

Rates of major bleeding and clinically relevant nonmajor bleeding were not significantly different between groups, according to results of a safety analysis. Major bleeding occurred in eight rivaroxaban patients and four placebo patients, or 1.98% and 0.99%, respectively (P = .265).

CASSINI was sponsored by Bayer and Janssen. Dr. Khorana reported disclosures related to Janssen, Bayer, PAREXEL, Sanofi, Pfizer, TriSalus Life Sciences, Halozyme, Seattle Genetics, AngioDynamics, and others.

SAN DIEGO – Prophylaxis with rivaroxaban significantly reduced the rate of venous thromboembolism and associated death in high-risk ambulatory cancer patients receiving systemic therapy, results of a randomized trial show.

The reduction in venous thromboembolism (VTE) or VTE-related death was not statistically significant in the primary analysis, in part because a large proportion of patients stopped taking the direct oral anticoagulant, according to investigator Alok A. Khorana, MD, of the Cleveland Clinic.

However, the reduction in events was significant in a prespecified secondary analysis limited to the on-treatment period, Dr. Khorana reported at the annual meeting of the American Society of Hematology, adding that rates of major and nonmajor bleeding were low.

Results are “eagerly awaited” from a different prophylaxis trial – the AVERT study – looking at another direct oral anticoagulant in high-risk cancer patients, Dr. Khorana said in a late-breaking abstracts session.

“If the findings of that trial are consistent with ours, then we certainly hope that these findings should inform future recommendations regarding thromboprophylaxis for high-risk ambulatory cancer patients, and then the landscape of anticoagulation in the cancer population should start to shift from management of events to primary prevention,” he said.

In the study by Dr. Khorana and his colleagues, known as CASSINI, 841 patients with various solid tumors and lymphomas were randomized to either rivaroxaban 10 mg or placebo once daily. The patients, enrolled at 143 study centers in 11 countries, all had a Khorana risk score of 2 or greater.

In the primary analysis period of 180 days, the composite endpoint of VTE or VTE-related death occurred in 5.95% of the rivaroxaban-treated group and 8.79% of the placebo group (hazard ratio, 0.66; 95% confidence interval, 0.40-1.09; P = .101). However, a total of 177 patients (43.7%) stopped rivaroxaban earlier than 180 days, and likewise, 203 patients (50.2%) stopped placebo early.

In a prespecified secondary analysis looking just at the period of time when patients were actually taking rivaroxaban or placebo, rivaroxaban did significantly reduce risk of VTE or VTE-related death, Dr. Khorana said. The composite endpoint occurred in 2.62% of the rivaroxaban patients and 6.41% of placebo patients in that on-treatment analysis (HR, 0.40; 95% CI, 0.20-0.80; P = .007).

Rates of major bleeding and clinically relevant nonmajor bleeding were not significantly different between groups, according to results of a safety analysis. Major bleeding occurred in eight rivaroxaban patients and four placebo patients, or 1.98% and 0.99%, respectively (P = .265).

CASSINI was sponsored by Bayer and Janssen. Dr. Khorana reported disclosures related to Janssen, Bayer, PAREXEL, Sanofi, Pfizer, TriSalus Life Sciences, Halozyme, Seattle Genetics, AngioDynamics, and others.

SAN ANTONIO – For patients with estrogen-receptor positive, HER2-negative metastatic breast cancer, the use of circulating tumor cell (CTC) counts can help clinicians decide with confidence between ordering first-line hormonal therapy or chemotherapy, investigators say.

In the phase 3 STIC CTC trial, patients were randomly assigned to receive therapy based on either the clinician’s judgment of the best course of therapy for each patient; or on the CTC count with a cutoff of less than 5 CT/7.5 mL, indicating hormonal therapy; and 5 CTC/7.5 mL or above, indicating higher-risk disease requiring chemotherapy. In the clinician’s choice arm, the CTC reading was recorded but not implemented, and in the CTC arm, the clinician’s choice was dismissed.

The trial met its primary noninferiority endpoint, indicating that, in the overall population, CTC counts can provide clinician’s with confidence in the therapeutic choice, said Francois-Clement Bidard, MD, PhD, from Institut Curie in Paris.

In a video interview, Dr. Bidard discussed the trial findings, including the provocative exploratory analysis suggesting that, in patients in whom there is discordance between CTC and clinician choice, chemotherapy may be a better therapeutic option.

The study was funded by the National Cancer Institute of France, Institut Curie, and Menarini Silicon Biosystems. Dr. Bidard disclosed research funding and travel grants from Menarini.

SAN ANTONIO – For patients with estrogen-receptor positive, HER2-negative metastatic breast cancer, the use of circulating tumor cell (CTC) counts can help clinicians decide with confidence between ordering first-line hormonal therapy or chemotherapy, investigators say.

In the phase 3 STIC CTC trial, patients were randomly assigned to receive therapy based on either the clinician’s judgment of the best course of therapy for each patient; or on the CTC count with a cutoff of less than 5 CT/7.5 mL, indicating hormonal therapy; and 5 CTC/7.5 mL or above, indicating higher-risk disease requiring chemotherapy. In the clinician’s choice arm, the CTC reading was recorded but not implemented, and in the CTC arm, the clinician’s choice was dismissed.

The trial met its primary noninferiority endpoint, indicating that, in the overall population, CTC counts can provide clinician’s with confidence in the therapeutic choice, said Francois-Clement Bidard, MD, PhD, from Institut Curie in Paris.

In a video interview, Dr. Bidard discussed the trial findings, including the provocative exploratory analysis suggesting that, in patients in whom there is discordance between CTC and clinician choice, chemotherapy may be a better therapeutic option.

The study was funded by the National Cancer Institute of France, Institut Curie, and Menarini Silicon Biosystems. Dr. Bidard disclosed research funding and travel grants from Menarini.

SAN ANTONIO – For patients with estrogen-receptor positive, HER2-negative metastatic breast cancer, the use of circulating tumor cell (CTC) counts can help clinicians decide with confidence between ordering first-line hormonal therapy or chemotherapy, investigators say.

In the phase 3 STIC CTC trial, patients were randomly assigned to receive therapy based on either the clinician’s judgment of the best course of therapy for each patient; or on the CTC count with a cutoff of less than 5 CT/7.5 mL, indicating hormonal therapy; and 5 CTC/7.5 mL or above, indicating higher-risk disease requiring chemotherapy. In the clinician’s choice arm, the CTC reading was recorded but not implemented, and in the CTC arm, the clinician’s choice was dismissed.

The trial met its primary noninferiority endpoint, indicating that, in the overall population, CTC counts can provide clinician’s with confidence in the therapeutic choice, said Francois-Clement Bidard, MD, PhD, from Institut Curie in Paris.

In a video interview, Dr. Bidard discussed the trial findings, including the provocative exploratory analysis suggesting that, in patients in whom there is discordance between CTC and clinician choice, chemotherapy may be a better therapeutic option.

The study was funded by the National Cancer Institute of France, Institut Curie, and Menarini Silicon Biosystems. Dr. Bidard disclosed research funding and travel grants from Menarini.

SAN ANTONIO – Both axillary radiation therapy and axillary lymph node dissection provide excellent, comparable locoregional control in patients with early-stage breast cancer who have a positive sentinel node, according to updated results of the European Organisation for Research and Treatment of Cancer’s AMAROS trial.
 

The 10-year cumulative incidence rate of axillary recurrence was 1.82% with radiation and 0.93% with lymph node dissection, a nonsignificant difference (hazard ratio, 1.71; P = .365). Distant metastasis–free survival and overall survival also were statistically on par. The findings reinforce the trial’s 5-year results, which additionally showed a markedly lower incidence of lymphedema with axillary radiation therapy. Lead investigator Emiel J. T. Rutgers, MD, PhD, reflected on hesitation in the uptake of axillary radiation therapy among oncologists and discussed the AMAROS results in the context of the ACOSOG Z11 trial. Dr. Rutgers, the principal investigator of the AMAROS trial and a surgical oncologist at the Netherlands Cancer Institute in Amsterdam, also described how the trial’s findings have altered practice at his institution.

Dr. Rutgers disclosed that he had no relevant conflicts of interest. The study was supported by the EORTC Charitable Trust.

SAN ANTONIO – Both axillary radiation therapy and axillary lymph node dissection provide excellent, comparable locoregional control in patients with early-stage breast cancer who have a positive sentinel node, according to updated results of the European Organisation for Research and Treatment of Cancer’s AMAROS trial.
 

The 10-year cumulative incidence rate of axillary recurrence was 1.82% with radiation and 0.93% with lymph node dissection, a nonsignificant difference (hazard ratio, 1.71; P = .365). Distant metastasis–free survival and overall survival also were statistically on par. The findings reinforce the trial’s 5-year results, which additionally showed a markedly lower incidence of lymphedema with axillary radiation therapy. Lead investigator Emiel J. T. Rutgers, MD, PhD, reflected on hesitation in the uptake of axillary radiation therapy among oncologists and discussed the AMAROS results in the context of the ACOSOG Z11 trial. Dr. Rutgers, the principal investigator of the AMAROS trial and a surgical oncologist at the Netherlands Cancer Institute in Amsterdam, also described how the trial’s findings have altered practice at his institution.

Dr. Rutgers disclosed that he had no relevant conflicts of interest. The study was supported by the EORTC Charitable Trust.

SAN ANTONIO – Both axillary radiation therapy and axillary lymph node dissection provide excellent, comparable locoregional control in patients with early-stage breast cancer who have a positive sentinel node, according to updated results of the European Organisation for Research and Treatment of Cancer’s AMAROS trial.
 

The 10-year cumulative incidence rate of axillary recurrence was 1.82% with radiation and 0.93% with lymph node dissection, a nonsignificant difference (hazard ratio, 1.71; P = .365). Distant metastasis–free survival and overall survival also were statistically on par. The findings reinforce the trial’s 5-year results, which additionally showed a markedly lower incidence of lymphedema with axillary radiation therapy. Lead investigator Emiel J. T. Rutgers, MD, PhD, reflected on hesitation in the uptake of axillary radiation therapy among oncologists and discussed the AMAROS results in the context of the ACOSOG Z11 trial. Dr. Rutgers, the principal investigator of the AMAROS trial and a surgical oncologist at the Netherlands Cancer Institute in Amsterdam, also described how the trial’s findings have altered practice at his institution.

Dr. Rutgers disclosed that he had no relevant conflicts of interest. The study was supported by the EORTC Charitable Trust.

SAN ANTONIO – Women with localized breast cancer who achieve a pathological complete response (pCR) after neoadjuvant chemotherapy may have little to gain from subsequent adjuvant chemotherapy except toxicity, according to a patient-level meta-analysis of more than 27,000 women. The analysis, reported by lead investigator Laura M. Spring, MD, at the San Antonio Breast Cancer Symposium, confirmed that, compared with residual disease, pCR was associated with significantly reduced risks of event-free survival events (hazard ratio, 0.31) and death (HR, 0.22). Moreover, the EFS benefit of a pCR was similar whether women went on to receive adjuvant chemotherapy (HR, 0.36) or not (HR, 0.36) (P = .60 for difference). Dr. Spring discussed overall and subgroup findings, implications for use of neoadjuvant chemotherapy, and how these new data may inform escalation and de-escalation of adjuvant therapy.

Dr. Spring disclosed that she has a consulting or advisory role with Novartis and that she receives institutional research funding from Tesaro. The study was supported by grants from the National Cancer Institute and Susan G. Komen.
 

SAN ANTONIO – Women with localized breast cancer who achieve a pathological complete response (pCR) after neoadjuvant chemotherapy may have little to gain from subsequent adjuvant chemotherapy except toxicity, according to a patient-level meta-analysis of more than 27,000 women. The analysis, reported by lead investigator Laura M. Spring, MD, at the San Antonio Breast Cancer Symposium, confirmed that, compared with residual disease, pCR was associated with significantly reduced risks of event-free survival events (hazard ratio, 0.31) and death (HR, 0.22). Moreover, the EFS benefit of a pCR was similar whether women went on to receive adjuvant chemotherapy (HR, 0.36) or not (HR, 0.36) (P = .60 for difference). Dr. Spring discussed overall and subgroup findings, implications for use of neoadjuvant chemotherapy, and how these new data may inform escalation and de-escalation of adjuvant therapy.

Dr. Spring disclosed that she has a consulting or advisory role with Novartis and that she receives institutional research funding from Tesaro. The study was supported by grants from the National Cancer Institute and Susan G. Komen.
 

SAN ANTONIO – Women with localized breast cancer who achieve a pathological complete response (pCR) after neoadjuvant chemotherapy may have little to gain from subsequent adjuvant chemotherapy except toxicity, according to a patient-level meta-analysis of more than 27,000 women. The analysis, reported by lead investigator Laura M. Spring, MD, at the San Antonio Breast Cancer Symposium, confirmed that, compared with residual disease, pCR was associated with significantly reduced risks of event-free survival events (hazard ratio, 0.31) and death (HR, 0.22). Moreover, the EFS benefit of a pCR was similar whether women went on to receive adjuvant chemotherapy (HR, 0.36) or not (HR, 0.36) (P = .60 for difference). Dr. Spring discussed overall and subgroup findings, implications for use of neoadjuvant chemotherapy, and how these new data may inform escalation and de-escalation of adjuvant therapy.

Dr. Spring disclosed that she has a consulting or advisory role with Novartis and that she receives institutional research funding from Tesaro. The study was supported by grants from the National Cancer Institute and Susan G. Komen.
 

SAN ANTONIO – A phase 3 randomized NRG Oncology trial (NSABP B-39/RTOG 0413) was unable to rule out the possibility that, after lumpectomy, partial breast irradiation is inferior to whole breast irradiation when it comes to the ipsilateral breast tumor recurrences (invasive disease or ductal carcinoma in situ), reported Frank Vicini, MD, of MHP Radiation Oncology Institute, Pontiac, Mich.
 

The hazard ratio for this event with the former versus latter modality was 1.22, with the 90% confidence interval (0.94-1.58) falling just outside the predefined range to declare the two modalities equivalent (0.667-1.5). However, the absolute difference in the 10-year cumulative incidence of ipsilateral breast tumor recurrences was just 0.7% (4.6% vs. 3.9%). In a video interview, Dr. Vicini discussed whether this difference is clinically important, and the implications of the trial’s findings, taken together, for offering partial breast irradiation to patients.

Dr. Vicini disclosed that he is a research adviser for ImpediMed. The study was sponsored by the National Cancer Institute.

SAN ANTONIO – A phase 3 randomized NRG Oncology trial (NSABP B-39/RTOG 0413) was unable to rule out the possibility that, after lumpectomy, partial breast irradiation is inferior to whole breast irradiation when it comes to the ipsilateral breast tumor recurrences (invasive disease or ductal carcinoma in situ), reported Frank Vicini, MD, of MHP Radiation Oncology Institute, Pontiac, Mich.
 

The hazard ratio for this event with the former versus latter modality was 1.22, with the 90% confidence interval (0.94-1.58) falling just outside the predefined range to declare the two modalities equivalent (0.667-1.5). However, the absolute difference in the 10-year cumulative incidence of ipsilateral breast tumor recurrences was just 0.7% (4.6% vs. 3.9%). In a video interview, Dr. Vicini discussed whether this difference is clinically important, and the implications of the trial’s findings, taken together, for offering partial breast irradiation to patients.

Dr. Vicini disclosed that he is a research adviser for ImpediMed. The study was sponsored by the National Cancer Institute.

SAN ANTONIO – A phase 3 randomized NRG Oncology trial (NSABP B-39/RTOG 0413) was unable to rule out the possibility that, after lumpectomy, partial breast irradiation is inferior to whole breast irradiation when it comes to the ipsilateral breast tumor recurrences (invasive disease or ductal carcinoma in situ), reported Frank Vicini, MD, of MHP Radiation Oncology Institute, Pontiac, Mich.
 

The hazard ratio for this event with the former versus latter modality was 1.22, with the 90% confidence interval (0.94-1.58) falling just outside the predefined range to declare the two modalities equivalent (0.667-1.5). However, the absolute difference in the 10-year cumulative incidence of ipsilateral breast tumor recurrences was just 0.7% (4.6% vs. 3.9%). In a video interview, Dr. Vicini discussed whether this difference is clinically important, and the implications of the trial’s findings, taken together, for offering partial breast irradiation to patients.

Dr. Vicini disclosed that he is a research adviser for ImpediMed. The study was sponsored by the National Cancer Institute.