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Physicians' Education Resource®, LLC, is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

This activity is not approved for AMA PRA Category 1 Credit

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This activity is supported by an educational grant from AstraZeneca.

Cancer Summaries and Commentaries™: Update from Chicago: Advances in the Treatment of Breast Cancer - PER Pulse™ Recaps
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PER Pulse™ Recap
PER Pulse™ Recaps
for Cancer Summaries and Commentaries™: Update from Chicago: Advances in the Treatment of Breast Cancer focuses on trials likely to be practice-changing for oncologists, immediately or in the near future. The PER Pulse™ Recap provides a brief overview and expert perspectives of data from the NRG Oncology/NSABP B-35 trial and the PALOMA-3 trial.



PER Pulse™ Recap

PER Pulse™ Recap

Medical Writer: Kim Farina, PhD


1 of 2
PER Pulse™ Recap:

Cancer Summaries and Commentaries™: Update from Chicago: Advances in the Treatment of Breast Cancer

The Cancer Summaries and Commentaries™: Update from Chicago: Advances in the Treatment of Breast Cancer is an online CME publication designed to update physicians on key clinical data and highlights in breast cancer presented at a major 2015 Oncology Annual Meeting held in Chicago. This is accompanied by audio commentary from Drs. William Gradishar and Debu Tripathy that provides insights into how new data fit into the current field and, when appropriate, how clinicians can integrate these findings into practice to improve patient care. This first of 2 PER Pulse™ Recaps summarizing the program focuses on primary results from a large phase III trial comparing an aromatase inhibitor versus tamoxifen in preventing recurrence in postmenopausal women with hormone-receptor-positive ductal carcinoma in situ (DCIS).

The NRG Oncology/NSABP B-35 trial compared 5 years of anastrozole 1 mg/day versus tamoxifen 20 mg/day (plus RT for both arms) in 3104 postmenopausal women with estrogen-receptor-positive or progesterone-receptor-positive DCIS who underwent lumpectomy and had no prior history of invasive breast cancer or DCIS (ASCO 2015 Abstract LBA500). At a mean follow-up of 9 years, more recurrences had occurred within the tamoxifen group than in the anastrozole group (breast cancer free interval: 114 vs. 84, respectively; hazard ratio [HR], 0.73; P=.03). In subgroup analysis, the benefit with anastrozole was limited to women age <60 years (P =.04 vs. tamoxifen). Although the secondary endpoints of disease-free survival (DFS) and overall survival were not met; DFS was prolonged in patients <60 years (88.8% anastrozole vs 81.5% tamoxifen; HR, .69; P=.02). Furthermore, significantly fewer cases of invasive contralateral breast cancer were reported in the anastrozole arm (20 vs 36; HR, 0.55; P=.03). No unacceptable safety signals were reported.

  • Dr. Tripathy stated that he views these data as practice changing and that he will now prefer to use an aromatase inhibitor over tamoxifen. However, he advises caution in using the subset analysis data (age) to guide decision making.
  • Dr. Gradishar commented that based on the results of this trial, anastrozole can be considered a reasonable alternative to tamoxifen in younger postmenopausal patients.


2 of 2
PER Pulse™ Recap:

Cancer Summaries and Commentaries™: Update from Chicago: Advances in the Treatment of Breast Cancer

The Cancer Summaries and Commentaries™: Update from Chicago: Advances in the Treatment of Breast Cancer is an online CME publication designed to update physicians on key clinical data and highlights in breast cancer presented at a major 2015 Oncology Annual Meeting held in Chicago, Illinois. This is accompanied by audio commentary from Drs. William Gradishar and Debu Tripathy that provides insights into how new data fit into the current field and, when appropriate, how clinicians can integrate these findings into practice to improve patient care.

This second of 2 PER Pulse™ Recaps summarizing the program focuses on results from the first interim analysis of a phase III trial that assessed the efficacy of palbociclib and fulvestrant in endocrine-resistant metastatic breast cancer.

The PALOMA-3 trial randomized 521 patients 2:1 to either palbociclib plus standard fulvestrant injection or placebo plus standard fulvestrant (ASCO 2015 Abstract LBA502). This trial included women with ER-positive/HER2-negative metastatic or locally advanced breast cancer who had progressed on prior endocrine therapy. Median progression free survival (PFS) was 5.4 months longer when palbociclib was added to fulvestrant (median PFS: 9.2 months vs. 3.8 months; hazard ratio, 0.42; 95% CI, 0.32-0.56; P < .001). An independent Data Monitoring Committee recommended early stopping and reporting of this trial based on the demonstrated efficacy of palbociclib and prespecified statistical boundaries. Fewer serious adverse events (AEs) were observed in the palbociclib arm versus the placebo arm (14% vs. 10%); however, infections (any grade) and AE-related dose reductions were more common with palbociclib (respectively, infections: 34% vs. 24%; interruptions 54% vs. 4%; reductions 32% vs. 2%). Neutropenia was the most common reason for AE-related dose reductions or interruptions in the palbociclib arm.

  • Dr. Tripathy said that because PALOMA-3 met its endpoint on preliminary analysis, palbociclib-fulvestrant combination therapy is likely to be approved as a second-line option for ER-positive/HER2-negative metastatic breast cancer.
  • Dr. Gradishar commented that PALOMA-3 reaffirms the results of PALOMA-1, namely, that pairing endocrine therapy with a CDK4/6 inhibitor improves outcomes. He noted that the biggest issue for clinicians using this regimen will be monitoring and managing hematologic adverse events.


Physicians' Education Resource®, LLC is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

This activity is not approved for AMA PRA Category 1 Credit™.

This activity is supported by an educational grant from AstraZeneca.




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