Citations 2
Primary results, NRG Oncology/NSABP B-35: A clinical trial of anastrozole (A) versus tamoxifen (tam) in postmenopausal patients with DCIS undergoing lumpectomy plus radiotherapy.
Margolese, Richard G., Julian, Thomas B. , Costantino, Joseph P., Vallow, Laura A., Albain, Kathy S. , Whitworth, Pat W. , Cianfrocca, Mary, Gross, Howard M., Soori, Gamini S. , Hopkins, Judith O. , Sturtz, Keren , Wozniak, Timothy F., Seay, Thomas E., Mamounas, Eleftherios P. , Cecchini, Reena S. , Ganz, Patricia A. , Brufsky, Adam , Fehrenbacher, Louis , Mamounas, Eleftherios P. , Wolmark, Norman
Journal of Clinical Oncology | March 8, 2019 | Volume: 33 | Issue: 15_suppl | Pages: LBA500-LBA500
Primary results, NRG Oncology/NSABP B-35: A clinical trial of anastrozole (A) versus tamoxifen (tam) in postmenopausal patients with DCIS undergoing lumpectomy plus radiotherapy.
Margolese, Richard G., Julian, Thomas B. , Costantino, Joseph P., Vallow, Laura A., Albain, Kathy S. , Whitworth, Pat W. , Cianfrocca, Mary, Gross, Howard M., Soori, Gamini S. , Hopkins, Judith O. , Sturtz, Keren , Wozniak, Timothy F., Seay, Thomas E., Mamounas, Eleftherios P. , Cecchini, Reena S. , Ganz, Peter , Brufsky, Adam , Fehrenbacher, Louis , Mamounas, Eleftherios P. , Wolmark, Norman
Journal of Clinical Oncology | February 24, 2017 | Volume: 33 | Issue: 18_suppl | Pages: LBA500-LBA500
10.1200/jco.2015.33.18_suppl.lba500
LBA500 Background: The primary endpoint of NSABP B-35, a phase III trial comparing 1 mg/day anastrozole to 20 mg/day tamoxifen, each given for 5 years, was breast cancer-free interval (BCFI), defined as the time from randomization to any breast cancer (BC) event including local, regional, or distant recurrence or contralateral disease, invasive or DCIS. Methods: Postmenopausal women with ER-receptor or PgR-receptor positive (by IHC analysis) DCIS and no invasive BC who had undergone a lumpectomy with clear resection margins were randomly assigned to receive either 20 mg/day tam or 1 mg/day A (blinded) for 5 years. Stratification was by age (<60 v ≥60). Results: From 1/6/2003 to 6/15/2006, 3,104 pts were entered and randomized (1552 in groups tam and A each). As of 2/28/15, follow-up information was available on 3,083 pts for OS and on 3,077 pts for all other disease-free endpoints, with mean time of follow-up of 8.6 years. There were 198 BCFI events, 114 in the tam group and 84 in the A group (HR, 0.73; p=0.03). 10-year point estimates for BCFI were 89.2% for tam and 93.5% for A. A significant time-by-treatment interaction (p=0.02) indicated that the effect was not evident until later in the study. There was a significant interaction between treatment and age group (p=0.04); benefit of A is only in women <60 years old. As to secondary endpoints, there were 495 DFS events, 260 in the tam group and 235 in the A group (HR, 0.89; p=0.21). 10-year point estimates for DFS were 77.9% for tam and 82.7% for A. There were 186 deaths, 88 in the tam group and 98 in the A group (HR, 1.11; p=0.48). 10-year point estimates for OS were 92.1% for tam, 92.5% for A. There were 8 deaths due to breast cancer in the tam group and 5 in the A group. There were 63 cases of invasive breast cancer in the tam group and 39 in the A group (HR, 0.61; p=0.02). There was a non-significant trend for a reduction in breast second primary cancers with A (HR, 0.68; p=0.07). Conclusions: Anastrozole provided a significant improvement compared to tamoxifen for BCFI, which was seen later in the study, primarily in women <60 years. Support: CA12027, 37377, 69651, 69974; 180868, 180822, 189867 196067, 114732; AstraZeneca Pharmaceuticals LP. Clinical trial information: NCT00053898.