(ChemotherapyAdvisor) – No evidence was found that extending adjuvant doxorubicin and cyclophosphamide or single-agent paclitaxel from 4 to 6 cycles improves clinical outcome in women with resected primary breast cancer and 0 to 3 positive nodes, the Cancer and Leukemia Group B 40101 study reported in a rapid communication in the Journal of Clinical Oncology online July 23.

The study enrolled 3,171 women with operable breast cancer and 0 to 3 positive nodes (94% were node-negative and 6% had 1 to 3 positive nodes) between 2002 and 2008 and randomly assigned them to either 4 or 6 cycles of either doxorubicin and cyclophosphamide or paclitaxel. Patients were stratified by estrogen receptor/progesterone receptor, HER2, and menopausal status.

The 4-year relapse-free survival at a median follow-up of 5.3 years was 90.9% for 6 cycles and 91.8% for 4 cycles (adjusted HR 1.03 [95% CI, 0.84–1.28]; P=0.77). The 4-year overall survival was 95.3% for 6 cycles and 96.3% for 4 cycles [HR 1.12 [95% CI, 0.84 to 1.49]; P=0.44). No interaction was observed between treatment duration and chemotherapy regimen, estrogen-receptor/progesterone receptor, or HER2 status on relapse-free or overall survival.

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This study demonstrates that “…patients can be spared longer and more toxic treatment with these regimens without fear of compromising breast cancer outcome,” Lawrence N. Shulman, MD, of the Dana-Farber Cancer Institute, Boston, MA, and colleagues concluded.