- The 10-year results of the CALGB 49907 trial confirm earlier 2-year results that standard adjuvant chemotherapy (ACT) is superior to capecitabine for elderly women with early breast cancer.
Why this matters
- Standard adjuvant chemotherapy remains the treatment of choice for elderly patients with early breast cancer.
- Patients ≥65 years with stage I-IIIb breast cancer (n=633) were randomly assigned to capecitabine or standard ACT (physician's choice of either CMF [cyclophosphamide, methotrexate, and fluorouracil] or AC [cyclophosphamide and doxorubicin]).
- The primary outcome was recurrence-free survival (RFS).
- Funding: NIH.
- Median follow-up was 11.4 years.
- 10-estimated RFS was 55.7% for standard ACT and 49.7% for capecitabine.
- Upon multivariate analysis, standard ACT was superior to capecitabine for RFS and breast cancer-specific survival (BCSS), but not OS:
- RFS: HR, 0.80 (P=.03);
- BCSS: HR, 0.62 (P=.03); and
- OS: HR, 0.84 (P=.16).
- Standard ACT in subgroup analysis was superior to capecitabine for hormone receptor-negative patients (RFS: HR, 0.66; P=.02), but not hormone-receptor-positive patients (HR, 0.89; P=.43).
- Across both treatments, 43.9% of patients died (13.1% from breast cancer, 16.4% from other causes, and 14.1% from causes unknown).
- OS results were diluted by death from competing risks.