Standard chemotherapy (CMF or AC) versus capecitabine in early-stage breast cancer (BC) patients aged 65 and older: Results of CALGB/CTSU 49907

507 Background: Older women with BC are underrepresented in clinical trials. Scant data exist on the effects of adjuvant chemotherapy (CRx) in these patients (pts). CALGB/CTSU 49907 was designed to compare the efficacy of capecitabine (X) with standard treatment (S) in BC pts ≥ 65 yrs old. Methods: Pts were randomized to X or S (CMF or AC per physician choice). Eligibility: Stage T1–4, N0–3, M0; PS 0–2, ≤ 84 days from surgery; adequate organ function. Regimens (all doses per M2): CMF (C, 100 mg d1–14 oral; M 40 mg d1,8; FU 600 mg d1,8) q4wk×6 cycles; AC (A 60 mg; C 600 mg) q3wk×4; X (2,000 d1–14) q3wk×6. Endocrine therapy was recommended after completion of CRx for hormone receptor positive (HR+) pts. A Bayesian design addressed equivalence of X to S; total sample size planned 600–1,800 pts with serial monitoring. The primary endpoint was relapse-free survival (RFS) defined as locoregional or distant relapse or death. We calculate Bayesian measures, including the probability of inferiority of X (that the ...