Journal of Clinical Oncology, 2008 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 26, No 15S (May 20 Supplement), 2008: 507
© 2008 American Society of Clinical Oncology

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Abstract

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

University of Vermont and Vermont Cancer Center, Burlington, VT; University of Texas M. D. Anderson Cancer Center, Houston, TX; Cancer and Leukemia Group B Statistical Center, Durham, NC; Memorial Sloan-Kettering Cancer Center, New York, NY; University of Chicago, Chicago, IL; Duke University, Durham, NC; Dana-Farber Cancer Center, Boston, MA

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) q4wkx6 cycles; AC (A 60 mg; C 600 mg) q3wkx4; X (2,000 d1–14) q3wkx6. 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 hazard ratio of X to S is greater than 1) and relate these to conventional p values. In unplanned subset analyses we repeat these calculations by HR status. Results: Pts were randomized between 9/2001 and 12/2006. Per protocol, accrual stopped with 633 pts (326 on S, 307 on X) based on predictive probability that with longer follow-up X was unlikely to be equivalent to S. Median follow-up is 2 yrs. Pt and tumor characteristics were similar in the 2 arms. Overall: 61% age 70+, 54% T > 2cm, 69% N+, 66% HR+. Adherence to X was excellent. Toxicity was moderate, with more myelosuppression on S, more hand-foot syndrome on X, and 2 drug-related deaths on X. Pts randomized to X were 2.4 (95% CI: 1.5–3.8) times more likely to experience an RFS event (adjusted p=0.0003) and 2.1 (95% CI: 1.2–3.7) times more likely to die (p=0.02). Probability of inferiority of X vs S was > 99% for both RFS and OS. Unplanned subset analysis showed a highly significant interaction between HR and CRx arm (p=0.0032 for RFS; p=0.0067 for OS). All advantage was for S in HR negative tumors; hazard ratios 5.1 (95% CI: 2.4–10.6) for RFS, 6.1 (95% CI: 2.1–18.0) for OS. Conclusions: X is inferior to S in older pts, particularly in those with HR-negative tumors. Analyses to be updated at ASCO 2008, including by HER-2 status.

Author Disclosure

Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Hoffman-La Roche Hoffman-La Roche

Abstract presentation from the 2008 ASCO Annual Meeting