Clinical benefit of bevacizumab (BV) plus first-line docetaxel (D) in elderly patients (pts) with locally recurrent (LR) or metastatic breast cancer (mBC): AVADO study

Abstract

1094^ Background: In the AVADO study, BV + D confirmed the clinical benefit of combining BV with taxane-based first-line chemotherapy. This analysis evaluated the safety and efficacy of BV + D in pts aged ≥65 years. Methods: Pts with HER2-negative, inoperable, LR or mBC received BV 7.5 or 15mg/kg + D 100mg/m2 or placebo (PL) + D. Pts had no prior chemotherapy for advanced disease, no CNS metastases, ECOG PS 0–1, adequate LVEF. D was administered q3w up to nine cycles, BV/PL q3w until disease progression/unacceptable toxicity. Results: BV + D significantly increased PFS compared with PL + D (BV 7.5: HR = 0.69, p=0.004; BV 15: HR = 0.61, p=0.0001) (Table) (median follow-up 10.2 months). BV significantly increased overall response rate (ORR) compared with PL. In the 127 (17.3%) pts aged ≥65 years, pts had a similar treatment benefit compared to the entire study population. Generally, BV had limited additional impact on the known side effects of D. No grade ≥3 GI perforation, wound-healing complications, CHF or proteinuria were reported. Conclusions: In this retrospective analysis of the AVADO study, addition of BV to D was generally well tolerated in elderly pts with mBC. The magnitude of the benefit in pts aged ≥65 years was similar to that in the overall study population but failed to reach statistical significance, probably due to the small sample size. [Table: see text] [Table: see text] ASCO Conflict of Interest Policy and Exceptions In compliance with the guidelines established by the ASCO Conflict of Interest Policy (J Clin Oncol. 2006 Jan 20;24[3]:519–521) and the Accreditation Council for Continuing Medical Education (ACCME), ASCO strives to promote balance, independence, objectivity, and scientific rigor through disclosure of financial and other interests, and identification and management of potential conflicts. According to the ASCO Conflict of Interest Policy, the following financial and other relationships must be disclosed: employment or leadership position, consultant or advisory role, stock ownership, honoraria, research funding, expert testimony, and other remuneration (J Clin Oncol. 2006 Jan 20;24[3]:520). The ASCO Conflict of Interest Policy disclosure requirements apply to all authors who submit abstracts to the Annual Meeting. For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol. 2006 Jan 20;24[3]:521). If a principal investigator holds any restricted relationships, his or her abstract will be ineligible for placement in the 2009 Annual Meeting unless the ASCO Ethics Committee grants an exception. Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area; (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research. NIH-sponsored trials are exempt from the Policy restrictions. Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings. For more information about the ASCO Conflict of Interest Policy and the exceptions process, please visit www.asco.org/conflictofinterest .