Journal of Clinical Oncology, 2008 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 26, No 15S (May 20 Supplement), 2008: 520
© 2008 American Society of Clinical Oncology

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Abstract

Phase II feasibility trial incorporating bevacizumab into dose-dense doxorubicin and cyclophosphamide followed by paclitaxel in patients with lymph node-positive breast cancer: A trial of the Eastern Cooperative Oncology Group (E2104)

Indiana University Simon Cancer Center, Indianapolis, IN; Dana-Farber Cancer Institute, Boston, MA; Mayo Clinic, Jacksonville, FL; Memorial Sloan-Kettering Cancer Center, New York, NY

520

Background: Little is known about the safety of combining bevacizumab and anthracyclines. Therefore, E2104 was a two-arm non-randomized phase II trial designed to evaluate the safety of incorporating bevacizumab into an anthracycline containing adjuvant therapy. Methods: Patients (pts) were sequentially assigned to one of two treatment arms. In addition to dose dense doxorubicin and cyclophosphamide followed by paclitaxel (ddAC>T), all pts received bevacizumab (10 mg/kg q2 wksx26) either initiated concurrently with AC (Arm A: ddBAC>BT>B) or initiated concurrently with paclitaxel (Arm B: ddAC>BT>B). The primary endpoint was the incidence of clinically apparent cardiac dysfunction (CHF). Results: From October 2005 to November 2006, 226 pts were enrolled (Arm A 104, Arm B 122). Median age was 50 (range 27–76). Myelosuppression was common (G3/4 neutropenia 26%) but febrile neutropenia was rare (3%). G3 hypertension/thrombosis/proteinuria/hemorrhage was reported by 11/2/1/<1% of pts. respectively. One pt developed Grade 4 cerebrovascular ischemia. Median follow-up is 14.6 mos. for Arm A and 10.8 mos. for Arm B; to date 52 pts in Arm A and 8 in Arm B have completed planned therapy. Median pre-treatment LVEF was 65% in Arm A and 64% in Arm B. Clinical CHF was reported in 2 pts in Arm A after 4 and 6 cycles; four pts had asymptomatic declines in LVEF to <40% after 4 (n=1) and 16 cycles (n=3). Two pts in Arm B reported clinical CHF due to diastolic dysfunction (both associated with a decline in LVEF to 40–50%) after 4 and 9 cycles; one pt had asymptomatic decline in LVEF to <40% after 8 cycles. Conclusions: Preliminary data suggests incorporation of bevacizumab into anthracycline-containing adjuvant therapy is feasible. Ongoing cardiac monitoring is required to define the true impact of bevacizumab on cardiac function.

Abstract presentation from the 2008 ASCO Annual Meeting