Journal of Clinical Oncology, 2008 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 26, No 15S (May 20 Supplement), 2008: 519
© 2008 American Society of Clinical Oncology

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Abstract

A pilot study of adjuvant bevacizumab and chemotherapy after neoadjuvant chemotherapy for high-risk breast cancer

Dana-Farber Cancer Institute, Boston, MA; Indiana University Simon Cancer Center, Indianapolis, IN; University of California San Francisco, San Francisco, CA; University of North Carolina Chapel Hill, Chapel Hill, NC

519

Background: Patients (pts) with residual breast cancer after neoadjuvant chemotherapy are at increased risk of recurrence, and may have chemotherapy-resistant disease. We sought to explore adjuvant antiangiogenic therapy combined with two different chemotherapy regimens in this population. Methods: Eligible pts had stage II-III breast cancer with residual invasive carcinoma at surgery following anthracycline-containing neoadjuvant chemotherapy. Treatment consisted of bevacizumab (B) 15 mg/kg every three weeks (1 cycle) for one year, starting no less than 1 month after surgery or 2 weeks after radiation. Sequential cohorts also received concurrent chemotherapy, either metronomic chemotherapy (CM): cyclophosphamide 50 mg PO qd, and methotrexate 2.5 mg PO d 1–2 each week for a total of 6 months, or capecitabine (X) 2,000 mg/m2/day 14d on/7d off for 18 weeks. Concurrent endocrine and/or trastuzumab therapy was allowed. The primary endpoint was feasibility and tolerability of the combination therapy. Results: 81 pts were treated with B + CM or B + X. Median age was 48y, 59% were stage III, 62% were hormone receptor positive, and 11% were HER2+. To date, the median number of cycles completed is 10 of a planned 17, with 12 pts completing treatment and 2 pts choosing to end treatment early. At a median on-study follow-up of 7.5 months, 6 pts (7%) have had tumor recurrence. Treatment-related toxicities include fatigue (41%), headache (32%), arthralgias (31%), and hypertension (23%). Preliminary analysis suggests B + CM has a more favorable side effect profile, as B + X led to more diarrhea, hand-foot syndrome, and grade 3/4 toxicity. 9 patients came off study for toxicity, including one patient with heart failure. Definitive feasibility/safety data and preliminary correlative studies will be available by June 2008. Conclusions: Adjuvant B + chemotherapy after neoadjuvant chemotherapy appears tolerable and feasible with side effects including fatigue, headache, arthralgias, and hypertension. The addition of X appears to contribute more toxicity. As previously demonstrated in our study of B monotherapy (Mayer et al, ASCO 2007, #561), the post- preoperative chemotherapy population remains high risk and merits novel therapies.

Author Disclosure

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Abstract presentation from the 2008 ASCO Annual Meeting