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

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



2008 ASCO Annual Meeting

Abstract No:



J Clin Oncol 26: 2008 (May 20 suppl; abstr 519)


E. L. Mayer, K. D. Miller, H. S. Rugo, J. M. Peppercorn, L. A. Carey,
N. Ryabin, K. Josephs, E. P. Winer, H. J. Burstein

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