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Feasibility trial of letrozole in combination with bevacizumab in patients with metastatic breast cancer
Journal of Clinical Oncology, 10/22/09

Traina TA et al. – Combination letrozole and bevacizumab was feasible with expected bevacizumab-related events of hypertension, headache, and proteinuria.

Methods

Patients with locally advanced breast cancer or MBC were treated with the aromatase inhibitor (AI) letrozole (2.5 mg orally daily) and the anti-VEGF antibody bevacizumab (15 mg/kg intravenously every 3 weeks0
Secondary end points included response rate, clinical benefit rate, and PFS
Prior nonsteroidal AIs permitted in absence of progressive disease

Results

43 patients treated
Median of 13 cycles (range, 1 to 71 cycles), select treatment-related toxicities included hypertension (58%; grades 2 and 3 in 19% and 26%), proteinuria (67%; grades 2 and 3 in 14% and 19%), headache (51%; grades 2 and 3 in 16% and 7%), fatigue (74%; grades 2 and 3 in 19% and 2%), and joint pain (63%; grades 2 and 3 in 19% and 0%)
84% of patients had at least stable disease on NSAI, confounding efficacy results
Partial responses were seen in 9% of patients and stable disease ᾕ 24 weeks noted in 67%
Median PFS 17.1 mos

Exclusive Author Commentary
Maura N. Dickler, 10/22/09

This study was designed as a feasibility trial to test the safety of letrozole in combination with bevacizumab, an anti-VEGF antibody. The rationale for this combination is based on animal models that suggest tumor angiogenesis as a mechanism that may help hormone-dependent breast cancers escape the effects of anti-estrogen therapy. By targeting tumor angiogenesis in combination with estrogen-lowering therapy, we hope to determine whether we can delay the development of resistance to standard endocrine therapy and therefore delay progression of metastatic disease. This feasibility study has led to a proof of concept study that is testing endocrine therapy (either letrozole or tamoxifen, per physician discretion) with or without bevacizumab in patients with hormone-receptor positive metastatic breast cancer in a randomized, double-blind phase 3 study that is presently accruing patients in the Cancer and Leukemia Group B (CALGB 40503).

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