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Feasibility trial of letrozole in combination with bevacizumab in patients with metastatic breast cancer.


ABSTRACT: PURPOSE:Preclinical models suggest that the use of anti-vascular endothelial growth factor (anti-VEGF) therapy with antiestrogens may prevent or delay the development of endocrine therapy resistance. We therefore performed a feasibility study to evaluate the safety of letrozole plus bevacizumab in patients with hormone receptor-positive metastatic breast cancer (MBC). 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 weeks). The primary end point was safety, defined by grade 4 toxicity using the National Cancer Institute Common Toxicity Criteria, version 3.0. Secondary end points included response rate, clinical benefit rate, and progression-free survival (PFS). Prior nonsteroidal AIs (NSAIs) were permitted in the absence of progressive disease. RESULTS:Forty-three patients were treated. After a 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%). Eighty-four percent of patients had at least stable disease on an NSAI, confounding efficacy results. Partial responses were seen in 9% of patients and stable disease >or= 24 weeks was noted in 67%. Median PFS was 17.1 months. CONCLUSION:Combination letrozole and bevacizumab was feasible with expected bevacizumab-related events of hypertension, headache, and proteinuria. Phase III proof-of-efficacy trials of endocrine therapy plus bevacizumab are in progress (Cancer and Leukemia Group B 40503).

SUBMITTER: Traina TA 

PROVIDER: S-EPMC3940895 | biostudies-literature | 2010 Feb

REPOSITORIES: biostudies-literature

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Feasibility trial of letrozole in combination with bevacizumab in patients with metastatic breast cancer.

Traina Tiffany A TA   Rugo Hope S HS   Caravelli James F JF   Patil Sujata S   Yeh Benjamin B   Melisko Michele E ME   Park John W JW   Geneus Stephanie S   Paulson Matthew M   Grothusen Jill J   Seidman Andrew D AD   Fornier Monica M   Lake Diana D   Dang Chau C   Robson Mark M   Theodoulou Maria M   Flombaum Carlos D CD   Norton Larry L   Hudis Clifford A CA   Dickler Maura N MN  

Journal of clinical oncology : official journal of the American Society of Clinical Oncology 20091019 4


<h4>Purpose</h4>Preclinical models suggest that the use of anti-vascular endothelial growth factor (anti-VEGF) therapy with antiestrogens may prevent or delay the development of endocrine therapy resistance. We therefore performed a feasibility study to evaluate the safety of letrozole plus bevacizumab in patients with hormone receptor-positive metastatic breast cancer (MBC).<h4>Methods</h4>Patients with locally advanced breast cancer or MBC were treated with the aromatase inhibitor (AI) letrozo  ...[more]

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