A phase II trial of erlotinib in combination with bevacizumab in patients with metastatic breast cancer.

Dickler, Maura N, Rugo, Hope S, Eberle, Carey A, Brogi, Edi, Caravelli, James F, Panageas, Katherine S, Boyd, Jeff, Yeh, Benjamin, Lake, Diana E, Dang, Chau T, Gilewski, Teresa A, Bromberg, Jacqueline F, Seidman, Andrew D, D'Andrea, Gabriella M, Moasser, Mark M, Melisko, Michele, Park, John W, Dancey, Janet, Norton, Larry, Hudis, Clifford A (December 2008) A phase II trial of erlotinib in combination with bevacizumab in patients with metastatic breast cancer. Clinical Cancer Research, 14 (23). pp. 7878-7883. ISSN 1078-0432

Abstract

PURPOSE: To evaluate the efficacy and toxicity of erlotinib plus bevacizumab in patients with metastatic breast cancer (MBC), targeting the epidermal growth factor receptor (EGFR/HER1) and the vascular endothelial growth factor (VEGF) pathway. EXPERIMENTAL DESIGN: Thirty-eight patients with MBC were enrolled and treated at two institutions with erlotinib, a small molecule EGFR tyrosine kinase inhibitor (150 mg p.o. daily) plus bevacizumab, an anti-VEGF antibody (15 mg/kg i.v. every 3 weeks). Patients had one to two prior chemotherapy regimens for metastatic disease. The primary end point was response rate by Response Evaluation Criteria in Solid Tumors criteria using a Simon 2-stage design. Secondary end points included toxicity, time to progression, response duration, and stabilization of disease of > or = 26 weeks. Correlative studies were done on tumor tissue, including EGFR expression and mutation analysis. RESULTS: One patient achieved a partial response for 52+ months. Fifteen patients had stable disease at first evaluation at 9 weeks; 4 of these patients had stable disease beyond 26 weeks. Median time to progression was 11 weeks (95% confidence interval, 8-18 weeks). Diarrhea of any grade was observed in 84% of patients (grade 3 in 3%); 76% experienced grade 1 or 2 skin rash, and 18% developed hypertension (grade 3 in 11%). The level of EGFR expression was not predictive of response to therapy. CONCLUSIONS: The combination of erlotinib and bevacizumab was well-tolerated but had limited activity in unselected patients with previously treated MBC. Biomarkers are needed to identify those MBC patients likely to respond to anti-EGFR/HER1 plus anti-VEGF therapy.

Item Type:	Paper
Subjects:	therapies > stem cells > Adult organs, tissues, organelles, cell types and functions > cell types and functions > cell types > germ cell > Adult organs, tissues, organelles, cell types and functions > cell types and functions > cell types > germ cell > Adult organs, tissues, organelles, cell types and functions > cell types and functions > cell types > germ cell > Adult organs, tissues, organelles, cell types and functions > cell types and functions > cell types > Adult organs, tissues, organelles, cell types and functions > cell types and functions > cell types > Adult organs, tissues, organelles, cell types and functions > cell types and functions > cell types > Adult organs, tissues, organelles, cell types and functions > cell types and functions > cell types > Adult organs, tissues, organelles, cell types and functions > cell types and functions > cell types > Adult organs, tissues, organelles, cell types and functions > cell types and functions > cell types > Adult ?? Aged ?? ?? Antibodies, Monoclonal ?? ?? Antibodies, Monoclonal, Humanized ?? ?? Antineoplastic Combined Chemotherapy Protocols ?? ?? Bevacizumab ?? ?? Breast Neoplasms ?? ?? Erlotinib Hydrochloride ?? ?? Female ?? ?? Humans ?? ?? Immunohistochemistry ?? ?? Middle Aged ?? ?? Quinazolines ?? ?? Treatment Outcome ??
CSHL Authors:	Boyd, Jeff
Communities:	CSHL labs > Boyd lab
SWORD Depositor:	CSHL Elements
Depositing User:	CSHL Elements
Date:	1 December 2008
Date Deposited:	23 Apr 2021 17:30
Last Modified:	23 Apr 2021 17:30
PMCID:	PMC2748748
URI:	https://repository.cshl.edu/id/eprint/39916

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