A phase I/II dose-escalation trial of bevacizumab in previously treated metastatic breast cancer
Section snippets
Patient eligibility
Women at least 18 years of age with histologically confirmed metastatic breast cancer who had relapsed following at least one conventional chemotherapy regimen (ie, anthracycline and/or taxane agent) for metastatic disease were eligible. Patients could have measurable or nonmeasurable (evaluable) disease, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and a life expectancy of at least 6 months. Written informed consent was required of all patients. The trial was
Patient characteristics
Seventy-five patients were enrolled into the study between November 1998 and April 2000; 18 at 3 mg/kg, 41 at 10 mg/kg, and 16 at 20 mg/kg. Demographic and baseline characteristics and prognostic factors are summarized in Table 1, Table 2. The majority of patients had infiltrating ductal carcinoma (83%). Although excluded by the protocol, four patients had received no prior chemotherapy for metastatic disease. The predominant site of metastatic disease was visceral in 59%, bone in 19%, and
Discussion
Bevacizumab, based on its mechanism of action, could have either cytostatic or cytotoxic effects, resulting in either slowed tumor growth and delay in time to tumor progression or objective responses. Evidence of both cytostatic and cytocidal effects were seen in this trial. Objective responses were observed, including one confirmed CR and four confirmed PRs. Although the highest response rate was seen at 10 mg/kg every other week, the sample size is too small to conclude whether doses higher
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Dr Cobleigh has received research grant support and honoraria and has served as a consultant to Genentech Inc. Dr Miller has received research grant support from and has served on the speakers’ bureau for Genentech Inc.