Faculty Publications

Burger RA, Sill M, Monk BJ, Greer B, Sorosky J

Phase II trial of bevacizumab in persistent or recurrent epithelial ovarian cancer (EOC) or primary peritoneal cancer (PPC): A Gynecologic Oncology Group (GOG) study

J Clin Oncol (Meeting Abstracts). 2005 June 1, 2005;23(16_suppl):5009-.

Abstract 5009 Background: Development of targeted therapeutics is considered critical to improve outcomes for patients with EOC/PPC. Vascular Endothelial Growth Factor (VEGF) appears to be a promoter of tumor progression via induction of angiogenesis. Bevacizumab is a recombinant humanized anti-human VEGF monoclonal antibody recently FDA-approved to treat metastatic colorectal cancer. Methods: Eligible patients had persistent or recurrent EOC/PPC after receiving 1-2 prior cytotoxic regimens, measurable disease, and GOG performance status [≤] 2. Treatment consisted of bevacizumab 15 mg/kg IV Q 3 weeks until disease progression or prohibitive toxicity. Primary endpoints were progression-free survival (PFS) at 6 months, objective response rate, and toxicity by NCI criteria. The single-stage design limits the probability of declaring the agent active to 10% when inactive according to both tumor response and PFS at 6 months but is capable of detecting activity on either scale with 90% power. Results: From 4/02 to 8/04, 64 patients were enrolled. Two were excluded for wrong primary and borderline histology; thus, the sample included 62 patients. Median age was 57 (range 18-79) years, and prior treatment consisted of 1 or 2 regimens in 23 and 39 patients, respectively. The median disease free interval from completion of primary cytotoxic chemotherapy to first recurrence was 6.5 months. Early results showed some patients had confirmed objective responses and PFS in some was at least 6 months. The following grade 3 or 4 toxicities were observed: allergy (1 grade 3), cardiovascular (4 grade 3; 1 grade 4), gastrointestinal (3 grade 3), hepatic (1 grade 3), pain (2 grade 3), and pulmonary (1 grade 4). As of 11/15/04, 36 patients were off study, including 29 for disease progression and 1 for toxicity in 33 cases reported. Conclusions: Preliminary evidence exists for objective responses to bevacizumab, presumably a cytostatic agent. Efficacy and toxicity data for this study is expected to reach maturity and be analyzed in March, 2005, and comprehensive results will be presented. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Genentech BioOncology