1. Combined weekly topotecan and biweekly bevacizumab in women with platinum-resistant ovarian, peritoneal, or fallopian tube cancer
- Author
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Pamela J. Paley, Kathryn F. McGonigle, Jacqueline Vuky, Benjamin E. Greer, Barbara A. Goff, Howard G. Muntz, Dan S. Veljovich, T. W. Malpass, and Heidi J. Gray
- Subjects
Adult ,Cancer Research ,medicine.medical_specialty ,Bevacizumab ,Platinum Compounds ,Neutropenia ,Antibodies, Monoclonal, Humanized ,Gastroenterology ,Drug Administration Schedule ,Primary peritoneal carcinoma ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Fallopian Tube Neoplasms ,Humans ,Peritoneal Neoplasms ,Aged ,Aged, 80 and over ,Ovarian Neoplasms ,business.industry ,Antibodies, Monoclonal ,Middle Aged ,medicine.disease ,Surgery ,Oncology ,Drug Resistance, Neoplasm ,Fallopian tube cancer ,Toxicity ,Female ,Topotecan ,business ,Progressive disease ,Febrile neutropenia ,medicine.drug - Abstract
BACKGROUND: A phase 2 trial was conducted to determine the toxicity and efficacy of combined weekly topotecan and biweekly bevacizumab in patients with primary or secondary platinum-resistant ovarian, peritoneal, or fallopian tube cancer (OC). METHODS: Patients were treated with bevacizumab 10 mg/kg on days 1 and 15 and topotecan 4 mg/m2 on days 1, 8, and 15 of a 28-day cycle until progressive disease (PD) or excessive toxicity. The primary endpoint was progression-free survival (PFS); secondary objectives included overall survival (OS), objective response, and toxicity. RESULTS: Patients (N = 40) received a median of 8 treatment cycles. Toxicity was generally mild or moderate, with neutropenia (18%), hypertension (20%), gastrointestinal toxicity (18%), pain (13%), metabolic toxicity (15%), bowel obstruction (10%), and cardiotoxicity (8%) being the most common grade 3 and 4 adverse events. No bowel perforations, febrile neutropenia, or treatment-related deaths occurred. Median PFS and OS were 7.8 (95% confidence interval [CI], 3.0-9.4) and 16.6 months (95% CI, 12.8-22.9), with 22 (55%) patients progression-free for ≥6 months. Ten (25%) patients had partial response (PR), 14 (35%) had stable disease (SD), and 16 (40%) had PD. Patients treated with 2 prior regimens received greater benefit than patients treated with 1: PR/SD, 78.9% versus 42.9% (P = .03); median PFS, 10.9 versus 2.8 months (P = .08); median OS, 22.9 versus 12.8 months (P = .02). CONCLUSIONS: A weekly topotecan and biweekly bevacizumab combination demonstrates acceptable toxicity and encouraging efficacy in patients with platinum-resistant OC; further study is warranted. Cancer 2011;. © 2011 American Cancer Society.
- Published
- 2011
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