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Combined weekly topotecan and biweekly bevacizumab in women with platinum-resistant ovarian, peritoneal, or fallopian tube cancer†‡
Results of a Phase 2 Study
Article first published online: 24 FEB 2011
Copyright © 2011 American Cancer Society
Volume 117, Issue 16, pages 3731–3740, 15 August 2011
How to Cite
McGonigle, K. F., Muntz, H. G., Vuky, J., Paley, P. J., Veljovich, D. S., Greer, B. E., Goff, B. A., Gray, H. J. and Malpass, T. W. (2011), Combined weekly topotecan and biweekly bevacizumab in women with platinum-resistant ovarian, peritoneal, or fallopian tube cancer. Cancer, 117: 3731–3740. doi: 10.1002/cncr.25967
This original research was presented in part at the 2008 American Society of Clinical Oncology, Chicago, Illinois (Journal of Clinical Oncology. 2008;26. Abstract 5551) and the 2009 Annual Meeting on Women's Cancer, San Antonio, Texas (Gynecologic Oncology. 2009;112:S145. Abstract 286).
The authors thank Cancer Research and Biostatistics, Seattle, Washington, for statistical analysis.
- Issue published online: 3 AUG 2011
- Article first published online: 24 FEB 2011
- Manuscript Revised: 5 JAN 2011
- Manuscript Accepted: 5 JAN 2011
- Manuscript Received: 24 NOV 2010
- angiogenesis inhibitors;
- topotecan, chemotherapy;
- ovarian cancer;
- primary peritoneal carcinoma;
- fallopian tube cancer
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).
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.
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).
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.