Efficacy and safety of bevacizumab in recurrent sex cord‐stromal ovarian tumors: Results of a phase 2 trial of the Gynecologic Oncology Group. Issue 3 (24th October 2013)

• Record Type: Journal Article
• Authors: Brown, Jubilee; Brady, William E.; Schink, Julian; Van Le, Linda; Leitao, Mario; Yamada, S. Diane; de Geest, Koen; Gershenson, David M.
• Is Part Of: Cancer. Volume 120:Issue 3(2014)
• Page Start: 344
• Page End: 351
• Publication Date: 2013-10-24
• Subjects: bevacizumab -- Gynecologic Oncology Group -- stromal ovarian tumors -- survival; Cancer -- Periodicals; Cancer -- Cytopathology -- Periodicals; 616.99405
• DOI: 10.1002/cncr.28421
• Languages: English
• ISSNs: 0008-543X

Abstract

Abstract : BACKGROUND: The Gynecologic Oncology Group conducted this phase 2 trial to estimate the antitumor activity of bevacizumab and to determine the nature and degree of toxicity in patients with recurrent sex cord‐stromal tumors of the ovary. METHODS: A prospective, multi‐institutional cooperative group trial was performed in women with recurrent, measurable ovarian stromal tumors. Patients were allowed to have unlimited prior therapy, excluding bevacizumab. Bevacizumab 15 mg/kg was administered intravenously on day 1 of every 21‐day cycle until patients developed disease progression or adverse effects that prohibited further treatment. The primary endpoint was the response rate (RR). Inhibin A and B levels were measured before each cycle, and the values were examined in relation to response and progression. RESULTS: Thirty‐six patients were enrolled, and all were eligible and evaluable. Patients received a median of 9 cycles of treatment (range, 2‐37 cycles). Six patients (16.7%) had partial responses (90% confidence interval, 7.5%‐30.3%), 28 patients (77.8%) had stable disease, and 2 patients (5.6%) had progressive disease. This met the criterion for declaring the regimen active. The median progression‐free survival was 9.3 months, and the median overall survival was not reached in during reporting period. Two grade 4 toxicities occurred, including hypertension and proteinuria; and the most common grade 3 toxicities were hypertension (n = 5) and pain (n = 5). Inhibin A and B values were lower in patients who responded to treatment. CONCLUSIONS: Bevacizumab has activity in the treatment of recurrent sex cord‐stromal tumors of the ovary, and its toxicity is acceptable. Further investigation is warranted. Cancer 2014;120:344–351 . © 2013 American Cancer Society . Abstract : Bevacizumab has activity in recurrent stromal ovarian tumors and appears to have an acceptable safety profile. Inhibin A and B appear to be associated with response to therapy.