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Efficacy and safety of bevacizumab in recurrent sex cord‐stromal ovarian tumors: Results of a phase 2 trial of the Gynecologic Oncology Group
Author(s) -
Brown Jubilee,
Brady William E.,
Schink Julian,
Le Linda,
Leitao Mario,
Yamada S. Diane,
Geest Koen,
Gershenson David M.
Publication year - 2013
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.28421
Subject(s) - medicine , bevacizumab , adverse effect , clinical endpoint , regimen , gynecologic oncology , oncology , phases of clinical research , surgery , randomized controlled trial , clinical trial , chemotherapy
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 .