Efficacy and safety of bevacizumab in recurrent sex cord-stromal ovarian tumors: results of a phase 2 trial of the Gynecologic Oncology Group.

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.

• Authors: Jubilee Brown, William E Brady, Julian Schink, Linda Van Le, Mario Leitao, S Diane Yamada, Koen de Geest, David M Gershenson
• Journal: Cancer (Cancer) Vol. 120 Issue 3 Pg. 344-51 (Feb 01 2014) ISSN: 1097-0142 [Electronic] United States
• PMID: 24166194 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
• Copyright: © 2013 American Cancer Society.

Chemical References

• Angiogenesis Inhibitors
• Antibodies, Monoclonal, Humanized
• inhibin A
• inhibin B
• Bevacizumab
• Inhibins

Topics

• Adult
• Aged
• Angiogenesis Inhibitors (therapeutic use)
• Antibodies, Monoclonal, Humanized (adverse effects, therapeutic use)
• Bevacizumab
• Female
• Humans
• Inhibins (blood)
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy)
• Ovarian Neoplasms (blood, drug therapy, mortality)
• Prospective Studies
• Sex Cord-Gonadal Stromal Tumors (blood, drug therapy, mortality)