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

Jubilee Brown, William E. Brady, Julian Schink, Linda Van Le, Mario Leitao, S. Diane Yamada, Koenraad De Geest, David M. Gershenson

Research output: Contribution to journalArticle

36 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)344-351
Number of pages8
JournalCancer
Volume120
Issue number3
DOIs
StatePublished - Feb 1 2014
Externally publishedYes

Fingerprint

Sex Cord-Gonadal Stromal Tumors
Safety
Ovary
Hypertension
Therapeutics
Bevacizumab
Proteinuria
Disease-Free Survival
Disease Progression
Confidence Intervals

Keywords

  • bevacizumab
  • Gynecologic Oncology Group
  • stromal ovarian tumors
  • survival

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Brown, J., Brady, W. E., Schink, J., Van Le, L., Leitao, M., Yamada, S. D., ... Gershenson, D. M. (2014). Efficacy and safety of bevacizumab in recurrent sex cord-stromal ovarian tumors: Results of a phase 2 trial of the Gynecologic Oncology Group. Cancer, 120(3), 344-351. https://doi.org/10.1002/cncr.28421

Efficacy and safety of bevacizumab in recurrent sex cord-stromal ovarian tumors : Results of a phase 2 trial of the Gynecologic Oncology Group. / Brown, Jubilee; Brady, William E.; Schink, Julian; Van Le, Linda; Leitao, Mario; Yamada, S. Diane; De Geest, Koenraad; Gershenson, David M.

In: Cancer, Vol. 120, No. 3, 01.02.2014, p. 344-351.

Research output: Contribution to journalArticle

Brown, Jubilee ; Brady, William E. ; Schink, Julian ; Van Le, Linda ; Leitao, Mario ; Yamada, S. Diane ; De Geest, Koenraad ; Gershenson, David M. / Efficacy and safety of bevacizumab in recurrent sex cord-stromal ovarian tumors : Results of a phase 2 trial of the Gynecologic Oncology Group. In: Cancer. 2014 ; Vol. 120, No. 3. pp. 344-351.
@article{8055a38af74246ffaa1695ea7fa666f6,
title = "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.",
keywords = "bevacizumab, Gynecologic Oncology Group, stromal ovarian tumors, survival",
author = "Jubilee Brown and Brady, {William E.} and Julian Schink and {Van Le}, Linda and Mario Leitao and Yamada, {S. Diane} and {De Geest}, Koenraad and Gershenson, {David M.}",
year = "2014",
month = "2",
day = "1",
doi = "10.1002/cncr.28421",
language = "English (US)",
volume = "120",
pages = "344--351",
journal = "Cancer",
issn = "0008-543X",
publisher = "John Wiley and Sons Inc.",
number = "3",

}

TY - JOUR

T1 - Efficacy and safety of bevacizumab in recurrent sex cord-stromal ovarian tumors

T2 - Results of a phase 2 trial of the Gynecologic Oncology Group

AU - Brown, Jubilee

AU - Brady, William E.

AU - Schink, Julian

AU - Van Le, Linda

AU - Leitao, Mario

AU - Yamada, S. Diane

AU - De Geest, Koenraad

AU - Gershenson, David M.

PY - 2014/2/1

Y1 - 2014/2/1

N2 - 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.

AB - 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.

KW - bevacizumab

KW - Gynecologic Oncology Group

KW - stromal ovarian tumors

KW - survival

UR - http://www.scopus.com/inward/record.url?scp=84892938554&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84892938554&partnerID=8YFLogxK

U2 - 10.1002/cncr.28421

DO - 10.1002/cncr.28421

M3 - Article

C2 - 24166194

AN - SCOPUS:84892938554

VL - 120

SP - 344

EP - 351

JO - Cancer

JF - Cancer

SN - 0008-543X

IS - 3

ER -