|
|
|
|
|
|
|
|
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.
0 comments :
Post a Comment
Your comments?
Note: Only a member of this blog may post a comment.