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Bevacizumab appears safe, effective for sex cord-stromal ovarian tumors
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Bevacizumab demonstrated activity in patients with recurrent sex cord-stromal tumors of the ovary, according to study results.
Researchers enrolled 36 patients from 2008 to 2011. Of them, 32 (88.9%) had granulosa cell tumors and four (11.1%) had unclassified sex-cord stromal tumors.
All patients had a Gynecologic Oncology Group performance status of 0 (n=30; 83.3%) or 1 (n=6; 16.7%).
Most patients (91.7%) had previously received chemotherapy; the median number of prior regimens was two. Six patients (16.7%) had previously received radiation therapy.
Researchers administered 15 mg/kg daily doses of bevacizumab (Avastin, Genentech) in 21-day cycles. Patients underwent a median of nine treatment cycles (range, 2-50).
Median follow-up was 32.5 months.
Overall, six patients achieved partial response (16.7%; 90% CI, 7.5-30.3) and 28 patients (77.8%) achieved confirmed stable disease. Two patients (5.6%) experienced disease progression.
The median time to response among partial responders was 8.2 months and the median duration of response was 18.6 months.
Median PFS was 9.3 months. Median OS was not reached.
The most common grade 3 adverse events associated with treatment were hypertension (n=5) and pain (n=5). Researchers observed one case each of grade 4 hypertension and proteinuria.
Four patients discontinued treatment due to toxicity.
Researchers found that inhibin A and B values significantly decreased in responders after the first cycle. One-unit increases in log levels of inhibin A (HR=1.15; 95% CI, 0.96-1.38) and B (HR=1.09; 95% CI, 0.89-1.33) were associated with an increased risk for disease progression and death, although these risks were not statistically significant.
“Bevacizumab administered as a single agent appears to be active and to have acceptable toxicity in women with recurrent sex cord-stromal tumors of the ovary,” the researchers wrote. “This represents a significant advance for women who have this rare disease, in whom effective treatment options are quite limited and disease is often chemorefractory.”
Disclosure: Researchers report an advisory board role with Biologics Inc., as well as compensation from Intuitive Surgical Corporation for consultant and speaking roles.
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