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Bevacizumab, carboplatin, paclitaxel combination safe, active in ovarian cancer
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Front-line bevacizumab plus paclitaxel and carboplatin demonstrated activity and appeared well tolerated in patients with newly-diagnosed ovarian cancer, according to results of a single-arm, phase 2 study.
The OCTAVIA study included 189 patients with International Federation of Gynecology and Obstetrics stage IIb to IV or grade 3/clear-cell stage I or IIA ovarian cancer. Most patients (74%) had stage IIIC or IV disease.
Treatment consisted of 7.5 mg/kg bevacizumab (Avastin, Genentech) on day 1, 80 mg/m2 paclitaxel weekly on days 1, 8 and 15, and IV carboplatin (area under the curve 6) on day 1 every 3 weeks for six to eight cycles. Patients then received single-agent bevacizumab, for a total treatment duration of 1 year.
PFS ˃18 months served as primary endpoint. Objective response rate, OS, safety and tolerability served as secondary endpoints.
Patients received a median of six chemotherapy cycles and 17 bevacizumab cycles. More than 90% of patients completed at least six chemotherapy cycles.
At the data cutoff 24 months after patient enrollment, 99 patients (52%) experienced disease progression and 19 patients (10%) died of ovarian cancer.
Median PFS was 23.7 months (95% CI, 19.8-26.4). The PFS rate at 1 year was 85.6%.
The response rate, according to RECIST criteria, was 84.6%. The median duration of response was 14.7 months.
Researchers observed grade ≥3 peripheral sensory neuropathy in 5% of patients and febrile neutropenia in 0.5% of patients.
The incidence of grade ≥3 adverse events associated with bevacizumab was comparable to that observed in phase 3 ovarian cancer trials, the researchers said.
One patient (0.5%) experienced gastrointestinal perforation. No treatment-related deaths occurred.
Disclosure: See the study for a full list of the researchers’ relevant financial disclosures.
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