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| |  Bevacizumab Plus Docetaxel Shows Promise for Ovarian Cancer, No Surprising Toxicities: Presented at SGO By Fred Gebhart SAN FRANCISCO -- March 18, 2010 -- Researchers reported preliminary results of a phase 2 study showing the efficacy of bevacizumab plus docetaxel for ovarian cancer here on March 15 at the Society of Gynecologic Oncologists (SGO) 41st Annual Meeting on Women’s Cancer. Bevacizumab and docetaxel have both shown activity against recurrent ovarian cancer as single agents, but little is known about the potential synergistic effects of the 2 agents in combination. The 2 agents used together have shown promising activity and tolerable side effects in breast cancer and prostate cancer while other trials suggest that bevacizumab may help reverse resistance to docetaxel. Robert Wenham, MD, Moffitt Cancer, Tampa, Florida, and colleagues opened a phase 2 trial to assess both the potential anticancer activity of the combination and the tolerability. The trial enrolled women with recurrent epithelial ovarian, tubal, or peritoneal cancer who had previously been treated with platinum compounds. All of the women in the trial had received 1, 2, or 3 cycles of platinum-based chemotherapy and had been platinum-free for less than 12 months at the time of enrolment. The women also had either had measurable disease or elevated CA-125, twice the normal level, at the time of enrolment. Enrolment opened in March 2007 noted lead author Robert Wenham, MD, Moffitt Cancer, Tampa, Florida, and remains open pending total enrolment of at least 40 evaluable patients. As of February 2010, a total of 34 women had been enrolled and 29 are evaluable for best response. Twelve women remain on active treatment. The treatment regimen consists of docetaxel 40 mg/m2 on days 1 and 8 with and bevacizumab 15 mg/kg on day 1 of a 21-day cycle. Treatment continued for at least 8 cycles, and patients discontinued therapy if they had a complete response. Patients who showed either a partial response or stable disease remained on treatment until progression or toxicity. The primary and secondary endpoints are progression-free survival, response rates, clinical benefit rates, and toxicity. Among the women enrolled as of February 2010, about half had a platinum-free interval of 6 months or less. The other half had between 6 and 12 months between ending chemotherapy and enrolling in this trial. Among the women in the trial, 85% had 1 or 2 courses of chemotherapy and the predominant histology was high-grade serous adenocarcinoma. Within the group, 23 cancers were ovarian, 9 were peritoneal, and 2 fallopian tube. Essentially all of the patients, 97%, reported an adverse event and 49% reported grade 3/4 toxicity. The 5 most common toxicities were fatigue (64% of patients), hyperlacrimation (45%), alopecia (45%), epistaxis (37%), diarrhoea (37%), and neutropenia (35%). The most common grade 3/4 events were neutropenia, leucopenia, and fatigue. Only 5% of patients had febrile neutropenia, with 2% grade 3. Elevated blood pressure was not common, with only 10% of patients reporting grade 1/2 hypertension. The median progression-free survival as of February 2010 is 6.2 months, with distinct differences based on length of time between the last platinum treatment and enrolment in the trial. For women with a platinum-free interval of <6 months, progression-free survival is 9.2 months compared with 4.4 months for women with a platinum-free interval of 6 to 12 months. The overall response rate to date is 58.5% and the clinical benefit, a combination of complete response, partial response, and stable disease, is 86.5%. The overall response rate and progression-free survival compare favourably with historical data for either drug as a single agent as well as other chemotherapeutic agents, Dr. Wenham noted. The combination of bevacizumab and docetaxel appear to be reasonably well tolerated. [Presentation title: A Phase II Trial of Docetaxel and Bevacizumab in Recurrent Ovarian Cancer Within 12 Months of Prior Platinum-Based Chemotherapy. Abstract 155]
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