June 02, 2015
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Bevacizumab combination improves PFS in advanced, recurrent endometrial cancer

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CHICAGO — The addition of bevacizumab to the combination of carboplatin and paclitaxel significantly increased PFS for patients with advanced-stage or recurrent endometrial cancer, according to a phase 2 study presented at the ASCO Annual Meeting.

Although the prognosis for advanced or recurrent endometrial cancer is poor, bevacizumab (Avastin, Genentech) has previously shown activity in advanced or recurrent endometrial cancer, according to study background. Data have indicated response rates range from 13% to 22% and 6-month disease control is approximately 40% with bevacizumab.

Domenica Lorusso, MD, a researcher with the National Cancer Institute of Milan in Italy, and colleagues conducted this randomized phase 2 trial to compare carboplatin and paclitaxel alone — the standard treatment in this setting — with a combination of those agents plus bevacizumab.

PFS served as the study’s primary endpoint.

Between 2012 and 2014, the researchers randomly assigned 108 patients with advanced or recurrent endometrial cancer to carboplatin and paclitaxel alone (n = 54) or with bevacizumab (n = 54). All patients received the standard dose of carboplatin and paclitaxel for 6 to 8 cycles. Those assigned additional bevacizumab received 15-mg/kg doses during the combination phase and as maintenance until the disease progressed or there was an unacceptable toxicity.

Median follow-up was 13 months as of March 2015.

The overall response rate was 72.7% (95% CI, 59.5-85.9) in the bevacizumab arm compared with 54.3% (95% CI, 39.9-68.7) in the carboplatin–paclitaxel alone arm.

There were 31 PFS events in the carboplatin–paclitaxel alone arm vs. 27 in the bevacizumab arm. The HR for PFS in favor of the bevacizumab combination was 0.57 (95% CI, 0.34-0.96).

Median PFS was 8.7 months (95% CI, 6.3-11.2) in the standard therapy arm and 13 months (95% CI, 9.2-16.8) in the bevacizumab arm.

Four patients assigned bevacizumab experienced grade 3 cardiac toxicities vs. zero patients in the standard treatment group.

Overall, eight patients experienced 13 serious adverse events. Those events included three instances of deep vein thrombosis, three incidences of retinal artery thrombosis, two cases of intracardiac thrombus as well as one silent myocardial infraction and one cerebrovascular accident.

“The addition of bevacizumab to carboplatin and paclitaxel significantly increased PFS in recurrent endometrial cancer,” Lorusso said during her presentation. “However, cardiovascular toxicity should still be carefully evaluated in a population with pre-existing cardiovascular risk factors before taking bevacizumab.”  – by Anthony SanFilippo

Reference: Lorusso D, et al. Abstract 5502. Presented at: ASCO Annual Meeting; May 29-June 2, 2015; Chicago.

Disclosure: Lorusso reports honoraria and research funding from and consultant/advisory roles with Amgen, AstraZeneca, Janssen-Cilag, PharMar and Roche. Please see the abstract for a list of all other researchers’ relevant financial disclosures.