CHICAGO — The addition of bevacizumab to chemotherapy improved OS, PFS and clinical response rates in women with relapsed cervical cancer, according to phase 3 results presented at the ASCO Annual Meeting.
Bevacizumab (Avastin, Genentech) is not currently FDA approved for any type of gynecologic cancer. The current study is the first to demonstrate a drug to significantly prolong OS in women with relapsed cervical cancer, according to researchers.
“Worldwide, there are about 500,000 new cases of cervical cancer each year, and more than half of these women will die,” Krishnansu Sujata Tewari, MD, professor of obstetrics and gynecology at the University of California Irvine, said during a press conference. “Cervical cancer is a unique cancer in that it’s caused by a virus, but we can screen for it and we can prevent it through vaccination.”
The current standard of care — cisplatin plus paclitaxel — extends survival for about 12 months or less, and once patients no longer respond, there are no other treatment options, Tewari said.
The randomized study conducted by Tewari and colleagues included 452 women with recurrent cervical cancer. Researchers randomly assigned the women to chemotherapy alone or chemotherapy plus bevacizumab.
Two chemotherapy regimens were used: Some patients received cisplatin plus paclitaxel, and the others received topotecan plus paclitaxel.
Median OS was 17 months among patients assigned to bevacizumab arm vs. 13.3 months among patients assigned to chemotherapy alone (P=.0035). The tumor shrinkage rate was higher in the bevacizumab arm (48% vs. 36%).
No new side effects were observed with bevacizumab, and all side effects were of low grade, researchers said.
Tewari and colleagues reported no significant differences in survival between the two chemotherapy regimens.
“We set the bar with this study,” Tewari said. “We knew that [cisplatin plus paclitaxel] improved survival by about 12 months, so if we could increase survival by about 4 months, we thought that would be clinically meaningful.
“This is also possibly a first step toward turning cervical cancer into a chronic disease, helping women live longer and allowing time for additional treatments that could further slow the cancer’s progression and improve survival.”
For more information:
Tewari KS. Abstract #3. Presented at: ASCO Annual Meeting; May 31-June 4, 2013; Chicago.
Disclosure: One of the researchers reports a consultant or advisory role with, as well as honoraria from, Roche/Genentech. The research was supported by NCI.