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Bevacizumab plus chemotherapy prolonged OS, PFS in cervical cancer
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.
Perspective
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The results of GOG 240 have been eagerly awaited by the gynecologic oncology community. Unfortunately, the prognosis for patients with advanced-stage or recurrent cervical cancer is dismal, and more effective therapeutic approaches are desperately needed. This study addresses two important questions: First, is a non-platinum doublet such as paclitaxel/topotecan superior to a platinum doublet (such as cisplatin/paclitaxel) in the modern era of chemoradiation when the majority of patients have been previously treated with cisplatin? Second, to what degree does the addition of bevacizumab to these cytotoxic regimens improve outcomes? Perhaps surprisingly, the non-platinum doublet was not superior to the platinum-arm. However, the improvement in median OS with the addition of bevacizumab from 13.3 to 17 months, with reasonable toxicity, was both statistically and clinically significant, and it represents an exciting advancement for patients with this devastating disease.
Perspective
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This important study demonstrates that the addition of bevacizumab to standard chemotherapy of metastatic and recurrent cervical cancer improves both PFS and OS. Although the overall impact on outcome was modest — a median 4-month improvement in OS — the results are clearly potentially clinically meaningful. Perhaps the most relevant added risk in this specific patient population is the potential for fistula formation. Therefore, it is essential that considerable clinical judgment is applied in the decision to utilize bevacizumab in this difficult setting.
Perspective
Back to TopThis study is very important because it’s the first time an OS benefit has been shown in cervical cancer and it’s the first time a drug has shown an OS benefit in all gynecologic cancers. For the 250,000 women who will die from cervical cancer, this is a paradigm shift in that patients will live longer and feel better. This is especially important for young women who are extraordinarily symptomatic from their disease burden.