ASCO 2013: Adding Bevacizumab to Chemotherapy Significantly Improves Response Rates and Survival in Women with Advanced Cervical Cancer
Adding bevacizumab (Avastin) to chemotherapy regimens with or without a platinum drug improved outcomes for women with metastatic or relapsed cervical cancer treated in a randomized phase III study. Presenting the results at the 2013 ASCO Annual Meeting (Abstract 3), lead author Krishnansu Sujata Tewari, MD, called the study “a triple-header,” with statistically significant improvements in overall survival, progression-free survival, and response rates. Dr. Tewari is Professor of Obstetrics and Gynecology at the University of California, Irvine, in Orange, California.
Four-armed Clinical Trial
In this four-armed clinical trial, 452 women with recurrent or metastatic cervical cancer were randomly assigned to treatment with a chemotherapy-alone regimen or with chemotherapy plus bevacizumab at 15 mg/kg.
The two chemotherapy regimens tested with or without the addition of bevacizumab were (1) cisplatin 50 mg/m2 plus paclitaxel 135 to 175 mg/m2 and (2) topotecan 0.75 mg/m2 on days 1 to 3 plus paclitaxel 175 mg/m2 on day 1. Cycles were repeated every 21 days until disease progression, unacceptable toxicity, or complete response. “The randomized treatment groups were similar with regard to age, histology, performance status, previous platinum as a radiosensitizer, and recurrence, persistence, or advanced disease,” the Gynecologic Oncology Group researchers reported.
Responses Lasted Longer
There were no significant differences in survival between the two chemotherapy alone arms. Overall, the median survival for patients who received bevacizumab plus chemotherapy was 17.0 months vs 13.3 months for those who received only chemotherapy (P = .0035). “This was a clinically meaningful difference,” Dr. Tewari said.
Tumor shrinkage rates were higher in patients who received bevacizumab (48% vs 36%; P = .0078), and responses lasted longer.
Quality-of-life Issues
“There were fatal adverse events in four patients in each group,” Dr. Tewari reported. Patients who received bevacizumab were more likely to have grade 3/4 bleeding (5% vs 1%), thrombosis/embolism (9% vs 2%), and gastrointestinal fistula (3% vs 0%).
“None of these side effects are new side effects,” Dr. Tewari said, noting that those side effects that occur more commonly in patients taking bevacizumab were at a low incidence. “The survival gains associated with bevacizumab did not come at a decrease in quality of life,” he said.
Practice-changing?
This is the first study showing that a targeted drug that blocks angiogenesis can prolong survival for women with gynecologic cancers.
“Women with advanced cervical cancer don’t have many options. We finally have a drug that helps [these] women live longer,” Dr. Tewari said. “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.”
Bevacizumab is currently approved by the FDA for use in several advanced cancers, but has not yet received approval in any gynecologic cancer. “I am hoping that this is a definitive study and that ultimately it will change practices,” Dr. Tewari stated. “We would hope that these data are strong enough to allow this drug to be approved, so that patients that need it can get it.”
“Treatment options for women with recurrent or advanced disease have been insufficient for far too long,” commented Carol Aghajanian, MD, Chief of the Gynecologic Medical Oncology Service at Memorial Sloan-Kettering Cancer Center in New York. “This study clearly shows how our nation’s investment in clinical cancer research pays off, offering the first ever treatment to extend the lives of women with aggressive cervical cancer,” she said.
“I agree that showing an extension of survival is the gold standard, and I think that this will be practice-changing,” said Dr. Aghajanian, but both she and Dr. Tewari noted that this won’t happen overnight.
This research was supported by the National Cancer Institute.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
