A randomised phase III study assessing two different chemotherapy regimens with or without bevacizumab finds that adding bevacizumab prolongs overall survival by an average of four months compared to chemotherapy alone.

The study represents the first time a targeted drug has significantly prolonged overall survival for women with metastatic or relapsed cervical cancer.

The study was performed by the Gynecologic Oncology Group.

Chemotherapy regimens are largely ineffective against advanced cervical cancer.

As a result, approximately 4,000 women in the U.S. die from the disease each year; worldwide cervical cancer takes a far higher toll, claiming 250,000 women’s lives every year.

This is the first study showing that a targeted drug that blocks blood vessel formation in the tumour (angiogenesis) can prolong survival for women with gynaecologic cancers.

“Women with advanced cervical cancer don’t have many options. We finally have a drug that helps women live longer,” said lead study author Krishnansu Sujata Tewari, MD, a professor of obstetrics and gynaecology at the University of California Irvine in Orange, Calif. “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.”

In this four-armed clinical trial, 452 women with recurrent of metastatic cervical cancer were randomly assigned to treatment with a chemotherapy regimen alone or a chemotherapy regimen plus bevacizumab. The two chemotherapy regimens tested were cisplatin plus paclitaxel and topotecan plus paclitaxel.

Those two regimens were compared to determine if topotecan would be more beneficial than cisplatin, a standard chemotherapy option in this setting. There were no significant differences in survival between the two chemotherapy 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. Tumour shrinkage rates were higher in patients who received the bevacizumab (48 percent vs. 36 percent) and responses lasted longer. Analysis of quality of life data will be reported at the ASCO Annual Meeting. Generally, the results indicate that survival benefit associated with bevacizumab did not come at the cost of diminished quality of life.

“Treatment options for women with recurrent or advanced disease have been insufficient for far too long. 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,” said Carol Aghajanian, MD, ASCO spokesperson and gynaecologic cancers expert.

Bevacizumab is currently approved by the FDA for use in several advanced cancers, but has not to date received approval in any gynecologic cancer.

The research was supported by the National Cancer Institute.

Source: ASCO