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FDA approves Avastin for treatment of advanced cervical cancer
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The FDA today approved bevacizumab for use in combination with chemotherapy for treatment of women with metastatic, recurrent or persistent cervical cancer, according to the drug’s manufacturer.
Bevacizumab (Avastin, Genentech) can be used with paclitaxel and cisplatin, or with paclitaxel and topotecan.
Prior to the FDA’s decision, chemotherapy alone was the only approved treatment for this patient population.
Sandra Horning
“Women with advanced cervical cancer now have the option of Avastin plus chemotherapy to help them live longer than with chemotherapy alone,” Sandra Horning, MD, Genentech’s chief medical officer and head of global product development, said in a press release.
Bevacizumab is now approved in the United States for treatment of five tumor types — cervical cancer, metastatic colorectal cancer, metastatic renal cell carcinoma, nonsquamous non–small cell lung cancer and recurrent glioblastoma.
The FDA based the cervical cancer approval in part on results of the GOG-0240 study, which included 452 women with metastatic, recurrent or persistent cervical cancer.
Women treated with bevacizumab plus chemotherapy demonstrated a statistically significant 26% reduction in risk for death compared with women treated with chemotherapy alone. Median OS was 16.8 months in the combination arm and 12.9 months in the chemotherapy alone arm (HR=0.74; P=.0132).
Researchers also reported a significantly higher rate of objective response in the bevacizumab arm (45% vs. 34%).
Patients assigned bevacizumab experienced significantly higher rates of grade ≥2 hypertension (29% vs. 6%) and grade ≥3 thrombosis (8.3% vs. 2.7%), as well as higher rates of gastrointestinal–vaginal fistulas (8.2% vs. 0.9%).
Researchers observed no increase in treatment-related deaths in the bevacizumab arm.
Perspective
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Maurie Markman, MD
The recent FDA approval of bevacizumab in combination with either cisplatin/paclitaxel or paclitaxel/topotecan in the treatment of persistent, recurrent or metastatic cervical cancer is an important acknowledgement of the favorable clinical impact of the anti-angiogenic agent in this most difficult setting.In the pivotal randomized phase 3 trial that led to regulatory approval, the addition of bevacizumab to one of the two cytotoxic regimens compared with chemotherapy alone resulted in an improvement in median OS (17 months vs. 13.3 months; HR=0.71; P=0.004) and a higher objective response rate (48% vs. 36%; P=0.008). The demonstration of an improvement in OS is particularly noteworthy in this notoriously difficult clinical circumstance.
The addition of bevacizumab was associated with the anticipated increased incidence of hypertension (grade >2 incidence, 25% vs. 2%), and potentially more problematic thromboembolic side effects (grade >3 incidence, 8% vs. 1%) and gastrointestinal fistulas (grade >3 incidence, 3% vs. 0%). Both the thrombolic events and the fistula formation are explained by the known biological effects of the anti-angiogenic agent.
It is reasonable to conclude that carefully selected patients with an adequate performance status and no relative or absolute contraindications for the use of bevacizumab (eg, pre-existing draining or infected cancer-related fistula) may benefit from receiving this agent, both in terms of improving quality of life (associated with a heightened opportunity to achieve an objective response and symptomatic relief) and OS.
In summary, bevacizumab is an important new agent to add to the oncologist’s armamentarium in the management of persistent, recurrent or metastatic cervix cancer.
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