CHICAGO -- Adding bevacizumab (Avastin) to chemotherapy significantly improved overall survival in women with metastatic or recurrent cervical cancer, according to results of a phase III trial presented here.
The median overall survival was 17.0 months for women receiving the combination, compared with 13.3 months for women receiving chemotherapy alone (P=0.0035), according to Krishnansu Sujata Tewari, MD, of the University of California Irvine.
This marks the first time that a targeted agent has prolonged survival in this cancer, he said at the annual meeting of the American Society of Clinical Oncology.
Action Points
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
- Note that the results of this randomized trial demonstrate that the addition of bevacizumab to standard chemotherapy for cervical cancer improved overall survival.
- Be aware that known bevacizumab side effects were observed in the bevacizumab group.
While a 4-month improvement in survival might not seem like much, Tewari said his team "observed it to be clinically meaningful."
The improvement in survival with the addition of bevacizumab was announced earlier this year on the recommendation of the trial's data safety monitoring committee. However, no details were given at that time.
The National Cancer Institute-funded trial, known as GOG240, involved 452 patients in the U.S. and Spain with recurrent, persistent, or metastatic cervical cancer that could not be cured with standard treatments.
Patients in the trial were assigned to one of four treatment arms: cisplatin plus paclitaxel (the current standard of care), topotecan plus paclitaxel, or the same two regimens with bevacizumab added. The latter drug was given at 15 mg/kg every 3 weeks until disease progression or excessive toxicity was seen.
An earlier interim analysis had found that the two chemotherapy regimens alone were equivalent, according to the National Cancer Institute.
Results of the new analysis showed the addition of bevacizumab was also associated with an improvement in the response rate: 48% versus 36% in the chemotherapy-only arm (P=0.008).
No new side effects were observed and the adverse events that did increase in the bevacizumab arms were expected, Tewari said. No one discontinued therapy due to side effects.
Importantly, "the survival improvement did not come with a deterioration in quality of life," as measured on a validated tool of psychical and functional quality of life adapted for cervical cancer patients, he said.
Experts were generally enthused. "It's a paradigm shift. Women live longer and feel better," said Jyoti Patel, MD, of Northwestern University Feinberg School of Medicine here.
Carol Aghajanian, MD, of Memorial Sloan-Kettering Cancer Center in New York City, said the study will eventually be practice-changing. "But first the data need to be formalized and published in a peer-reviewed journal and the data sent to the [FDA], as bevacizumab is not yet approved for this indication," she said.
Bevacizumab maker Roche/Genentech is in discussions with the FDA about the new data, a company spokesman said.
Disclosures
The GOG 240 trial was sponsored by the National Cancer Institute (NCI). Genentech provided support for the trial under the Cooperative Research and Development Agreement with the NCI for the clinical development of bevacizumab.
None of the authors reported any conflicts of interest.
Primary Source
American Society of Clinical Oncology
Source Reference: Tewari KS, "Incorporation of bevacizumab in the treatment of recurrent and metastatic cervical cancer: a phase III randomized trial of the Gynecologic Oncology Group" ASCO 2013; Abstract 3.