FDA approves new cervical cancer treatment based on UC Irvine-led study
Clinical trial found therapy effective in recurrent and metastatic cancer
August 14, 2014
The U.S. Food and Drug Administration today approved bevacizumab, also known as Avastin, to treat persistent, recurrent or metastatic cervical cancer.
The approval is based on a clinical trial led by UCI Health gynecologic oncologist Dr. Krishnansu S. Tewari and conducted by the Gynecological Oncology Group, now known as NRG Oncology.
The phase 3 randomized trial enrolled 452 women, including UCI Health patients, and found that combining chemotherapy with bevacizumab extended median survival to 17 months, compared to 13.3 months for those receiving chemotherapy without it. The FDA approval allows its use in combination with paclitaxel and cisplatin or paclitaxel and topotecan.
Treatment with bevacizumab — an anti-angiogenesis agent that inhibits a tumor’s ability to form new blood vessels — caused no significant deterioration in patients' quality of life, Tewari said. Trial results appeared in the Feb. 20, 2014 issue of the New England Journal of Medicine.
“This trial showed for the first time that a targeted agent could improve overall survival in a gynecologic cancer,” said Tewari, a professor of obstetrics & gynecology at the University of California, Irvine. “Women with metastatic or recurrent cervical cancer don’t have many options. Now we finally have a therapy that helps them live longer.”
The findings already have changed U.S. treatment for advanced cervical cancer. Within a month of the study’s presentation at the June 2013 meeting of the American Society of Clinical Oncology, the National Comprehensive Cancer Network listed the cisplatin-paclitaxel-bevacizumab triplet in the NCCN Cervical Cancer Treatment Guidelines Update.
Although a difference of 3.7 months may not seem like a long time, Tewari said it is important to understand that this patient population responds very poorly to even one line of therapy and that those minimal responses tend to be short-lived.
“We do not have the luxury of treating women who have advanced cervical cancer with multiple lines of therapy over many years, as we do with more [chemotherapy] sensitive malignancies such as ovarian or breast cancer,” Tewari said. “However, these findings show that we may be on the cusp of converting this disease from a terminal to a chronic condition where the 3.7 months provides a window of opportunity in which patients might benefit from new therapies, including other anti-angiogenesis drugs and immunotherapies that are now being studied.”
Cervical cancer is one of the most common cancers worldwide and is responsible for at least 250,000 deaths annually. Although screening with Pap smears and high-risk HPV DNA testing has reduced the incidence and mortality, each year about 12,000 U.S. women are diagnosed with the disease and more than 4,000 die of it.
“The vast majority of these deaths are young women in the prime of their lives and often with young children,” Tewari said. “This study population represents an under-served group that often lacks healthcare insurance or access to potentially lifesaving cancer screening and treatment.”
He called the trial results a “triple-header.” Among patients who received bevacizumab along with chemotherapy:
- There was a “highly statistically significant” difference in overall survival — a median of 3.7 months.
- The response rate, or the percentage of patients whose cancer shrank or disappeared after treatment, was better — 48 percent versus 26 percent.
- Progression-free survival, or the length of time during and after treatment a patient lives with the disease but it does not get worse, also was better — 8.2 months compared with 5.9 months.
Trial results were first presented at the March 2013 annual meeting on women's cancer by the Society of Gynecologic Oncology and later at the June 2013 American Society of Clinical Oncology annual meeting, the world's largest oncology gathering. The abstract was one of five of the more than 5,500 abstract submissions to be featured in the ASCO general plenary session.
The multiple center, multinational trial — known as GOG 240 — was conducted by the Gynecologic Oncology Group and funded by the National Cancer Institute. Genentech provided support for the trial under the Cooperative Research & Development Agreement with NCI for the clinical development of bevacizumab.
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