Women Who Have Invasive Cervical Cancer Benefit From Addition Of Chemotherapy To Radiation Treatment

"Overall, the patients who received chemotherapy were more likely to survive their disease," says Perry W. Grigsby, M.D., professor of radiology at Mallinckrodt Institute of Radiology at Washington University School of Medicine in St. Louis. David G. Mutch, M.D., associate professor of obstetrics and gynecology and director of the Division of Gynecologic Oncology, also participated in the study along with other physicians in the division.

The national study by the Radiation Therapy Oncology Group (RTOG) is one of three studies that will be reported in the April 15 issue of the New England Journal of Medicine. Other investigators were in the RTOG study were at New York University, the State University of New York Health Science Center and other institutions. It was funded by the National Cancer Institute.

The articles are being released in advance of publication because of their potential implications for public health. The National Cancer Institute also is issuing a rare clinical announcement on the studies' findings and those of two other unpublished studies. In the announcement, NCI director Richard Klausner says, "The findings of these five trails are remarkably consistent. They are likely to change the standard of care for invasive cervical cancer."

The RTOG study examined whether the addition of two chemotherapy drugs to a seven-week regimen of radiation treatment affected the survival of women who had locally advanced cervical cancer.

All of the 386 women evaluated in the study received radiation to the pelvis and abdomen that reached the lymph nodes, where cervical cancer tends to spread. They underwent daily treatments with an external beam of radiation and several days of exposure to rod-shaped applicators containing radioactive pellets, which were placed within the vagina and uterus. Half of the women in the study also received the drugs cisplatin and 5-fluorouracil during at least the first and fourth weeks of radiation treatment. About 100 of the volunteers were treated at Washington University School of Medicine in St. Louis.

The RTOG study showed that 73 percent of the women who received chemotherapy and radiation treatment survived for at least five years, whereas those given only radiation treatment had a 58 percent survival rate. The first group of women also were less likely to have died of their cancer or to have had further cancer identified in follow-up visits. Their disease-free survival rate was 66 percent, compared with 40 percent for women treated only with radiation therapy. The other four studies showed similar advantages to adding chemotherapy to radiation regimens.

Mutch supervised the chemotherapy of the women enrolled in the RTOG study at the School of Medicine along with Thomas J. Herzog, M.D., Janet S. Rader, M.D., and Alaa A. Elbendary, M.D, assistant professors of obstetrics and gynecology. Mutch says the results of this study and the other four provide a gynecologic milestone. "This is a significant advance in the treatment of women with gynecologic cancers that can't be operated on," he says. "For the first time, we've been able to demonstrate a survival advantage by adding a therapeutic treatment. This underscores the importance of people participating in clinical trials."

Mutch and Grigsby also participated in the other two national trials whose results will be reported in the New England Journal on April 15. The two studies compared treatment options that differed somewhat from those in the RTOG study, but they reached similar conclusions.

Grigsby notes, though, that chemotherapy isn't the solution for all women with cervical cancer. "But this study shows that patients with advanced cervical cancer, and therefore with bigger tumors, do need chemotherapy," he says.

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Support for the RTOG study was provided by the National Cancer Institute, grant number U10 CA21661.

The articles to be published in the April 15 issue of the New England Journal of Medicine will be available at the journal's Web site (http://www.nejm.org) at 10 a.m. EST, Monday, Feb. 22.

The National Cancer Institute's clinical announcement will be available at http://cancertrials.nci.nih.gov at 10 a.m. EST, Monday, Feb. 22.