NCI Issues Clinical Announcement on Cervical Cancer: Chemotherapy Plus Radiation Improves Survival

National Cancer Institute
Monday, 22 February 1999

The National Cancer Institute (NCI) today mailed a clinical announcement to thousands of physicians stating that strong consideration should be given to adding chemotherapy to radiation therapy in the treatment of invasive cervical cancer. (Also see Cervical Cancer Backgrounder).

The mailing alerts physicians who treat cancer to the findings of five different studies — all large, randomized clinical trials -- showing that women in the studies benefitted from the use of radiation therapy and chemotherapy given together. Up to now, surgery or radiation therapy alone has been considered the standard treatment for cervical cancer that has spread locally (within the cervix) or regionally (within the pelvis).

"The findings of these five trials are remarkably consistent," said NCI Director Richard D. Klausner, M.D. "They are likely to change the standard of care for invasive cervical cancer."

Three of the studies cited in NCI's clinical announcement will appear in the New England Journal of Medicine. Because of their potential implications for public health, the articles about these studies were released today, in advance of their publication date, and are accessible on the Journal's Web site at www.nejm.org. The remaining two studies will be published later in 1999.

Several hundred women were enrolled in each of the five trials, which were carried out by NCI's Clinical Trials Cooperative Groups in centers around the country. Their cancers varied from disease confined to the cervix to disease that had spread from the cervix to other pelvic tissues.

In three of the studies, women were randomly divided into groups, or "arms" that received either radiation alone or radiation plus concomitant chemotherapy (given at the same time as the radiation therapy). The chemotherapy agents used were cisplatin and 5-fluorouracil, also known as 5-FU (two studies) and cisplatin alone (one study). In all three trials, the proportion of women alive after about three years of follow-up was higher in the groups receiving chemotherapy plus radiation than in those receiving only radiation therapy.

In the two other studies, all patients received concomitant chemotherapy and radiation. However, the chemotherapy drugs differed between the arms. In one arm of each of these trials, the chemotherapy used was hydroxyurea while in the other arms, the chemotherapy included cisplatin. In both trials, the groups who received cisplatin had better survival rates.

NCI's clinical announcement states that, although the best chemotherapy regimen for cervical cancer has not been determined, "significant results were seen using cisplatin alone or cisplatin in combination with 5-FU and other agents."

NCI's Clinical Announcement is available from the NCI Press Office (301) 496-6641 and on NCI's Web site for clinical trials: http://cancertrials.nci.nih.gov. It can also be obtained from CancerFax; call (301) 402-5874 from a fax machine and use the CancerFax code number for this document, 400262, when prompted.

For more information, or to contact National Cancer Institute, see their website at: www.cancer.gov