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FDA Approves New Combination Therapy for Cervical Cancer

Summary: The US Food and Drug Administration has approved the use of topotecan (Hycamtin) along with cisplatin for the treatment of women who have very advanced cervical cancer. The decision was based on a randomized, multi-center trial that found treatment with these 2 drugs is better than treatment with cisplatin alone.

Why it's important: Although the death rate from cervical cancer has been dropping steadily since the introduction of the Pap test, the disease is still deadly. The American Cancer Society estimates that in 2006, 3,700 American women will die of cervical cancer. Although chemotherapy cannot cure this cancer, it can prolong life and often improve its quality. The new drug combination is a small step along the road to longer and better survival.

What's already known: Most women with cervical cancer can be cured with surgery as long as the disease hasn't spread outside the cervix (the lower, narrow portion of the uterus). But in about 43% of women the cancer has already spread to nearby lymph nodes or other sites by the time it is first diagnosed. These women are less likely to be cured with surgery and often find the cancer coming back in either their pelvis or distant organs. Once this stage of the disease is reached, cure is not possible. But chemotherapy can prolong the lives of these women and often relieve some of their symptoms. In the past, the single best treatment was with the drug cisplatin. Clinical trials that added other drugs to the cisplatin didn't find any benefit until this study was done.

How this study was done: Women with advanced cervical cancer (stage IV) were entered into this clinical trial, which tested the benefit of treatment with cisplatin alone versus treatment with cisplatin and a second drug, topotecan. The women were not able to have surgery or radiation to treat their cancer because it had spread throughout their pelvis or to distant sites. About 15% of women in each group had cancer that had spread both throughout the pelvis and to distant sites. This trial enrolled 293 women, who were randomly assigned to 1 of 2 groups -- a cisplatin-only group and topotecan/cisplatin group.

What was found: Women who got the combination of topotecan and cisplatin lived longer than those who only got cisplatin. Women on both drugs lived, on average, 9.4 months compared with a survival of 6.5 months for the women who received only cisplatin. Women who received the combination had more bad side effects, such as lower blood counts, nausea, and vomiting. But when the women were asked to assess their quality of life, there was no difference between the 2 groups.

The bottom line: Adding topotecan to cisplatin lengthens survival in women with advanced cancer of the cervix, although the benefit is small. Regular Pap tests are one way to reduce the death toll from this disease. Cervical cancer grows slowly and can be detected in Pap testing and cured well before it becomes lethal. The ACS recommends that all women begin having Pap tests from about 3 years after starting vaginal intercourse or by age 21 at the latest. A newly approved vaccine against HPV (human papillomavirus) will also help cut cervical cancer deaths by protecting vaccinated women from 2 strains of HPV that cause most cases of cervical cancer.

Citations: "Randomized Phase III Trial of Cisplatin With or Without Topotecan in Carcinoma of the Uterine Cervix: A Gynecologic Oncology Group Study." Published in the July 20, 2005, Journal of Clinical Oncology (Vol. 23, No. 21:4626-4633). First author Harry J. Long III, Mayo Clinic College of Medicine, Rochester, MN.

"Quality of Life Outcomes From a Randomized Phase III Trial of Cisplatin With or Without Topotecan in Advanced Carcinoma of the Cervix: A Gynecologic Oncology Group Study." Published in the July 20, 2005, Journal of Clinical Oncology (Vol. 23, No. 21:4617-4625). First author: Bradley J. Monk, University of California Irvine Medical Center.