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Adapted from the NCI Cancer Bulletin, vol. 6/no. 12, June 16, 2009 (see the current issue ³).

Making the chemotherapy drug gemcitabine ⁴ part of the initial treatment of locally advanced cervical cancer and also part of therapy following primary treatment significantly improved survival for women with locally advanced cervical cancer, according to the results of an international, phase III clinical trial.

Presented recently at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting, the results ⁵ have important implications for the treatment of women with cervical cancer in developing countries, where 70 to 80 percent of women with the disease are diagnosed at a locally advanced stage due to a lack of widespread screening programs, said lead investigator Alfonso Dueñas-González, M.D., Ph.D., of the National Cancer Institute of Mexico.

More than 500 women with stage IIB to stage IVA cervical cancer--from countries as disparate as Pakistan and Panama--participated in the trial. They were randomly assigned to the experimental treatment arm, which included cisplatin ⁶ and gemcitabine with concurrent external-beam radiation therapy, followed by brachytherapy and adjuvant chemotherapy with gemcitabine and cisplatin. Women in the standard treatment group received cisplatin and concurrent external-beam radiation therapy followed by brachytherapy alone.

Approximately 75 percent of women who received the experimental treatment did not experience progression of their disease 3 years after treatment, compared with 65 percent of women who received standard treatment. Overall survival was also improved, with 78 percent of women in the experimental treatment arm alive after 3 years compared with 69 percent of women in the standard treatment arm. The research team had expected more toxicity with the addition of gemcitabine, and that is what they saw.

"Overall, the frequency of grade III and IV toxicities was higher in the experimental arm, mainly hematological toxicity," Dr. Dueñas-González said. Grade IV toxicities were low overall, he added, and generally toxicities in the experimental arm were "tolerable and manageable."

The trial "in all likelihood defines a new standard of care" for patients with locally advanced cervical cancer, said Dr. Eric Winer, chief of the Division of Women's Cancers at Dana-Farber Cancer Institute.

Glossary Terms

Additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. Adjuvant therapy may include chemotherapy, radiation therapy, hormone therapy, targeted therapy, or biological therapy.

A type of radiation therapy in which radioactive material sealed in needles, seeds, wires, or catheters is placed directly into or near a tumor. Also called implant radiation therapy, internal radiation therapy, and radiation brachytherapy.

A type of radiation therapy that uses a machine to aim high-energy rays at the cancer from outside of the body. Also called external radiation therapy.