Treatment Regimen Extends Survival for Women with Cervical Cancer
Adapted from the NCI Cancer Bulletin 1.
Making the chemotherapy drug gemcitabine 2 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 3 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 4 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.
Longer-term data were subsequently published in the May 1, 2011, Journal of Clinical Oncology (see the journal abstract 5).