National Cancer Insitutue: Treatment regimen extends survival for women with cervical cancer

Bethesda, MD

Making the chemotherapy drug gemcitabine 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 have important implications for the treatment of women with cervical cancer in developing countries, where 70 to 80 percent of women are diagnosed at a locally advanced stage due to a lack of widespread screening programs, said lead investigator Dr. Alfonso Dueñas-González 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 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 only by brachytherapy.

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 improved by more than 40 percent, the researchers reported. 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.
Standard Treatment for Anal Cancer Confirmed

The largest clinical study of patients with anal cancer has found that the current standard treatment should not be changed. In addition, patients in the study did not benefit from maintenance chemotherapy that was designed to prevent a recurrence, according to the ACT II study, a phase III, randomized trial involving 940 patients.

Most of the 5,000 patients diagnosed with anal cancer in the United States each year have the squamous cell type, which often responds to radiation therapy and chemotherapy. For a decade, the treatment for anal cancer has been radiation plus 5-fluorouracil (5-FU) and mitomycin-C chemotherapy. In this trial, British researchers asked whether replacing mitomycin-C with cisplatin could improve results for patients, but the answer was no. Furthermore, patients did not benefit from maintenance chemotherapy with cisplatin and 5-FU.

Overall, however, the patients had very good results relative to the international trials published to date, noted Dr. Roger James of the Maidstone Hospital in Kent, who presented the findings at the recent ASCO annual meeting. At 6 months, 95 percent of patients in both groups had all signs of cancer disappear, and at 3 years, nearly 85 percent of the patients in the trial were alive.

Cisplatin was evaluated because it is commonly used to treat other squamous cell cancers, the researchers said, noting that it is not as convenient to deliver and has different toxicities than mitomycin-C chemotherapy. Future trials will likely ask whether certain patients might benefit from other forms of maintenance therapy.

Misread Pap Test Malpractice Lawsuits

 Subscribe to Cervical Cancer News Information Links