Adding the chemotherapy drug cisplatin to a treatment plan of radiation therapy and high–dose rate brachytherapy for patients with stage IIIB cervical cancer is beneficial, according to research presented recently at the American Society for Radiation Oncology’s 55th Annual Meeting.1
The randomized, controlled trial studied a total of 147 women in Brazil with stage IIIB squamous cell cervical cancer. Each patient received external-beam radiation of 45 Gy to the pelvic region in 25 fractions, 14.4 Gy boost to the compromised parametrium, and high–dose rate brachytherapy in the amount of four weekly fractions of 7 Gy prescribed to point A (the crossing of the uterine artery and the ureter).
Seventy-five patients received only radiation therapy and high–dose rate brachytherapy treatment (the radiation therapy group), and 72 patients received radiation therapy and high–dose rate brachytherapy plus weekly intravenous doses of 40 mg/m2 of cisplatin during the pelvic radiotherapy sessions (the cisplatin plus radiation therapy group). The research was conducted from 2003 through 2010, with follow-up lasting until January 2013.
Kaplan-Meier survival curves were performed comparing the 5-year disease-free survival and the overall survival of the cisplatin-plus-radiotherapy group and the radiation therapy alone group. Differences in survival were assessed utilizing the log-rank test. Patients in the cisplatin plus radiation therapy group had significantly better disease-free survival (hazard ratio [HR] = 0.52, 95% confidence interval [CI] = 0.28–0.98, P = .04) and had a better overall survival, but without statistical significance (HR = 0.67, 95% CI = 0.37–1.183, P = .16).
Toxicity levels in the cisplatin-plus-radiotherapy group were similar to those in the radiation therapy alone group, with grades 1 and 2 acute toxicity at 37.5% for cisplatin-plus-radiotherapy group, and 28% for the radiotherapy-alone group (P = .29). Late toxicity grades 3 and 4 were 9.7% for the cisplatin-plus-radiotherapy group and 3% for the radiotherapy-alone group (P = .29).
“In testing a new approach of chemotherapy with traditional external-beam radiation therapy and high–dose-rate brachytherapy, we were extremely cautious about possible toxicity for the patients,” said Antonio Zuliani, MD, lead author of the study and a radiation oncologist at Campinas State University in Campinas, Brazil. “We were pleased by an increase in local control and the very low toxicity rates. We believe that these results demonstrate that this combined treatment protocol is safe to offer to patients and provides some beneficial improvements—in disease-free survival and toxicity levels.” ■
Disclosure: Dr. Zuliani reported no potential conflicts of interest.
1. Zuliani AC, Sarian LO, Esteves SC, et al: Efficacy of concomitant cisplatin plus radiotherapy and high dose rate brachytherapy vs radiotherapy alone for stage IIIB epidermoid cervical cancer. A 10-year randomized controlled trial. American Society for Radiation Oncology 55th Annual Meeting. Abstract 8. Presented September 22, 2013.