Concomitant cisplatin plus radiotherapy and high-dose-rate brachytherapy versus radiotherapy alone for stage IIIB epidermoid cervical cancer: a randomized controlled trial.

PURPOSE: The benefits of chemoradiotherapy (CRT) for cervical cancer compared with radiation (RT) alone seem to diminish in later-stage disease. However, these modalities have not been directly compared for disease-free interval (DFI) and overall survival (OS) of women with stage IIIB cervical cancer. PATIENTS AND METHODS: We conducted a randomized controlled clinical trial comparing DFI and OS of 147 women with stage IIIB squamous cervical cancer who received either cisplatin plus RT (CRT) or RT alone (72 patients in the CRT group and 75 patients in the RT-only group).
RESULTS: The CRT group had significantly better DFI (hazard ratio [HR], 0.52; 95% CI, 0.29 to 0.93; P = .02). However, patients in the CRT group did not have significantly better OS than those in the RT-only group (HR, 0.67; 95% CI, 0.38 to 1.17; P = .16). Toxicity was graded according to criteria of the Radiation Therapy Oncology Group. The organs affected (excluding hematologic effects) did not differ significantly between groups. Also, late toxicity events and organs affected were not significantly disproportionate between the study groups.
CONCLUSION: For stage IIIB cervical cancer, the addition of cisplatin offers a small but significant benefit in DFI, with acceptable toxicity.

RCT Entities:   Population Interventions Outcomes