Radiotherapy versus Concurrent 5-Day Cisplatin and Radiotherapy in Locally Advanced Cervical Carcinoma

Abstract

To prove the superiority of concurrent radiochemotherapy (RTCT) over radiotherapy (RT) alone in locally advanced cervical carcinoma. In this randomized monocentric phase III study, 566 patients with squamous cell carcinoma of the cervix were included: 284 in arm A (RT) and 282 in arm B (concurrent RTCT with cisplatin 20 mg/m(2) x 5 days). 238 patients (42%) were in stage IIB, 209 (37%) in stage IIIA, and 119 (21%) in stage IIIB. The median follow-up was 62.8 months. RT to the pelvis was delivered to a dose of 46 Gy/23 fractions. A cervical boost was given using the X-ray arch technique or high-dose-rate intracavitary brachytherapy at a dose of 10 Gy. Thereafter, patients were evaluated: those with good response optionally underwent surgery and the others continued RT until 64 Gy/pelvis (with or without CT according to randomization) and 14 Gy/central tumor volume. The 5-year survival rate was statistically significantly superior in the concurrent RTCT group (74%) versus the RT group (64%; p < 0.05). In patients undergoing surgery after RT or RTCT, superior results were obtained, compared to the nonoperated patients: 5-year survival rate 86% versus 53% (p < 0.01). 192 failures were recorded: 109 (38%) after RT alone versus 83 (29%) after concurrent RTCT (p < 0.01). The results of this study prove the obvious superiority of concurrent RTCT with 5-day cisplatin compared to RT alone in patients with locally advanced cervical carcinoma, regarding local control (78% vs. 67%) and 5-year survival rates (74% vs. 64%).