Radiochemotherapy versus Radiochemotherapy plus Surgery in Stage IIB Cervical Cancer. A Phase III Single Institution Randomized Trial

Journal of Radiotheraphy & Medical Oncology December 2014 Vol.20 No 2: 47-53 Address for correspondence: Patricia Şuteu Prof. Dr. Ion Chiricuţă Oncology Institute Str. Republicii nr. 34-36 400015 Cluj-Napoca, Romania Email: [email protected] Background: In the Prof. Dr. Ion Chiricuţă Oncology Institute, treatment of stage IIB cervical cancer usually comprises surgery after radiochemotherapy (RCT). Aim: To compare the overall survival (OS), disease-free survival (DFS) and treatment failures after exclusive RCT versus RCT+surgery in patients with stage IIB cervical cancer included in a phase IIb single institution randomized trial. Material and methods: During September 2006November 2010, 111 patients with histologically confirmed cervical cancer stage IIB were randomly assigned in 2 arms: 59 in arm A with RCT+surgery and 52 in arm B with exclusive RCT. Treatment failure was defined as local recurrence, lymph node metastasis (lombo-aortic, supraclavicular) or organ metastasis. Results: The median age was 47 years and the median follow-up was 66.3 months. Eleven patients (9.9%) died: 6 (10.16%) in arm A, 5 (9.61%) in arm B; 2 deaths were not cervical-cancer related. The 5-year OS was 92% in arm A and 89% in arm B (p=0.6). The 5-year DFS rates were 88% in arm B and 89% in arm A (p=0.76). There were 12 (11%) treatment failures: 6 (10.16%) in arm A and 6 (11.53%) in arm B (p=0.82). Local recurrence was observed in 4 (7.69%) cases in arm B and one (1.69%) case in arm A. Distant metastases occurred in 5 patients (8.47%) in arm A and 2 (3.84%) in arm B. Conclusions: Despite a higher local recurrence rate in patients without surgery, there are no statistically significant differences between the two treatment modalities, regarding OS, DFS and treatment failure.