Pulsed-dose-rate vs. high-dose-rate intracavitary radiotherapy for locally advanced carcinoma of cervix: A prospective randomized study

PURPOSE: To compare late radiation toxicities in patients with carcinoma of cervix treated with pulsed-dose-rate (PDR) vs. high-dose-rate (HDR) intracavitary radiotherapy (ICRT). METHODS AND MATERIALS: Between July 2010 to April 2012, 37 patients with Stage (International Federation of Gynecology and Obstetrics 2009) squamous cell carcinoma of cervix were randomized to receive either HDR (7 Gy each in three fractions, repeated weekly) or PDR (70 cGy hourly pulses for 39 hours, total 27 Gy) ICRT after external beam radiotherapy. Late rectal and bladder toxicities were assessed using Radiation Therapy Oncology Group criteria, and vaginal toxicity was graded as per common terminology criteria for adverse events. Overall survival and disease-free survival were estimated using Kaplan-Meier method. RESULTS; Nineteen patients received HDR and 18 received PDR ICRT with median followup 34 and 29 months, respectively. In HDR vs. PDR arm, late rectal toxicities grade >= 2 (16.7% vs. 21.1%, p = 1.000), grade >= 3 (10.5% vs. 0%, p = 0.486), late bladder toxicities grade >= 2 (10.5% vs. 0%, p = 0.486), and late vaginal toxicities grade >= 2 (15,8% vs. 5.6%, p = 0.604) were not statistically different. For HDR and PDR ICRT groups, 4-year disease-free survival was 67.1% vs. 71.8% (p = 0.195) and overall survival was 77% vs. 75% (p = 0.322), respectively. CONCLUSION: In this small group of patients, there were fewer events in form of late radiation toxicities in PDR arm, although statistically not significant. Further studies are required to define role of PDR compared to HDR ICRT in cervical carcinoma. (C) 2016 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.