BACKGROUND: A combination of vaginal brachytherapy and external beam radiotherapy was compared with brachytherapy alone in medium-risk endometrial carcinomas. Quality-of-life analysis is an important part of a randomized study to find out the optimal adjuvant treatment for this group of patients. OBJECTIVE: To evaluate the value of adjuvant external beam pelvic radiotherapy in adjunct to vaginal brachytherapy in medium-risk endometrial carcinoma. Quality-of-life evaluation is the main topic of this report. METHODS: A consecutive series of 527 evaluable patients were included in this randomized trial. Median follow-up for patients alive was 62 months. The primary study end points were locoregional recurrences and overall survival. Secondary end points were recurrence-free survival, toxicity, and quality-of-life. European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-OV28 modules were used to evaluate global health status, functional scales, and symptom scales. RESULTS: Five-year locoregional relapse rates were 1.5% after external beam (ERT) plus vaginal irradiation (VBT) and 5% after vaginal irradiation alone (P = 0.013), and 5-year overall survival (OS) rates were 89% and 90%, respectively. External beam radiotherapy was associated with a higher rate of adverse effects from the intestine and the bladder, and quality-of-life parameters deteriorated at the end of radiotherapy but recovered to normal levels within a few months. There was a significant difference in favor of VBT alone with regard to adverse effects of the bowel and urinary tract, and quality-of-life. CONCLUSIONS: Despite a significant locoregional control benefit with combined radiotherapy, no survival improvement was recorded; but increased late toxicity from the intestine and the bladder. External beam irradiation decreased global health status during and after treatment, and 3 functional scale items (physical, role, and social). Six of 11 symptom items showed a pattern favoring vaginal brachytherapy alone.
RCT Entities:
BACKGROUND: A combination of vaginal brachytherapy and external beam radiotherapy was compared with brachytherapy alone in medium-risk endometrial carcinomas. Quality-of-life analysis is an important part of a randomized study to find out the optimal adjuvant treatment for this group of patients. OBJECTIVE: To evaluate the value of adjuvant external beam pelvic radiotherapy in adjunct to vaginal brachytherapy in medium-risk endometrial carcinoma. Quality-of-life evaluation is the main topic of this report. METHODS: A consecutive series of 527 evaluable patients were included in this randomized trial. Median follow-up for patients alive was 62 months. The primary study end points were locoregional recurrences and overall survival. Secondary end points were recurrence-free survival, toxicity, and quality-of-life. European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-OV28 modules were used to evaluate global health status, functional scales, and symptom scales. RESULTS: Five-year locoregional relapse rates were 1.5% after external beam (ERT) plus vaginal irradiation (VBT) and 5% after vaginal irradiation alone (P = 0.013), and 5-year overall survival (OS) rates were 89% and 90%, respectively. External beam radiotherapy was associated with a higher rate of adverse effects from the intestine and the bladder, and quality-of-life parameters deteriorated at the end of radiotherapy but recovered to normal levels within a few months. There was a significant difference in favor of VBT alone with regard to adverse effects of the bowel and urinary tract, and quality-of-life. CONCLUSIONS: Despite a significant locoregional control benefit with combined radiotherapy, no survival improvement was recorded; but increased late toxicity from the intestine and the bladder. External beam irradiation decreased global health status during and after treatment, and 3 functional scale items (physical, role, and social). Six of 11 symptom items showed a pattern favoring vaginal brachytherapy alone.
Authors: A Smits; J McGrane; A Lopes; E Kent; R Bekkers; L Massuger; N Simpson; K Galaal Journal: Int J Clin Oncol Date: 2017-06-15 Impact factor: 3.402
Authors: Sean Soisson; Patricia A Ganz; David Gaffney; Kerry Rowe; John Snyder; Yuan Wan; Vikrant Deshmukh; Mike Newman; Alison Fraser; Ken Smith; Kimberly Herget; Heidi A Hanson; Yelena P Wu; Joseph Stanford; Theresa L Werner; Veronica Wendy Setiawan; Mia Hashibe Journal: Gynecol Oncol Date: 2017-12-27 Impact factor: 5.482
Authors: Thomas M Atkinson; Angela M Stover; Daniel F Storfer; Rebecca M Saracino; Thomas A D'Agostino; Denise Pergolizzi; Konstantina Matsoukas; Yuelin Li; Ethan Basch Journal: Epidemiol Rev Date: 2017-01-01 Impact factor: 6.222
Authors: Matthew M Harkenrider; Alec M Block; Kaled M Alektiar; David K Gaffney; Ellen Jones; Ann Klopp; Akila N Viswanathan; William Small Journal: Brachytherapy Date: 2016-05-31 Impact factor: 2.362
Authors: Theresa A Lawrie; John T Green; Mark Beresford; Linda Wedlake; Sorrel Burden; Susan E Davidson; Simon Lal; Caroline C Henson; H Jervoise N Andreyev Journal: Cochrane Database Syst Rev Date: 2018-01-23
Authors: R A Sunil; Devang Bhavsar; M N Shruthi; U Suryanarayan Kunikullaya; R K Vyas; Ankita Parikh; Maitrik Jayantkumar Mehta; Pooja Nandwani Patel Journal: J Contemp Brachytherapy Date: 2018-04-30
Authors: Yaowen Zhang; Carlos Ascaso; Antonio Herreros; Joan Sánchez; Sebastia Sabater; Marta Del Pino; Yan Li; Gabriela Gómez; Aureli Torné; Albert Biete; Ángeles Rovirosa Journal: Rep Pract Oncol Radiother Date: 2020-01-14