PURPOSE: To evaluate the value of adjuvant external beam pelvic radiotherapy as adjunct to vaginal brachytherapy (VBT) in medium-risk endometrial carcinoma, with regard to locoregional tumor control, recurrences, survival, and toxicity. METHODS AND MATERIALS: Consecutive series of 527 evaluable patients were included in this randomized trial. Median follow-up for patients alive was 62 months. The primary study endpoints were locoregional recurrences and overall survival. Secondary endpoints were recurrence-free survival, recurrence-free interval, cancer-specific survival, and toxicity. RESULTS: Five-year locoregional relapse rates were 1.5% after external beam radiotherapy (EBRT) plus VBT and 5% after vaginal irradiation alone (p = 0.013), and 5-year overall survival rates were 89% and 90%, respectively (p = 0.548). Endometrial cancer-related death rates were 3.8% after EBRT plus VBT and 6.8% after VBT (p = 0.118). Pelvic recurrences (exclusively vaginal recurrence) were reduced by 93% by the addition of EBRT to VBT. Deep myometrial infiltration was a significant prognostic factor in this medium-risk group of endometrioid carcinomas but not International Federation of Gynecology and Obstetrics grade or DNA ploidy. Combined radiotherapy was well tolerated, with serious (Grade 3) late side effects of less than 2%. However, there was a significant difference in favor of VBT alone. CONCLUSIONS: Despite a significant locoregional control benefit with combined radiotherapy, no survival improvement was recorded, but increased late toxicity was noted in the intestine, bladder, and vagina. Combined RT should probably be reserved for high-risk cases with two or more high-risk factors. VBT alone should be the adjuvant treatment option for purely medium-risk cases.
RCT Entities:
PURPOSE: To evaluate the value of adjuvant external beam pelvic radiotherapy as adjunct to vaginal brachytherapy (VBT) in medium-risk endometrial carcinoma, with regard to locoregional tumor control, recurrences, survival, and toxicity. METHODS AND MATERIALS: Consecutive series of 527 evaluable patients were included in this randomized trial. Median follow-up for patients alive was 62 months. The primary study endpoints were locoregional recurrences and overall survival. Secondary endpoints were recurrence-free survival, recurrence-free interval, cancer-specific survival, and toxicity. RESULTS: Five-year locoregional relapse rates were 1.5% after external beam radiotherapy (EBRT) plus VBT and 5% after vaginal irradiation alone (p = 0.013), and 5-year overall survival rates were 89% and 90%, respectively (p = 0.548). Endometrial cancer-related death rates were 3.8% after EBRT plus VBT and 6.8% after VBT (p = 0.118). Pelvic recurrences (exclusively vaginal recurrence) were reduced by 93% by the addition of EBRT to VBT. Deep myometrial infiltration was a significant prognostic factor in this medium-risk group of endometrioid carcinomas but not International Federation of Gynecology and Obstetrics grade or DNA ploidy. Combined radiotherapy was well tolerated, with serious (Grade 3) late side effects of less than 2%. However, there was a significant difference in favor of VBT alone. CONCLUSIONS: Despite a significant locoregional control benefit with combined radiotherapy, no survival improvement was recorded, but increased late toxicity was noted in the intestine, bladder, and vagina. Combined RT should probably be reserved for high-risk cases with two or more high-risk factors. VBT alone should be the adjuvant treatment option for purely medium-risk cases.
Authors: Rebecca Anne Shuford; Caleb R Dulaney; Omer L Burnett; Kevin W Byram; Andrew M McDonald Journal: Int J Gynecol Cancer Date: 2016-04-21 Impact factor: 3.437
Authors: Marco Johannes Battista; Marcus Schmidt; Nicole Rieks; Isabel Sicking; Stefan Albrich; Michael Eichbaum; Heinz Koelbl; Peter Mallmann; Gerald Hoffmann; Eric Steiner Journal: J Cancer Res Clin Oncol Date: 2014-09-26 Impact factor: 4.553
Authors: Nicole Concin; Carien L Creutzberg; Ignace Vergote; David Cibula; Mansoor Raza Mirza; Simone Marnitz; Jonathan A Ledermann; Tjalling Bosse; Cyrus Chargari; Anna Fagotti; Christina Fotopoulou; Antonio González-Martín; Sigurd F Lax; Domenica Lorusso; Christian Marth; Philippe Morice; Remi A Nout; Dearbhaile E O'Donnell; Denis Querleu; Maria Rosaria Raspollini; Jalid Sehouli; Alina E Sturdza; Alexandra Taylor; Anneke M Westermann; Pauline Wimberger; Nicoletta Colombo; François Planchamp; Xavier Matias-Guiu Journal: Virchows Arch Date: 2021-02 Impact factor: 4.064