title: External pelvic and vaginal irradiation versus vaginal irradiation alone as postoperative therapy in medium-risk endometrial carcinoma--a prospective randomized study.
abstract: OBJECTIVE
  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
  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.affiliation: Department of Gynecological Oncology, Örebro University Hospital, Örebro, Sweden. bengt.sorbe@orebroll.se
authors.forename: Bengt
authors.initials: B
authors.lastname: Sorbe
authors.forename: György
authors.initials: G
authors.lastname: Horvath
authors.forename: Håkan
authors.initials: H
authors.lastname: Andersson
authors.forename: Karin
authors.initials: K
authors.lastname: Boman
authors.forename: Caroline
authors.initials: C
authors.lastname: Lundgren
authors.forename: Birgitta
authors.initials: B
authors.lastname: Pettersson
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001918:Brachytherapy / Q000009:adverse effects / Q000379:methods; D018572:Disease-Free Survival; D016889:Endometrial Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007422:Intestines / Q000528:radiation effects; D008875:Middle Aged; D009215:Myometrium / Q000473:pathology; D009364:Neoplasm Recurrence, Local / Q000401:mortality / Q000473:pathology; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects / Q000379:methods; D013548:Sweden; D001743:Urinary Bladder / Q000528:radiation effects; D014621:Vagina / Q000528:radiation effects