title: Long-term outcome and quality of life of patients with endometrial carcinoma treated with or without pelvic radiotherapy in the post operative radiation therapy in endometrial carcinoma 1 (PORTEC-1) trial.
abstract: OBJECTIVE
  To determine the long-term outcome and health-related quality of life (HRQL) of patients with endometrial carcinoma (EC) treated with or without pelvic radiotherapy in the Post Operative Radiation Therapy in Endometrial Carcinoma 1 (PORTEC-1) trial.
  
  
  METHODS
  Between 1990 and 1997, 714 patients with stage IC grade 1 to 2 or IB grade 2 to 3 EC were randomly allocated to pelvic external-beam radiotherapy (EBRT) or no additional treatment (NAT). HRQL was evaluated with the Short Form 36-Item (SF-36) questionnaire; subscales from the European Organisation for Research and Treatment of Cancer (EORTC) PR25 module for bowel and bladder symptoms and the OV28 and CX24 modules for sexual symptoms; and demographic questions. Analysis was by intention-to-treat.
  
  
  RESULTS
  Median follow-up was 13.3 years. The 15-year actuarial locoregional recurrence rates were 5.8% for EBRT versus 15.5% for NAT (P < .001), and 15-year overall survival was 52% versus 60% (P = .14). Of the 351 patients confirmed to be alive with correct address, 246 (70%) returned the questionnaire. Patients treated with EBRT reported significant (P < .01) and clinically relevant higher rates of urinary incontinence, diarrhea, and fecal leakage leading to more limitations in daily activities. Increased symptoms were reflected by the frequent use of incontinence materials after EBRT (day and night use, 42.9% v 15.2% for NAT; P < .001). Patients treated with EBRT reported lower scores on the SF-36 scales "physical functioning" (P = .004) and "role-physical" (P = .003).
  
  
  CONCLUSIONS
  EBRT for endometrial cancer is associated with long-term urinary and bowel symptoms and lower physical and role-physical functioning, even 15 years after treatment. Despite its efficacy in reducing locoregional recurrence, EBRT should be avoided in patients with low- and intermediate-risk EC.
authors: Department of Clinical Oncology, Leiden University Medical Center, PO PO Box 9600, 2300 RC Leiden, The Netherlands. r.a.nout@lumc.nl
authors: Remi A
authors: RA
authors: Nout
authors: Lonneke V
authors: LV
authors: van de Poll-Franse
authors: Marnix L M
authors: ML
authors: Lybeert
authors: Carla C
authors: CC
authors: Wárlám-Rodenhuis
authors: Jan J
authors: JJ
authors: Jobsen
authors: Jan Willem M
authors: JW
authors: Mens
authors: Ludy C H W
authors: LC
authors: Lutgens
authors: Betty
authors: B
authors: Pras
authors: Wim L J
authors: WL
authors: van Putten
authors: Carien L
authors: CL
authors: Creutzberg
mesh_terms: D016889:Endometrial Neoplasms / Q000523:psychology / Q000532:radiotherapy* / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D010388:Pelvis; D011184:Postoperative Period; D011788:Quality of Life; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects; D012008:Recurrence; D011795:Surveys and Questionnaires; D016896:Treatment Outcome