title: Fifteen-year radiotherapy outcomes of the randomized PORTEC-1 trial for endometrial carcinoma.
abstract: OBJECTIVE
  To evaluate the very long-term results of the randomized Post Operative Radiation Therapy in Endometrial Carcinoma (PORTEC)-1 trial for patients with Stage I endometrial carcinoma (EC), focusing on the role of prognostic factors for treatment selection and the long-term risk of second cancers.
  
  
  METHODS
  The PORTEC trial (1990-1997) included 714 patients with Stage IC Grade 1-2 or Stage IB Grade 2-3 EC. After surgery, patients were randomly allocated to external-beam pelvic radiotherapy (EBRT) or no additional treatment (NAT). Analysis was by intention to treat.
  
  
  RESULTS
  426 patients were alive at the date of analysis. The median follow-up time was 13.3 years. The 15-year actuarial locoregional recurrence (LRR) rates were 6% for EBRT vs. 15.5% for NAT (p < 0.0001). The 15-year overall survival was 52% vs. 60% (p = 0.14), and the failure-free survival was 50% vs. 54% (p = 0.94). For patients with high-intermediate risk criteria, the 15-year overall survival was 41% vs. 48% (p = 0.51), and the 15-year EC-related death was 14% vs. 13%. Most LRR in the NAT group were vaginal recurrences (11.0% of 15.5%). The 15-year rates of distant metastases were 9% vs. 7% (p = 0.25). Second primary cancers had been diagnosed over 15 years in 19% of all patients, 22% vs. 16% for EBRT vs. NAT (p = 0.10), with observed vs. expected ratios of 1.6 (EBRT) and 1.2 (NAT) compared with a matched population (p = NS). Multivariate analysis confirmed the prognostic significance of Grade 3 for LRR (hazard ratio [HR] 3.4, p = 0.0003) and for EC death (HR 7.3, p < 0.0001), of age >60 (HR 3.9, p = 0.002 for LRR and 2.7, p = 0.01 for EC death) and myometrial invasion >50% (HR 1.9, p = 0.03 and HR 1.9, p = 0.02).
  
  
  CONCLUSIONS
  The 15-year outcomes of PORTEC-1 confirm the relevance of HIR criteria for treatment selection, and a trend for long-term risk of second cancers. EBRT should be avoided in patients with low- and intermediate-risk EC.
authors.affiliation: Department of Clinical Oncology, Leiden University Medical Center, The Netherlands. c.l.creutzberg@lumc.nl
authors.forename: Carien L
authors.initials: CL
authors.lastname: Creutzberg
authors.forename: Remi A
authors.initials: RA
authors.lastname: Nout
authors.forename: Marnix L M
authors.initials: ML
authors.lastname: Lybeert
authors.forename: Carla C
authors.initials: CC
authors.lastname: Wárlám-Rodenhuis
authors.forename: Jan J
authors.initials: JJ
authors.lastname: Jobsen
authors.forename: Jan-Willem M
authors.initials: JW
authors.lastname: Mens
authors.forename: Ludy C H W
authors.initials: LC
authors.lastname: Lutgens
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Pras
authors.forename: Lonneke V
authors.initials: LV
authors.lastname: van de Poll-Franse
authors.forename: Wim L J
authors.initials: WL
authors.lastname: van Putten
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D001943:Breast Neoplasms / Q000453:epidemiology; D018572:Disease-Free Survival; D016889:Endometrial Neoplasms / Q000401:mortality* / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D005260:Female; D006801:Humans; D008875:Middle Aged; D060787:Neoplasm Grading; D009364:Neoplasm Recurrence, Local / Q000401:mortality; D016609:Neoplasms, Second Primary / Q000453:epidemiology; D011379:Prognosis; D012306:Risk; D016896:Treatment Outcome; D014625:Vaginal Neoplasms / Q000556:secondary