title: Surgery and postoperative radiotherapy versus surgery alone for patients with stage-1 endometrial carcinoma: multicentre randomised trial. PORTEC Study Group. Post Operative Radiation Therapy in Endometrial Carcinoma.
abstract: BACKGROUND
  Postoperative radiotherapy for International Federation of Gynaecology and Obstetrics (FIGO) stage-1 endometrial carcinoma is a subject of controversy due to the low relapse rate and the lack of data from randomised trials. We did a multicentre prospective randomised trial to find whether postoperative pelvic radiotherapy improves locoregional control and survival for patients with stage-1 endometrial carcinoma.
  
  
  METHODS
  Patients with stage-1 endometrial carcinoma (grade 1 with deep [> or =50%] myometrial invasion, grade 2 with any invasion, or grade 3 with superficial [<50%] invasion) were enrolled. After total abdominal hysterectomy and bilateral salpingo-oophorectomy, without lymphadenectomy, 715 patients from 19 radiation oncology centres were randomised to pelvic radiotherapy (46 Gy) or no further treatment. The primary study endpoints were locoregional recurrence and death, with treatment-related morbidity and survival after relapse as secondary endpoints.
  
  
  RESULTS
  Analysis was done according to the intention-to-treat principle. Of the 715 patients, 714 could be evaluated. The median duration of follow-up was 52 months. 5-year actuarial locoregional recurrence rates were 4% in the radiotherapy group and 14% in the control group (p<0.001). Actuarial 5-year overall survival rates were similar in the two groups: 81% (radiotherapy) and 85% (controls), p=0.31. Endometrial-cancer-related death rates were 9% in the radiotherapy group and 6% in the control group (p=0.37). Treatment-related complications occurred in 25% of radiotherapy patients, and in 6% of the controls (p<0.0001). Two-thirds of the complications were grade 1. Grade 3-4 complications were seen in eight patients, of which seven were in the radiotherapy group (2%). 2-year survival after vaginal recurrence was 79%, in contrast to 21% after pelvic recurrence or distant metastases. Survival after relapse was significantly (p=0.02) better for patients in the control group. Multivariate analysis showed that for locoregional recurrence, radiotherapy and age below 60 years were significant favourable prognostic factors.
  
  
  CONCLUSIONS
  Postoperative radiotherapy in stage-1 endometrial carcinoma reduces locoregional recurrence but has no impact on overall survival. Radiotherapy increases treatment-related morbidity. Postoperative radiotherapy is not indicated in patients with stage-1 endometrial carcinoma below 60 years and patients with grade-2 tumours with superficial invasion.
authors.affiliation: Department of Radiation Oncology, University Hospital Rotterdam-Daniel den Hoed Cancer Center, The Netherlands. creutzberg@rtdh.azr.nl
authors.forename: C L
authors.initials: CL
authors.lastname: Creutzberg
authors.forename: W L
authors.initials: WL
authors.lastname: van Putten
authors.forename: P C
authors.initials: PC
authors.lastname: Koper
authors.forename: M L
authors.initials: ML
authors.lastname: Lybeert
authors.forename: J J
authors.initials: JJ
authors.lastname: Jobsen
authors.forename: C C
authors.initials: CC
authors.lastname: Wárlám-Rodenhuis
authors.forename: K A
authors.initials: KA
authors.lastname: De Winter
authors.forename: L C
authors.initials: LC
authors.lastname: Lutgens
authors.forename: A C
authors.initials: AC
authors.lastname: van den Bergh
authors.forename: E
authors.initials: E
authors.lastname: van de Steen-Banasik
authors.forename: H
authors.initials: H
authors.lastname: Beerman
authors.forename: M
authors.initials: M
authors.lastname: van Lent
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery*; D000368:Aged; D018196:Carcinoma, Adenosquamous / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery*; D016889:Endometrial Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery*; D005260:Female; D006801:Humans; D007044:Hysterectomy; D008197:Lymph Node Excision; D008679:Metaplasia; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000209:etiology; D009367:Neoplasm Staging; D010052:Ovariectomy; D011379:Prognosis; D011446:Prospective Studies; D018714:Radiotherapy, Adjuvant; D016019:Survival Analysis; D016896:Treatment Outcome