title: Systematic pelvic lymphadenectomy vs. no lymphadenectomy in early-stage endometrial carcinoma: randomized clinical trial.
abstract: BACKGROUND
  Pelvic lymph nodes are the most common site of extrauterine tumor spread in early-stage endometrial cancer, but the clinical impact of lymphadenectomy has not been addressed in randomized studies. We conducted a randomized clinical trial to determine whether the addition of pelvic systematic lymphadenectomy to standard hysterectomy with bilateral salpingo-oophorectomy improves overall and disease-free survival.
  
  
  METHODS
  From October 1, 1996, through March 31, 2006, 514 eligible patients with preoperative International Federation of Gynecology and Obstetrics stage I endometrial carcinoma were randomly assigned to undergo pelvic systematic lymphadenectomy (n = 264) or no lymphadenectomy (n = 250). Patients' clinical data, pathological tumor characteristics, and operative and early postoperative data were recorded at discharge from hospital. Late postoperative complications, adjuvant therapy, and follow-up data were collected 6 months after surgery. Survival was analyzed by use of the log-rank test and a Cox multivariable regression analysis. All statistical tests were two-sided.
  
  
  RESULTS
  The median number of lymph nodes removed was 30 (interquartile range = 22-42) in the pelvic systematic lymphadenectomy arm and 0 (interquartile range = 0-0) in the no-lymphadenectomy arm (P < .001). Both early and late postoperative complications occurred statistically significantly more frequently in patients who had received pelvic systematic lymphadenectomy (81 patients in the lymphadenectomy arm and 34 patients in the no-lymphadenectomy arm, P = .001). Pelvic systematic lymphadenectomy improved surgical staging as statistically significantly more patients with lymph node metastases were found in the lymphadenectomy arm than in the no-lymphadenectomy arm (13.3% vs 3.2%, difference = 10.1%, 95% confidence interval [CI] = 5.3% to 14.9%, P < .001). At a median follow-up of 49 months, 78 events (ie, recurrence or death) had been observed and 53 patients had died. The unadjusted risks for first event and death were similar between the two arms (hazard ratio [HR] for first event = 1.10, 95% CI = 0.70 to 1.71, P = .68, and HR for death = 1.20, 95% CI = 0.70 to 2.07, P = .50). The 5-year disease-free and overall survival rates in an intention-to-treat analysis were similar between arms (81.0% and 85.9% in the lymphadenectomy arm and 81.7% and 90.0% in the no-lymphadenectomy arm, respectively).
  
  
  CONCLUSIONS
  Although systematic pelvic lymphadenectomy statistically significantly improved surgical staging, it did not improve disease-free or overall survival.
authors.affiliation: Department of Obstetrics and Gynecology, La Sapienza University of Rome, Rome, Italy. pierluigi.benedettipanici@uniroma1.it
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Benedetti Panici
authors.forename: Stefano
authors.initials: S
authors.lastname: Basile
authors.forename: Francesco
authors.initials: F
authors.lastname: Maneschi
authors.forename: Andrea
authors.initials: A
authors.lastname: Alberto Lissoni
authors.forename: Mauro
authors.initials: M
authors.lastname: Signorelli
authors.forename: Giovanni
authors.initials: G
authors.lastname: Scambia
authors.forename: Roberto
authors.initials: R
authors.lastname: Angioli
authors.forename: Saverio
authors.initials: S
authors.lastname: Tateo
authors.forename: Giorgia
authors.initials: G
authors.lastname: Mangili
authors.forename: Dionyssios
authors.initials: D
authors.lastname: Katsaros
authors.forename: Gaetano
authors.initials: G
authors.lastname: Garozzo
authors.forename: Elio
authors.initials: E
authors.lastname: Campagnutta
authors.forename: Nicoletta
authors.initials: N
authors.lastname: Donadello
authors.forename: Stefano
authors.initials: S
authors.lastname: Greggi
authors.forename: Mauro
authors.initials: M
authors.lastname: Melpignano
authors.forename: Francesco
authors.initials: F
authors.lastname: Raspagliesi
authors.forename: Nicola
authors.initials: N
authors.lastname: Ragni
authors.forename: Gennaro
authors.initials: G
authors.lastname: Cormio
authors.forename: Roberto
authors.initials: R
authors.lastname: Grassi
authors.forename: Massimo
authors.initials: M
authors.lastname: Franchi
authors.forename: Diana
authors.initials: D
authors.lastname: Giannarelli
authors.forename: Roldano
authors.initials: R
authors.lastname: Fossati
authors.forename: Valter
authors.initials: V
authors.lastname: Torri
authors.forename: Mariangela
authors.initials: M
authors.lastname: Amoroso
authors.forename: Clara
authors.initials: C
authors.lastname: Crocè
authors.forename: Costantino
authors.initials: C
authors.lastname: Mangioni
mesh_terms: D018262:Adenocarcinoma, Clear Cell / Q000401:mortality / Q000473:pathology; D000231:Adenocarcinoma, Papillary / Q000401:mortality / Q000473:pathology; D000368:Aged; D018269:Carcinoma, Endometrioid / Q000401:mortality / Q000473:pathology; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D018284:Cystadenocarcinoma, Serous / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D016889:Endometrial Neoplasms / Q000188:drug therapy / Q000401:mortality* / Q000473:pathology* / Q000532:radiotherapy / Q000601:surgery; D005260:Female; D006801:Humans; D007044:Hysterectomy; D053208:Kaplan-Meier Estimate; D008197:Lymph Node Excision; D008875:Middle Aged; D018200:Mixed Tumor, Mullerian / Q000401:mortality / Q000473:pathology; D009367:Neoplasm Staging; D010052:Ovariectomy / Q000379:methods; D018579:Patient Selection; D011237:Predictive Value of Tests; D011379:Prognosis; D016016:Proportional Hazards Models; D011446:Prospective Studies; D018714:Radiotherapy, Adjuvant; D012107:Research Design