title: Systematic aortic and pelvic lymphadenectomy versus resection of bulky nodes only in optimally debulked advanced ovarian cancer: a randomized clinical trial.
abstract: BACKGROUND
  The role of systematic aortic and pelvic lymphadenectomy in patients with optimally debulked advanced ovarian cancer is unclear and has not been addressed by randomized studies. We conducted a randomized clinical trial to determine whether systematic aortic and pelvic lymphadenectomy improves progression-free and overall survival compared with resection of bulky nodes only.
  
  
  METHODS
  From January 1991 through May 2003, 427 eligible patients with International Federation of Gynecology and Obstetrics (FIGO) stage IIIB-C and IV epithelial ovarian carcinoma were randomly assigned to undergo systematic pelvic and para-aortic lymphadenectomy (n = 216) or resection of bulky nodes only (n = 211). Progression-free survival and overall survival were analyzed using a log-rank statistic and a Cox multivariable regression analysis. All statistical tests were two-sided.
  
  
  RESULTS
  After a median follow-up of 68.4 months, 292 events (i.e., recurrences or deaths) were observed, and 202 patients had died. Sites of first recurrences were similar in both arms. The adjusted risk for first event was statistically significantly lower in the systematic lymphadenectomy arm (hazard ratio [HR] = .75, 95% confidence interval [CI] = 0.59 to 0.94; P = .01) than in the no-lymphadenectomy arm, corresponding to 5-year progression-free survival rates of 31.2 and 21.6% in the systematic lymphadenectomy and control arms, respectively (difference = 9.6%, 95% CI = 1.5% to 21.6%), and to median progression-free survival of 29.4 and 22.4 months, respectively (difference = 7 months, 95% CI = 1.0 to 14.4 months). The risk of death was similar in both arms (HR = 0.97, 95% CI = 0.74 to 1.29; P = .85), corresponding to 5-year overall survival rates of 48.5 and 47%, respectively (difference = 1.5%, 95% CI = -8.4% to 10.6%), and to median overall survival of 58.7 and 56.3 months, respectively (difference = 2.4 months, 95% CI = -11.8 to 21.0 months). Median operating time was longer, and the percentage of patients requiring blood transfusions was higher in the systematic lymphadenectomy arm than in the no-lymphadenectomy arm (300 versus 210 minutes, P<.001, and 72% versus 59%; P = .006, respectively).
  
  
  CONCLUSIONS
  Systematic lymphadenectomy improves progression-free but not overall survival in women with optimally debulked advanced ovarian carcinoma.
authors.affiliation: Università La Sapienza, Rome, Italy.
authors.forename: Pierluigi Benedetti
authors.initials: PB
authors.lastname: Panici
authors.forename: Angelo
authors.initials: A
authors.lastname: Maggioni
authors.forename: Neville
authors.initials: N
authors.lastname: Hacker
authors.forename: Fabio
authors.initials: F
authors.lastname: Landoni
authors.forename: Sven
authors.initials: S
authors.lastname: Ackermann
authors.forename: Elio
authors.initials: E
authors.lastname: Campagnutta
authors.forename: Karl
authors.initials: K
authors.lastname: Tamussino
authors.forename: Raimund
authors.initials: R
authors.lastname: Winter
authors.forename: Antonio
authors.initials: A
authors.lastname: Pellegrino
authors.forename: Stefano
authors.initials: S
authors.lastname: Greggi
authors.forename: Roberto
authors.initials: R
authors.lastname: Angioli
authors.forename: Natalina
authors.initials: N
authors.lastname: Manci
authors.forename: Giovanni
authors.initials: G
authors.lastname: Scambia
authors.forename: Tiziana
authors.initials: T
authors.lastname: Dell'Anna
authors.forename: Roldano
authors.initials: R
authors.lastname: Fossati
authors.forename: Irene
authors.initials: I
authors.lastname: Floriani
authors.forename: Rita S
authors.initials: RS
authors.lastname: Rossi
authors.forename: Roberto
authors.initials: R
authors.lastname: Grassi
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Favalli
authors.forename: Francesco
authors.initials: F
authors.lastname: Raspagliesi
authors.forename: Diana
authors.initials: D
authors.lastname: Giannarelli
authors.forename: Luca
authors.initials: L
authors.lastname: Martella
authors.forename: Costantino
authors.initials: C
authors.lastname: Mangioni
mesh_terms: D000328:Adult; D000368:Aged; D001011:Aorta; D002277:Carcinoma / Q000188:drug therapy / Q000401:mortality / Q000556:secondary / Q000601:surgery*; D017024:Chemotherapy, Adjuvant; D018450:Disease Progression; D005260:Female; D006801:Humans; D008197:Lymph Node Excision / Q000009:adverse effects / Q000379:methods*; D008198:Lymph Nodes / Q000473:pathology* / Q000601:surgery; D008207:Lymphatic Metastasis; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D018579:Patient Selection; D010388:Pelvis; D011237:Predictive Value of Tests; D011379:Prognosis; D016016:Proportional Hazards Models; D016019:Survival Analysis; D016896:Treatment Outcome