title: Systematic lymphadenectomy in ovarian cancer at second-look surgery: a randomised clinical trial.
abstract: BACKGROUND
  The role of systematic aortic and pelvic lymphadenectomy (SAPL) at second-look surgery in early stage or optimally debulked advanced ovarian cancer is unclear and never addressed by randomised studies.
  
  
  METHODS
  From January 1991 through May 2001, 308 patients with the International Federation of Gynaecology and Obstetrics stage IA-IV epithelial ovarian carcinoma were randomly assigned to undergo SAPL (n=158) or resection of bulky nodes only (n=150). Primary end point was overall survival (OS).
  
  
  RESULTS
  The median operating time, blood loss, percentage of patients requiring blood transfusions and hospital stay were higher in the SAPL than in the control arm (P<0.001). The median number of resected nodes and the percentage of women with nodal metastases were higher in the SAPL arm as well (44% vs 8%, P<0.001 and 24.2% vs 13.3%, P:0.02). After a median follow-up of 111 months, 171 events (i.e., recurrences or deaths) were observed, and 124 patients had died. Sites of first recurrences were similar in both arms. The adjusted risk for progression and death were not statistically different (hazard ratio (HR) for progression=1.18, 95% confidence interval (CI)=0.87-1.59; P=0.29; 5-year progression-free survival (PFS)=40.9% and 53.8%; HR for death=1.04, 95% CI=0.733-1.49; P=0.81; 5-year OS=63.5% and 67.4%, in the SAPL and in the control arm, respectively).
  
  
  CONCLUSIONS
  SAPL in second-look surgery for advanced ovarian cancer did not improve PFS and OS.
authors.affiliation: S Gerardo Hospital, Monza, Italy.
authors.forename: T
authors.initials: T
authors.lastname: Dell' Anna
authors.forename: M
authors.initials: M
authors.lastname: Signorelli
authors.forename: P
authors.initials: P
authors.lastname: Benedetti-Panici
authors.forename: A
authors.initials: A
authors.lastname: Maggioni
authors.forename: R
authors.initials: R
authors.lastname: Fossati
authors.forename: R
authors.initials: R
authors.lastname: Fruscio
authors.forename: R
authors.initials: R
authors.lastname: Milani
authors.forename: L
authors.initials: L
authors.lastname: Bocciolone
authors.forename: A
authors.initials: A
authors.lastname: Buda
authors.forename: C
authors.initials: C
authors.lastname: Mangioni
authors.forename: G
authors.initials: G
authors.lastname: Scambia
authors.forename: R
authors.initials: R
authors.lastname: Angioli
authors.forename: E
authors.initials: E
authors.lastname: Campagnutta
authors.forename: R
authors.initials: R
authors.lastname: Grassi
authors.forename: F
authors.initials: F
authors.lastname: Landoni
mesh_terms: D000328:Adult; D000077216:Carcinoma, Ovarian Epithelial; D017024:Chemotherapy, Adjuvant; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008197:Lymph Node Excision / Q000379:methods; D008198:Lymph Nodes / Q000601:surgery*; D008875:Middle Aged; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy / Q000473:pathology / Q000601:surgery*; D010051:Ovarian Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000601:surgery*; D024162:Second-Look Surgery; D016896:Treatment Outcome