title: Randomised study of systematic lymphadenectomy in patients with epithelial ovarian cancer macroscopically confined to the pelvis.
abstract: No randomised trials have addressed the value of systematic aortic and pelvic lymphadenectomy (SL) in ovarian cancer macroscopically confined to the pelvis. This study was conducted to investigate the role of SL compared with lymph nodes sampling (CONTROL) in the management of early stage ovarian cancer. A total of 268 eligible patients with macroscopically intrapelvic ovarian carcinoma were randomised to SL (N=138) or CONTROL (N=130). The primary objective was to compare the proportion of patients with retroperitoneal nodal involvement between the two groups. Median operating time was longer and more patients required blood transfusions in the SL arm than the CONTROL arm (240 vs 150 min, P<0.001, and 36 vs 22%, P=0.012, respectively). More patients in the SL group had positive nodes at histologic examination than patients on CONTROL (9 vs 22%, P=0.007). Postoperative chemotherapy was delivered in 66% and 51% of patients with negative nodes on CONTROL and SL, respectively (P=0.03). At a median follow-up of 87.8 months, the adjusted risks for progression (hazard ratio [HR]=0.72, 95%CI=0.46-1.21, P=0.16) and death (HR=0.85, 95%CI=0.49-1.47, P=0.56) were lower, but not statistically significant, in the SL than the CONTROL arm. Five-year progression-free survival was 71.3 and 78.3% (difference=7.0%, 95% CI=-3.4-14.3%) and 5-year overall survival was 81.3 and 84.2% (difference=2.9%, 95% CI=-7.0-9.2%) respectively for CONTROL and SL. SL detects a higher proportion of patients with metastatic lymph nodes. This trial may have lacked power to exclude clinically important effects of SL on progression free and overall survival.
authors.affiliation: Istituto Europeo di Oncologia, Milan, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Maggioni
authors.forename: P
authors.initials: P
authors.lastname: Benedetti Panici
authors.forename: T
authors.initials: T
authors.lastname: Dell'Anna
authors.forename: F
authors.initials: F
authors.lastname: Landoni
authors.forename: A
authors.initials: A
authors.lastname: Lissoni
authors.forename: A
authors.initials: A
authors.lastname: Pellegrino
authors.forename: R S
authors.initials: RS
authors.lastname: Rossi
authors.forename: S
authors.initials: S
authors.lastname: Chiari
authors.forename: E
authors.initials: E
authors.lastname: Campagnutta
authors.forename: S
authors.initials: S
authors.lastname: Greggi
authors.forename: R
authors.initials: R
authors.lastname: Angioli
authors.forename: N
authors.initials: N
authors.lastname: Manci
authors.forename: M
authors.initials: M
authors.lastname: Calcagno
authors.forename: G
authors.initials: G
authors.lastname: Scambia
authors.forename: R
authors.initials: R
authors.lastname: Fossati
authors.forename: I
authors.initials: I
authors.lastname: Floriani
authors.forename: V
authors.initials: V
authors.lastname: Torri
authors.forename: R
authors.initials: R
authors.lastname: Grassi
authors.forename: C
authors.initials: C
authors.lastname: Mangioni
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D017024:Chemotherapy, Adjuvant; D018450:Disease Progression; D005260:Female; D006801:Humans; D008197:Lymph Node Excision; D008198:Lymph Nodes / Q000473:pathology / Q000601:surgery; D008207:Lymphatic Metastasis; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000601:surgery*; D010386:Pelvic Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000601:surgery*; D012307:Risk Factors; D015996:Survival Rate; D016896:Treatment Outcome