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 ¼ 138) or CONTROL (N ¼ 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, Po0.001, and 36 vs 22%, P ¼ 0.012, respectively). More patients in the SL group had positive nodes at histologic examination than patients on CONTROL (9 vs 22%, P ¼ 0.007). Postoperative chemotherapy was delivered in 66% and 51% of patients with negative nodes on CONTROL and SL, respectively (P ¼ 0.03). At a median follow-up of 87.8 months, the adjusted risks for progression (hazard ratio [HR] ¼ 0.72, 95%CI ¼ 0.46 -1.21, P ¼ 0.16) and death (HR ¼ 0.85, 95%CI ¼ 0.49 -1.47, P ¼ 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 ¼ 7.0%, 95% CI ¼ -3.4 -14.3%) and 5-year overall survival was 81.3 and 84.2% (difference ¼ 2.9%, 95% CI ¼ À7.0 -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.

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Objective. Optimal primary cytoreductive surgery (OPCS) plus adjuvant chemotherapy (AC) represents the standard management for patients with advanced ovarian cancer (AOC). Recently, some authors have suggested the use of neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS) in patients with unresectable AOC. This study has been started to evaluate the role of diagnostic open laparoscopy (DOL) in predicting who are the best candidates to OPCS.Methods. All patients newly diagnosed as affected by AOC were submitted to DOL in order to establish the possibility of OPCS considered as no residual tumor left after operation. Patients considered not susceptible of OPCS were submitted to three cycles of NACT, administered every 3 weeks (Carboplatin, targeted AUC = 6, plus paclitaxel 175 mg/mq), followed by IDS and adjuvant chemotherapy.Results. From January 2000 to March 2004, 87 patients with AOC underwent DOL. Fifty-three patients (61%) were judged operable and therefore submitted to primary cytoreductive surgery (Group A). Optimal debulking rate in this group of patients was 96%. Thirty-four patients were judged affected by disease not cytoriducible to absent residual tumor and therefore scheduled for NACT-IDS-AC (Group B). Twenty-five patients were judged with partial clinical response and were therefore scheduled for IDS and AC. Optimal debulking rate (no residual tumor ) in Group B patients was 80%.No major perioperative complications, due to laparoscopy, occurred. All Group B patients received the first cycle of chemotherapy the day after DOL.In 34 patients (39%), an explorative laparotomy was avoided. With a median follow-up of 22 months (range 2 -49 months), the proportions surviving were 87% and 60% in Group A and Group B patients, respectively.Conclusion. DOL could be considered a valid diagnostic tool in evaluating the extent of disease in AOC. Our data suggest that the use of DOL leads to decrease the rate of primary cytoreductive surgery for AOC; on the other hand, a higher optimal debulking rate (no residual tumor) at primary surgery is achieved.

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