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.
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.
Systematic lymphadenectomy has a diagnostic value in early-stage ovarian cancer, thanks to the possibility of accurate clinical staging. As up to 22% of women, who were presumed to have early-stage ovarian cancers, are upstaged during the lymphadenectomy procedure, accurate staging can help to avoid unnecessary postoperative chemotherapy. In patients affected by advanced ovarian cancer, systematic lymphadenectomy statistically significantly improves progression-free survival and reduces recurrence rates despite a higher incidence of postoperative complications. As improvement of overall survival is not statistically significant, further studies are needed to balance risks and benefits of systematic lymphadenectomy in advanced-stage disease.
BackgroundMyo-inositol (MI), successfully used in polycystic ovary syndrome (PCOS), was administered with α-LA to exploit its action of favouring the passage of other molecules through biological barriers, and also considering its anti-inflammatory effect.MethodsPCOS patients, according to the Rotterdam ESHRE–ASRM criteria, with anovulation and infertility > 1 year, were included in this open and prospective study. The preliminary phase was aimed at determining a set of MI-resistant PCOS patients. This treatment involved 2 g MI, taken twice per day by oral route, for three months. The Homeostasis Model Assessment (HOMA) index and MI plasma levels were measured. In the main phase, previously selected MI-resistant patients received the same daily amount of MI plus 50 mg α-LA twice a day, for a further three months. Ovulation was assessed using ultrasound examination on days 12, 14 and 20 of the cycle. The HOMA index, lipid, hormone and MI plasma levels were detected at baseline and at the end of this phase.ResultsThirty-seven anovulatory PCOS subjects were included in the study. Following MI treatment, 23 of the 37 women (62%) ovulated, while 14 (38%) were resistant and did not ovulate. In the latter group, MI plasma levels did not increase. These MI-resistant patients underwent treatment in the main phase of the study, receiving MI and α-LA. After this combined treatment, 12 (86%) of them ovulated. Their MI plasma levels were found to be significantly higher than at baseline; also, a hormone and lipid profile improvement was recorded.ConclusionThe combination of MI with α-LA allowed us to obtain significant progress in the treatment of PCOS MI-resistant patients. Therefore, this new formulation was able to re-establish ovulation, greatly increasing the chances of desired pregnancy.Trial RegistrationClinical trial registration number: NCT03422289 (ClinicalTrials.gov registry).
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