a b s t r a c tObjective. There is a need to develop and validate biomarkers for treatment response and survival in tuboovarian high-grade serous carcinoma (HGSC). The chemotherapy response score (CRS) stratifies patients into Gynecologic Oncology 154 (2019) 441-448 complete/near-complete (CRS3), partial (CRS2), and no/minimal (CRS1) response after neoadjuvant chemotherapy (NACT). Our aim was to review current evidence to determine whether the CRS is prognostic in women with tubo-ovarian HGSC treated with NACT.Methods. We established an international collaboration to conduct a systematic review and meta-analysis, pooling individual patient data from 16 sites in 11 countries. Patients had stage IIIC/IV HGSC, 3-4 NACT cycles and N6-months follow-up. Random effects models were used to derive combined odds ratios in the pooled population to investigate associations between CRS and progression free and overall survival (PFS and OS).Results. 877 patients were included from published and unpublished studies. Median PFS and OS were 15 months (IQR 5-65) and 28 months (IQR 7-92) respectively. CRS3 was seen in 249 patients (28%). The pooled hazard ratios (HR) for PFS and OS for CRS3 versus CRS1/CRS2 were 0·55 (95% CI, 0·45-0·66; P b 0·001) and 0·65 (95% CI 0·50-0·85, P = 0·002) respectively; no heterogeneity was identified (PFS: Q = 6·42, P = 0·698, I2 = 0·0%; OS: Q = 6·89, P = 0·648, I2 = 0·0%). CRS was significantly associated with PFS and OS in multivariate models adjusting for age and stage. Of 306 patients with known germline BRCA1/2 status, those with BRCA1/2 mutations (n = 80) were more likely to achieve CRS3 (P = 0·027).Conclusions. CRS3 was significantly associated with improved PFS and OS compared to CRS1/2. This validation of CRS in a real-world setting demonstrates it to be a robust and reproducible biomarker with potential to be incorporated into therapeutic decision-making and clinical trial design.• The Chemotherapy response score (CRS) assesses histological effect in ovarian cancer after neoadjuvant chemotherapy (NACT). • The CRS is associated with progression-free and overall survival.• CRS could provide useful information to estimate a patient's probability of early vs. late relapse.• The CRS is an appealing primary endpoint in clinical trials as a surrogate for survival as it can be measured earlier. • We recommend the CRS be incorporated as an endpoint in clinical trials of novel therapeutic agents that have a NACT arm.
Objective To systematically evaluate pregnancy and labor course, obstetrical complications, and maternal and neonatal outcomes in women with endometriosis, stratifying according to the specific location of the disease. Study Design We retrospectively analyzed our prospectively maintained obstetrical database from January 2011 to August 2014 to identify all women with a previous histological diagnosis of endometriosis who delivered at our institution (cases). We divided the cases according to the specific location of the disease (deep infiltrating endometriosis, ovarian endometriosis, and peritoneal endometriosis). As controls, we identified all unaffected women who delivered in the year 2013. To avoid the confounding effect of parity, we limited our analysis to nulliparous women. Results A total of 118 nulliparous women with endometriosis and 1,690 nulliparous controls were identified. Women with endometriosis were significantly older, had a lower body mass index, and had a higher incidence of assisted reproductive technology. The duration of pregnancy was significantly shorter among women with endometriosis. A higher incidence of placenta previa (3.4 vs. 0.5%; p = 0.006), hypertension (11 vs. 5.9%; p = 0.04), cesarean section (41.5 vs. 24.2%; p < 0.0001), and vacuum delivery (10.1 vs. 2.9%; p = 0.006) was found in women with endometriosis. Neonatal outcomes were similar between groups. The incidence of placenta previa in patients with deep endometriosis was 11.7 versus 0.5% among controls (p < 0.0001), whereas in women with ovarian and peritoneal endometriosis, it was similar to the controls. Conclusion Women with endometriosis have a higher incidence of vacuum delivery, cesarean section, and placenta previa compared with unaffected women. The higher risk of placenta previa is attributable exclusively to women with deep endometriosis. Neonatal outcomes are unaffected by the presence of the disease.
Vaginal cuff dehiscence, a severe and potentially detrimental complication, has significantly increased after the introduction of endoscopic hysterectomy. The aim of this systematic review and meta-analysis of the available literature was to identify the incidence of, and possible strategies to prevent, this complication after total laparoscopic hysterectomy and total robotic hysterectomy. Data Sources: PubMed, ClinicalTrials.gov, Scopus, and Web of Science databases were systematically queried to identify all articles reporting either laparoscopic or robot-assisted hysterectomies for benign indications in which vaginal dehiscence was reported as an outcome. Reference lists of the identified studies were manually searched. Only papers written in English were considered. Methods of Study Selection: The Population, Intervention, Comparison, and Outcome framework for the review included (1) population of interest: women who underwent conventional and robot-assisted laparoscopic hysterectomy; (2) interventions: possible methods to prevent vaginal dehiscence; (3) comparison: experimental strategies vs standard treatment or alternative strategy for each item of intervention; and (4) outcome: rate of vaginal dehiscence. Series of subtotal hysterectomies and radical hysterectomies in addition to reports that combined both benign and malignant cases were excluded. The meta-analysis was performed using RevMan version 5.4.1 (Cochrane Training, London, United Kingdom). Two independent reviewers identified all reports comparing 2 or more possible strategies to prevent vaginal dehiscence. Tabulation, Integration, and Results: A total of 460 articles were identified. Of these, 20 (6 randomized, 2 prospective, and 12 retrospective) studies were included in this review for a total of 19 392 patients. The incidence of vaginal dehiscence after total laparoscopic hysterectomy ranged between 0.64% and 1.35%. Robotic hysterectomy was associated with a risk of vaginal dehiscence of approximately 1.64%. No study compared early vs delayed resumption of coital activity nor analyzed the role of training in laparoscopic suturing. No study specifically assessed the impact of electrosurgery on the risk of vaginal dehiscence in endoscopic hysterectomies for benign indications. Double-layer and reinforced sutures did not decrease the risk of dehiscence. Barbed sutures reduced the risk of separation compared with nonbarbed closure (0.4% [4/1108] vs 2% [22/1097]; odds ratio [OR] 0.25; 95% confidence interval [CI], 0.11−0.57). However, these data came mainly from retrospective series. Excluding studies on the use of self-anchoring sutures during robotic hysterectomy, there was no significant difference in the risk of dehiscence between barbed and nonbarbed sutures (0.5% [4/890] vs 1.4% [181/776]; OR 0.38; 95% CI, 0.13−1.10). Transvaginal suture of the vault at the end of an endoscopic hysterectomy seemed to increase the risk of dehiscence when compared with laparoscopic closure (2.3% [23/1002] vs 1.16% [11/944]; OR 1.97; 95% CI, 1.00−3.88). Conclu...
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