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In this study, for the first time, we demonstrated the presence of microRNAs and extracellular vesicles in human blastocoel fluid. The bioinformatic and comparative analyses identified the biological function of blastocoel fluid microRNAs and suggested a potential role inside the human blastocyst. We found 89 microRNAs, expressed at different levels, able to regulate critical signaling pathways controlling embryo development, such as pluripotency, cell reprogramming, epigenetic modifications, intercellular communication, cell adhesion and cell fate. Blastocoel fluid microRNAs reflect the miRNome of embryonic cells and their presence, associated with the discovery of extracellular vesicles, inside blastocoel fluid, strongly suggests their important role in mediating cell communication among blastocyst cells. Their characterization is important to better understand the earliest stages of embryogenesis and the complex circuits regulating pluripotency. Moreover, blastocoel fluid microRNA profiles could be influenced by blastocyst quality, therefore, microRNAs might be used to assess embryo potential in IVF cycles.

Background Vulvar cancer is a rare gynecological malignancy that primarily affects women of postmenopausal age. Treatment is mainly surgical, particularly for vulvar squamous cell carcinoma, the most prevalent histotype. In patients with unifocal tumors with a maximum diameter of <4 cm, in the absence of suspected inguinal lymph nodes, sentinel lymph node (SLN) biopsy is recommended. The use of a radioactive tracer is mandatory; the use of the vital blue dye is optional. Results Two patients diagnosed with vulvar squamous cell carcinoma (FIGO IB stage) underwent bilateral radical vulvectomy, SLN search and removal, and bilateral inguinal lymphadenectomy at the Cannizzaro Hospital Operative Unit of Obstetrics and Gynecology Department (Catania, Italy). Three milliliters of indocyanine green (ICG) 0.5 mg/mL was administered in 3 peritumoral injections under general anesthesia to screen the SLN. The images were acquired using an intraoperative infrared camera system, which allowed intraoperative visualization of the SLN. An SLN was identified for each patient. The lymph nodes examined by the pathologist were negative for metastatic localization of the disease. However, patients underwent bilateral inguinofemoral lymphadenectomy, as this procedure is not currently codified as a gold standard for the detection of SLN in vulvar cancer. All the lymph nodes removed were negative for the localization of vulvar carcinoma metastases. Conclusions The potential of the administration of indocyanine green (ICG) allows the execution of SLN biopsy, avoiding the multiple administrations of radiocolloid in the pre-operative phase, painful for the patient, elimination, and exposure to radioactivity. Therefore, while requiring standardization of the methodology and a large-scale application, this procedure could open a new surgical management perspective in patients with early-stage vulvar cancer.

Introduction/Background*The role of volume of sentinel lymph nodes (SLNs) disease (macro-micrometastases and ITCs) in endometrial cancer is not clearly defined. We aimed to asses predictive factors for SLNs involvement and recurrence free survival (RFS) in patients with endometrial cancer.MethodologyA multicenter retrospective evaluation of endometrial cancer patients with positive (macro-micro metastases or ITCs) SLNs, treated between 2003 and 2020, was performed. Predictive factors for nodal involvement (endometrioid vs non-endometrioid histology, grading, lymphovascular-space invasion (LVSI), myometrial invasion (MI), cervical stromal invasion, ESGO/ESTRO/ESP risk group), adjuvant therapy and oncological outcomes were evaluated.Result(s)*142 patients were identified among 12 participating centers performing SLN mapping. In 64.8% of cases a low-volume disease (≤2 mm) was found in SLNs: 33 (23.2%) ITCs and 59 (41.6%) micrometastases. Factors influencing volume of nodal metastases were: grading [p:0.002] (G1 associated with low-volume disease), LVSI [p:0.007] and MI >50% [p:0.008] (both associated with macrometastases). There were: 20 (14.1%) low-risk, 14 (9.8%) intermediate, 88 (62%) high-intermediate and 20 (14.1%) high-risk according to 2020-ESGO/ESTRO/ESP risk group (on uterus). 17 (18.5%) patients with low-volume disease (8 micrometastases and 9 ITCs) did not receive any adjuvant therapy. At a mean follow-up of 34.6 months (range 1 –215) months, 21 (14.8%) relapses were recorded, only one among patients not receiving any adjuvant, none in the ESGO/ESTRO/ESP low risk group. The RFS at 2-years for the micrometastatic patients was 91%, similar to ITCs patients (79.1%), regardless of adjuvant treatment, but statistically better than patients with macrometastases (72.3%) [p: 0.026]. There was a trend to distinct RFS according to ESGO/ESTRO/ESP risk group, but none of the comparisons reached significance. The only factors affecting RFS were deep MI [p:0.03] and cervical stromal invasion [p:0.046].Conclusion*More than half of patients with positive SLNs had low-volume disease. Grading, MI and LVSI predicted volume of nodal metastases. MI and cervical invasion affected RFS; while adjuvant treatment did not seem significantly associated with RFS in patients with low-volume disease. Longer follow-up time and a larger sample size are needed to understand the role of adjuvant therapy in low-volume metastatic SLNs.

Introduction/Background*In the last decade, sentinel lymph node mapping (SLNM) has gained a central role in endometrial cancer (EC) surgical staging. However, different technical steps of SLNM still remain object of discussione. Terofere, a randomized control trial (RCT) was conducted to compare cervical and hysteroscopic indocyanine green (ICG) injection for SLNM of newly diagnosed EC undergoing surgical staging. The prima-ry endpoint of the study was to compare these two techniques in term of para-aortic detection rate.MethodologyThis RCT included women with apparent stage I or II histologically confirmed endometrial cancer undergoing surgery were included in the study. Two groups were distinguished according to two different techniques of indocyanine green (ICG) sentinel lymph node mapping (SLNM): cervical versus hysteroscopic injection. This randomized trial was not blinded for both the patients and the surgeons.Result(s)*Since March 2017 until April 2019, 165 patients were randomized: 85 (51.5%) in the cervical group and 80 (48.5%) in the hysteroscopic group. After randomization, 14 (8.5%) patients were excluded from the study. Finally, 151 patients were included in the analysis: 82 (54.3%) in the cervical group and 69 (45.7%) in the hysteroscopic group. Hysteroscopy injection demonstrated a 10% higher accuracy to detect SNLs in the paraaortic area compared to cervical injection, although this difference did not reach statistical significance. The hysteroscopic technique was better in detecting isolated SLN para-aortic (5.8% vs 0%). Cervical injection was correlated with higher SLN detection rates at pelvic level compared to hysteroscopic injection. Pelvic and overall detection was superior in the cervical group.Conclusion*The current study suggests the use of cervical injection rather than hysteroscopic injection due to its better identification of sentinel nodes (particularly in the pelvic area). Although, detection of SLN in the para-aortic area was slightly superior in patients undergoing a hysteroscopic injection, no significant difference with cervical injection was detected.

Background: Based on the efficacy of pegylated liposomal doxorubicin (PLD) in relapsed ovarian cancer, we are conducting a phase III study comparing carboplatin plus either paclitaxel or PLD as first-line therapy in advanced ovarian cancer. Because of limited phase I and II data on PLD plus carboplatin in this setting, we conducted an interim activity analysis. Patients and Methods: Patients with stage 1c-IV epithelial ovarian cancer were randomized to carboplatin AUC 5 plus either paclitaxel 175 mg/m 2 or PLD 30 mg/m 2 every 3 weeks for 6 cycles. The interim activity analysis was planned according to a single-stage phase II design with an auspicated 50% response rate; 50 patients eligible for response assessment were required. Response was defined according to RECIST (Response Evaluation Criteria in Solid Tumors). Results: A complete response was achieved in 14 patients (28%) and a partial response in 20 (40%), which produced an overall response rate of 68%. The activity exceeded the minimum required for study continuation. Stable disease was reported in an additional 10 patients (20%). Conclusions: The adopted schedule of PLD plus carboplatin demonstrates activity as a first-line treatment for advanced ovarian cancer.

Adnexal torsion is a surgical emergency requiring early diagnosis in order to avoid demolitive surgery. Adnexal torsion’s diagnosis could be very difficult in pediatric patients because children cannot explain symptoms accurately. Furthermore reproductive organs lie high in abdomen, causing unclear examinations findings. For reducing diagnostic mistakes or delay clinical and hematological criteria could be useful. No radiological criteria (CT or MRI) should be taken in count because of the costs and the required time. By combining clinical presentation in patients with OT three useful diagnostic variables have been identified: age, duration of pain, vomiting. Presence of vomiting, short duration of abdominal pain and high CRP levels have great predictive value for the diagnosis of adnexal torsion. In those patients an exploratory laparoscopy should be performed without any doubt and/or delay. These data may aid physicians in the evaluation of abdominal pain in premenarchal girls.

Risk of relapse or progression remains high in the treatment of most patients with epithelial ovarian cancer, and development of a molecular predictor could be a valuable tool for stratification of patients by risk. We aimed to develop a microRNA (miRNA)-based molecular classifier that can predict risk of progression or relapse in patients with epithelial ovarian cancer. We analysed miRNA expression profiles in three cohorts of samples collected at diagnosis. We used 179 samples from a Multicenter Italian Trial in Ovarian cancer trial (cohort OC179) to develop the model and 263 samples from two cancer centres (cohort OC263) and 452 samples from The Cancer Genome Atlas epithelial ovarian cancer series (cohort OC452) to validate the model. The primary clinical endpoint was progression-free survival, and we adapted a semi-supervised prediction method to the miRNA expression profile of OC179 to identify miRNAs that predict risk of progression. We assessed the independent prognostic role of the model using multivariable analysis with a Cox regression model. We identified 35 miRNAs that predicted risk of progression or relapse and used them to create a prognostic model, the 35-miRNA-based predictor of Risk of Ovarian Cancer Relapse or progression (MiROvaR). MiROvaR was able to classify patients in OC179 into a high-risk group (89 patients; median progression-free survival 18 months [95% CI 15–22]) and a low-risk group (90 patients; median progression-free survival 38 months [24–not estimable]; hazard ratio [HR] 1·85 [1·29–2·64], p=0·00082). MiROvaR was a significant predictor of progression in the two validation sets (OC263 HR 3·16, 95% CI 2·33–4·29, p<0·0001; OC452 HR 1·39, 95% CI 1·11–1·74, p=0·0047) and maintained its independent prognostic effect when adjusted for relevant clinical covariates using multivariable analyses (OC179: adjusted HR 1·48, 95% CI 1·03–2·13, p=0·036; OC263: adjusted HR 3·09 [2·24–4·28], p<0·0001; and OC452: HR 1·41 [1·11–1·79], p=0·0047). MiROvaR is a potential predictor of epithelial ovarian cancer progression and has prognostic value independent of relevant clinical covariates. MiROvaR warrants further investigation for the development of a clinical-grade prognostic assay. AIRC and CARIPLO Foundation.

Background: A common tactic used by athletes to improve performance, lessen tiredness, and hasten recovery is dietary supplementation. We aimed to assess the role of a microalgae dietary liquid supplement additivated with Copper 22.5% NRV in water polo players’ performance. Methods: Twenty male water polo players were split into two groups: ten (spirulina group) took a twice-daily nutritional supplement containing 15 mL of spirulina liquid extract (titrated in Phycocyanin 1 mg/mL) and additivated with Copper 22.5% NRV for eight weeks, and ten (the placebo group) did not take the supplement. Subjective evaluations were finished using the Athlete’s Subjective Performance Scale (ASPS). Levels of the biomarker creatine phosphokinase (CPK) were also assessed. Results: The spirulina group’s mean total ASPS score increased significantly from baseline to follow-up and was significantly better than that of the placebo group (p < 0.001). Conversely, ASPS ratings in the placebo group slightly decreased. A positive correlation between spirulina supplementation and less severe ASPS was found using correlation matrix analysis. However, there was a slight difference in CPK levels from the baseline to the follow-up in the spirulina group. Conclusions: A dietary supplement comprising spirulina and copper may help water polo players’ subjective performance measurements by lowering muscular tension. Larger, randomized controlled trials are yet required.

ObjectiveTo explore the clinical and biological prognostic factors for advanced ovarian cancer patients receiving first-line treatment with carboplatin, paclitaxel, and bevacizumab.MethodsA multicenter, phase IV, single arm trial was performed. Patients with advanced (FIGO (International Federation of Gynecology and Obstetrics) stage IIIB-IV) or recurrent, previously untreated, ovarian cancer received carboplatin (AUC (area under the curve) 5), paclitaxel (175 mg/m2) plus bevacizumab (15 mg/kg) on day 1 for six 3-weekly cycles followed by bevacizumab single agent (15 mg/kg) until progression or unacceptable toxicity up to a maximum of 22 total cycles. Here we report the final analysis on the role of clinical prognostic factors. The study had 80% power with a two-tailed 0.01 α error to detect a 0.60 hazard ratio with a factor expressed in at least 20% of the population. Both progression-free and overall survival were used as endpoints.ResultsFrom October 2012 to November 2014, 398 eligible patients were treated. After a median follow-up of 32.3 months (IQR 24.1–40.4), median progression-free survival was 20.8 months (95% CI 19.1 to 22.0) and median overall survival was 41.1 months (95% CI 39.1 to 43.5). Clinical factors significantly predicting progression-free and overall survival were performance status, stage, and residual disease after primary surgery. Neither baseline blood pressure/antihypertensive treatment nor the development of hypertension during bevacizumab were prognostic. There were two deaths possibly related to treatment, but no unexpected safety signal was reported.ConclusionsEfficacy and safety of bevacizumab in combination with carboplatin and paclitaxel and as maintenance were comparable to previous data. Hypertension, either at baseline or developed during treatment, was not prognostic. Performance status, stage, and residual disease after primary surgery remain the most important clinical prognostic factors.Trial registration numberEudraCT 2012-003043-29; NCT01706120.