Indocyanine green fluorescence applied to gynecologic oncology: beyond sentinel lymph node.

Indocyanine green (ICG), a well-known molecule employed in medicine for over five decades, has emerged as a versatile dye widely embraced across various surgical disciplines. In gynecologic oncology, its prevalent use revolves around the detection of sentinel lymph nodes. However, the true potential of ICG extends beyond this singular application, owing to its pragmatic utility, cost-effectiveness, and safety profile. Furthermore, ICG has been introduced in the theranostic landscape, marking a significant juncture in the evolution of its clinical utility. This narrative review aims to describe the expanding horizons of ICG fluorescence in gynecologic oncology, beyond the sentinel lymph node biopsy. The manifold applications reported within this manuscript include: 1) lymphography; 2) angiography; 3) nerve visualization; 4) ICG-driven resections; and 5) theranostic. The extensive exploration across these numerous applications, some of which are still in the pre-clinical phase, serves as a hypothesis generator, aiming to stimulate the development of clinical studies capable of expanding the use of this drug in our field, enhancing the care of gynecological cancer patients.

ESGO-ESMO-ESP consensus conference recommendations on ovarian cancer: pathology and molecular biology and early, advanced and recurrent disease.

The European Society of Gynaecological Oncology, the European Society for Medical Oncology (ESMO) and the European Society of Pathology held a consensus conference (CC) on ovarian cancer on 15-16 June 2022 in Valencia, Spain. The CC panel included 44 experts in the management of ovarian cancer and pathology, an ESMO scientific advisor and a methodologist. The aim was to discuss new or contentious topics and develop recommendations to improve and harmonise the management of patients with ovarian cancer. Eighteen questions were identified for discussion under four main topics: (i) pathology and molecular biology, (ii) early-stage disease and pelvic mass in pregnancy, (iii) advanced stage (including older/frail patients) and (iv) recurrent disease. The panel was divided into four working groups (WGs) to each address questions relating to one of the four topics outlined above, based on their expertise. Relevant scientific literature was reviewed in advance. Recommendations were developed by the WGs and then presented to the entire panel for further discussion and amendment before voting. This manuscript focuses on the recommendation statements that reached a consensus, their voting results and a summary of evidence supporting each recommendation.

A cost-effectiveness analysis of an integrated clinical-radiogenomic screening program for the identification of BRCA 1/2 carriers (e-PROBE study).

Current approach to identify BRCA 1/2 carriers in the general population is ineffective as most of the carriers remain undiagnosed. Radiomics is an emerging tool for large scale quantitative analysis of features from standard diagnostic imaging and has been applied also to identify gene mutational status. The objective of this study was to evaluate the clinical and economic impact of integrating a radiogenomics model with clinical and family history data in identifying BRCA mutation carriers in the general population. This cost-effective analysis compares three different approaches to women selection for BRCA testing: established clinical criteria/family history (model 1); established clinical criteria/family history and the currently available radiogenomic model (49% sensitivity and 87% specificity) based on ultrasound images (model 2); same approach used in model 2 but simulating an improvement of the performances of the radiogenomic model (80% sensitivity and 95% specificity) (model 3). All models were trained with literature data. Direct costs were calculated according to the rates currently used in Italy. The analysis was performed simulating different scenarios on the generation of 18-year-old girls in Italy (274,000 people). The main outcome was to identify the most effective model comparing the number of years of BRCA-cancer healthy life expectancy (HLYs). An incremental cost-effectiveness ratio (ICER) was also derived to determine the cost in order to increase BRCA carriers-healthy life span by 1 year. Compared to model 1, model 2 increases the detection rate of BRCA carriers by 41.8%, reduces the rate of BRCA-related cancers by 23.7%, generating over a 62-year observation period a cost increase by 2.51 €/Year/Person. Moreover, model 3 further increases BRCA carriers detection (+ 68.3%) and decrease in BRCA-related cancers (- 38.4%) is observed compared to model 1. Model 3 increases costs by 0.7 €/Year/Person. After one generation, the estimated ICER in the general population amounts to about 3800€ and 653€ in model 2 and model 3 respectively. Model 2 has a massive effect after only one generation in detecting carriers in the general population with only a small cost increment. The clinical impact is limited mainly due to the current low acceptance rate of risk-reducing surgeries. Further multicentric studies are required before implementing the integrated clinical-radiogenomic model in clinical practice.

Imaging in gynecological disease (27): clinical and ultrasound characteristics of recurrent ovarian stromal cell tumors.

OBJECTIVE: To describe the clinical and ultrasound characteristics of recurrent granulosa cell and Sertoli-Leydig cell tumors. METHODS: This was a retrospective observational study performed at Fondazione Policlinico Universitario A. Gemelli, Istituto di Ricovero e Cura a Carattere Scientifico, IRCCS, Rome (Gemelli center), Italy. Patients with a histological diagnosis of recurrent granulosa cell tumor or Sertoli-Leydig cell tumor were identified from the database of the Department of Gynecological Oncology. Those who had undergone a preoperative ultrasound examination at the Gemelli center between 2012 and 2020 were included, and the data retrieved from the original ultrasound reports. In all of these reports, the recurrent tumors were described using International Ovarian Tumor Analysis (IOTA) terminology. If a patient had more than one episode of relapse, information from all episodes was collected. If there was more than one recurrent tumor at the same ultrasound examination, all tumors were included. One expert sonographer also reviewed all available ultrasound images to identify typical ultrasound patterns using pattern recognition. RESULTS: We identified 30 patients with a histological diagnosis of recurrent granulosa cell tumor (25 patients, 55 tumors) or Sertoli-Leydig cell tumor (five patients, seven tumors). All 30 had undergone at least one preoperative ultrasound examination at the Gemelli center and were included. These women had a total of 66 episodes of relapse, of which a preoperative ultrasound examination had been performed at the Gemelli center in 34, revealing 62 recurrent lesions: one in 22/34 (64.7%) episodes of relapse, two in 4/34 (11.8%) episodes and three or more in 8/34 (23.5%) episodes. Most recurrent granulosa cell tumors (38/55, 69.1%) and recurrent Sertoli-Leydig tumors (6/7, 85.7%) were classified as solid or multilocular-solid tumors, while 8/55 (14.5%) recurrent granulosa cell tumors and 1/7 (14.3%) recurrent Sertoli-Leydig cell tumors were unilocular cysts and 9/55 (16.4%) recurrent granulosa cell tumors were multilocular cysts. The nine unilocular cysts had contents that were anechoic (n = 2) or had low-level echogenicity (n = 7), had either smooth (n = 4) or irregular (n = 5) internal cyst walls, and ranged in largest diameter from 8 to 38 mm, with three being < 20 mm and five being 20-30 mm. On retrospective review of the images, two typical ultrasound patterns were described: small solid tumor measuring < 2 cm (15/62, 24.2%) and tumor with vascularized echogenic ground-glass-like content (12/62, 19.4%). CONCLUSIONS: Some granulosa cell and Sertoli-Leydig cell recurrences manifest one of two typical ultrasound patterns, while some appear as unilocular cysts. These are usually classified as benign, but in patients being followed up for a granulosa cell tumor or Sertoli-Leydig cell tumor, a unilocular cyst should be considered suspicious of recurrence. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

The new surgical robot Hugo™ RAS for total hysterectomy: a pilot study.

Background: With the rising popularity of robotic surgery, Hugo™ RAS is one of the newest surgical robotic platforms. Investigating the reliability of this tool is the first step toward validating its use in clinical practice; and presently there arelimited data available regarding this. The literature is constantly enriched with initial experiences, however no study has demonstrated the safety of this platform yet. Objectives: This study aimed to investigate its reliability during total hysterectomy. Materials and Methods: A series of 20 consecutive patients scheduled for minimally invasive total hysterectomy with or without salpingo-oophorectomy for benign disease or prophylactic surgery were selected to undergo surgery with Hugo™ RAS. Data regarding any malfunction or breakdown of the robotic system as well as intra- and post-operative complications were prospectively recorded. Results: Fifteen of the twenty patients (75.0%) underwent surgery for benign uterine diseases, and five (25.0%) underwent prophylactic surgery. Among the entire series, an instrument fault occurred in one case (5.0%). The problem was solved in 4.8 minutes and without complications for the patient. The median total operative time was 127 min (range, 98-255 min). The median estimated blood loss was 50 mL (range:30-125 mL). No intraoperative complications were observed. One patient (5.0%) developed Clavien-Dindo grade 2 post-operative complication. Conclusions: In this pilot study, Hugo™ RAS showed high reliability, similar to other robotic devices. What is new?: Present findings suggest that Hugo™ RAS is a viable option for major surgical procedures and deserves further investigation in clinical practice.

Laparoscopic selection for surgery in epithelial ovarian cancer. A short review.

The role of laparoscopy as a treatment selection method in ovarian cancer patients is receiving growing attention in surgical practice in both early and advanced-stage disease. When the disease is confined to the ovary, intraoperative laparoscopic assessment of the tumour features is needed to select the best surgical approach in order to prevent intraoperative spillage of cancer cells which would negatively impact patient prognosis. The role of laparoscopy as a disease distribution assessment tool in cases of advanced-stage disease is now accepted by current guidelines as an effective treatment strategy selection. Indeed, a published and validated laparoscopic scoring system, based on laparoscopic assessed intra-abdominal disease dissemination features have been demonstrated to be a reliable predictor of optimal cytoreduction achievement. This subsequently reduces the exploratory laparotomy rate in both primary and interval debulking surgery setting. Furthermore, in cases of recurrent disease, the use of laparoscopy to predict whether complete tumour resection can be achieved is accepted by available guidelines. In this setting, the combination of laparoscopy and imaging techniques to manage platinum sensitive recurrent ovarian cancer cases showed a high accuracy in appropriately selected patients for secondary cytoreductive surgery. In this article we describe the role of laparoscopy in the treatment selection-process in ovarian cancer patients.

The first European gynaecological procedure with the new surgical robot Hugo™ RAS. A total hysterectomy and salpingo-oophorectomy in a woman affected by BRCA-1 mutation.

Background: The benefits of minimally invasive surgery are well known in gynaecology. Robotic-assisted surgery has gained widespread acceptance within the surgical community and seems to be the most rapidly developing sector of minimally invasive surgery. Objectives: This video shows the salient steps of total hysterectomy with new robotic technology, Hugo™ RAS. The objectives were to introduce and demonstrate the feasibility, efficacy, and safety of this new advanced device. Materials and Methods: A sixty-two years-old woman affected by BRCA-1 mutation underwent the first European gynaecological surgical procedure using the new surgical robot Hugo™ RAS in the Division of Gynecologic Oncology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. Main Outcomes measures: Docking and operative times. Results: The docking time was 6 minutes and the total operative time was 58 minutes. There were no system errors and faults in the robotic arms. The surgeon found no friction or rasping in the arms. The estimated blood loss was 30 mL. No intraoperative complications were recorded. Conclusion: Gynaecological surgery with Hugo™ RAS seems feasible, safe and effective as shown by initial experiences in urological surgery. A larger case series would confirm the current experience and determine whether this technology could offer any additional benefit.

Surgical outcomes of diaphragmatic resection during cytoreductive surgery for advanced gynecological ovarian neoplasia: A randomized single center clinical trial - DRAGON.

INTRODUCTION: Ovarian cancer (OC) represent nearly 4% of gynecologic malignancies and it is often diagnosed at advanced stage. Diaphragmatic surgery, a fundamental step of advanced stage ovarian cancer (ASOC) debulking surgery, is associated with a high post-operative complication incidence, which is supposedly reduced with thoracostomy tube placement. We assessed the role of intra-operative thoracostomy tube placement, as a prevention measure for post-operative complications, after diaphragmatic resection. METHODS: This was a single center prospective randomized trial. Ovarian cancer patients, who underwent mono-lateral diaphragmatic resection, were randomized 1:1 into two arms. Arm A included patients receiving intra-operative thoracostomy tube placement (TP); Arm B patients did not receive thoracostomy tube placement (NTP). After surgery, all patients underwent seriate chest x-ray and ultrasound to record thoracic complications. Statistical analysis included uni- and multivariable logistic regression model (proportional odds model). RESULTS: Three hundred seventy-one patients were screened and 88 patients were enrolled: 44 in arm A and B, respectively. No statistically significant differences for intra-operative (p = 0.291) and any grade of post-operative complication (p = 0.072) were detected, while 6.8% of patients in arm A and 22.7% in arm B experienced severe respiratory symptoms (p = 0.035); 18.2% of patients in arm A had a moderate/large pleural effusion versus 65.9% in arm B (p < 0.0001). At multivariable analysis, results confirmed that the NTP-group had a higher risk to receive post-operative thoracostomy tube placement due to pleural effusion than the TP-group (odds ratio [95% Confidence Interval] = 14.5 [3.7-57.4]). CONCLUSIONS: Thoracostomy intra-operative tube placement after diaphragmatic resection is effective to prevent post-operative thoracic complications. The extension of resection does not influence outcomes and the risk of post-operative thoracentesis or TP remain elevated.

Impact of surgeon learning curve in minimally invasive radical hysterectomy on early stage cervical cancer patient survival.

Background: Recently, it has been sustained that only surgeons skilled in minimally invasive radical hysterectomy (MI-RH) could provide valuable oncological outcomes in early-stage cervical cancer. Still, literature lacks data correlating surgeon experience with patient survival rate. We aimed to investigate the impact of surgeon training on this rate. Methods: This is a retrospective study of 243 early-stage cervical cancer treated with MI-RH. Multiple regression analyses were undertaken to investigate the impact of the surgeons learning curve, according to the number of MI-RH, on patients prognosis. Results: A steady trend of reduction in disease recurrence risk is associated with increased surgeon experience. The peak of the learning curve was shown at the 19th MI-RH (hazard ratio of disease-free survival: 0.321; 95%CI: 0.140-0.737; p= 0.007). The 3 years disease-free survival that a surgeon could provide to patients is significantly lower at the beginning of his/her learning path comparing to what he/she could guarantee once adequate experience had been achieved (75.4% and 91.6% respectively, p=0.005). Surgeon experience appears to be an independent prognostic factor. Conclusion: The experience that a surgeon can achieve practicing in MI-RH significantly influences oncological outcomes of early-stage cervical cancer patients. Future studies comparing minimally invasive and open surgery should take this into account. It would be advisable that the scientific community precisely establishes the minimum training required in the field of MI-RH for early-stage cervical cancer.

Optimizing the number of cycles of neoadjuvant chemotherapy in advanced epithelial ovarian carcinoma: A propensity-score matching analysis.

OBJECTIVE: Neoadjuvant chemotherapy and interval debulking surgery are now widely offered in ovarian cancer patients unsuitable for surgery; the number of preoperative NACT cycles to be given is still an issue. Our aim was to compare survival outcomes of patients with advanced ovarian cancer treated with ≤4 or more NACT cycles. METHODS: A cohort of AEOC patients with stage III-IV epithelial OC who underwent NACT followed by IDS was identified. Patients were classified in group A (≤4 cycles) and group B (>4 cycles). Selection bias from the heterogeneity of demographic and clinical characteristics was avoided using propensity score matching (2:1 ratio). RESULTS: 140 (group A) and 70 (group B) patients were included. After the propensity score matching, there were no imbalances in baseline characteristics. BRCA status was associated to improved OS (HR = 0.41; 95%CI 0.18.0.92, p = 0.032) and residual tumor to decreased OS (HR = 1.93; 95%CI 1.08-3.46, p = 0.026). Statistically significant differences were not observed in OS (2-year OS 82.4% for group A versus 77.1% for group B, p = 0.109) and PFS (2-year PFS 29.7% for group A versus 20.0% for group A, p = 0.875). In group B, the administration of >4 cycles was related to an additional chance of achieving complete (12.9%) and partial (34.3%) responses compared to responses after 3-4 cycles. CONCLUSIONS: Receiving more than 4 cycles of NACT is no detrimental in terms of OS and PFS in advanced ovarian cancer. Response rates can increase following further cycles administration.

Sentinel lymph node detection in endometrial cancer with indocyanine green: laparoscopic versus robotic approach.

BACKGROUND: The aims of the present study were to assess bilateral sentinel lymph node (SLN) mapping with laparoscopic versus robotic approach, to assess variables affecting bilateral detection rates and to assess survival difference in patients with no/unilateral, compared to bilateral SLN detection. METHODS: This is a retrospective, single-centre, observational cohort study, including patients with endometrial cancer FIGO stage IA-IVB, treated with minimally invasive primary surgery and undergoing indocyanine green (ICG) injection to detect SLN, between January 2015 and December 2019. RESULTS: Of the 549 included patients, 286 (52.1%) and 263 (47.9%) underwent the laparoscopic and robotic approach respectively. 387 (70.5%) patients had bilateral SLN mapping, 102 (18.6%) and 60 (10.9%) had unilateral and no mapping, respectively. Patients who underwent the robotic approach were older (median 61 versus 64 years, p=0.046) and had a higher BMI (median 26.0 versus 34.8 kg/m2, p<0.001). No difference in any SLN mapping or in SLN bilateral detection was evident between the laparoscopic or robotic approach (p=0.892 and p=0.507 respectively). Patients with bilateral SLN detection in the entire cohort were younger (p<0.001) and had a better 3-year disease-free survival (DFS) compared to patients with no/unilateral SLN mapping (77.0% versus 66.3%, respectively, p=0.036). No 3-year overall survival (OS) difference was reported (p=0.491). CONCLUSION: SLN mapping and bilateral SLN detection with ICG in endometrial cancer was not different in the laparoscopic and robotic approach, even though patients undergoing the robotic approach were older and more obese. Bilateral SLN detection was associated with improved 3-year DFS, but not with 3-year OS, compared to no and unilateral SLN detection.

Fusion imaging in preoperative assessment of extent of disease in patients with advanced ovarian cancer: feasibility and agreement with laparoscopic findings.

OBJECTIVES: Fusion imaging is an emerging technique that combines real-time ultrasound examination with images acquired previously using other modalities, such as computed tomography (CT), magnetic resonance imaging and positron emission tomography. The primary aim of this study was to evaluate the feasibility of fusion imaging in patients with suspicion of ovarian or peritoneal cancer. Secondary aims were: to compare the agreement of findings on fusion imaging, CT alone and ultrasound imaging alone with laparoscopic findings, in the assessment of extent of intra-abdominal disease; and to evaluate the time required for the fusion imaging technique. METHODS: Patients with clinical and/or radiographic suspicion of advanced ovarian or peritoneal cancer who were candidates for surgery were enrolled prospectively between December 2019 and September 2020. All patients underwent a CT scan and ultrasound and fusion imaging to evaluate the presence or absence of the following abdominal-cancer features according to the laparoscopy-based scoring model (predictive index value (PIV)): supracolic omental disease, visceral carcinomatosis on the liver, lesser omental carcinomatosis and/or visceral carcinomatosis on the lesser curvature of the stomach and/or spleen, involvement of the paracolic gutter(s) and/or anterior abdominal wall, involvement of the diaphragm and visceral carcinomatosis on the small and/or large bowel (regardless of rectosigmoid involvement). The feasibility of the fusion examination in these patients was evaluated. Agreement of each imaging method (ultrasound, CT and fusion imaging) with laparoscopy (considered as reference standard) was calculated using Cohen's kappa coefficient. RESULTS: Fifty-two patients were enrolled into the study. Fusion imaging was feasible in 51 (98%) of these patients (in one patient, it was not possible for technical reasons). Two patients were excluded because laparoscopy was not performed, leaving 49 women in the final analysis. Kappa values for CT, ultrasound and fusion imaging, using laparoscopy as the reference standard, in assessing the PIV parameters were, respectively: 0.781, 0.845 and 0.896 for the great omentum; 0.329, 0.608 and 0.847 for the liver surface; 0.472, 0.549 and 0.756 for the lesser omentum and/or stomach and/or spleen; 0.385, 0.588 and 0.795 for the paracolic gutter(s) and/or anterior abdominal wall; 0.385, 0.497 and 0.657 for the diaphragm; and 0.336, 0.410 and 0.469 for the bowel. The median time needed to perform the fusion examination was 20 (range, 10-40) min. CONCLUSION: Fusion of CT images and real-time ultrasound imaging is feasible in patients with suspicion of ovarian or peritoneal cancer and improves the agreement with surgical findings when compared with ultrasound or CT scan alone. © 2021 International Society of Ultrasound in Obstetrics and Gynecology.

Rectosigmoid Mesorectal-Sparing Resection in Advanced Ovarian Cancer Surgery.

Ovarian cancer is the most lethal of all gynecologic cancers.1 Primary debulking surgery (PDS) with achievement of no residual tumor (RT, 0) still is the recommended treatment, and the one with the greatest prognostic impact.2,3 Given the usual disease spread, several surgical procedures often are needed, and one of the most frequent is rectosigmoid resection.4 Anastomotic leak is the most feared complication. Other common complications are persistent urinary, defecatory, and sexual dysfunction due to autonomic nervous system injuries during surgery.5 Even if mesorectal resection is not deemed part of the treatment paradigm for advanced ovarian cancer (AOC), total mesorectal excision (TME) is the most common surgical technique used. However, for selected cases, with detection of no lymphadenopathies at the origin of the of the inferior mesenteric artery and a favorable ratio between the length of the left colon and the extent of the bowel carcinomatosis, a mesorectal-sparing resection with the preservation of the superior rectal artery and the mesorectal tissue should be pursued. This report presents the case of a 54-year-old woman with a diagnosis of FIGO stage 3C AOC who underwent PDS. The video (video 1) provides a step-by-step description of the surgical technique adopted for colorectal resection with mesorectal-sparing technique. Rectosigmoid mesorectal-sparing resection is feasible and could be a viable option for selected cases of AOC, maximizing the blood supply to colorectal anastomosis while minimizing the risk of both anastomotic leak and pelvic autonomic nervous system dysfunction.6.

[Detecting Large Germline Rearrangements of BRCA1 by Next Generation Tumor Sequencing].

A majority of BRCA1/2 (BRCA) pathogenic variants (PVs) are single nucleotide substitutions or small insertions/deletions. Copy number variations (CNVs), also known as large genomic rearrangements (LGRs), have been identified in BRCA genes. LGRs detection is a mandatory analysis in hereditary breast and ovarian cancer families, if no predisposing PVs are found by sequencing. Next generation sequencing (NGS) may be used to detect structural variation, since quantitative analysis of sequencing reads, when coupled with appropriate bioinformatics tools, is capable of estimating and predicting germline LGRs (gLGRs). However, applying this approach to tumor tissue is challenging, and the pipelines for determination of CNV are yet to be optimized. The aim of this study was to validate the Next Generation Tumor Sequencing (NGTS) technology to detect various gLGRs of BRCA1 locus in surgical tumor tissue samples. In this study, seven different BRCA1 gLGRs, previously found in high-grade serous ovarian cancers (HGSOC) patients, were detected in tumor samples collected from the patients at a time of HGSOC surgery. This study demonstrated that NGS can accurately detect BRCA1 gLGRs in primary tumors, suggesting that gLGR evaluation in BRCA1 locus should be performed in cases when the screening for BRCA alterations starts from tumor instead of blood. NGS sequencing of tumor samples may become the preferred method to detect both somatic and germline gLGRs in BRCA-encoding loci.

Bevacizumab as maintenance treatment in BRCA mutated patients with advanced ovarian cancer: A large, retrospective, multicenter case-control study.

OBJECTIVE: The aim of this study was to investigate the correlation between BRCA mutational status and response to bevacizumab in a large advanced ovarian cancer (AOC) series. METHODS: This is a multicenter, retrospective case-control study including upfront AOC treated between January 2015 and June 2019. The main inclusion criteria were: having received three weekly carboplatin-paclitaxel as first-line treatment, with or without Bevacizumab maintenance, knowledge of the BRCA mutational status. RESULTS: Overall, 441 patients were included; 183 (41.5%) patients received bevacizumab (Cases), and 258 (58.5%) did not receive it (Controls). The BRCA mutated patients (BRCAmut) were 58 (39%) in the Cases group and 90 (34.9%) in the Controls group (p = .77). Patients who received bevacizumab had a significant 4-months increase in median progression free survival (mPFS: 21 vs. 17 months, p = .033). Concerning BRCAmut patients, no differences were shown between those who received bevacizumab or not in terms of mPFS (24 vs. 22 months, p = .3). Conversely, in BRCA wild-type (BRCAwt) population bevacizumab administration significantly prolonged mPFS (20 vs 15 months, p = .019). At multivariate analysis, independent factors of prolonged PFS were BRCA status (OR = 0.60), having received PDS (OR = 0.69), and complete cytoreduction (OR = 0.50), but not the bevacizumab administration (OR = 0.83, p = .22). CONCLUSIONS: No evidence of oncological benefit in terms of PFS and OS related to bevacizumab maintenance therapy was found in BRCAmut patients. Differently, BRCAwt patients seem to benefit from antiangiogenic treatment in terms of mPFS.

Laparoscopic vs percutaneous hysterectomy in obese patients: a prospective evaluation.

BACKGROUND: Treatment of obese female patients represents a real challenge. Indeed, obesity among women has reached epidemic levels not only elevating the cardiovascular and endocrinological risks, but also increasing the incidence of various gynecological pathologies (e.g. endometrial cancer and hyperplasia, uterine fibroids, genital prolapse) which commonly require hysterectomy as a surgical solution. In the last decade, minimally invasive surgery has emerged as an approach reducing the invasiveness of the standard laparoscopic surgical procedures while maintaining efficacy and feasibility. As such, in this study we aimed to evaluate the feasibility of percutaneous hysterectomy (PSS-H) approach in obese patients by reporting the first prospective comparison between the PSS-H to laparoscopic hysterectomy (LPS-H). METHODS: In this multicentric comparative prospective study, 45 patients affected by benign and malignant gynecological conditions were considered eligible for minimally invasive surgery (MIS). Fifteen patients received PSS-H and 30 LPS-H. All patients enrolled received a total hysterectomy ± bilateral salpingo-oophorectomy, with or without lymph nodal staging. RESULTS: No statistically significant differences were noted in operative time and estimated blood loss between the two groups. Four patients in PSS-H group and 3 in LPS-H group received lymph node staging. A multifunctional energy device was used in all PSS-H and 73.3% of LPS-H procedures (p=0.038). There were no conversions to laparotomy in either group and similarly there were no conversions to conventional laparoscopy in the PSS-H group. In the LPS-H group, there was one (3.3%) case of major bleeding( ≥ 500 mls). We recorded one vaginal cuff bleeding in PSS-H, whereas for LPS-H we reported 4 (13.3%) 30-days complications (p=0.651). No differences in visual analogue scale (VAS) score were recorded. A significant disparity was noted in cosmetic outcome at discharge (p=0.001), but not after 30 days. CONCLUSION: We demonstrated for the first time, in a prospective comparison between PSS and LPS approaches, that PSS-H may represent a valid alternative to performing total hysterectomy in obese patients.

Salvage lymphadenectomy in recurrent ovarian cancer patients: Analysis of clinical outcome and BRCA1/2 gene mutational status.

OBJECTIVE: This study is aimed to analyze the clinical outcome of recurrent ovarian cancer patients bearing isolated lymph-node recurrence (ILNR) who underwent salvage lymphadenectomy (SL). The prognostic role of clinicopathological variables and the mutational status of BRCA1/2 have also been investigated. METHODS: This retrospective, single-institutional study included women with platinum-sensitive lymph node recurrence underwent to SL between June 2008 and June 2018. Univariate and multivariate analysis was performed to evaluate the impact of clinical parameters, and BRCA1/2 mutational status on post salvage lymphadenectomy progression-free survival (PSL-PFS). RESULTS: As of June 2019, the median follow-up after SL was 30 months, and the relapse has been documented in 48 (56.5%) patients. In the whole series, the median PSL-PFS was 21 months, and the 3-year PSL-PFS was 36.7%. The median PSL-PFS, according to patients with ILNR (N = 71) versus patients with lymph-nodes and other sites of disease (N = 14), was 27 months versus 12 months, respectively. Univariate analysis of variables conditioning PSL-PFS showed that platinum-free interval (PFI) ≥12 months, normal Ca125 serum levels, and number of metastatic lymph-nodes ≤3 played a statistically significant favorable role. In multivariate analysis, PFI duration ≥12 months and the number of metastatic lymph nodes ≤3 were shown to keep their favorable, independent prognostic value on PSL-PFS. CONCLUSIONS: In the context of SL, the patients with long PFI and low metastatic lymph node numbers at ILNR diagnosis have the best outcome. The BRCA mutational status seems not associated with clinical variables and PSL-PFS, differently from other sites of disease in ROC patients.

Minimal residual disease at primary debulking surgery versus complete tumor resection at interval debulking surgery in advanced epithelial ovarian cancer: A survival analysis.

OBJECTIVES: To compare survival outcomes and peri-operative complications in patients with advanced ovarian cancer with 1-10 mm residual disease (RD) at primary debulking surgery (PDS) versus those achieving no gross residual disease (NGR) at interval debulking surgery (IDS). METHODS: Patients operated with the intent of complete cytoreduction for epithelial ovarian/fallopian tube/primary peritoneal cancer, FIGO stage IIIC-IV, RD 1-10 mm at PDS and NGR at IDS, between 01/2010 and 12/2016, were retrospectively included. All patients had at least 2-years of follow-up completed. RESULTS: 207 patients were included (59 PDS and 148 IDS). Patients in PDS group were younger and had a higher surgical complexity score. There was a higher rate of intra- and major early post-operative complications in the group of PDS vs IDS (16.9% vs 1.3% and 28.8% vs 2.0%, p < 0.0001 respectively). After a median follow up of 56.4 months (range 59.2-65.4), 117 (56.5%) patients died of disease in the whole population. Forty-eight (81.4%) patients had progression/recurrent disease in the PDS group and 120 (81.1%) in the IDS group. Median PFS was 16.2 months and 18.9 months for PDS and IDS group, respectively (p = 0.111). Median OS was 41.4 months and 52.4 months for PDS and IDS group, respectively (p = 0.022). CONCLUSIONS: IDS should be considered the preferred treatment in case millimetric residual disease is expected at PDS in view of the superimposable PFS and the reduced number of perioperative complications.