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ObjectiveGynecological sarcomas account for 3% of all gynecological malignancies and are associated with a poor prognosis. Due to the rarity and heterogeneity of gynecological sarcomas there is still no consensus on optimal therapeutic strategies. This study’s objective was to describe the treatment strategies used in patients with gynecological sarcomas in the primary course of disease.MethodsThe German prospective registry for gynecological sarcoma (REGSA) is the largest registry for gynecological sarcomas in Germany, Austria and Switzerland. Primary inclusion criteria for REGSA are histological diagnosis of sarcoma of the female genital tract, sarcoma of the breast or uterine smooth muscle tumors of uncertain malignant potential (STUMP). We evaluated data of the REGSA registry on therapeutic strategies used for primary treatment from August 2015 to February 2021.ResultsA total of 723 patients from 120 centers were included. Data on therapeutic strategies for primary treatment were available in 605 cases. Overall, 580 (95.9%) patients underwent primary surgery, 472 (81.4%) of whom underwent only hysterectomy. Morcellation was reported in 11.4% (n=54) of all hysterectomies. A total of 42.8% (n=202) had no further surgical interventions, whereas an additional salpingo-ophorectomy was performed in 54% (n=255) of patients. An additional lymphadenectomy was performed in 12.7% (n=60), an omentectomy in 9.5% (n=45) and intestinal resection in 6.1% (n=29) of all patients. Among 448 patients with available information, 21.4% (n=96) received chemo- or targeted therapies, more commonly as single-agent treatment than as drug combinations. Information about anti-hormonal treatment was available for 423 patients, among which 42 (9.9%) received anti-hormonal treatment, 23 (54.8%) of whom with low-grade endometrial stroma sarcomas. For radiotherapy, data of 437 patients were available, among which 29 (6.6%) patients underwent radiotherapy.ConclusionOur study showed that treatment of patients with gynecologic sarcomas is heterogeneous. Further trials are needed along with more information on treatment modalities, therapy response and patient-reported outcomes to implement new treatment strategies.

BackgroundThere is limited information about the impact of radical surgery including pelvic and para-aortic lymphadenectomy and subsequent platinum-based chemotherapy on sexuality in patients with advanced ovarian cancer.ObjectiveTo evaluate the impact of radical surgery including pelvic and para-aortic lymphadenectomy and subsequent platinum-based chemotherapy on sexuality in patients with advanced ovarian cancer as a sub-protocol of the prospectively randomized LION trial.MethodsThe Sexual Activity Questionnaire was applied to assess sexual function according to its sub-scales activity, pleasure, and discomfort. The 'orgasm' sub-scale from the Female Sexual Function Index was also added. The questionnaire was administered in combination with the EORTC QLQ-C30 questionnaire at baseline prior surgery, after 6, 12, and 24 months. The primary endpoint was changes in sexual function.ResultsOverall, 495 patients received the questionnaires. 254 (51%) responded at baseline. Of these, 55 (22%) patients were sexually active, 182 (72%) were sexually inactive, and for 17 (7%) patients' data were not available. There was a total of 55/495 (11%) patients at 6 months, 139 (28%) patients at 12 months, and 81 (16%) patients at 24 months. Median age was 60.5 years (range 21.4–75.8). At baseline, sexually active responders were significantly younger (median age 51.5 years,) than sexually inactive responders (median age 61.8 years) and tended to have a better performance status. Discomfort evaluated as dryness of the vagina and pain during sexual intercourse was significantly worse at 12 months than at baseline (pConclusionThe majority of patients were sexually inactive; however, in those who were sexually active, pain during intercourse was worse at 12 months. In addition, the orgasm sub-scale demonstrated worse results in patients who underwent complete lymphadenectomy. The study suggests that surgery in the retroperitoneal space may influence sexual function.

1 Introduction/Background* Advanced epithelial ovarian cancer (EOC) is a severe disease with high mortality rate. Achieving complete cytoreduction (R=0; CCR) is crucial for the patient’s prognosis. Extensive peritoneal carcinomatosis is often the limiting factor for achieving CCR in EOC and therefore is the deciding factor for therapy planning. The Peritoneal Cancer Index (PCI) after Sugarbaker has been an established tool to describe the extension of the disease. A patient presenting a PCI Methodology The data of 23 patients treated in our hospital between 01/2015 und 12/2020 with inoperable EOC were retrospectively analyzed. Clinical and radiological data were collected and statistically analysed (univariate analysis: Chi-Square Tests, Mann-Whitney U test and multivariate analysis: Binary logistic regression, ROC-curve). Result(s)* The reduction of the PCI itself after neoadjuvant chemotherapy showed to be a powerful predictor for complete cytoreduction (CCR), but it also showed to be significant even if the different PCI baseline values were considered. The reduction of the initial PCI score by minimum 8.5 points was a better predictor for CCR than the PCI Neither the RECIST analysis2 of the CT-scans nor the reduction of the tumor marker CA-125 proved to be a significant predictor. Conclusion* Whether CCR can be achieved during debulking surgery, is best predicted by the reduction of the PCI. A combination of the three markers might be even more powerful. Larger studies are needed to confirm this.

BACKGROUND/AIM This study investigated the cardiophrenic lymph node (CPLN) status before and after neoadjuvant chemotherapy (NACT), as its presence seems to have a rather prognostic significance in patients with advanced ovarian cancer. PATIENTS AND METHODS The baseline computed tomography scans of 66 patients with advanced ovarian cancer primary treated with NACT between March 2015 and June 2020 were reviewed. A CPLN enlargement was defined as ≥5 mm. RESULTS 44% (n=29) of the patients had enlarged CPLNs; 10.7% (n=3) showed a complete response, 71.4% (n=20) a partial response, and 17.9% (n=5) a stable disease after NACT. There was no significant difference between the response to NACT measured according to the status of CPLN compared to other biomarkers in the CPLN group. CONCLUSION Patients with CPLN enlargement have a tendency to an impaired prognosis. The response of CPLN to NACT was comparable to the response of established biomarkers, adding a monitoring function to the CPLN.

5556 Background: Standard treatment for advanced ovarian cancer (aOC) includes primary cytoreductive surgery followed by chemotherapy (PDS > CTX). There is strong evidence that this strategy is accompanied by high risk for early failure in some patients (pts) but prospective multicenter data for this specific question are lacking. Methods: 64 AGO-sites prospectively registered pts with suspected aOC and collected following variables prior to start of therapy: age, Charlson Comorbidity Index (CCI), timed up and go test (TUG), ASA and ECOG performance score, weight, height, estimated ascites, albumin, creatinine, hemoglobin, leucocytes, platelets, CA125, patient reported outcome measures according to EORTC QLQ-C30 and OV28, hospital anxiety and depression score (HADS), physician-assessed suspected FIGO IV stage, abdominal pain requiring treatment, abdominal bloating, dyspnea and required palliative paracentesis (ascites, pleural effusions). Treatment followed according to investigator’s decision. Primary objective was to predict the unfavorable event of death or progression within 10 months after primary diagnosis. We applied univariate and multiple logistic regression with stepwise variable selection after multiple imputation of missing data in order to identify relevant predictors. Results: 223 pts with aOC FIGO IIIB to IVB and PDS were analyzed. Median age was 63 years (range 31-86). 52 (23.3%) pts experienced progression or death within 10 months from time of enrolment. In univariate regression, age (odds ratio (OR) 1.612 per 10 years), ASA (III vs I/II: OR 3.217), TUG (OR 1.087), body height (OR 0.541 per 10cm), ECOG (1 vs 0 OR 2.326, 2-3 vs 0 OR 4.102), estimated ascites ( > 500cc vs. none OR 2.811), paracentesis (OR 1.991), platelets (upper limit of normal (ULN) vs norm or < lower limit of normal (LLN) OR 1.998), albumin ( < LLN vs norm or > ULN OR 2.053), creatinine ( > ULN vs norm OR 3.969) and baseline QoL single-item subscales appetite loss (“very much” vs “not at all” OR 2.611), constipation (“quite a bit” vs “not at all” OR 4.903), and multi-item subscales global health status (OR 0.982 per 1 point) and nausea/vomiting (OR 1.013 per 1 point) were significant (p < 0.05). Multiple logistic regression identified age (OR 1.459 per 10 years), ASA (III vs I/II: OR 2.427), constipation (“quite a bit” vs “not at all” OR 3.786) and global health (OR: 0.985 per 1 point) as independent predictors of progression or death within 10 months after primary diagnosis (p < 0.05). Conclusions: A significant proportion of aOC pts undergoing PDS > CTX are at high-risk for early failure. The finding of independent risk factors including self-ratings of QoL at time of diagnosis should be confirmed and tested against other models to facilitate a more tailored treatment of high-risk pts and design of future trials in aOC. Clinical trial information: NCT02828618.

Introduction The benefit of systematic lymphadenectomy (LNE) in low-stage, low-grade ovarian carcinoma is unknown. However, most guidelines still recommend LNE in these patients. Prior studies examining the benefit of this invasive procedure have been hampered small numbers, and large-scale studies that consider modern classification are needed. Methods A cohort of 666 pathology-reviewed and immunohistochemistry-validated endometrioid ovarian carcinomas has recently been evaluated using endometrial carcinoma-inspired molecular subtyping. This molecularly characterized series is now being used to assess the value of LNE. Contributing centers are performing detailed chart reviews, so that surgical procedures and lymph node status can be correlated with molecular subtype and outcomes. Results 349 stage I, 181 stage II, 85 stage III, and 22 stage IV cases with a median OS follow-up of 6.11 years (RevKM) were collected from 17 centres across Canada and Europe. Analysis of the first 70/666 cases revealed positive nodes in only a single presumed low stage patient after systematic pelvic and paraaortic LNE (n=1/44). LNE was not performed in 3/44 and restricted to pelvic nodes in 6/44 low-stage cases, all of which were pN0. Tumor spread beyond the Uterus and/or Adnexa was associated with positive nodes in 33%. Conclusion Preliminary results indicate that abandonment of LNE in low-stage, low-grade endometrioid ovarian carcinoma may reduce morbidity without worsening prognosis for these patients. Completion and expansion of our international team initiative stands to provide a powerful statement on the value of LNE, and influence of molecular subtype on disease spread, possibly improving precision care for ovarian carcinoma patients.

Introduction: Younger women are particularly affected by the increase in the incidence of vulvar cancer. The purpose of this study was to investigate how clinical characteristics differ depending on the patient´s age and what role the age of initial diagnosis plays in the prognosis. Patients andMethods: Included patients were divided into groups aged below or above 50 years. The disease-free survival (DFS) was calculated and a multivariate discriminant analysis was conducted. Results: Of the 300 patients, 79 were ≤50 years and 221 were >50 years. The median age was 64 years (19-96 years). There were no differences between the groups regarding lymph node (LN) status and distant metastasis, but T1 tumours were more frequent in patients ≤50 years (77% vs. 62%, p = 0.02). The DFS only differed between the groups when there were no LN metastases. The nodal status was the predominant prognostic factor for the DFS regardless of age. In node-free patients, the 5-year DFS was 49% for the ≤50 years group and 89% for the >50 years group (p = 0.008), whereas there was no difference if a LN was involved. Conclusion: In node-free patients, the risk for recurrence is lower for patients older than 50 years.

IntroductionThis study aimed to investigate Sugarbaker’s peritoneal cancer index (PCI) as a prognostic indicator for the resectability of ovarian carcinoma (OC), as depicted in the study using the completeness of cytoreduction score (CCS).Currently, the intraoperative assessment of operability in OC surgery is primarily a subjective measurement that is dependent on the surgeon.MethodsThe retrospective data from 98 patients with OC International Federation of Gynecology and Obstetrics (FIGO) III to IV who had received surgery between January 2010 and December 2011 were analyzed. The PCI and the CCS were determined retrospectively using surgical reports, histological findings, and intraoperative photographic documentation. Receiver operating characteristic curves and ordinal regression were applied to evaluate the predictability of CCS using the PCI.ResultsOf 98 patients, 80 (81.6%) were staged FIGO III and 18 (18.4%) FIGO IV. A statistically significant correlation was demonstrated between the PCI and CCS (P < 0.01). A receiver operating characteristic curve with an area under the curve of 0.839 demonstrated the high precision in discrimination with which the PCI could predict the CCS. Using ordinal regression, it was possible to estimate the probabilities of achieving CCS 0, CCS 1, CCS 2, or CCS 3 for a given PCI (pseudo R2 according to Cox and Snell 0.428, Nagelkerke 0.476, and McFadden 0.244).ConclusionsThe PCI more precisely defined the heterogeneous group of patients with OC FIGO III. The PCI provided objectivity and reproducibility, and it seems to be a possible prognostic indicator for OC resectability.

Objectives and methods Vulvar carcinomas are rare genital malignancies. While advanced primary cancer chemoradiation is often preferred over pelvic exenteration (PE), PE is often the only therapy available in cases of recurrence. In a retrospective study, we analyzed predictive factors and outcomes of patients who underwent exenteration for vulvar cancer in our department during the past 10 years. Results We identified 27 patients; 9 of them suffered from primary disease, and 18 had experienced a recurrence. A total of 18 patients presented with stage FIGO III, and 9 patients presented with stage IV. In 10 patients, the disease had spread to the inguinal lymph nodes, and in 3 patients, it had also spread to the pelvic nodes. At the end of surgery, all patients were macroscopically tumor free, which was confirmed microscopically in 20 patients (74%, R0), with the other 7 patients having microscopic tumor remnants. For all patients, median time of survival was 37 months, the five-year survival rate (5YSR) was 62%, and the overall survival (OS) was 59%. Patients with tumor-free lymph nodes had an OS of 76% and a 5YSR of 83% vs. 40% and 36%, respectively, for patients with tumorous spread to the nodes (p = 0.03). The 5YSR correlated to the degree of resection (R0 vs. R1, 74% vs. 21%, p = 0.01). Conclusion PE is a therapeutic option in advanced primary or relapsed vulvar carcinoma, offering median- to long-term survival for many patients. Carcinomatous spread to regional lymph nodes and complete resection are the most important prognostic factors.

Objectives: To evaluate whether preoperative magnetic resonance imaging (MRI) allows prediction of complete tumour resection in patients planned for pelvic exenteration (PE). Study design: Data of all patients treated by PE at a gynaecologic cancer centre between 6/1999 and 5/ 2005 were studied retrospectively. Preoperative MRI scans were re-analysed blindly with respect to invasion of neighbouring organs, muscular pelvic side wall, vessels and lymph nodes by an experienced team of radiologist and gynaecologic oncologist, finally also giving estimation whether complete removal of tumour would be feasible. Results: 43 patients were identified: all of them underwent PE. The histopathological investigation of the exenteration specimen demonstrated microscopic complete resection status in 20 cases (46.5%). None of the investigated parameter showed a correlation to complete resection of tumour. Sensitivity for final microscopic results relative to preoperative prediction by radiographic findings was 85%, specificity was 52%. The positive predictive value for tumour-free status was 60% (17/28), the negative 80% (12/15). Conclusions: Preoperative MRI cannot predict the surgical outcome with sufficient accuracy, hence on its own is inappropriate for prediction of complete tumour resection and final histological margin status in patients undergoing PE.

Ovarian cyst is a common gynecologic finding. Renal cysts develop in 15% of women older than 70 years, and nephroptosis in 20% of the population, primarily in women. Herein, we review these conditions and present a case in which the patient had a cystic kidney in combination with nephroptosis. At vaginal ultrasound performed with the patient in an upright position, the kidney slid down into the pelvis, thus imitating an ovarian mass. At laparoscopy, the patient was positioned head down, and the kidney, lying near the diaphragm, was not seen.

TPS5602 Background: Primary cytoreductive surgery (PDS) followed by chemotherapy has been considered as standard management for advanced ovarian cancer patients (pts) over decades. An alternative approach of interval debulking surgery (IDS) following neoadjuvant chemotherapy (NACT) was subsequently reported by two randomized phase III trials (EORTC‐GCG, CHORUS). Owing to important limitations of these studies, especially regarding surgical quality, optimal timing of surgical therapy in advanced ovarian cancer is still unclear. Methods: TRUST is an international open, randomized, controlled multicenter trial investigating overall survival (OS; primary endpoint) after PDS vs NACT and subsequent IDS in pts with FIGO stage IIIB‐IVB ovarian, tubal, and peritoneal carcinoma. Secondary objectives are safety of complete tumor resection, progression‐free survival and quality of life (QoL) as well as surgical morbidity. In order to guarantee adequate surgical quality, participating centers need to fulfill specific quality assurance criteria (e.g. ≥50% complete resection rate in upfront surgery for FIGO IIIB-IV pts, ≥36 debulking-surgeries/year) and agree to independent audits by TRUST Quality committee delegates. A 1:1 randomization to PDS or NACT followed by IDS stratified by center and age‐ECOG combination (ECOG 0 and age ≤65 years vs ECOG > 0 or age > 65 years) is performed. Pts in the PDS arm will undergo surgery followed by 6 cycles of platinum-based chemotherapy, whereas pts in the IDS arm will be treated with 3 cycles of NACT after histologic confirmation of the disease, followed by IDS and subsequently 3 cycles of platinum-based chemotherapy. Intention of surgery for both groups will be complete tumor resection as per guideline recommendations. Health related QoL will be assessed using the EORTC QLQ‐C30, QLQ‐OV28, and EQ‐5D‐3L questionnaires. For sample size planning, we considered a prolongation of median OS from 45 months in the IDS arm to 60 months in the PDS arm (HR 0.75) as clinically relevant. 380 events are needed to obtain a power of 80% in two‐sided log-rank test with significance level of 0.05. The primary analysis will be done in the ITT‐population of 686 randomized pts. By Feb 3 2017, 46 pts were randomized. Clinical trial information: NCT02828618.

Background. This study was performed to identify pathologic and clinical features that best correlate with lymph node metastasis and disease free survival among patients with Stage I and II cervical cancer treated by radical hysterectomy. Methods. Three hundred-seventy patients with complete clinical information and pathologic material, including cone and cervical biopsies, were selected for analysis. Of these patients, 301 with clinical stages I and II disease were the subject of this paper. The results of patients with microinvasive carcinoma of the cervix, as defined by the Society of Gynecologic Oncologists (depth of invasion ≤3 mm and no lymph node vascular space invasion), were reported previously' and excluded from this analysis. Patients with small cell carcinoma of the cervix were found to have a very poor prognosis (disease free 5-year survival of 36%) and were also excluded from this analysis (Sevin BU, Nadji M, Metkoch MW, Lu Y, Averette HE. Unpublished data, 1995). Variables studied were patient age, weight, race, marital status, and economic status ; tumor size ; depth of invasion ; lymph node-vascular space involvement ; cell type ; tumor grade ; lymph node metastasis ; and number of lymph nodes removed. The influence of these variables on survival was examined by univariate analysis with use of Cox's regression model and the log rank test for comparison of survival curves. Results. Factors that predict disease free survival, ranked by degree of significance, were depth of invasion, tumor size, lymph node-vascular space invasion, number of positive nodes, tumor volume, clinical stage, and tumor extension to the vagina or surgical margins. Conclusions. Radical hysterectomy and bilateral lymphadenectomy is standard therapy for patients with Stage IB and IIA carcinoma of the cervix. A variety of surgically defined risk factors predict 5-year disease free survival, and many of these factors are related. Identification of independent risk factors requires a multivariate analysis of data.

Background. Recent reports indicate that certain pre- and intraoperatively determined risk factors are predictive of pelvic lymph node metastases from endometrial cancer, allowing selective pelvic lymph node dissection. The objective of this study was to evaluate the accuracy of pre-, pre-/intra- and postoperatively determined tumor characteristics. Methods. The study is based on 100 patients treated from 1987-1991 with total abdominal hysterectomy and bilateral salpingo-oophorectomy. In all patients thorough pelvic Iymphadenectomies were performed [no sampling]. These patients were evaluated according to different macroscopic and histologic tumor characteristics retrospectively in a blind fashion (the lymph node status was later determined separately). Multivariate analysis was applied and the results were compared using receiver operator characteristic curves. In 15 of 100 patients, pelvic lymph node metastases could be histologically demonstrated. Results. Multivariate analysis of 22 tumor characteristics identified the following as being independent in relation to pelvic lymph node metastases: preoperatively determined characteristics: serous papillary tumor type, invasion of myometrium, and histologic grade (Christo-pherson); pre-/intraoperatively: serous papillary type, histologic grade (Christopherson), and cervical involvement; and postoperatively: lymphangiosis carcinomatosa and hemangiosis carcinomatosa. Receiver operator characteristic curves show that for pelvic node metastases the postoperatively determined histologic findings are more predictive than all other factors that can be evaluated pre- and/or intraoperatively. Conclusion. Pre- and intraoperative tumor characteristics can determine the individual risk for pelvic lymph node involvement, but additional studies address ing the therapeutic value of pelvic lymphadenectomy would be necessary to define a probability threshold for lymphadenectomy in a decision analysis.

Objective Whereas pelvic exenteration is an established therapy for the treatment of recurrent cervical carcinoma, it is not often performed for primary locally advanced cervical cancer (LACC). Study Design This retrospective study analyzed survival data and prognostic factors of 35 patients with LACC who were treated by pelvic exenteration. Results After surgery, 33 patients (97%) were macroscopically free of tumor. In 20 patients, pelvic lymph nodes (LN) were involved, and in 6 of these, metastatic tissue had reached the paraaortal nodes. Overall, the patients' mean 5 year survival was 43%, and the median survival time was 30 months; these values ranged from 15% to 70% and from 15 to 44 months, respectively, depending on LN involvement ( P = .006). Pelvic LN involvement was the only significant factor for overall survival found in the multivariate analysis ( P = .02). Conclusion In LACC with free LNs and no distant metastases, pelvic exenteration has good long-term results.

Recent studies have renewed an old controversy about the efficacy of adjuvant radiotherapy following mastectomy for breast cancer. Radiotherapy is usually recommended for advanced disease, but whether or not to use it in pT1-T2 pN0 situations is still being debated. This study was designed to clarify whether or not routine radiotherapy of the chest wall following mastectomy reduces the risk of local recurrence and if it influences the overall survival rate.Retrospective analysis of patients treated with mastectomy for pT1-T2 pN0 tumors and no systemic treatment. Patients treated with radiotherapy of the chest wall following mastectomy (Group A) are compared with those treated with mastectomy alone (Group B).A total of 918 patients underwent mastectomy. Patients who received adjuvant radiotherapy after mastectomy (n = 114) had a significantly lower risk for local recurrence. Ten years after the primary diagnosis, 98.1% of the patients with radiotherapy were disease free compared to 86.4% of the patients without radiotherapy. The average time interval from primary diagnosis until local recurrence was 8.9 years in Group A and 2.8 years in Group B. The Cox regression analysis including radiotherapy, tumor size and tumor grading found the highest risk for local recurrence for patients without radiotherapy (p0.0004). In terms of overall survival however, the Kaplan-Meier analysis showed no difference between the two groups (p = 0.8787) and the Cox regression analysis failed to show any impact on overall survival.With observation spanning over 35 years, this study shows that adjuvant radiotherapy of the chest wall following mastectomy reduces the risk for local recurrence in node-negative patients with pT1-T2 tumors but has no impact on the overall survival rate.