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PurposeIndocyanine green (ICG) is frequently used for the detection of the sentinel lymph node (SLN) in gynecology, but it carries the loss of the presurgical SLN mapping provided by [99mTc]-based colloids. Hybrid tracers such as ICG-[99mTc]Tc-albumin nanocolloid combine the benefits of both components. The aim of this study was to evaluate the feasibility and applicability of this hybrid tracer injected by transvaginal ultrasound-guided myometrial injection of radiotracer (TUMIR) approach in the detection of SLNs in patients with intermediate- and high-risk EC.MethodsFifty-two patients with intermediate- and high-risk EC underwent SLN biopsy after injection of a hybrid tracer using the TUMIR approach, followed by pelvic and paraaortic lymphadenectomy. SLNs were detected preoperatively by lymphoscintigraphic study and intraoperatively by gamma probe and near-infrared (NIR) optical laparoscopic camera.ResultsPreoperative lymphatic drainage was obtained in 69% and intraoperative detection in 71.4% of patients. A total of 146 SLNs (4.17 SLNs/patient) were biopsied. Pelvic bilateral detection was observed in 57% of the women and paraaortic drainage in 34% of the patients. The radioactive component allowed the detection of SLN in 97.1% of the patients, while the fluorescent component detected 80%. In more than 17% of the patients with intraoperative detection, SLNs were detected only by the radioactive signal. Lymph node metastasis was identified in 14.3% of patients submitted to SLNB. The sensitivity and negative predictive value for metastatic involvement were 100%.ConclusionTUMIR injection of a hybrid tracer in patients with intermediate- and high-risk EC combines the benefits of the radiotracer and the fluorescence methods with a single tracer. The method increases the paraaortic detection rate and allows a potential increase in SLN detection. Notwithstanding, based on our findings, the radioactive component of the hybrid tracer cannot be obviated.

Objectives Accurate assessment of disease extent is required to select the best primary treatment for advanced epithelial ovarian cancer patients. Estimation of tumour burden is challenging and it is usually performed by means of a surgical procedure. Imaging techniques and tumour markers can help to estimate tumour burden non-invasively. 2-[ 18 F]FDG PET/CT allows the evaluation of the whole-body disease. This study aimed to correlate HE4 and CA125 serum concentrations with tumour burden evaluated by volumetric 2-[ 18 F]FDG PET/CT parameters in advanced high-grade epithelial ovarian cancer. Methods We included 66 patients who underwent 2-[ 18 F]FDG PET/CT and serum tumour markers determination before primary treatment. Volumes of interest were delimited in every pathological uptake. Whole-body metabolic tumour volume (wb_MTV) and total lesion glycolysis (wb_TLG) were calculated summing up every VOI’s MTV value. SUVmax thresholds were set at 40% (MTV40 and TLG40) and 50% (MTV50 and TLG50). In addition, four VOI subgroups were defined: peritoneal carcinomatosis, retroperitoneal nodes, supradiaphragmatic nodes, and distant metastases. MTV and TLG were calculated for each group by adding up the corresponding MTV values. TLG was calculated likewise. Results wb_MTV and wb_TLG were found to be significantly correlated with serum CA125 and HE4 concentrations. The strongest correlation was observed between HE4 and wb_MTV40 ( r  = 0.62, p  < 0.001). Pearson’s correlation coefficients between peritoneal carcinomatosis MTV40 and tumour markers were 0.61 ( p  < 0.0001) and 0.29 ( p  = 0.02) for HE4 and CA125 respectively. None of these tumour markers showed a positive correlation with tumour load outside the abdominal cavity assessed by volumetric parameters. Conclusion HE4 performs better than CA125 to predict metabolic tumour burden in high-grade epithelial ovarian cancer before primary treatment. 2-[18F]FDG PET/CT volumetric parameters arise as feasible tools for the objective assessment of tumour load and its anatomical distribution. These results support the usefulness of HE4 and PET/CT to improve the stratification of these patients in clinical practice. Key Points • In patients with high-grade advanced ovarian epithelial carcinoma, both CA125 and HE4 correlate to whole-body tumour burden assessed by PET/CT before primary treatment. • HE4 estimates peritoneal disease much better than CA125. • PET/CT volumetric parameters arise as feasible tools for the objective assessment of tumour load and its anatomical distribution.

Background: Assessment of the peritoneal cancer burden is crucial for determining the optimal treatment in advanced ovarian cancer (AOC). Effective non-invasive methods to predict tumour load remain limited. This study aimed to assess the applicability of 2-[18F]FDG PET/CT volumetric parameters, metabolic tumour volume (MTV), and total lesion glycolysis (TLG) for predicting the surgical peritoneal cancer index (PCI) in AOC before primary treatment. Methods: Patients with high-grade serous or undifferentiated AOC who underwent surgical PCI evaluation and 2-[18F]FDG PET/CT between 01/2013 and 12/2018 were included. MTV and TLG were calculated using thresholds of 40% and 50% (MTV40, MTV50, TLG40, and TLG50). Correlations between the peritoneal carcinomatosis MTV (car_MTV) and TLG (car_TLG) were analysed. The capacity of volumetric parameters to estimate PCIs above or below 14 and 20 was assessed for the whole abdominal cavity and in per-quadrant analysis, specifically for upper-abdomen areas 1, 2, and 3 (MTV40_1, 2, 3 and TLG40_1, 2, 3). Results: MTV40, MTV50, TLG40, and TLG50 significantly correlated with the PCI in the final study population (n = 45). MTV40 showed a Pearson coefficient of 0.41 (p = 0.003). MTV3_40 (AUC 0.79) and TLG3_40 (AUC 0.81) presented the highest AUCs for predicting a PCI above or below 14. The volumetric parameters allowed the prediction of a PCI greater or less than 20, with an AUC of 0.77 for MTV40_1 and 0.78 for TLG40_1. Conclusions: 2-[18F]FDG PET/CT MTV and TLG correlate significantly with the surgical PCI when assessing peritoneal carcinomatosis or quadrant-specific disease. This approach offers a reliable non-invasive method for evaluating tumour burden in AOC.

Several questions regarding the role of vaccination in women treated for high-grade cervical intraepithelial lesion (HSIL) have not been clarified. One of the main queries is whether the time at which the vaccine is administered (before or after treatment) influences the protection against post-treatment HSIL. A second unanswered question is whether the vaccine has any effect in women with persistent HPV after treatment. We aimed to address these questions in a study of 398 women undergoing excisional treatment from July 2016 to December 2019. Vaccination was funded and offered to all women undergoing treatment. A total of 306 women (76.9%) accepted HPV vaccination (vaccinated group): 113 (36.9%) received the first dose before excision and 193 (63.1%) after the procedure. A total of 92 women (23.1%) refused the vaccine (non-vaccinated group). Women vaccinated before treatment showed a lower rate of post-treatment HSIL compared with non-vaccinated women (0.9% vs. 6.5%; p = 0.047). Among women with persistent HPV infection after treatment, those who had received the vaccine showed a lower prevalence of post-treatment HSIL than non-vaccinated women (2.6% vs. 10.5%; p = 0.043). In conclusion, this study shows that HPV vaccination before treatment reduces the prevalence of post-treatment HSIL and suggests that vaccination might even benefit women with persistent HPV after treatment.

(1) OBJECTIVE: To assess the performance of CA125, HE4, ROMA index and CPH-I index to preoperatively identify epithelial ovarian cancer (EOC) or metastatic cancer in the ovary (MCO). (2) METHODS: single center retrospective study, including women with a diagnosis of adnexal mass. We obtained the AUC, sensitivity, specificity and predictive values were of HE4, CA125, ROMA and CPH-I for the diagnosis of EOC and MCO. Subgroup analysis for women harboring adnexal masses with inconclusive diagnosis of malignancy by ultrasound features and Stage I EOC was performed. (3) RESULTS: 1071 patients were included, 852 (79.6%) presented benign/borderline tumors and 219 (20.4%) presented EOC/MCO. AUC for HE4 was higher than for CA125 (0.91 vs. 0.87). No differences were seen between AUC of ROMA and CPH-I, but they were both higher than HE4 AUC. None of the tumor markers alone achieved a sensitivity of 90%; HE4 was highly specific (93.5%). ROMA showed a sensitivity and specificity of 91.1% and 84.6% respectively, while CPH-I showed a sensitivity of 91.1% with 79.2% specificity. For patients with inconclusive diagnosis of malignancy by ultrasound features and with Stage I EOC, ROMA showed the best diagnostic performance (4) CONCLUSIONS: ROMA and CPH-I perform better than tumor markers alone to identify patients harboring EOC or MCO. They can be helpful to assess the risk of malignancy of adnexal masses, especially in cases where ultrasonographic diagnosis is challenging (stage I EOC, inconclusive diagnosis of malignancy by ultrasound features).

Objective: To evaluate whether E7 mRNA can predict the risk of progression in women with HPV16 infection. Design: A prospective observational study. Setting: A tertiary university hospital. Population: A cohort of 139 women referred to colposcopy for an abnormal screening result fulfilling the following inclusion criteria: (1) a positive test result confirming HPV16 infection; (2) a biopsy sample with a histological diagnosis of an absence of lesion or low-grade SIL/CIN grade1 (LSIL/CIN1); (3) no previous HPV vaccination; (4) no pregnancy; and (5) no previous cervical treatments; and (6) no immunosuppression. Methods: At the first visit, all women underwent a cervical sample for liquid-based cytology, HPV testing and genotyping, and HPV16 E7 mRNA analysis and a colposcopy with at least one colposcopy-guided biopsy. Follow-up visits were scheduled every six months. In each control, a liquid-based Pap smear, HPV testing, as well as a colposcopy examination with biopsy if necessary were performed. Main outcome measures: Histological diagnosis of HSIL/CIN2+ at any time during follow-up. Results: E7 mRNA expression was positive in 55/127 (43.3%) women included in the study and seven (12.7%) progressed to HSIL/CIN2+. In contrast, only 1/72 (1.4%) women with no HPV16 E7 mRNA expression progressed (p = 0.027). HPV16 E7 mRNA expression was associated with a 10-fold increased risk of progression (HR 10.0; 95% CI 1.2–81.4). Conclusions: HPV16 E7 mRNA could be useful for risk stratification of women with HPV16 infection in whom a HSIL/CIN2+ has been ruled out. Funding: Instituto de Salud Carlos III (ICSIII)-Fondo de Investigación Sanitaria and ERDF ‘One Way to Europe’ (PI17/00772).

Introduction/BackgroundTo investigate the molecular classification of endometrial carcinoma (EC) and atypical endometrial hyperplasia (AEH) treated with fertility-sparing therapy, and to determine its relationship to oncologic and reproductive outcome.MethodologyPatients who received fertility-sparing therapy and molecular classification tested by next generation sequencing in Hospital Clínic of Barcelona from January 2007 to june 2022 were retrospectively collected. The relationships between molecular classification and clinicopathological factors and treatment outcomes were analyzed.Results35 women were included: 22 (62.9%) patients with AEH and 13 (37.1%) with stage IA EC (11 grade 1 and 2 grade 2) Median age of the patients was 36.4 years (range 23–45) and BMI 29.0±6 Kg/m2. The 85% were nulliparous, 60% were infertile and 35% presented abnormal uterine bleeding.Of the 35 patients, 29 cases (82.9%) had complete response (CR) after treatment, with median CR time of 8 months, 8.6 cases (1%) had partial response, and 6 cases (17%) had recurrence. Only 10 patients (28,6%) underwent definitive surgery.The global live birth rate was 33%, among patients who attempted to conceive (17), the pregnancy rate was 41.2%. We found a higher rate among patients who underwent fertility treatments (IVFs). There were 14% of spontaneous abortion and 28.6% of IVFs failures.The cases were distributed as no specific molecular profile (NSMP) 33 cases (94,3%), high microsatellite instability (MSI-H) 2 cases (5,7%), POLE ultra-mutated 0 cases and copy number high (CNH) 0 cases.ConclusionFertility-sparing management presented a high response rate in patients with endometrial cancer. Assisted reproductive techniques increase pregnancy rates. Molecular classification is fesible in biopsy of patients with EC and AEH treated with fertility-sparing therapy. However, there are few cases in POLE ultra-mutated and CNH subtypes, which need further clinical research.DisclosuresThe authors have nothing to disclose.

Introduction/BackgroundSurgery is considered the mainstay of treatment in early stages of vulvar cancer and in association with radio-chemotherapy for advanced disease. Despite surgical treatment provides good local control of the disease, it often entails significant functional and anatomical impairment, affecting sexual function, body image perception and global quality of life.Advances in reconstructive techniques enables an improvement in functional and aesthetic results, guarantees an adequate coverage of larger tumors and assures safe surgical margin. In addition, intraoperative indocyanine green (ICG) angiography is acquiring interest as a useful tool in flap-based surgeries, revealing perfusion defects than can be correct intraoperatively.MethodologyWe report the case of a 78-year-old woman with an HPV-independent squamous cell carcinoma of the vulva (FIGO staging 2021 II), managed in our gynecological oncology unit in collaboration with plastic surgeons. A radical vulvectomy, adding the clitoral area, was performed to enable a complete exeresis of the malignant lesion with adequate surgical margins. Unilateral medial thigh fasciocutaneous advancement flap was the reconstructive technique performed, and intraoperative ICG angiography was also used to analyze flap perfusion and correct flap edges.ResultsIn Figure 1 are represented some steps during the surgery. After complete tumor resection, flap preparation and placement over the genitalia defect, flap perfusion was evaluated using intraoperative ICG angiography. A distal perfusion defect in the upper-inner edge was detected and correct by removing the distal 2 cm.ConclusionPlastic reconstructive techniques added to vulvar cancer surgery offers the opportunity to amplify surgical treatment to larger tumors while optimizing functional and anatomic results. Intraoperative ICG angiography can improve these reconstructive surgery results by guiding the surgeon in early detection and correction of potential vascular defects.DisclosuresAuthors have no conflict of interest to declare.

Introduction/BackgroundThe removal of substantial vulvar tumors often requires radical vulvectomy, resulting in extensive defects of vulvar tissue. Flap reconstruction is performed to prevent tension in the surgical wound. Postoperative complications (20–60%) such as dehiscence, infection, necrosis and reintervention are frequent.There are expensive or complex methods to assess flap viability. Indocyanine green (ICG) may be a cost-effective and efficient tool for evaluating the vitality of vulvar flaps.This study aims to intraoperatively assess the perfusion of flaps in vulvar cancer reconstructive surgery, using ICG Fluorescence Angiography.MethodologyThis single-center, ambispective study included patients with vulvar cancer who required surgical treatment and subsequent vulvar flap reconstructive surgery.When the reconstructive surgery finished, 25 mg of indocyanine green were intravenously injected, followed by the evaluation of the proper perfusion of the vulvar flap using a fluorescence camera.ResultsTen patients undergoing vulvar reconstructive surgery with flap procedures were included from September 2020 to September 2023. Median age was 77 years.Primary vulvar surgery was performed in 50% of the patients, while the other 50% underwent recurrent surgeries. 40% of the patients had received previous radiotherapy. The average tumor size was 40 mm. 50% of the performed flaps were VYadvancement flaps.There were no reported intraoperative complications or side effects associated with the ICG. Flap vascularization was evaluated 5–10 minutes after the injection by ICG imaging. In three flaps a low perfusion area was identified and removed. 90% experienced minor dehiscence at the flap level. Two patients developed mild surgical site infections.ConclusionIntraoperative ICG imaging is a feasible method that allows an accurate assessment of the flap vascularization in vulvar reconstruction as well as the identification and removal of a low vascular perfusion area to avoid postoperative complications. Future studies with larger samples are required to further evaluate the possibilities of this technique in vulvar reconstruction.DisclosuresThe authors have no financial interest to declare in relation to the content of this abstract.Abstract 1215 Figure 1

Correspondence to Dr Nuria Agusti, Department of Gynecologic Oncology, Hospital Clinic de Barcelona, Barcelona, Spain; NAGUSTI@clinic.cat Systematic pelvic and para-aortic lymphadenectomy is part of early-stage epithelial ovarian cancer staging surgery.1 Although lymph node involvement rate is only 15% (6%–30%), this procedure is associated with a potential severe morbidity with no evidence suggesting a therapeutic value. Schematic surgical image showing the 99m Tc-albumin nanocolloid injection in the utero-ovarian ligament before performing the adnexectomy In conclusion, the description of this new surgical procedure in 10 steps allows its standardization and distribution among surgical teams. Ethics approval This study involves human participants and was approved by the ethics committee of the Hospital Clinic of Barcelona (reference number HCB/2021/0130).