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Introduction/BackgroundLymphatic drainage pathways in vaginal cancer depend on the localization of the tumor. The upper two thirds of the vagina usually drain primarily to deep pelvic nodes, the lower one-third drains into the inguinal and femoral nodes. However, some studies documented large variance of the lymph drainage. The recomended surgical approach for distal vaginal lesions involved radical resection of infiltrated vagina to achieve adequate negative margins and inguinal lymph node dissection.MethodologyA case report.Results72 year-old woman has been referred to University hospital of Ostrava with histologically confirmed adenocarcinoma of the vagina. Gynaecological examination revealed the exophytic tumor size of 3 × 1.5 × 1.5 centimeters involving lower posterior wall of the vagina. The distance from the vaginal entrance was 1 centimeter. Ultrasounography detected vascularised exophytic tumor of distal part of vagina with no spread to the rectal wall or lymfadenopathy in the groins and in the pelvis. Surgical treatment has been recommended. The radiolabeled technetium-99 m colloid has been injected in four quadrants around the lesion directly into the junction of tumor and normal vaginal mucosa two hours before surgery. Following lymphoscintigraphy showed no activity in the groins but detected sentinel lymph nodes in pelvis. In operating room the isosulfan blue has been injected in the same manner. Pelvic sentinel nodes were detected by gamma counter and blue dye and removed by laparoscopic approach. After systematic pelvic lymphadenectomy the radical excision of vaginal tumor with clear margin was performed. Histological findings confirmed adenocarcinoma of vagina, clear margins of excision and no involvement of lymph nodes.ConclusionThe lymph drainage of the vagina has a large variance. Preoperative lymphoscintigraphy is able to identify the nodes most at risk for metastatic disease (the sentinel nodes) and helps to choose optimal surgical approach in treatment of vaginal cancer patients.DisclosureNothing to disclose

Introduction/Background*SENTIX is a prospective cohort multicentric international study on sentinel lymph node (SLN) biopsy without pelvic lymph node dissection (PLND) in patients with early-stage cervical cancer. SLN frozen section (FS) and pathological ultrastaging were mandatory by the protocol. Samples from SLN were reviewed centrally for pathological assessment quality control. Only sites experienced in SLN biopsy technique could join the trial.MethodologyIn total, 47 sites from 18 countries participated in the trial. Patients with FIGO 2009 stages T1A1/LVSI+ – T1B1 (<4 cm or ≤ 2 cm for fertility sparing), with common tumour types and no suspicious lymph nodes on imaging were registered in the trial. Patients remained in the trial after the surgery if SLN were detected on both sides of the pelvis and if SLN were negative on FS histological evaluation. Blue dye, radioactive tracer, indocyanine green or their combinations were all eligible tracers for SLN detection. Intraoperative SLN pathological processing consisted of SLN examination in one randomly selected slice. SLN ultrastaging protocol included a complete processing of all SLN tissue in slices of 2 mm thickness, 2 sections in 150 μm from each block until no tissue left, one stained with H&E and second examined immunohistochemically.Result(s)*Altogether 733 patients were registered until Sentix enrolment closure in October 2020, 83 patients were excluded (table 1) and 650 patients was analysed. Patients` characteristics are shown in table 1. Bilateral SLN detection rate reached 95%. FS detected macrometastases (MAC) in 44 cases and micrometastasis (MIC) in 4 cases. SLN ultrastaging found additional 9 cases with MAC, 26 with micrometastases (MIC) and all 19 cases with isolated tumor cells (ITC). Sensitivity of FS was 83.0% for the detection of MAC, 57.8% for pN1 status (MAC or MIC) and 47.1% for any type of SLN involvement (MAC, MIC, ITC). Table 2.Abstract 950 Table 1Patient’s characteristics (N=733)Abstract 950 Table 2SLN status assessed by frozen section and final ultastaging (N=650)Conclusion*High bilateral detection rate of 95% was achieved in Sentix sites experienced in the SLN biopsy technique. Intraoperative pathological assessment of SLN failed to detect majority of MIC (86.7%), all cases with ITC and 42.2% with pN1 (MIC or MAC).

Introduction/Background*Lower limb lymphoedema (LLL) is the most disabling adverse effect of surgical staging of pelvic lymph nodes. In studies, LLL is often assessed by calculation of limb volumes based on five circumference measurements. However, the lack of standardisation of this method hinders direct comparison between the studies and makes LLL reporting unreliable. The aim of our study is to report outcomes from a prospective SENTIX trial that have implications for the standardisation of LLL assessment.MethodologyIn the prospective international multicentre trial SENTIX (ENGOT-cx2/CEEGOG CX-01), a group of 150 patients with stage IA1–IB2 cervical cancer treated by uterine surgery with bilateral SLN biopsy was prospectively evaluated by objective LLL assessment, based on limb volume change (LVC) using circumferrential limb measurements and subjective patient-reported swelling. The assessments were conducted in six-month periods over 24 months post-surgery.Result(s)*Patient LVC substantially fluctuated in both positive and negative directions (figure 1), which were comparable in frequency up to 14% +/- LVC increments. Thirty-eight patients experienced persistent LVC increase and >10% classified as LLL, for whom median time to onset was nine months (95% CI: 7.0-11.0). Some 34.2% of cases experienced onset later than one year after the surgery. Thirty-three patients (22%) experienced transient oedema characterised as LVC >10%, which resolved without intervention between two consequent follow-up visits (figure 2). No significant correlation between LVC >10% and a patient-reported swelling was observed.Abstract 959 Figure 1Distribution of the limb volume change (from preoperative assesment; LVC) of right and left lower limb during the folloe-up-period. Each dot on the violin plot represents the LVC of one patient’s limb. 6M: six months post-surgery; 12M months post-surgery; 18M months post-surgery; 24M: 24 months post-surgery.Abstract 959 Figure 2Incidence of transient oedema. Each dot marks the transient oedema (>10% LVC increase from preoperative measurement) of one patient. Boxplots depict the median value of respective transient oedema LVI (%); the percentile range was set at 25% and 50%; the whisker is between minimal and maximal calculated value. FU; follow-up; LVC: limb volume change.Conclusion*Our study showed that lower-limb volumes after surgical treatment of cervical cancer significantly fluctuate in positive and negative directions. A diagnostic threshold for LLL should be increased to >15% LVC. Transient oedema occurs frequently, and its distinction from persistent LLL requires repeated measurements. One-third of new LLL cases were diagnosed in the second year of follow-up, highlighting the importance of a sufficient follow-up period duration. Finally, patient-reported limb swelling correlated poorly with LVC and should only be used as an adjunct to objective LLL assessment.

Introduction/BackgroundLymph node status is the most important prognostic factor in vulvar cancer. Histologically, sentinel nodes may be representative of the status of the other regional nodes. Identification and histopathologic evaluation of sentinel nodes could then have a significant impact on clinical management and surgery. The aim of the study was to assess the sensitivity, negative prognostic value, accuracy and false negativity of the sentinel lymph node (SLN) procedure during 14 years.MethodologyFrom June 2004 to Deceember 2017, 112 patients with vulvar cancer, clinical stages FIGO IA-IB, underwent surgical tretament in onco-gynecologic center of University Hospital Ostrava. Demographic, surgical, and pathologic data on all patients were prospectively entered in a database. Of 86 women with early-stage squamous cell vulvar cancer included in the study, nineteen had lateral lesions and 67 had midline lesions. SLN detection was performed by using a radioactive tracer and blue dye, followed by radical vulvectomy or radical wide excision with uni ⁄bilateral inguinofemoral lymphadenectomy. SLNs were subsequently examined with haematoxylin-eosin and immunohistochemistry.ResultsEighty- six patients underwent the SLN procedure by combined method. The detection rate per patient was 97,7%, and side specific detection rate was 88,1%. For 19 patients with lateral lesion the detection rate per patient and side specific detection rate was 100% and for patients with midline tumor 97,0% a 87,0% respectively. In total, fifty-one positive SLNs were detected in thirty-two of 86 patients (37,2%). From a total 51 positive SLNs, micrometastases were found in ten SLNs. We experienced only one case with a false negativity of SLN. Sensitivity, negative predictive value, accuracy and false negativity of SLN detection were 96,9%, 98,1%, 97,7% and 3.1% respectively.ConclusionThe SLN biopsy performed by an experienced team during long time period is a accurate method, with high accuracy and low false negativity in patients with early-stage vulvar cancer.DisclosureNothing to disclose.

Introduction/BackgroundDespite the use of nerve-sparing technique, bladder dysfunction remains the leading morbidity associated with parametrectomy (radical hysterectomy or trachelectomy). Our aim was to analyze the time to postoperative voiding recovery and the factors influencing it in the SENTIX trial cohort, in whom different types of surgical approach and parametrectomy was used.MethodologyThe SENTIX trial is a prospective cohort international study on sentinel lymph node biopsy without pelvic lymphadenectomy in patients with early-stage cervical cancer (≤4 cm or ≤2cm in fertility sparing). It entails 46 sites from 18 countries. Ad hoc analysis of data from the SENTIX trial was performed to assess factors influencing voiding recovery, which was defined as the number of days from surgery to bladder catheter or epicystostomy removal with post-voiding urine residuum <50 mL.ResultThe characteristics of the cohort of 372 patients are shown in table 1. Median (range) voiding recovery time was 3 (0–21) days; it was <7 days in 288 (78.5%) patients and <1 month in 357 (97.3%). Among 10 (2.7%) patients with recovery >1 month, only 1 case (80 days) was not associated with any severe intraoperative complication (6 cases) or adjuvant radiotherapy (3 cases). Tumor size >2 cm, open surgery, and a more extensive type of parametrectomy significantly influenced voiding recovery (figure 1). In multivariate analysis, only previous pregnancy and type of parametrectomy were significant (table 2).Abstract – Figure 1Kaplan - Meier curve for time to voiding recovery according to type of parametrectomyAbstract – Table 1Main characteristics of patients (N=372)Abstract – Table 2Predictors of voiding recovery >7 days: multivariate analysisPredictorsOR (95% CI)pType of parametrectomyB5.248 (1.683; 16.366)0.004C14.401 (1.458; 13.285)0.009C26.190 (1.939; 19.761)0.002not donereferencePrevious pregnancyno0.270 (0.092; 0.790)0.017yesreferenceConclusionVoiding recovery time is directly related to the extent of parametrectomy. It is, however, temporary and almost all patients recover within 1 month, even after a more radical procedure (C2). The higher risk associated with laparotomy reflects a tendency to be more radical with open surgery.DisclosureThis work was supported by a grant from the Czech Research Council (No 16-31643A). There are no conflicts of interest.

Introduction/BackgroundSENTIX is a prospective cohort multicenter international study on sentinel lymph node (SLN) biopsy without pelvic lymph node dissection (PLND) in patients with early-stage cervical cancer. SLN frozen section (FS) and pathological ultrastaging were mandatory. Samples from SLN were reviewed centrally for pathological assessment quality control. Only sites experienced in SLN biopsy technique were eligible.MethodologyIn total, 47 sites from 18 countries participated in the study. Patients with stages T1a1/LVSI+ - T1b2 (<4 cm or ≤2 cm for fertility sparing), with common tumor types and no suspicious lymph nodes on imaging were pre-registered in the study. Patients remained registered after the surgery if SLN were detected on both sides and if SLN were negative on frozen section. Blue dye, radioactive tracer, indocyanine -green (ICG) or their combinations were all eligible tracers for SLN detection. SLN ultrastaging protocol included a complete processing of all SLN tissue in slices of 2 mm thickness, 2 sections in 150 µm from each block until no tissue left, one stained with H&E and second examined immunohistochemically.ResultsData from 372 patients were analyzed who were pre-registered at the time when the number of cases treated per protocol reached 300. Patient characteristics are shown in table 1. Bilateral detection rate reached 91%. table 2 shows factors influencing SLN detection. Frozen section detected macrometastases (MAC) in 22 cases. SLN ultrastaging found additional 7 cases with MAC, 19 with micrometastases (MIC) and 11 with isolated tumor cells (ITC). Sensitivity of FS was 75.9% for the detection of MAC and 37.3% for any type of SLN involvement.ConclusionHigh bilateral detection can be achieved in sites experienced in the SLN biopsy technique. We did not confirm a higher detection rate using ICG. FS failed to detect 26/48 (54%) of cases with MIC or MAC in SLN.DisclosureThis work was supported by a grant from the Czech Research Council (No 16-31643A). Conflict of interest: None of the authors declare a conflict of interest.Abstract EP334 Table 1Preoperative characteristics of patients (N=372)Abstract EP334 Table 2Factors influencing bilateral detection rate of SLN

Introduction/BackgroundThe quality of pathological assessment is of pivotal importance in the management of cervical cancer patients if pelvic lymph node dissection (PLND) is to be replaced by sentinel lymph node (SLN) biopsy only.MethodologyThe aim was to report the results of the quality control of pathological SLN assessment in the group of 300 patients treated per protocol. All specimens and full pathology reports from at least two patients per site were reviewed centrally in Prague. SLN ultrastaging protocol included a complete processing of all SLN tissue in slices of 2 mm thickness, 2 sections in 150 µm from each block until no tissue left, one stained with H&E and second examined immunohistochemically. The findings were classified as: Minor (minor protocol deviations), Major (additional sections completed at central pathology), or Critical (deviations could not have been fixed at central pathology). In the case of Major or Critical findings, sites were requested to submit all samples from all additional patients for the second-round assessment.ResultsSamples from 77 cases from 36 sites with at least 1 patient treated per protocol were submitted for the central reading. Minor findings were identified in 27% of cases, Major in 30%, and Critical in 4%. Samples from 18 patients were submitted for the second control round; 9 were without deviations 7 had Minor, 2 Major, and 1 Critical findings. One site was prematurely closed due to repeated Critical findings. The most frequent deviations included incompletely processed SLN (36/95) and a lower number of immunohistochemical staining (31/95).ConclusionMajor deviations from the SLN protocol were identified in 33% of sites and 31% of samples. These deviations can impact detection of small metastases and, consequently, the safety of the SLN concept. Central pathology reading allowed for substantial improvement of SLN pathological assessment during the trial.Disclosure Acknowledgements: This work was supported by a grant from the Czech Research Council (No 16-31643A). None of the authors declare a conflict of interest.

Introduction/BackgroundL1 cell adhesion molecule (L1CAM) belongs to the immunoglobulin superfamily of cell adhesion molecules and promotes cell proliferation, invasion, and metastasis. We aimed to study L1CAM expression in early-stage cervical cancer patients and assess its relationship to lymphovascular invasion (LVSI), histological type, degree of differentiation, tumor size, and lymph node involvement.MethodologyWe study the patients with cervical cancer who underwent surgery in our department (2007 – 2017). An immunohistochemical examination of L1CAM expression was provided. Those in which the presence of L1CAM was confirmed in more than 10% of tumor cells were marked as positive. We enrolled in total 187 patients in stages FIGO I and II. The histological tumor types were adenocarcinoma 20, adenosquamous 14, and squamous carcinoma 153. And grading distribution was 46 tumors in grade 1, 106 in grade 2, and 33 in grade 3. We confirm up to 2 cm in 71 tumors and 116 tumors over 2 cm. LVSI was evident in 67 tumors. Pelvic lymphadenectomy was performed in 169 patients; positive metastasis was in 38.ResultsL1CAM expression was positive in 39 (20.9%) tumors. We observed a significant difference in L1CAM expression in adenocarcinoma and adenosquamous carcinoma compared to squamous carcinoma (p=0.001). We noticed a difference in tumor size greater than or equal to 2 cm (p=0.005). L1CAM expression did not affect the degree of differentiation and the presence of LVSI (p=0.521; p=0.115, respectively). We also did not observe a difference in L1CAM expression regarding pelvic lymph node involvement (p=0.949).Abstract 2022-RA-425-ESGO Table 1The clinicopathological study group distribution in relation to the LICAM statusAbstract 2022-RA-425-ESGO Figure 1The clinicopathological study group distribution in relation to the L1CAM statusConclusionOur study did not confirm the increased L1CAM expression in cervical cancer as an adverse prognostic factor for LSVI, grade, and pelvic lymph node involvement. However, a significant relationship was seen between L1CAM expression, histological type of tumor, and its size. The study was supported by grant 24/RVO-FNOs/2020