Complete Pelvic Lymphadenectomy Research Articles

Effectiveness of sentinel lymph node biopsy and bilateral pelvic nodal dissection using methylene blue dye in early-stage operable cervical cancer—A prospective study

ObjectiveTo evaluate the effectiveness of methylene blue dye in detecting sentinel lymph nodes (SLNs) in women with early-stage operable (defined as FIGO I-IIA) cervical cancer. It also aims to evaluate procedural challenges and accuracy. MethodThis prospective study, which focused on 20 women with early-stage cervical cancer, was carried out between June 2016 and December 2017. These patients had SLN mapping with methylene blue dye injections and thorough examinations, including imaging. All patients underwent radical hysterectomy and complete bilateral pelvic lymphadenectomy. No additional investigation was done on the lymph node in cases where a metastasis was found in the first H&E-stained segment of the sentinel node. Result20 patients were included in the analysis. The median age of the subjects was 53, and 95 % of them had squamous cell carcinoma. 90 % of the time, the identification of SLNs was effective, and 55 SLNs were found, of which 52.7 % were on the right side of the pelvis and 47.3 % on the left. The obturator group had the most nodes, followed by the external and internal iliac groups in descending order of occurrence. Metastasis was detected in 3 patients, resulting in a sensitivity of 100 % and a specificity of 93.75 % for SLN biopsy. Notably, no false-negative SLNs were found. Complications related to methylene blue usage included urine discoloration in 30 % of patients. ConclusionThis trial highlights the promising efficacy and safety of methylene blue dye alone for SLN identification in early-stage operable cervical cancer, with a notably higher success rate. Despite limitations like a small sample size, healthcare professionals and researchers can build upon the insights from this study to enhance cervical cancer management.

Mapping sentinel lymph nodes in early-stage ovarian cancer (MELISA) trial - a further step towards lymphadenectomy replacement

ObjectiveSistematic pelvic and para-aortic lymphadenectomy is part of the staging surgery for early-stage epithelial ovarian cancer, with no therapeutic value. The Mapping Sentinel Lymph Nodes In Early-Stage Ovarian Cancer (MELISA) trial prospectively assessed the SLN detection rate and the diagnostic accuracy of the SLN mapping technique in patients with early-stage epithelial ovarian cancer. MethodsThis prospective, single-arm study included patients diagnosed with early-stage epithelial ovarian cancer (FIGO stages I and II), via either primary surgery or re-staging surgery. SLN mapping was performed by injecting 0.2 mL of 37-mBq 99mTc-nanocoloid albumin and 2 mL of 2.5 mg/mL indocyanine green into the infundibulopelvic and utero-ovarian ligaments. After removal of SLNs, a complete systematic pelvic and para-aortic lymphadenectomy was performed. SLN Ultrastaging analysis was applied. The primary outcome was the overall SLN detection rate, either with one or both tracers. Secondary outcomes were the diagnostic accuracy of detecting lymph node metastases and factors that may influence SLN detection. ResultsThirty patients were included. SLNs were identified in 27 patients (90%). Detection rates in primary and re-staging surgery were 89% and 92%, respectively. Para-aortic drainage was the predominant lymphatic spread, observed in 26 of 27 patients. Ultrastaging pathologic reports listed 1 SLN with macrometastasis, 1 with micrometastasis, and 5 with isolated tumor cells; the sensitivity of SLN mapping was 100%, with a false-negative rate of 0%. Univariate analysis showed a nonsignificant higher proportion of patients with uterine fibroids, adenomyosis, and endometriosis (100%, 67%, 67%, respectively) in patients in whom SLNs were not detected. ConclusionSLN mapping has a high detection rate (90%) and is an accurate technique for detecting lymph node involvement in early-stage epithelial ovarian cancer. SLN mapping is a potential alternative to systematic lymphadenectomy to reduce associated morbidity, but further research is needed to evaluate the impact of SLN mapping on oncologic outcomes and its cost-effectiveness.

Rolul ganglionului-santinelă în tratamentul actual al cancerului de endometru

Introduction. Endometrial cancer is the most prevailing gynecological malignancy in developed countries, with an incidence rising annually. For years, systematic lymphadenectomy had been the preferred method for staging purposes, but a less aggressive approach, with no negative impact on the oncologic outcomes, is the current trend in endometrial cancer management. In this review, we aim to evaluate the role of sentinel lymph node (SLN) mapping as an eligible alternative to complete pelvic lymphadenectomy in the surgical staging process, as well as its influence on the adjuvant treatment options. Materials and method. We analyzed the leading international guidelines regarding sentinel lymph node mapping in endometrial cancer, published between 2018 and 2023, as well as several studies that met the inclusion criteria, from the PubMed database, to outline the recommended surgical techniques, the algorithm, the accuracy, and the advantages of the SLN sampling procedure compared to pelvic lymphadenectomy. Results. Most international guidelines conclude that SLN sampling is the desirable alternative to systematic lymphadenectomy. However, it is agreed that, in case of failed SLN mapping, the radical option consisting in complete pelvic lymphadenectomy is recommended. As far as high-risk patients are concerned, most of the reviewed studies and guidelines encourage the use of SLN mapping in the treatment of endometrial cancer. Our findings revealed high sensitivity and detection rates of SLN mapping, influenced especially by the type of tracer used, indocyanine green having the best outcomes. Conclusions. Considering the high sensitivity and the low morbidity rates of the procedure, SLN mapping is soon to become a gold standard practice for the surgical staging process of endometrial cancer in many gynecologic oncology centers. Thus, SLN mapping represents a viable alternative to complete pelvic lymphadenectomy, acknowledging the principles of minimally invasive surgery and personalized medicine, without compromising the oncologic outcomes.

Same-day dismissal for endometrial cancer robotic surgery: feasibility factors.

The aim of this study was to investigate the factors in feasibility and safety of same-day dismissal (SDD) of endometrial cancer patients undergoing robotic hysterectomy and staging. A single-institution retrospective chart review of endometrial cancer patients who underwent robotic hysterectomy and staging between 2012 and 2021 was performed. Patient demographics, medical and surgical history, intra- and postoperative events were examined as possible factors related to non-SDD. These factors were analyzed using univariate (chi-square test) and multivariate logistic regression analysis. Of the 292 patients, 117 (40%) had SDD, and 175 (60%) had non-SDD. The SDD rate increased from 13.8% to 88% over the 10-year study period. The factors significantly associated with non-SDD (p < 0.05) were surgery in the first 5years after the introduction of the SDD and ERAS protocols (2012-2016), age > 75years, and comorbidities such as cardiovascular diseases, anemia (Hb < 11g/dl), and anticoagulant therapy. Extensive adhesiolysis, the performance of complete pelvic and/or aortic lymphadenectomy, operating time > 180min, and PACU discharge after 2:00 p.m. were significant factors for non-SDD. Sentinel lymph node sampling was significantly associated with SDD (OR 0.050; CI 0.273-0.934, p = 0.029). We reported no significant difference in the number, setting and timing of any unscheduled postoperative contacts, complications, and readmissions between SDD and non-SDD groups. SDD after robotic hysterectomy and staging for endometrial cancer is feasible and safe. There are patient and surgery factors for the failure of SDD. The sentinel lymph node sampling was significantly associated with achieving SDD. Trial registration: Institutional Review Board approved the study protocol (#: 1764-05).

Clinical application of laparoscopic sentinel lymph node mapping in early staged cervical cancer

Objective: To investigate the application of sentinel lymph node biopsy (SLNB) in early-staged cervical cancer by laparoscopy. Methods: It was a prospective, single-arm, single-center clinical study. Seventy-eight cases of cervical cancer patients were collected from July 2015 to December 2018 at the Fourth Hospital of Hebei Medical University. All the patients were injected with tracer into the disease-free block of cervical tissue after anesthesia by the same surgeon who learned sentinel lymph node (SLN) mapping technique in Memorial Sloan-Kettering Cancer Center, and underwent SLN mapping followed by complete pelvic lymphadenectomy. Moreover, all the dissected lymph nodes were stained with hematoxylin eosin staining (HE) pathological examination. Besides, the negative SLN on hematoxylin-eosin staining were detected by immunohistochemistry cytokeratin staining micro-metastasis. To analyze the distribution, detection rate, false negative rate the sensitivity and negative predictive value of the SLN in early-staged cervical cancer by laparoscopy, and explore the value of SLN mapping in predicting the lymph nodes metastasis in early-staged cervical cancer. Results: The overall detection rate of SLN in cervical cancer was 99% (77/78), bilateral detection rate was 87% (68/78). The average of 12.4 lymph node (LN) and 3.6 SLN were dissected for each patients each side. SLN of cervical cancer were mainly distributed in the obturator space (61.5%, 343/558), followed by external iliac (23.5%, 131/558), common iliac (7.3%, 41/558), para-uterine (3.8%, 21/558), internal iliac (2.2%, 12/558), para abdominal aorta (1.1%, 6/558), and anterior sacral lymphatic drainage area (0.7%, 4/558). Fourteen cases of LN metastasis were found among all 78 cases. There were a total of 38 positive LN, including 26 SLN metastasis and 12 none sentinel LN metastasis. Through immunohistochemical staining and pathological ultra-staging, 1 SLN was found to be isolated tumor cells (ITC), and 5 SLNs were found to be micro-metastases (MIC), accounting for 23% (6/26) of positive SLN. SLN mapping with pathological ultra-staging improved the prediction of LN metastasis in cervical cancer (2/14). Metastatic SLN mainly distributed in the obturator space (65%, 17/26), peri-uterine region (12%, 3/26), common iliac region (15%, 4/26), and external iliac region (8%, 2/26). The consistency of the diagnosis of lymph node metastasis by SLN biopsy and postoperative retroperitoneal lymph node metastasis showed that the Kappa value was 1.000 (P<0.001), indicated that the metastasis status of SLN and retroperitoneal lymph node were completely consistent. The sensitivity, specificity, accuracy, false-negative rate, and negative predictive value of SLN biopsy in the diagnosis of lymph node metastasis were 100%, 100%, 100%, 0, and 100%, respectively. Conclusions: SLN in early-staged cervical cancer patients were mainly distributed in the obturator and external iliac space, pathalogical ultra-staging of SLN could improve the prediction of LN metastasis. Intraoperative SLN mapping is safe, feasible and could predict the state of retroperitoneal LN metastasis in early-staged cervical cancer. SLNB may replace systemic pelvic lymphadenectomy.

The Role of Sentinel Lymph Node Mapping in High-grade Endometrial Cancer.

Total hysterectomy with lymph node assessment is the current standard-of-care for surgical staging in apparent early-stage endometrial cancer. Compared to the traditional complete pelvic lymphadenectomy with or without para-aortic lymphadenectomy, sentinel lymph node (SLN) mapping results in fewer surgical complications, decreased operative time, and lower rates of chronic lymphedema. The technique is endorsed by the National Comprehensive Cancer Network and the Society of Gynecologic Oncology guidelines, and over the past two decades the majority of gynecologic oncologists worldwide have adopted SLN mapping into their practice. However, as the results of the initial SLN studies were mostly based on low-grade tumors, adoption of the technique in high-grade tumors has been slower and more controversial. In this review, we discuss the most recent studies evaluating the SLN mapping in high-grade endometrial cancers. The results of these studies suggest that the SLN detection rate is acceptably high and the negative predictive value is sufficiently low to support the use of SLN mapping in high-grade endometrial tumors to replace complete lymphadenectomy. Validity of SLN mapping techniques does, however, require following a standard algorithm, and success depends also on surgeon expertise. Moreover, the impact of SLN mapping on overall survival in high-grade tumors requires future prospective randomized studies. Finally, a transition toward near-universal SLN mapping techniques for endometrial cancers could significantly impact on the adequacy of gynecologic oncology fellows' surgical training and competency in lymphadenectomy.

Status of the Sentinel Lymph Node in Patients with Endometrial Cancer Stage I-II.

Endometrial cancer (EC) is the most common gynecological cancer in developed countries. In literature, there are discordant data regarding the therapeutic value of systematic lymphadenectomy whereas the importance of lymph node status for determining prognosis and the need for adjuvant treatment is undoubted. Given the low risk of lymph node metastases in stage I-II of EC and the significant surgical and postoperative risks when performing a complete pelvic lymphadenectomy, the surgical approach in these patients is controversial, ranging from no nodal evaluation to comprehensive pelvic and aortic lymphadenectomy. The recent introduction of sentinel node detection represents the mid-way between the execution and omission of node dissection in EC patients. Indeed, the sentinel node mapping has rapidly emerged as an alternative to complete lymphadenectomy to reduce morbidity. In the present research, we discuss the role of sentinel node mapping in the surgical management of EC in early stage. Results of study on SLN in EC in early stages seem to be promising, but only a small series have been published so far.

Diagnostic accuracy of frozen section and patterns of nodal spread in high grade endometrial cancer: a secondary analysis of the SENTOR prospective cohort study

<h3>Objectives:</h3> Recent studies have shown that sentinel lymph node (SLN) biopsy accurately detects nodal metastases in patients with high-grade endometrial cancer (EC). SLN biopsy has the potential to replace complete lymphadenectomy for surgical staging in patients with high-grade EC, provided that an SLN algorithm is followed (side-specific pelvic and para-aortic lymphadenectomy for non-mapped hemipelves). The aim of this study was to define the accuracy of intraoperative frozen section for the detection of metastases in SLN biopsy and describe the pattern of lymph node (LN) spread in patients with high-grade EC. <h3>Methods:</h3> We performed a secondary analysis of clinicopathologic data from the SENTOR prospective cohort study evaluating SLN node biopsy at 3 designated cancer centres in Toronto, Canada (ClinicalTrials.gov ID: NCT01886066). Patients with clinical stage I high-grade EC (grade 3 endometrioid, serous, clear cell, carcinosarcoma, undifferentiated, or mixed tumors) undergoing laparoscopic or robotic primary hysterectomy were enrolled. The primary outcome was sensitivity of frozen section of the SLN specimen, compared to a standardized ultrastaging protocol. Secondary outcomes included the pattern and characteristics of LN spread. <h3>Results:</h3> There were 126 patients with high-grade EC with median age 66 years (range: 44-86) and median BMI 26.9 kg/m² (range: 17.6-49.3). Frozen section was performed on surgical specimens from 212 hemipelves; SLNs were identified in 202 specimens (95.7%) and fatty tissue alone was identified in 10 specimens (4.7%). Of the 202 hemipelves in which SLNs were identified, 24 were positive for metastatic disease. Frozen section correctly identified only 12, yielding a sensitivity of 50% (12/24, 95% CI 29.6-70.4) and negative predictive value of 94% (178/202, 95% CI 89-96.5). A total of 24 patients had LN metastases: 16 (13%) had isolated pelvic metastases, 7 (6%) had both pelvic and para-aortic metastases and 1 (0.8%) had an isolated para-aortic metastasis. All para-aortic metastases (n=8) occurred in non-sentinel LNs, among patients with serous (n=5), carcinosarcoma (n=2), and dedifferentiated (n=1) histology. One patient with isolated para-aortic metastases (carcinosarcoma, p53 abnormal) did not have a mapped SLN, but was identified by the SLN algorithm. Nodal metastases occurred in 10% of patients (3/30) with grade 3 endometrioid histology (all pelvic), compared to 33% of patients (15/46) with serous histology (10 pelvic alone, 5 pelvic and para-aortic). <h3>Conclusions:</h3> Intraoperative frozen section of SLNs in high-grade EC patients has poor sensitivity. However, frozen section may still be beneficial to confirm the presence of nodal tissue and ensure adherence to an SLN algorithm, including complete pelvic and para-aortic lymphadenectomy for non-mapped hemipelves. Because isolated para-aortic metastases are rare, para-aortic lymphadenectomy may be omitted in patients in which SLNs were successfully mapped to the pelvis.

Sentinel lymph node mapping in early-stage cervical cancer – A national prospective multicenter study (SENTIREC trial)

ObjectivesSentinel lymph node (SLN) mapping may replace staging radical pelvic lymphadenectomy in women with early-stage cervical cancer. In a national multicenter setting, we evaluated SLN mapping in women with early-stage cervical cancer and investigated the accuracy of SLN mapping and FDG-PET/CT in tumors >20 mm. MethodsWe prospectively included women with early-stage cervical cancer from March 2017–January 2021 to undergo SLN mapping. Women with tumors >20 mm underwent completion pelvic lymphadenectomy and removal of FDG-PET/CT positive nodes. We determined SLN detection rates, incidence of nodal disease, sensitivity and negative predictive value (NPV) of SLN mapping, and the sensitivity, specificity, NPV, and positive predictive value (PPV) of FDG-PET/CT. ResultsWe included 245 women, and 38 (15.5%) had nodal metastasis. The SLN detection rate was 96.3% (236/245), with 82.0% (201/245) bilateral detection. In a stratified analysis of 103 women with tumors >20 mm, 27 (26.2%) had nodal metastases. The sensitivity of SLN mapping adhering to the algorithm was 96.3% (95% CI 81.0–99.9%) and the NPV 98.7% (95% CI 93.0–100%). For FDG-PET/CT imaging the sensitivity was 14.8% (95% CI 4.2–33.7%), the specificity 85.5% (95% CI 75.6–92.5%), the NPV 73.9% (95% CI 63.4–82.7%), and the PPV 26.7% (95% CI 7.8–55.1%). ConclusionsSLN mapping seems to be an adequate staging procedure in early-stage cervical cancer tumors ≤20 mm. In tumors >20 mm, SLN mapping is highly sensitive but demands full adherence to the SLN algorithm. We recommend completion pelvic lymphadenectomy in tumors >20 mm until the oncological safety is established. FDG-PET/CT for nodal staging of women with early-stage cervical cancer seems limited.

An evolution in sentinel node mapping for cervical cancer.

The technique of sentinel lymph node (SLN) biopsy has emerged as an alternative to complete pelvic lymphadenectomy to establish lymph node status in early stage cervical cancers. Traditional lymph node stripping techniques are associated with high rates of patient morbidity, such as lymphedema. For the majority of patients who are free of lymph node metastases this morbidity seems unnecessary if an alternative technique can achieve the same accuracy.

Sentinel lymph node biopsy in endometrial cancer: state of the art.

Endometrial cancer (EC) is the most common gynecological neoplasm in developed countries. In literature, there are discordant data regarding the therapeutic value of systematic lymphadenectomy whereas the importance of lymph node status for determining prognosis and the need for adjuvant treatment is undoubted. Given the low risk of lymph-node metastases in the apparent early-stage disease and the significant surgical and postoperative risks when performing a complete pelvic lymphadenectomy, the surgical approach in these patients is controversial, ranging from no nodal evaluation to comprehensive pelvic and aortic lymphadenectomy. The recent introduction of sentinel node mapping represents the mid-way between the execution and omission of node dissection in EC patients. Indeed, the sentinel node mapping has rapidly emerged as an alternative to complete lymphadenectomy to reduce morbidity. In the present review, we discuss the role of sentinel node mapping in the surgical management of EC evaluating all aspects of this procedure.

The uterine pathological features associated with sentinel lymph node metastasis in endometrial carcinomas.

BackgroundIn recent years, sentinel lymph node excision and ultrastaging have been performed in endometrial carcinomas to obtain information about lymph node status, avoiding unnecessary complete pelvic and paraaortic lymphadenectomy. The purpose of this retrospective study was to provide a comprehensive evaluation of the pathological features of endometrial carcinomas and their significance in association with sentinel lymph node involvement.MethodsPatients with endometrial carcinomas, preceded by sentinel lymph node mapping, were classified into Group-I and Group-II with negative and positive involvement, respectively. The pathological features, associated with sentinel lymph node involvement, were statistically analyzed, including determination of test performance parameters.ResultsAmong 70 patients who had undergone hysterectomy and sentinel lymph node excision, 61 had carcinoma and 9 had atypical hyperplasia. There were 50 patients in Group-I and 10 in Group-II. In Group-II, the significant pathological features were: 1) lower uterine segment involvement (100%), 2) an average tumor size of ≥5 CM, 3) lymphovascular invasion (50%), 4) cervical stromal invasion (40%), and 5) depth of myometrial invasion of ≥50% (50%). The incidences of these pathological features were significantly less in Group-I. Statistical analyses singled out “lower uterine segment involvement” as the most important feature.ConclusionsWe have identified five pathological features which are associated with sentinel lymph node involvement. Since lower uterine segment involvement has occurred in all cases of the Group-II cohort, we recommend FIGO and other organizations that determine staging rules should consider whether tumors that involve the lower uterine segment should be staged as higher than “1a”, if the findings in this small series are confirmed by other studies. The results of this study may guide pathologists and oncologists in the diagnostic and therapeutic approaches to management of endometrial carcinomas.

Diffusion-weighted magnetic resonance imaging in evaluating malignant lymph node invasion in patients with female genital neoplasms

Background/Aim. Functional imaging, including diffusion-weighted magnetic resonance imaging (DWI MRI) and apparent diffusion coefficient (ADC) map, provides promising results in discrimination benign from malignant pelvic and inguinal lymph nodes in patients with gynecological malignancies. The aim of the study was to assess diagnostic performances of DWI in differentiation between benign and malignant pelvic and inguinal lymph nodes in patients with gynecological malignancies. Methods. The prospective clinical study was conducted at the Clinical Center of Vojvodina, Serbia, from 2013 to 2016, comprising 80 patients with malignant gynecological tumors. Preoperatively, all patients underwent MRI examination, followed by standard surgical treatment with complete pelvic and/or inguinal lymphadenectomy. A combination of ADC value criteria and size-based criteria yields MRI the following diagnostic performances in discrimination between benign and malignant lymph nodes: sensitivity 95%, specificity 92%, overall accuracy 92.5%, positive predictive value 46%, and negative predictive value 99.6%. Histopathological examination of surgically removed material and lymph nodes separated in pelvic and inguinal anatomic groups was performed after the surgery. Results. A total of 2,320 lymph nodes were mapped and histopathologically examined in 80 patients included in the study. Metastases in lymph nodes were histopathologically confirmed in 28 (35%) patients. Measured ADC values were significantly lower in metastatic (mean ? standard deviation (SD), ADC: 0.8725 ? 10-3 ? 0.0125 ? 10-3 mm2/s) than benign lymph nodes (mean ? SD, ADC: 1.116 ? 10-3 ? 0.1848 ? 10-3 mm2/s; p = 0.001). If ADC value of 0.860 ? 10-3 mm2/s was determined as a cut-off value for discrimination between benign and malignant lymph nodes, DWI sensitivity was 89%, specificity 85%, and overall accuracy was 86%, positive predictive values 30%, and negative predictive value 99%. Conclusion. DWI MRI sequence is a fast, simple, non-invasive method that aids significantly to MRI diagnostic performances in dis-crimination between benign and malignant pelvic and inguinal lymph nodes.

Does the Sentinel Lymph Node Sampling Alone Improve Quality of Life in Early Cervical Cancer Management?

Objective: In this subanalysis of the prospective randomized multicenter SENTICOL 2 study, we compared the quality of life (QoL), in two arms, in association with lower-limb consequences in women with early stage cervical cancer undergoing randomized sentinel lymph node (SLN) sampling alone or SLN sampling and full pelvic lymphadenectomy.Methods: 206 patients with an early stage cervical cancer and a negative SLN, were randomized. Every patient had a SLN detection based on a combination of radio-isotope (Nanocis®) and blue dye (Bleu Patenté®) injections. One hundred and One patients, the “standard” group, had complete pelvic lymphadenectomy, 105 patients, the “SLN alone” group, had SLN biopsy without lymphadenectomy. At each visit (V0: preoperative, V1: 1 month, V2: 3 months and V3: 6 months following surgery) the patients completed a Short Form Health Survey (SF36) questionnaire and another questionnaire related to leg lymphedema. SF36 scores variations (compared to the baseline values) were assessed with a standard analysis and by an evaluation of the area under the curve (AUC). Several lower-limb circumferences and signs were also determined.Results: General characteristics of the patients were well–balanced between groups. Physical function and general health dimensions of the SF36 scale were significantly improved at V1 and V2 in the “SLN alone” group. Mental health was also statistically better in the “SLN alone” group at V2. Other dimensions were similar. The two groups had similar evaluation at V3. AUC of SF36 sub-scores was also in favor of the “SLN alone” arm, but the difference was not statistically significant. The analysis about the lymphedema of the legs showed a reduced (but not significant) risk in the “SLN alone” group for the top-of-thigh and the mid-thigh perimeters. Lymphedema symptoms reported by the patients were significantly less severe in the “SLN alone” group.Conclusion: Our study demonstrates a trend for a better quality of life and less severe leg heaviness and leg fatigue when a full pelvic lymphadenectomy is avoided.

Safety and efficacy of neoadjuvant intravesical oncolytic MV-NIS in patients undergoing radical cystectomy (RC) for urothelial carcinoma but ineligible for neoadjuvant cisplatin-based chemotherapy.

TPS3172 Background: Bladder cancer is a leading cause of cancer death in the United States. Over 90% of bladder cancer cases are urothelial carcinomas (UC) that may present as a non-muscle-invasive (NMIBC) or muscle-invasive disease (MIBC). Standard of care for NMIBC includes transurethral resection of bladder tumor (TURBT), intravesical chemotherapy and immunotherapy with Bacillus Calmette-Guerin (BCG). Patients (pts) with high-grade BCG-refractory NMIBC or MIBC undergo RC, which involves complete bladder removal and pelvic lymphadenectomy. RC severely impacts quality of life with significant morbidity. Oncolytic viruses are showing promise in UC, and MV-NIS has proven efficacy in other tumor types. MV-NIS is an investigational oncolytic measles virus with an excellent safety profile, irrespective of route of administration (n &gt; 100). MV-NIS-related adverse events are limited to infusion reactions and transient CBC changes, and little local toxicity is anticipated with intravesical therapy. Clinical efficacy of this oncolytic may be related to absence of measles immunity. Based on this, the clinical strategy for MV-NIS is focused on targeting immune-privileged sites via intra-tumoral or intravesical routes, alone or in combination with checkpoint inhibitors. We hypothesize that intravesical therapy with oncolytic MV-NIS can improve clinical outcomes for (a) BCG refractory NMIBC pts to avoid or delay the need for RC; and (b) MIBC pts undergoing RC. Methods: This study is enrolling pts undergoing RC who are ineligible to receive neoadjuvant chemotherapy. The trial has 2 stages to (a) determine the safety and tolerability of intravesical MV-NIS, and (b) assess preliminary efficacy. Part (a) includes 4-24 pts in a timing cohort with doses administered at increasing durations (1-4 weeks) prior to RC to establish safety of a single MV-NIS dose. Part (b) includes an expansion cohort (n = 12) to evaluate the safety and efficacy of 2 intravesical doses of MV-NIS at 2-week intervals prior to RC. Safety is assessed using NCI-CTCAE V5 and Clavien-Dindo grading of operative complications. The efficacy endpoint is pathologic stage at time of RC (pT0 rate), which can be compared to pre-study TURBT stage. Additional exploratory studies include PK and PD analyses in urine, blood and tumor. Enrollment is ongoing at 2 Mayo Clinic sites (Rochester, MN and Jacksonville, FL) and the study has now progressed from the timing cohort into the expansion cohort. Clinical trial information: NCT03171493 .

Value of indocyanine green pelvic lymph node mapping in the surgical approach of cervical cancer.

Lymph node metastasis is a significant predictive factor for disease recurrence and survival in cervical cancer patients and relevant for therapeutic strategies. We evaluated the clinical value of indocyanine green (ICG) by measuring the sensitivity and negative predictive value of sentinel lymph node mapping compared with the gold standard of complete lymphadenectomy in detecting lymph node metastases for cervical cancer. We utilized the near-infrared imaging agent ICG to detect tumor-infested lymph nodes in the pelvis analogue to a classical sentinel lymph node procedure by analyzing data from 20 patients who had undergone surgery for cervical cancer at our institution. A laparoscopic lymph node mapping procedure by means of ICG, followed by a complete pelvic lymphadenectomy with or without paraaortic lymphadenectomy was done in all patients. Histological examination identified seven patients with tumor-positive pelvic nodes, whereas mapping with ICG identified only five of these patients. Detection rate of positive nodes by ICG mapping and false negative rate was 71.4% and 28.6%, respectively; bilateral detection rate was 83.3%. One of the two false negative patients additionally suffered from deep infiltrating endometriosis. Our results indicate that ICG can identify the relevant pelvic nodes independent of tumor size, provided bilateral detection is achieved and additional, related diseases are excluded. This trial is registered within the German Clinical Trial Register (DRKS-ID: DRKS00014692).

Cervical versus endometrial injection for sentinel lymph node detection in endometrial cancer: a randomized clinical trial

ObjectiveTo evaluate the relationship between pelvic/para-aortic sentinel lymph node status and two different injection sites of 99m-technetium (99mTc)-labeled phytate in patients with endometrial cancer.MethodsThis was a randomized controlled trial involving...

Does small volume metastatic lymph node disease affect long-term prognosis in early cervical cancer?

IntroductionAs sentinel lymph node biopsy is evolving to an accepted standard of care, clinicians are being faced with more frequent cases of small volume nodal metastatic disease. The objective of...

Sentinel lymph node biopsy in early stage endometrial cancer: a Turkish gynecologic oncology group study (TRSGO-SLN-001)

ObjectiveThe aim of this multicenter study was to evaluate the feasibility of sentinel lymph node (SLN) mapping in clinically uterine confined endometrial cancer.MethodsPatients who underwent primary surgery for endometrial cancer...

Robotic sentinel lymph node (SLN) mapping in endometrial cancer: SLN symmetry and implications of mapping failure

PurposeTo establish the bilateral pelvic concordance rate of the sentinel lymph node (SLN) and determine the likelihood of lymph node metastasis in cases of mapping failure.MethodsA database analysis was performed...