Sentinel Node Navigation Surgery Research Articles

Quality of Life and Nutritional Outcomes of Stomach-Preserving Surgery for Early Gastric Cancer: A Secondary Analysis of the SENORITA Randomized Clinical Trial.

The Sentinel Node Oriented Tailored Approach (SENORITA) randomized clinical trial evaluated quality of life (QoL) and nutritional outcomes between the laparoscopic sentinel node navigation surgery (LSNNS) and laparoscopic standard gastrectomy (LSG). However, there has been no report on the QoL and nutritional outcomes of patients who underwent stomach-preserving surgery among the LSNNS group. To compare long-term QoL and nutritional outcomes between patients who underwent stomach-preserving surgery and those who underwent standard gastrectomy and to identify factors associated with poor QoL outcomes in patients who underwent stomach-preserving surgery. This study is a secondary analysis of the SENORITA trial, a randomized clinical trial comparing LSNNS with LSG. Patients from 7 tertiary or general hospitals across the Republic of Korea were enrolled from March 2013 to December 2016, with follow-up through 5 years. Data were analyzed between August and September 2022. Among trial participants, patients who underwent actual laparoscopic standard gastrectomy in the LSG group and those who underwent stomach-preserving surgery in the LSNNS group were included. Patients who did not complete the baseline or any follow-up questionnaire were excluded. Stomach-preserving surgery vs standard gastrectomy. Overall European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC QLQ-C30) and stomach module (STO22) scores, body mass index, hemoglobin, protein, and albumin levels. A total of 194 and 257 patients who underwent stomach-preserving surgery and standard gastrectomy, respectively, were included in this study (mean [SD] age, 55.6 [10.6] years; 249 [55.2%] male). The stomach-preserving group had better QoL scores at 3 months postoperatively in terms of physical function (87.2 vs 83.9), dyspnea (5.9 vs 11.2), appetite loss (13.1 vs 19.4), dysphagia (8.0 vs 12.7), eating restriction (10.9 vs 18.2), anxiety (29.0 vs 35.2), taste change (7.4 vs 13.0), and body image (19.5 vs 27.2). At 1 year postoperatively, the stomach-preserving group had significantly higher body mass index (23.9 vs 22.1, calculated as weight in kilograms divided by height in meters squared) and hemoglobin (14.3 vs 13.3 g/dL), albumin (4.3 vs 4.25 g/dL), and protein (7.3 vs 7.1 g/dL) levels compared to the standard group. Multivariable analyses showed that tumor location (greater curvature, lower third) was favorably associated with global health status (β, 10.5; 95% CI, 3.2 to 17.8), reflux (β, -8.4; 95% CI, -14.7 to -2.1), and eating restriction (β, -5.7; 95% CI, -10.3 to -1.0) at 3 months postoperatively in the stomach-preserving group. Segmental resection was associated with risk of diarrhea (β, 40.6; 95% CI, 3.1 to 78.1) and eating restriction (β, 15.1; 95% CI, 1.1 to 29.1) at 3 years postoperatively. Stomach-preserving surgery after sentinel node evaluation was associated with better long-term QoL and nutritional outcomes than standard gastrectomy. These findings may help facilitate decision-making regarding treatment for patients with early-stage gastric cancer. ClinicalTrials.gov Identifier: NCT01804998.

Gastric Cancer Surgery: Balancing Oncological Efficacy against Postoperative Morbidity and Function Detriment.

Significant progress has been made in the surgical management of gastric cancer over the years, and previous discrepancies in surgical practice between different parts of the world have gradually lessened. A transition from the earlier period of progressively more extensive surgery to the current trend of a more tailored and evidence-based approach is clear. Prophylactic resection of adjacent anatomical structures or neighboring organs and extensive lymph node dissections that were once assumed to increase the chances of long-term survival are now performed selectively. Laparoscopic gastrectomy has been widely adopted and its indications have steadily expanded, from early cancers located in the distal part of the stomach, to locally advanced tumors where total gastrectomy is required. In parallel, function-preserving surgery has also evolved and now constitutes a valid option for early gastric cancer. Pylorus-preserving and proximal gastrectomy have improved the postoperative quality of life of patients, and sentinel node navigation surgery is being explored as the next step in the process of further refining the minimally invasive concept. Moreover, innovative techniques such as indocyanine green fluorescence imaging and robot-assisted gastrectomy are being introduced in clinical practice. These technologies hold promise for enhancing surgical precision, ultimately improving the oncological and functional outcomes.

Feasibility of intraoperative pathologic examination for sentinel lymph nodes during sentinel node navigation surgery in early gastric cancer: results of pathologic protocol for SENORITA trial.

During sentinel node navigation surgery in patients with gastric cancer, intraoperative pathologic examination of sentinel nodes is crucial in determining the extent of surgery. In this study, we evaluated the feasibility and accuracy of intraoperative pathologic protocols using data from a prospective, multicenter, randomized trial. A retrospective analysis was conducted using data from the SEntinel Node ORIented Tailored Approach trials from 2013 to 2016. All sentinel lymph nodes were evaluated during surgery with hematoxylin-eosin (HE) staining using a representative section at the largest plane for lymph nodes. For permanent histologic evaluation, sentinel basin nodes were stained with HE and cytokeratin immunohistochemistry in formalin-fixed, paraffin-embedded (FFPE) sections and examined with HE for three deeper-step sections at 200-μm intervals. The failure rate of identification by frozen section and the metastasis rate in non-sentinel basins were investigated. Of the 237 patients who underwent sentinel node basin dissection, 30 had lymph node metastases on permanent pathology. Thirteen patients had macrometastasis confirmed in frozen sections as well as FFPE sections (failure rate: 0%). Patients with negative sentinel nodes in frozen sections but micrometastasis in FFPE sections had no lymph node recurrence during the follow-up period (0%, 0/6). However, in cases with tumor-positive nodes in frozen sections, metastases in non-sentinel basins were detected in the paraffin blocks (8.3%, 2/24). The single-section HE staining method is sufficient for detecting macrometastasis via intraoperative pathological examination. If a negative frozen-section result is confirmed, sentinel basin dissection can be performed safely. Otherwise, standard surgery is required.

Sentinel Node Navigation Surgery for Early Gastric Cancer: A Narrative Review.

Early gastric cancer (EGC) refers to malignant tumor lesions that are limited to the mucosa and submucosa layers, regardless of the presence of lymph node metastasis. Typically, EGC has a low rate of perigastric lymph node metastasis, and long-term survival outcomes are good after radical surgical treatment. The primary objective of surgical treatment for EGC is to achieve functional preservation while ensuring a radical cure. Sentinel node navigation surgery (SNNS) is a surgical technique used in the treatment of EGC. This approach achieves functional preservation by limiting lymph node dissection and performing restrictive gastrectomy guided by intraoperative negative sentinel node (SN) biopsy. Despite the apparent improvement in the detection rate of SN with the emergence of various tracing dyes and laparoscopic fluorescence systems, the oncological safety of SNNS remains a controversial research topic. SNNS, as a true form of stomach preservation surgery that enhances the quality of life, has become a topic of interest in the EGC field. In recent years, scholars from Japan and South Korea have conducted extensive research on the feasibility and safety of SNNS in the treatment of EGC. This article aims to provide reference choices for surgeons treating EGC by reviewing relevant research on SNNS for EGC in recent years.

Clinical Efficacy of Laparoscopic Sentinel Node Navigation Surgery for Stomach Preservation in Patients With Early Gastric Cancer: 5-year Results of the SENORITA Trial.

This study aimed to compare laparoscopic standard gastrectomy (LSG) and laparoscopic sentinel node navigation surgery (LSNNS) for EGC in terms of 5-year long-term oncologic outcomes. The oncological safety of LSNNS for early gastric cancer (EGC) has not been confirmed. Three-year disease-free survival (DFS), which is the primary endpoint of the phase III multicenter randomized controlled clinical trial (SEntinel Node ORIented Tailored Approach [SENORITA] trial), did not show the non-inferiority of LSNNS relative to LSG. The SENORITA trial, a multicenter randomized clinical trial, was designed to show that LSNNS is non-inferior to LSG in terms of 3-year DFS. In the present study, we collected 5-year follow-up data from 527 patients recruited in the SENORITA trial as the full analysis set (FAS). Disease-free survival (DFS), overall survival (OS), disease-specific survival (DSS), and recurrence patterns were evaluated using the FAS of both LSG (n=269) and LSNNS (n=258). The 5-year DFS was not significantly different between the LSG and LSNNS groups (P=0.0561). During the 5-year follow-up, gastric cancer-related events, such as metachronous cancer, were more frequent in the LSNNS group than in the LSG group. However, ten recurrent cancers in the remnant stomach of both groups were curatively resected by additional gastrectomy and one by additional endoscopic resection. Two of the 198 patients who underwent local resection for stomach preservation based on the LSNNS results developed distant metastasis. However, there was no statistically significant difference in the 5-year OS and DSS (P=0.7403 and P=0.9586, respectively) between the two groups. The 5-year DFS, DSS and OS did not differ significantly between the two groups. Considering the benefits of LSNNS on postoperative quality of life, LSNNS could be recommended as an alternative treatment option for EGC.

Clinical outcomes of sentinel node navigation surgery in patients with preoperatively estimated stage IA endometrial cancer and evaluation of validity for continuing sentinel node navigation surgery based on dispersion of recurrence probability.

To evaluate the feasibility of the use and continuation of sentinel lymph node navigation surgery (SNNS) as an alternative to pelvic lymph node dissection (PLND) for patients with preoperatively estimated stage IA endometrial cancer. This retrospective study selected the electronic medical records of all patients who had received CT scans and MRI imaging before surgery from April 1, 2009 to March 31, 2021. Sentinel lymph nodes (SLNs) were detected by administrating 99mTc-phytate and/or indocyanine green into the cervix, and the clinical outcomes of the patients who underwent SNNS or PLND were evaluated. Furthermore, in case of nodal recurrence, a new procedure to determine whether the facility should continue with SNNS or not was developed that compares the maximum likelihood hypothesis and an alternative one based on recurrence rates. Among 137 patients, SLN biopsies with ultrastaging were performed on 91 patients. The SLN detection rate was 95.6%. Over a 59-month median observation period, no statistically significant differences were shown in overall survival, disease-specific survival and disease-free survival between the SNNS and PLND groups when introducing the propensity score method (p-values: 0.06, 0.153, and 0.625, respectively). Our procedure demonstrated that, in our department without recurrence up to the 65th attempt, it was possible to continue SNNS if a recurrence occurs at the 66th attempt. This study suggests the validity of SNNS as an alternative to PLND. Even in the absence of evidence from randomized controlled trials, we can confirm the validity of continuing SNNS using our procedure.

Progress in the treatment of early gastric cancer with Laparoscopic and endoscopic cooperative surgery

With the introduction of minimally invasive methods into the field of surgery, the concept of early gastric cancer (EGC) treating has gradually changed from the pursuit of standardized traditional surgical methods to precise, individualized, interdisciplinary collaborative management. Both endoscopic therapy and laparoscopic surgery have their limitations for early gastric cancer treatment. Meanwhile, Laparoscopic and endoscopic cooperative surgery (LECS) combines the advantages of endoscopy and laparoscopy to perform local gastric resection and regional lymph node dissection, providing a more effective surgical approach for radical resection of early gastric cancer. The application of LECS in the treatment of early gastric cancer has been increasing, from the initial laparoscopy-assisted endoscopic full-thickness resection to the evolvement of a variety of improved procedures such as combined laparoscopic and endoscopic approach for neoplasia with a non-exposure technique, non-exposed endoscopic wall-inversion surgery, and the possibility of combined (sentinel lymph node drainage area) regional lymph node dissection or sentinel lymph node navigation surgery, which expands the indications for endoscopic surgery and maximizes the preservation of normal gastric tissue structure and function while ensuring radical treatment, and will certainly become an important development direction in the treatment of early gastric cancer in the future.

A combined approach for individualized lymphadenectomy in gastric cancer patients.

Introduction: Gastric cancer ranks as the fifth most common cancer globally. The presence of lymph node metastasis is a significant prognostic factor influencing survival. Postoperative morbidity and nodal staging accuracy are heavily affected by the extent of lymph node dissection. Our study aimed to explore the potential integration of two contemporary methods, sentinel node navigation surgery (SNNS) and the Maruyama Computer Program (MCP), to improve the accuracy of nodal staging. Materials and methods: We conducted a prospective data collection involving patients with gastric adenocarcinoma from 2008 to 2018 at the Department of Surgery, University of Debrecen, Hungary. Data from 100 consecutive patients were collected. The primary and secondary endpoints included evaluating the rate of node-negative patients and the diagnostic accuracy of our combined approach. Results: Sentinel node mapping was successful in 97 out of 100 patients. We found that using the threshold value of the Maruyama Index (MI) ≥ 28, all metastatic stations of sentinel-node-negative patients could be identified. Our method achieved 100% sensitivity and negative predictive value, with a specificity of 60.42% (95% CI = 46.31%-72.98%). Discussion: The combined application of SNNS and MCP has proven to be an effective diagnostic technique in the synergistic approach for identifying metastasis-positive lymph node stations. Despite its limitations, this combination may assist clinicians in customizing lymphadenectomy for gastric cancer patients.

Long-term quality of life and nutritional results of stomach-preserving surgery after sentinel node evaluation in patients with early gastric cancer: A multicenter, randomized phase 3 trial (SENORITA).

4070 Background: In the SENORITA trial, laparoscopic sentinel node navigation surgery (LSNNS) showed no significant difference in overall and disease specific survivals compared with laparoscopic standard gastrectomy (LSG). Here, we present the effect of stomach preservation surgery on QoL and nutritional outcomes, and identify risk factors affecting QoL in stomach preservation surgery. Methods: SENORITA was a prospective multicenter randomized trial. Patients diagnosed with early gastric cancer of 3 cm or less were randomly allocated (1:1) to LSNNS or LSG. The primary endpoint was 3-year disease-free survival. This analysis focuses on long-term quality of life and nutritional outcomes of patients who finally underwent stomach-preservation surgery in the LSNNS group. QoL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and stomach module (STO22) at 3, 12, 24, and 36 months after surgery. Linear mixed model analyses were used to evaluate differences between treatment groups. This trial is registered with ClinicalTrials.gov, NCT01804998. Results: From March 2013 to March 2017, a total of 580 patients were randomly assigned in the SENROTA trial. Among them, 258 patients underwent sentinel node navigation surgery and 198 finally underwent stomach preservation surgery. QoL data was available in 194 patients and compared with those of 257 patients who underwent standard gastrectomy. The stomach-preservation group had better QoL in physical function, dyspnea, and appetite loss of C30 and dysphagia, pain, reflux symptoms, eating restriction, anxiety, taste change, body image, and total score of STO22. Regarding nutritional outcomes, body mass index, hemoglobin, protein, and albumin levels were significantly higher in the stomach-preservation group than in the gastrectomy group. In multivariate analyses, tumor location (greater curvature) was an independent favorable factor affecting global health status, reflux symptoms, eating restriction, and total score of STO22 at 3 months in the stomach-preservation group. Segmental resection was a risk factor for diarrhea and eating restriction at postoperative 3 year. Conclusions: The stomach-preservation surgery had better long-term QoL and nutritional outcomes compared with standard gastrectomy. These findings can help decision making about treatment for patients with early gastric cancer, especially or elderly or nutritionally high risk patients. Clinical trial information: NCT01804998 .

Phase II study on feasibility of sentinel lymph node biopsy for ycN0 patients treated with primary chemotherapy in cT1-3N1M0 breast cancer (SHARE study).

583 Background: Sentinel lymph node biopsy (SLNB)-guided axillary management is still debated for clinically node-positive breast cancer (BC) patients treated with neoadjuvant chemotherapy (NAC). Several phase II studies demonstrated high false-negative rates (FNR) in ycN0 BC, but precise diagnostic imaging for nodal involvement may reduce FNR. To explore ideal imaging and lymphatic mapping, the Japanese Society for Sentinel Node Navigation Surgery conducted a prospective non-randomized phase 2 study (SHARE study, UMIN000030558). Methods: Clinical T1-3N1M0 BC was eligible under multimodal imaging of breast ultrasound, CT and/or MR mammography. Nodal metastasis was histologically confirmed. Standard regimen for NAC was performed by physician’s choice. In case of ycN0 BC, SLNB was planned and lymphatic mapping depended on each institutional practice. The primary endpoint is FNR of SLNB and secondary endpoints are the identification rate and outcome of ycN0 BC patients at 2 years after surgery. Moreover, in cases of pN0(sn), pN0(i+)(sn) and pN1mi(sn), SLNB followed by lymph node sampling had been allowed instead of axillary lymph node dissection. Based on an estimated FNR of 5%, 224 patients were needed to give 80% power to reject the null hypothesis that the threshold of FNR is 15% with a one-sided type I error rate of 5%. Results: Between February 2018 and May 2021, 185 patients from 19 institutes were registered. After 27 ineligible cases of protocol deviation, non-ycN0 or withdrawal of SLNB were excluded, 158 ycN0 cases underwent SLNB and sentinel lymph nodes were detected in 153 cases. Among them, the median age was 52 years old. Clinical stage was IIA in 40 cases, IIB in 105 and IIIA in 8. Luminal subtype classified by ER, PR and HER2 expression was found in 60 cases, HER2 in 34, Luminal-HER2 in 35 and triple-negative in 24. Finally, 61 cases had positive nodes, which included 7 false-negative cases. FNR was 11.5% (90% confidence interval, 5.5% and 20.5%). The identification rate was 96.8% and the accuracy rate was 95.4%. Before NAC, multimodal imaging was performed in 148 cases (96.7%) and 1 nodal metastasis was detected in 62 cases (40.5%). When multimodal imaging, 1 nodal metastasis, multiple tracers, multiple sentinel lymph nodes were considered for subset analysis, the FNR was 12.1%, 9.1%, 11.1%, and 10.6%, respectively. If isolated tumor cells in lymph nodes had been defined as pathologically negative even after NAC, the FNR was 7.1%. Conclusions: Multimodal imaging could not improve FNR in ycN0 BC. However, SLNB-guided axillary management should be considered when one positive-node is clinically converted to ycN0 after NAC. We will report the outcome of ycN0 BC cases next year. Clinical trial information: UMIN000030558 .

Determining the precise extent of sentinel basins during laparoscopic gastrectomy for early gastric cancer

PurposeBy analyzing sentinel basin dissection (SBD) data from the SEntinel Node ORIented Tailored Approach (SENORITA) trial, we sought to determine the precise extent of the sentinel basin (SB) without a tracer.Materials and methodsThis study investigated SB length in patients (n = 25) who underwent laparoscopic SBD for early gastric cancer (EGC) in the SENORITA trial. SB length along the greater curvature (GC) and lesser curvature (LC) was measured intraoperatively before performing SBD.ResultsIn all 25 cases, along the LC of the stomach, the lengths of the SB were 3.7 cm [2.0–5.0] (median [min–max]) proximally and 3.0 cm [2.3–5.5] distally; along the GC side, the lengths of the SB were 6.8 cm [3.5–11.0] proximally and 7.0 cm [3.8–9.5] distally from the tumors. The SB length at the GC or LC side was not significantly different between subgroups categorized by tumor depth, size, and longitudinal location. When tumors were located at the anterior wall of the stomach, the length of the proximal SB (10.0 cm [9.0–11.0]) at the GC side was the longest. In cases with several sentinel lymph nodes (SLNs), the lengths of the SB at the GC side were significantly longer than those with fewer SLNs. However, the lengths of the SB were similar on the LC side regardless of the number of SLNs.ConclusionsThis pilot study had some limitations of a small number of enrolled patients, the lack of research on the specific station of SLNs, and the inaccurate indication for sentinel node navigation surgery (SNNS) without tracer. Nevertheless, the present study which reported the extents of SBs might be the first step towards simplifying procedures in laparoscopic SNNS for stomach preservation in EGC.

Efficacy and prognosis of robotic surgery with sentinel node navigation surgery in endometrial cancer.

This study aimed to validate the surgical and oncologic outcomes of robotic surgery with sentinel node navigation surgery (SNNS) in endometrial cancer. This study included 130 patients with endometrial cancer, who underwent robotic surgery, including hysterectomy, bilateral salpingo-oophorectomy, and pelvic SNNS at the Department of Obstetrics and Gynecology of Kagoshima University Hospital. Pelvic sentinel lymph nodes (SLNs) were identified using the uterine cervix 99m Technetium-labeled phytate and indocyanine green injections. Surgery-related and survival outcomes were also evaluated. The median operative and console times and volume of blood loss were 204 (range: 101-555) minutes, 152 (range: 70-453) minutes, and 20 (range: 2-620) mL, respectively. The bilateral and unilateral pelvic SLN detection rates were 90.0% (117/130) and 5.4% (7/130), respectively, and the identification rate (the rate at which at least one SLN could be identified on either side) was 95% (124/130). Lower extremity lymphedema occurred in only 1 patient (0.8%), and no pelvic lymphocele occurred. Recurrence occurred in 3 patients (2.3%), and the recurrence site was the abdominal cavity, with dissemination in 2 patients and vaginal stump in one. The 3-year recurrence-free survival and 3-year overall survival rates were 97.1% and 98.9%, respectively. Robotic surgery with SNNS for endometrial cancer showed a high SLN identification rate, low occurrence rates of lower extremity lymphedema and pelvic lymphocele, and excellent oncologic outcomes.

Recent Advances in Sentinel Node Navigation Surgery for Early Gastric Cancer

Maintaining the postoperative quality of life (QOL) while ensuring curability without overtreatment is important in the treatment of early gastric cancer. Postoperative QOL is anticipated to be maintained through minimally invasive function-preserving gastrectomy in early gastric cancer. The concept of the sentinel lymph node (SN) basin is essential to maintain the curability of early gastric cancer using minimally invasive function-preserving gastrectomy. However, additional resection after surgery is difficult to perform in gastric cancer. Thus, the SN basin theory is important. Recently, a multicenter randomized phase III trial in South Korea (SENORITA trial) proved that laparoscopic sentinel node navigation surgery (LSNNS) for stomach preservation results in better postoperative QOL compared with standard gastrectomy in patients with early gastric cancer. LSNNS contributes to patients' QOL based on the concept that curability is not impaired. A multicenter nonrandomized phase III trial is ongoing in Japan, and oncologic safety is expected to be demonstrated. LSNNS has been established as a treatment option for selected patients with early gastric cancer, and its application will become widespread in the future.

Stannous colloid mixed with indocyanine green as a tracer for sentinel lymph node navigation surgery

The combined use of a vital dye and radioactive colloid reportedly performs better in detecting sentinel lymph nodes (SLNs) for cancers than the use of either of them alone. However, especially for gastric cancer, two endoscopic procedures are required to administer these two tracers, which burdens the patients and practitioners. Here we propose the use of stannous colloid (SnC) mixed with indocyanine green (ICG) as a new mixed tracer (SnC–ICG); its characteristics were investigated in vivo and in vitro to estimate its usefulness for SLN navigation. The tracers were administered to rats and the accumulation of radioactivity and/or near-infrared fluorescence were evaluated in the regional lymph nodes (LNs) using single positron emission computed tomography and near-infrared fluorescence imaging, respectively. SnC–ICG showed significantly better clearance from the injection site and better migration to primary LNs than the single administration of SnC or ICG aqueous solution. SnC–ICG demonstrated a wide particle size variability, stabilized to 1200-nm upon the addition of albumin in vitro; These properties could contribute to its behavior in vivo. The use of SnC–ICG could contribute better performance to detect SLNs for gastric cancer with less burden on both patients and medical practitioners.

The Use of Indocyanine Green (ICG) and Near-Infrared (NIR) Fluorescence-Guided Imaging in Gastric Cancer Surgery: A Narrative Review.

Near-infrared fluorescence imaging with indocyanine green is an emerging technology gaining clinical relevance in the field of oncosurgery. In recent decades, it has also been applied in gastric cancer surgery, spreading among surgeons thanks to the diffusion of minimally invasive approaches and the related development of new optic tools. Its most relevant uses in gastric cancer surgery are sentinel node navigation surgery, lymph node mapping during lymphadenectomy, assessment of vascular anatomy, and assessment of anastomotic perfusion. There is still debate regarding the most effective application, but with relatively no collateral effects and without compromising the operative time, indocyanine green fluorescence imaging carved out a role for itself in gastric resections. This review aims to summarize the current indications and evidence for the use of this tool, including the relevant practical details such as dosages and times of administration.

Observational study of axilla treatment for breast cancer patients with 1 to 3 positive micrometastases or macrometastases in sentinel lymph nodes.

e12576 Background: From the results of ACOSOG Z0011, IBCSG23-01 and AMAROS trials, axilla surgery in node-positive breast cancer (BC) tends to be less invasive with sentinel node biopsy (SNB) followed by adjuvant therapy and regional node irradiation (RNI). However, optimized axilla treatment including SNB without RNI is still debated. The Japanese Society for Sentinel Node Navigation Surgery conducted a multi-institutional prospective cohort study to compare SNB with SNB followed by axillary lymph node dissection (ALND) in cases with positive-sentinel lymph nodes (SLN)(UMIN No. 000011782, Jpn J Clin Oncol, p.876-9, 2014). Methods: Female BC patients with cT1-3N0-1M0 were eligible. When 1 to 3 positive micrometastases or macrometastases in SLN were confirmed by histological or molecular diagnosis, SNB alone or additional ALND had been decided by physician’s discretion. Primary chemotherapy before or after SNB was acceptable for registration. Lymph node sampling was also allowed in the SNB group. Cases with bilateral BC, isolated tumor cells only in SLN, past history of invasive cancer within 5 years at the registration were ineligible. The primary endpoint was the 5-year recurrence rate of regional node (RN) in the SNB group. The secondary endpoint was overall survival (OS). We planned to collect 240 patients to reject that the 5-year recurrence rate of RN was more than 10% assuming the rate 5%. To compare the SNB group and ALND group, the propensity score matching (PSM) was performed. Matching variables were initial treatment, metastatic size and numbers of SLN, clinical stage, age, body mass index, menopausal status, family history, past history of invasive cancer, breast surgery. Results: Eight-hundred eighty cases had been registered between 2013 and 2016. In the 871 eligible cases, 308 cases were the SNB group. At the median follow-up of 6.3 years, 5-year recurrence rate of RN was 2.7% [95% confidence interval, 1.4% to 5.4%] and 5-year OS was 97.6% [94.9% to 98.8%]. After PSM, 209 cases were matched in the SNB and ALND group. Among them, 343 cases (82%) received operation at initial treatment. Partial and total mastectomy was performed in 225 (54%) and 193 cases (46%), respectively. One-positive SLN was recorded in 366 cases (88%), 2 in 48 (11%) and 3 in 4 (1%). Macrometastases and micrometastases in SLN were diagnosed in 271 (65%) and 147 cases (35%), respectively. Three-hundred seventy-six cases (90%) belonged to luminal-like subtype. RNI was underwent in 42 cases (20%) of the SNB group and 13 cases (6%) of the ALND group. Five-year recurrence rate of RN was 2.1% [0.8% to 5.5%] and 2.0% [0.8% to 5.3%] for the SNB and ALND group, respectively. Conclusions: Our series suggests that RNI is not necessary for regional control in cases with 1 to 3 positive SLN. In conclusion, SNB alone is acceptable in cases with fewer metastatic SLN. Clinical trial information: UMIN No. 000011782.

Clinical efficacy of laparoscopic sentinel node navigation surgery for early gastric cancer: Five-year results of SENORITA trial.

4050 Background: A phase III multicenter randomized controlled clinical trial (SEntinel Node ORIented Tailored Approach [SENORITA] trial) has been performed to confirm the oncologic safety of laparoscopic sentinel node navigation surgery (LSNNS) for early gastric cancer (EGC). The results did not show the non-inferiority of LSNNS relative to laparoscopic standard gastrectomy (LSG) in terms of 3-year disease-free survival (DFS), the primary endpoint of the SENORITA trial even though the improved quality of life (QOL) in the LSNNS group. However, the long-term oncologic outcomes of LSNNS have not been compared with conventional surgery. This study was planned to investigate the comparison of LSG and LSNNS for EGC in terms of 5 years survival. Methods: We collected 5-year follow-up data of 527 patients recruited in the SENORITA trial. The overall survival (OS), disease-free survival (DFS), and recurrence pattern were evaluated in full analysis sets of both LSG (n = 269) and LSNNS (n = 258). Results: The mean follow-up period was 58.5 and 57.7 months in LSNNS and LSG groups. There was no statistically significant difference in 5-year OS (p = 0.7403) and DFS (p = 0.0561) between LSG and LSNNS. In terms of DFS, additional five events in the LSG group and 7 in LSNNS occurred after a 3-year follow-up until 5-years. Primary site recurrence in 1 LSNNS, and metachronous gastric cancer occurred in one LSG and two in LSNNS were diagnosed from 3 to 5-year follow-up period. Other organ cancer developed in two vs. three and other deaths occurred in two v s. one in each group, respectively, from 3 to 5-year follow-up. Overall survival events were 6 in LSG and 7 in LSNNS, and disease-specific death events were two patients in both groups until five years. Conclusions: Although the SENORITA trial did not show non-inferiority of LSNNS in the primary endpoint, 3-year DFS relative to LSG, the 5-year DFS and OS did not reveal the statistical difference between the two groups. Considering the benefit of LSNNS regarding the postoperative QOL, LSNNS could be recommended as an alternative treatment option of LSG for EGC. Clinical trial information: NCT01804998.

Sentinel node navigation surgery in cervical cancer: a systematic review and metaanalysis.

Sentinel node navigation surgery (SNNS) is used in clinical practice for the treatment of cervical cancer. This study aimed to elucidate the appropriate sentinel lymph node (SLN) mapping method and assess the safety and benefits of SNNS. We searched the PubMed, Ichushi, and Cochrane Library databases for randomized controlled trials (RCT) and studies on SLN in cervical cancer from January 2012 to December 2020. Two authors independently assessed study quality and extracted data. We quantitatively analyzed the detection rate, sensitivity/specificity, and complications and reviewed information, including the survival data of SLN biopsy (SLNB) without pelvic lymphadenectomy (PLND). The detection rate of SLN mapping in the unilateral pelvis was median 95.7% and 100% and in the bilateral pelvis was median 80.4% and 90% for technetium-99m (Tc) with/without blue dye (Tc w/wo BD) and indocyanine green (ICG) alone, respectively. The sensitivity and specificity of each tracer were high; the area under the curve of each tracer was 0.988 (Tc w/wo BD), 0.931 (BD w/wo Tc), 0.966 (ICG), and 0.977 (carbon nanoparticle). Morbidities including lymphedema, neurological symptoms and blood loss were associated with PLND. One RCT and five studies all showed SNNS without systematic PLND does not impair recurrence or survival in early-stage cervical cancer with a tumor size ≤ 2-4cm. Both Tc w/wo BD and ICG are appropriate SLN tracers. SNNS can reduce the morbidities associated with PLND without affecting disease progression in early-stage cervical cancer.

190: ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) AND ROBOTIC SENTINEL NODE NAVIGATION SURGERY FOR EARLY GASTRIC CANCER: FIRST EXPERIENCE AND PRELIMINARY RESULTS

Abstract Background and aim Early gastric cancer (EGC) is defined as a cancer limited to mucosa (T1a) and submucosa (T1b). The 5-year survival rates are respectively 96% and 83% for T1a and T1b. Despite endoscopic submucosal dissection (ESD) is considered the standard treatment for EGC, literature reports a quite considerable rate of lymph-node metastasis (2% to 18%). Combined surgical-endoscopic treatment can achieve accurate resection of EGC, solving the problem of lymphadenectomy which cannot be performed endoscopically. Near infrared (NIR) fluorescence imaging with indocyanine green (ICG) was recently introduced for lymphatic mapping in several tumors. The aim of the study is to evaluate the feasibility and safety of ESD in combination with robotic ICG guided sentinel node navigation surgery (SNNS). Methods ICG was endoscopically injected intraoperatively into the submucosal layer around the tumor. Intraoperative NIR imaging with ICG was carried out with a near-infrared camera system built into the robotic platform. The first lymph node which had taken up ICG appeared as a green spot and was identified as the sentinel node (SN). SN was then sent for extemporaneous histopathological examination. When ICG fluorescence extended to the second nodal stations a ICG guided robotic basin lymphadenectomy was performed. Basin lymph nodes were sent for definitive histopathological analysis. If no tumoral cells were identified in the SN, an ESD with standard technique was conducted. If the SN pathological examination revealed tumoral cells, a robotic radical resection and D2 lymphadenectomy was completed. Results Seven ESDs with SNNS and basin lymphadenectomy basin were performed. No gastric perforations or other intraoperative complications were registered. Mean operative time was 148.6 minutes. All the procedures histologically resulted in complete excisions. No lymph nodes metastasis was demonstrated in either the SN or the basin lymph nodes. A mean of 12 lymph-nodes was collected. Mean hospitalization time was 2.8 days. Conclusion In our preliminary experience, combined ESD and SNNS could be recommended as a safe and effective treatment for EGC in patients with potential risk of LN metastasis or in patients with multiple comorbidity in order to avoid more invasive organ resections.

Laparoscopic sentinel node navigation surgery in gastric cancer to reduce surgical radicality

Laparoscopic sentinel node navigation surgery in gastric cancer to reduce surgical radicality