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1.
Cancer Med ; 13(9): e7248, 2024 May.
Article in English | MEDLINE | ID: mdl-38733197

ABSTRACT

BACKGROUND: Sentinel lymph node biopsy (SLNB) is a common choice for axillary surgery in patients with early-stage breast cancer (BC) who have clinically negative lymph nodes. Most research indicates that obesity is a prognostic factor for BC patients, but studies assessing its association with the rate of positive sentinel lymph nodes (SLN) and the prognosis of patients with early BC undergoing SLNB are limited. METHODS: Between 2013 and 2016, 7062 early-stage BC patients from the Shanghai Cancer Center of Fudan University were included. Based on the Chinese Body Mass Index (BMI) classification standards, the patients were divided into three groups as follows: normal weight, overweight, and obese. Propensity score matching analysis was used to balance the baseline characteristics of the participants. Logistic regression analysis was used to determine the association between obesity and positive SLN rate. Cox regression analysis was used to investigate whether obesity was an independent prognostic factor for early-stage BC patients who had undergone SLNB. RESULTS: No significant association was observed between obesity and positive SLN rate in early-stage BC patients who had undergone SLNB. However, multivariate analysis revealed that compared to patients with normal BMI, the overall survival (hazard ratio (HR) 2.240, 95% confidence interval (CI) 1.27-3.95, p = 0.005) and disease-free survival (HR 1.750, 95% CI 1.16-2.62, p = 0.007) were poorer in patients with high BMI. CONCLUSION: Obesity is an independent prognostic factor for early-stage BC patients who undergo SLNB; however, it does not affect the positive SLN rate.


Subject(s)
Body Mass Index , Breast Neoplasms , Obesity , Sentinel Lymph Node Biopsy , Humans , Female , Breast Neoplasms/pathology , Breast Neoplasms/mortality , Breast Neoplasms/surgery , Obesity/complications , Middle Aged , Retrospective Studies , Prognosis , Adult , Aged , Sentinel Lymph Node/pathology , Sentinel Lymph Node/surgery , Neoplasm Staging , Lymphatic Metastasis
2.
N Engl J Med ; 390(13): 1163-1175, 2024 Apr 04.
Article in English | MEDLINE | ID: mdl-38598571

ABSTRACT

BACKGROUND: Trials evaluating the omission of completion axillary-lymph-node dissection in patients with clinically node-negative breast cancer and sentinel-lymph-node metastases have been compromised by limited statistical power, uncertain nodal radiotherapy target volumes, and a scarcity of data on relevant clinical subgroups. METHODS: We conducted a noninferiority trial in which patients with clinically node-negative primary T1 to T3 breast cancer (tumor size, T1, ≤20 mm; T2, 21 to 50 mm; and T3, >50 mm in the largest dimension) with one or two sentinel-node macrometastases (metastasis size, >2 mm in the largest dimension) were randomly assigned in a 1:1 ratio to completion axillary-lymph-node dissection or its omission (sentinel-node biopsy only). Adjuvant treatment and radiation therapy were used in accordance with national guidelines. The primary end point was overall survival. We report here the per-protocol and modified intention-to-treat analyses of the prespecified secondary end point of recurrence-free survival. To show noninferiority of sentinel-node biopsy only, the upper boundary of the confidence interval for the hazard ratio for recurrence or death had to be below 1.44. RESULTS: Between January 2015 and December 2021, a total of 2766 patients were enrolled across five countries. The per-protocol population included 2540 patients, of whom 1335 were assigned to undergo sentinel-node biopsy only and 1205 to undergo completion axillary-lymph-node dissection (dissection group). Radiation therapy including nodal target volumes was administered to 1192 of 1326 patients (89.9%) in the sentinel-node biopsy-only group and to 1058 of 1197 (88.4%) in the dissection group. The median follow-up was 46.8 months (range, 1.5 to 94.5). Overall, 191 patients had recurrence or died. The estimated 5-year recurrence-free survival was 89.7% (95% confidence interval [CI], 87.5 to 91.9) in the sentinel-node biopsy-only group and 88.7% (95% CI, 86.3 to 91.1) in the dissection group, with a country-adjusted hazard ratio for recurrence or death of 0.89 (95% CI, 0.66 to 1.19), which was significantly (P<0.001) below the prespecified noninferiority margin. CONCLUSIONS: The omission of completion axillary-lymph-node dissection was noninferior to the more extensive surgery in patients with clinically node-negative breast cancer who had sentinel-node macrometastases, most of whom received nodal radiation therapy. (Funded by the Swedish Research Council and others; SENOMAC ClinicalTrials.gov number, NCT02240472.).


Subject(s)
Breast Neoplasms , Lymph Node Excision , Lymphadenopathy , Sentinel Lymph Node Biopsy , Sentinel Lymph Node , Female , Humans , Axilla , Breast Neoplasms/mortality , Breast Neoplasms/pathology , Breast Neoplasms/secondary , Breast Neoplasms/therapy , Disease-Free Survival , Lymph Node Excision/methods , Lymph Nodes/pathology , Lymph Nodes/surgery , Lymphadenopathy/pathology , Lymphadenopathy/radiotherapy , Lymphadenopathy/surgery , Sentinel Lymph Node/pathology , Sentinel Lymph Node/surgery , Combined Modality Therapy , Follow-Up Studies
3.
Anticancer Res ; 44(5): 2021-2030, 2024 May.
Article in English | MEDLINE | ID: mdl-38677765

ABSTRACT

BACKGROUND/AIM: In the context of surgical de-escalation in early breast cancer (EBC), this study aimed to evaluate the contrast enhancement ultrasound (CEUS) sentinel lymph node (SLN) procedure as a non-invasive axillary staging procedure in EBC in comparison with standard SLN biopsy (SLNB). PATIENTS AND METHODS: A subanalysis of the AX-CES study, a prospective single-arm, monocentric phase 3 study was performed (EudraCT: 2020-000393-20). The study included patients with EBC undergoing upfront surgery and SLN resection, with no prior history of locoregional treatment, and weighing between 40-85 kg. All patients underwent the CEUS SLN procedure as a non-invasive axillary staging procedure, with CEUS SLN accumulation marked using blue dye. After the CEUS SLN procedure, all patients underwent the standard mapping procedure. Data on success rate, systemic reactions, mean procedure time, mean surgical procedure, mean procedure without axillary staging, CEUS SLN appearance (normal/pathological), SLN number, and concordance with standard mapping procedure were collected. RESULTS: After the CEUS SLN procedure, 29 LNs among 16 patients were identified and marked. In all cases, CEUS SLN revealed at least one LN enhancement. Six (37.50%) LNs were defined as pathological after the CEUS SLN procedure. Definitive staining of CEUS SLN pathology revealed metastatic involvement in four (66.67%) of the cases. Two SLNs were identified during the CEUS SLN procedure; however, owing to the low disease burden, no change in the surgical plan was reported. CONCLUSION: The CEUS SLN procedure shows promise as a technique for non-invasive assessment of the axilla, potentially enabling safe axillary de-escalation in EBC by estimating the axillary disease burden.


Subject(s)
Axilla , Breast Neoplasms , Contrast Media , Neoplasm Staging , Sentinel Lymph Node Biopsy , Sulfur Hexafluoride , Humans , Breast Neoplasms/pathology , Breast Neoplasms/diagnostic imaging , Breast Neoplasms/surgery , Female , Contrast Media/administration & dosage , Middle Aged , Aged , Prospective Studies , Sentinel Lymph Node Biopsy/methods , Sulfur Hexafluoride/administration & dosage , Ultrasonography/methods , Microbubbles , Lymphatic Metastasis/diagnostic imaging , Sentinel Lymph Node/pathology , Sentinel Lymph Node/diagnostic imaging , Sentinel Lymph Node/surgery , Adult
4.
World J Surg Oncol ; 22(1): 100, 2024 Apr 17.
Article in English | MEDLINE | ID: mdl-38627759

ABSTRACT

BACKGROUND: Some studies have suggested that axillary lymph node dissection (ALND) can be avoided in women with cN0 breast cancer with 1-2 positive sentinel nodes (SLNs). However, these studies included only a few patients with invasive lobular carcinoma (ILC), so the validity of omitting ALDN in these patients remains controversial. This study compared the frequency of non-sentinel lymph nodes (non-SLNs) metastases in ILC and invasive ductal carcinoma (IDC). MATERIALS METHODS: Data relating to a total of 2583 patients with infiltrating breast carcinoma operated at our institution between 2012 and 2023 were retrospectively analyzed: 2242 (86.8%) with IDC and 341 (13.2%) with ILC. We compared the incidence of metastasis to SLNs and non-SLNs between the ILC and IDC cohorts and examined factors that influenced non-SLNs metastasis. RESULTS: SLN biopsies were performed in 315 patients with ILC and 2018 patients with IDC. Metastases to the SLNs were found in 78/315 (24.8%) patients with ILC and in 460 (22.8%) patients with IDC (p = 0.31). The incidence of metastases to non-SLNs was significantly higher (p = 0.02) in ILC (52/78-66.7%) compared to IDC (207/460 - 45%). Multivariate analysis showed that ILC was the most influential predictive factor in predicting the presence of metastasis to non-SLNs. CONCLUSIONS: ILC cases have more non-SLNs metastases than IDC cases in SLN-positive patients. The ILC is essential for predicting non-SLN positivity in macro-metastases in the SLN. The option of omitting ALND in patients with ILC with 1-2 positive SLNs still requires further investigation.


Subject(s)
Breast Neoplasms , Carcinoma, Ductal, Breast , Carcinoma, Lobular , Sentinel Lymph Node , Humans , Female , Sentinel Lymph Node Biopsy , Lymphatic Metastasis/pathology , Carcinoma, Lobular/pathology , Retrospective Studies , Carcinoma, Ductal, Breast/pathology , Breast Neoplasms/surgery , Breast Neoplasms/pathology , Sentinel Lymph Node/surgery , Sentinel Lymph Node/pathology , Lymph Node Excision , Lymph Nodes/pathology , Axilla/pathology
5.
Asian Pac J Cancer Prev ; 25(4): 1113-1119, 2024 Apr 01.
Article in English | MEDLINE | ID: mdl-38679970

ABSTRACT

BACKGROUND: Sentinel lymph node (SLN) is the first lymph node to drain the lymph from a particular region involved by cancer. The commonly performed intraoperative methods for SLN evaluation are touch imprint cytology (TIC) and frozen section (FS). The present study aimed to determine the sensitivity, specificity and accuracy of TIC and FS with histopathological diagnosis as gold standard. MATERIALS AND METHODS: The nodes were bissected along their long axis and wet surface was imprinted on to clean glass slides followed by toluidine blue and rapid Papanicolaou staining. Subsequently the lymph node slices were cut at three levels using the cryostat machine and stained with Hematoxylin and eosin stain. The cytological and FS findings were compared and the specificity, sensitivity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) of TIC and FS was evaluated taking histopathological diagnosis as gold standard. In addition, pooled sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy for touch imprint cytology and frozen section were assessed for the studies included in the meta-analysis. RESULTS: The specificity, sensitivity, diagnostic accuracy, positive predictive value and negative predictive value of touch imprint cytology were 100%, 88.2%, 90%, 100% and 60% respectively. The specificity, sensitivity, diagnostic accuracy, PPV and NPV of frozen section were 100%, 94.1%, 95%, 100% and 75% respectively. The sensitivity of TIC and FS for detection of micrometastasis was 60% and 80% respectively. The pooled sensitivity and specificity for touch imprint cytology were 85.24% (95% CI, 83.46%-86.90%), and 98.99% (95% CI, 98.69%-99.23%) respectively. The pooled sensitivity and specificity for frozen section examination were 90.45% (95% CI, 85.15%-94.34%), and 100% (95% CI, 99.24%-100%) respectively. CONCLUSION: Even though the sensitivity of FS was better than imprint cytology in detection of micrometastasis, TIC is a rapid inexpensive technique which can be utilized in remote areas in absence of cryostat machine. The sensitivity of the two techniques with respect to detection of macrometastasis was comparable. This meta-analysis highlights the accuracy of the touch imprint cytology and frozen section examination in the intra-operative detection of malignancy in breast cancer.


Subject(s)
Breast Neoplasms , Frozen Sections , Sentinel Lymph Node Biopsy , Sentinel Lymph Node , Humans , Frozen Sections/methods , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Female , Sentinel Lymph Node/pathology , Sentinel Lymph Node/surgery , Sentinel Lymph Node Biopsy/methods , Cytodiagnosis/methods , Prognosis , Lymphatic Metastasis/pathology , Lymphatic Metastasis/diagnosis , Sensitivity and Specificity , Intraoperative Period , Cytology
6.
Sci Rep ; 14(1): 9596, 2024 04 26.
Article in English | MEDLINE | ID: mdl-38671007

ABSTRACT

We aimed to analyze the risk factors and construct a new nomogram to predict non-sentinel lymph node (NSLN) metastasis for cT1-2 breast cancer patients with positivity after sentinel lymph node biopsy (SLNB). A total of 830 breast cancer patients who underwent surgery between 2016 and 2021 at multi-center were included in the retrospective analysis. Patients were divided into training (n = 410), internal validation (n = 298), and external validation cohorts (n = 122) based on periods and centers. A nomogram-based prediction model for the risk of NSLN metastasis was constructed by incorporating independent predictors of NSLN metastasis identified through univariate and multivariate logistic regression analyses in the training cohort and then validated by validation cohorts. The multivariate logistic regression analysis revealed that the number of positive sentinel lymph nodes (SLNs) (P < 0.001), the proportion of positive SLNs (P = 0.029), lymph-vascular invasion (P = 0.029), perineural invasion (P = 0.023), and estrogen receptor (ER) status (P = 0.034) were independent risk factors for NSLN metastasis. The area under the receiver operating characteristics curve (AUC) value of this model was 0.730 (95% CI 0.676-0.785) for the training, 0.701 (95% CI 0.630-0.773) for internal validation, and 0.813 (95% CI 0.734-0.891) for external validation cohorts. Decision curve analysis also showed that the model could be effectively applied in clinical practice. The proposed nomogram estimated the likelihood of positive NSLNs and assisted the surgeon in deciding whether to perform further axillary lymph node dissection (ALND) and avoid non-essential ALND as well as postoperative complications.


Subject(s)
Breast Neoplasms , Lymphatic Metastasis , Nomograms , Sentinel Lymph Node Biopsy , Sentinel Lymph Node , Humans , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Female , Lymphatic Metastasis/pathology , Middle Aged , Sentinel Lymph Node Biopsy/methods , Sentinel Lymph Node/pathology , Sentinel Lymph Node/surgery , Retrospective Studies , Aged , Adult , Risk Factors , ROC Curve , Lymph Nodes/pathology , Lymph Nodes/surgery
7.
J Cardiothorac Surg ; 19(1): 145, 2024 Mar 19.
Article in English | MEDLINE | ID: mdl-38504315

ABSTRACT

BACKGROUND: Mapping of the pulmonary lymphatic system by near-infrared (NIR) fluorescence imaging might not always identify the first lymph node relay. The aim of this study was to determine the clinicopathologic factors allowing the identification of sentinel lymph nodes (SLNs) by NIR fluorescence imaging in thoracic surgery for non-small-cell lung cancer (NSCLC). METHODS: We conducted a retrospective review of 92 patients treated for suspected or confirmed cN0 lung cancer with curative intent who underwent an intraoperative injection of indocyanine green (ICG) either by direct peritumoral injection or by endobronchial injection using electromagnetic navigational bronchoscopy (ENB). After exclusion of patients for technical failure, benign disease and metastasis, we analyzed the clinicopathologic findings of 65 patients treated for localized-stage NSCLC, comparing the group with identification of SLNs (SLN-positive group) with the group without identification of SLNs (SLN-negative group). RESULTS: Forty-eight patients (73.8%) were SLN-positive. Patients with SLN positivity were more frequently female (50%) than the SLN-negative patients were (11.8%) (p = 0.006). The mean value of diffusing capacity for carbon monoxide (DLCO) was lower among the patients in the SLN-negative group (64.7% ± 16.7%) than the SLN-positive group (77.6% ± 17.2%, p < 0.01). The ratio of forced expiratory volume in one second to forced vital capacity (FEV1/FCV) was higher in the SLN-positive group (69.0% vs. 60.8%, p = 0.02). Patients who were SLN-negative were characterized by a severe degree of emphysema (p = 0.003). There was no significant difference in pathologic characteristics. On univariate analyses, age, female sex, DLCO, FEV1/FVC, degree of emphysema, and tumor size were significantly associated with SLN detection. On multivariate analysis, DLCO > 75% (HR = 4.92, 95% CI: 1.27-24.7; p = 0.03) and female sex (HR = 5.55, 95% CI: 1.25-39.33; p = 0.04) were independently associated with SLN detection. CONCLUSIONS: At a time of resurgence in the use of the sentinel lymph node mapping technique in the field of thoracic surgery, this study enabled us to identify, using multivariate analysis, two predictive factors for success: DLCO > 75% and female sex. Larger datasets are needed to confirm our results.


Subject(s)
Carcinoma, Non-Small-Cell Lung , Emphysema , Lung Neoplasms , Sentinel Lymph Node , Humans , Female , Sentinel Lymph Node/diagnostic imaging , Sentinel Lymph Node/pathology , Sentinel Lymph Node/surgery , Carcinoma, Non-Small-Cell Lung/pathology , Sentinel Lymph Node Biopsy/methods , Lymphatic Metastasis/pathology , Lung Neoplasms/surgery , Lung Neoplasms/pathology , Spectroscopy, Near-Infrared/methods , Lymph Nodes/pathology , Emphysema/pathology , Emphysema/surgery
8.
Lancet Oncol ; 25(4): 509-517, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38547894

ABSTRACT

BACKGROUND: The introduction of adjuvant systemic treatment for patients with high-risk melanomas necessitates accurate staging of disease. However, inconsistencies in outcomes exist between disease stages as defined by the American Joint Committee on Cancer (8th edition). We aimed to develop a tool to predict patient-specific outcomes in people with melanoma rather than grouping patients according to disease stage. METHODS: Patients older than 13 years with confirmed primary melanoma who underwent sentinel lymph node biopsy (SLNB) between Oct 29, 1997, and Nov 11, 2013, at four European melanoma centres (based in Berlin, Germany; Amsterdam and Rotterdam, the Netherlands; and Warsaw, Poland) were included in the development cohort. Potential predictors of recurrence-free and melanoma-specific survival assessed were sex, age, presence of ulceration, primary tumour location, histological subtype, Breslow thickness, sentinel node status, number of sentinel nodes removed, maximum diameter of the largest sentinel node metastasis, and Dewar classification. A prognostic model and nomogram were developed to predict 5-year recurrence-free survival on a continuous scale in patients with stage pT1b or higher melanomas. This model was also calibrated to predict melanoma-specific survival. Model performance was assessed by discrimination (area under the time-dependent receiver operating characteristics curve [AUC]) and calibration. External validation was done in a cohort of patients with primary melanomas who underwent SLNB between Jan 30, 1997, and Dec 12, 2013, at the Melanoma Institute Australia (Sydney, NSW, Australia). FINDINGS: The development cohort consisted of 4071 patients, of whom 2075 (51%) were female and 1996 (49%) were male. 889 (22%) had sentinel node-positive disease and 3182 (78%) had sentinel node-negative disease. The validation cohort comprised 4822 patients, of whom 1965 (41%) were female and 2857 (59%) were male. 891 (18%) had sentinel node-positive disease and 3931 (82%) had sentinel node-negative disease. Median follow-up was 4·8 years (IQR 2·3-7·8) in the development cohort and 5·0 years (2·2-8·9) in the validation cohort. In the development cohort, 5-year recurrence-free survival was 73·5% (95% CI 72·0-75·1) and 5-year melanoma-specific survival was 86·5% (85·3-87·8). In the validation cohort, the corresponding estimates were 66·1% (64·6-67·7) and 83·3% (82·0-84·6), respectively. The final model contained six prognostic factors: sentinel node status, Breslow thickness, presence of ulceration, age at SLNB, primary tumour location, and maximum diameter of the largest sentinel node metastasis. In the development cohort, for the model's prediction of recurrence-free survival, the AUC was 0·80 (95% CI 0·78-0·81); for prediction of melanoma-specific survival, the AUC was 0·81 (0·79-0·84). External validation showed good calibration for both outcomes, with AUCs of 0·73 (0·71-0·75) and 0·76 (0·74-0·78), respectively. INTERPRETATION: Our prediction model and nomogram accurately predicted patient-specific risk probabilities for 5-year recurrence-free and melanoma-specific survival. These tools could have important implications for clinical decision making when considering adjuvant treatments in patients with high-risk melanomas. FUNDING: Erasmus Medical Centre Cancer Institute.


Subject(s)
Lymphadenopathy , Melanoma , Sentinel Lymph Node , Skin Neoplasms , Humans , Male , Female , Melanoma/pathology , Sentinel Lymph Node Biopsy , Skin Neoplasms/pathology , Retrospective Studies , Lymphatic Metastasis , Sentinel Lymph Node/surgery , Sentinel Lymph Node/pathology , Prognosis , Lymphadenopathy/pathology
12.
Int J Gynecol Cancer ; 34(5): 689-696, 2024 May 06.
Article in English | MEDLINE | ID: mdl-38514100

ABSTRACT

OBJECTIVE: Ultrastaging is accurate in detecting nodal metastases, but increases costs and may not be necessary in certain low-risk subgroups. In this study we examined the risk of nodal involvement detected by sentinel lymph node (SLN) biopsy in a large population of apparent early-stage endometrial cancer and stratified by histopathologic characteristics. Furthermore, we aimed to identify a subgroup in which ultrastaging may be omitted. METHODS: We retrospectively included patients who underwent SLN (with bilateral mapping and no empty nodal packets on final pathology) ± systematic lymphadenectomy for apparent early-stage endometrial cancer at two referral cancer centers. Lymph node status was determined by SLN only, regardless of non-SLN findings. The incidence of macrometastasis, micrometastasis, and isolated tumor cells (ITC) was measured in the overall population and after stratification by histotype (endometrioid vs serous), myometrial invasion (none, <50%, ≥50%), and grade (G1, G2, G3). RESULTS: Bilateral SLN mapping was accomplished in 1570 patients: 1359 endometrioid and 211 non-endometrioid, of which 117 were serous. The incidence of macrometastasis, micrometastasis, and ITC was 3.8%, 3.4%, and 4.8%, respectively. In patients with endometrioid histology (n=1359) there were 2.9% macrometastases, 3.2% micrometastases, and 5.3% ITC. No macro/micrometastases and only one ITC were found in a subset of 274 patients with low-grade (G1-G2) endometrioid endometrial cancer without myometrial invasion (all <1%). The incidence of micro/macrometastasis was higher, 2.8%, in 708 patients with low-grade endometrioid endometrial cancer invading <50% of the myometrium. In patients with serous histology (n=117), the incidence of macrometastases, micrometastasis, and ITC was 11.1%, 6.0%, and 1.7%, respectively. For serous carcinoma without myometrial invasion (n=36), two patients had micrometastases for an incidence of 5.6%. CONCLUSIONS: Ultrastaging may be safely omitted in patients with low-grade endometrioid endometrial cancer without myometrial invasion. No other subgroups with a risk of nodal metastasis of less than 1% have been identified.


Subject(s)
Endometrial Neoplasms , Lymphatic Metastasis , Neoplasm Staging , Sentinel Lymph Node Biopsy , Sentinel Lymph Node , Humans , Female , Endometrial Neoplasms/pathology , Endometrial Neoplasms/surgery , Endometrial Neoplasms/epidemiology , Retrospective Studies , Middle Aged , Aged , Incidence , Sentinel Lymph Node/pathology , Sentinel Lymph Node/surgery , Adult , Aged, 80 and over , Neoplasm Micrometastasis/pathology
13.
Br J Surg ; 111(2)2024 Jan 31.
Article in English | MEDLINE | ID: mdl-38325801

ABSTRACT

BACKGROUND: Superparamagnetic iron nanoparticles perform comparably to radioisotope ± blue dye for sentinel lymph node detection in breast cancer, even when injected up to 8 weeks before surgery. Using superparamagnetic iron nanoparticles for sentinel lymph node detection after primary systemic therapy, and the maximum time frame of superparamagnetic iron nanoparticle administration have not been investigated. METHODS: This cohort study included cN0/1-to-ycN0 patients undergoing sentinel lymph node detection or targeted axillary dissection. All patients received superparamagnetic iron nanoparticles either before primary systemic therapy or before surgery, and radioisotope on the day of surgery. RESULTS: For 113 patients analysed, superparamagnetic iron nanoparticles were injected a median of 3 (range 0-248) days before surgery, with a 97.4% detection rate compared with 91.2% for radioisotope (P = 0.057). Concordance for radioisotope was 97.1% and this was not affected by timing of superparamagnetic iron nanoparticle injection (Kendall's tau 0.027; P = 0.746). The median sentinel lymph node yield was 3 (interquartile range (i.q.r.) 2-3) for superparamagnetic iron nanoparticles and 2 (i.q.r. 2-3) for radioisotope (P < 0.001). In targeted axillary dissection, detection was 100% for superparamagnetic iron nanoparticles and 81.8% for radioisotope (P = 0.124). The index node was magnetic in 93.9% and radioactive in 66.7% (P = 0.007), an outcome that was not affected by any factors. For patients with metastases, superparamagnetic iron nanoparticle detection was 100% and radioisotope-based detection was 84.2% (P = 0.083), with superparamagnetic iron nanoparticles detecting more metastatic sentinel lymph nodes (median of 1 (i.q.r. 1-2) for superparamagnetic iron nanoparticles compared with a median of 1 (i.q.r. 0-1) for radioisotope; P = 0.005). CONCLUSION: Injection before primary systemic therapy is feasible and does not affect concordance with radioisotope. Superparamagnetic iron nanoparticles perform comparably to radioisotope, but detect more sentinel lymph nodes and have a higher rate of detection of metastatic sentinel lymph nodes.


Subject(s)
Breast Neoplasms , Sentinel Lymph Node , Humans , Female , Breast Neoplasms/surgery , Breast Neoplasms/pathology , Sentinel Lymph Node Biopsy , Cohort Studies , Sentinel Lymph Node/diagnostic imaging , Sentinel Lymph Node/surgery , Sentinel Lymph Node/pathology , Radioisotopes , Lymph Nodes/diagnostic imaging , Lymph Nodes/pathology , Axilla/pathology
14.
Gynecol Oncol ; 182: 179-187, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38335900

ABSTRACT

INTRODUCTION: It is unclear if sentinel node (SLN) mapping can replace pelvic- (PLD) and paraaortic lymphadenectomy (PALD) for high-risk endometrial cancer (EC). A diagnostically safe surgical algorithm, taking failed mapping cases into account, is not defined. We aimed to investigate the diagnostic accuracy of SLN mapping algorithms in women with exclusively high-risk EC. METHODS: We undertook a prospective national diagnostic cohort study of SLN mapping in women with high-risk EC from March 2017 to January 2023. The power calculation was based on the negative predictive value (NPV). Women underwent SLN mapping, PLD and PALD besides removal of suspicious and any FDG/PET-positive lymph nodes. Accuracy analyses were performed for five algorithms. RESULTS: 170/216 included women underwent SLN mapping, PLD and PALD and were included in accuracy analyses. 42/170 (24.7%) had nodal metastasis. The algorithm SLN and PLD in case of failed mapping, demonstrated a sensitivity of 86% (95% CI 74-100) and an NPV of 96% (95% CI 91-100). The sensitivity increased to 93% (95% CI 83-100) and the NPV to 98% (95% CI 94-100) if PLD was combined with removal of any PET-positive lymph nodes. Equivalent results were obtained if PLD and PALD were performed in non-mapping cases; sensitivity 93% (95% CI 83-100) and NPV 98% (95% CI 95-100). CONCLUSION: SLN-mapping is a safe staging procedure in women with high-risk EC if strictly adhering to a surgical algorithm including removal of any PET-positive lymph nodes independent of location and PLD or PLD and PALD in case of failed mapping.


Subject(s)
Endometrial Neoplasms , Endometriosis , Sentinel Lymph Node , Female , Humans , Sentinel Lymph Node Biopsy/methods , Sentinel Lymph Node/diagnostic imaging , Sentinel Lymph Node/surgery , Sentinel Lymph Node/pathology , Prospective Studies , Cohort Studies , Endometrial Neoplasms/diagnostic imaging , Endometrial Neoplasms/surgery , Lymph Node Excision/methods , Endometriosis/surgery , Algorithms , Lymph Nodes/diagnostic imaging , Lymph Nodes/surgery , Lymph Nodes/pathology , Neoplasm Staging
15.
ACS Sens ; 9(3): 1339-1348, 2024 Mar 22.
Article in English | MEDLINE | ID: mdl-38382082

ABSTRACT

Accurately determining the metastatic status of sentinel lymph nodes (SLNs) through noninvasive imaging with high imaging resolution and sensitivity is crucial for cancer therapy. Herein, we report a dual-tracer-based NIR-II ratiometric fluorescence nanoplatform combining targeted and nontargeted moieties to determine the metastatic status of SLNs through the recording of ratio signals. Ratiometric fluorescence imaging revealed approximately 2-fold increases in signals in tumor-draining SLNs compared to inflamed and normal SLNs. Additionally, inflamed SLNs were diagnosed by combining the ratio value with the enlarged size outputted by NIR-II fluorescence imaging. The metastatic status diagnostic results obtained through NIR-II ratiometric fluorescence signals were further confirmed by standard H&E staining, indicating that the ratiometric fluorescence strategy could achieve distant metastases detection. Furthermore, the superior imaging quality of ratiometric probes enables visualization of the detailed change in the lymphatic network accompanying tumor growth. Compared to clinically available and state-of-the-art NIR contrast agents, our dual-tracer-based NIR-II ratiometric fluorescence probes provide significantly improved performance, allowing for the quick assessment of lymphatic function and guiding the removal of tumor-infiltrating SLNs during cancer surgery.


Subject(s)
Sentinel Lymph Node , Humans , Sentinel Lymph Node/diagnostic imaging , Sentinel Lymph Node/pathology , Sentinel Lymph Node/surgery , Fluorescent Dyes , Lymphatic Metastasis/pathology , Indocyanine Green , Optical Imaging
16.
Ann Surg Oncol ; 31(5): 3168-3176, 2024 May.
Article in English | MEDLINE | ID: mdl-38368292

ABSTRACT

OBJECTIVE: This study aimed to determine whether sentinel lymph node biopsy (SLNB) alone could afford oncological outcomes comparable with axillary lymph node dissection (ALND) in patients with early breast cancer without palpable lymphadenopathy who underwent total mastectomy (TM) and were SLN-positive. METHODS: This study analyzed clinical data of 6747 patients with breast cancer who underwent TM between 2014 and 2018 in two tertiary hospitals in Korea. Overall, 643 clinical stage T1-3 N0 patients who did not receive neoadjuvant therapy and had one to two metastatic SLNs at the time of surgery were included. Propensity score matching was performed between the SLNB alone and ALND groups, adjusting for clinical T stage and number of metastatic SLNs. In total, 237 patients were allocated to each group. RESULTS: Mean number of metastatic SLNs was 1.2 for the SLNB group and 1.6 for the ALND group. With a median follow-up of 65.0 months, 5 year disease-free survival was 90.8% for the SLNB group and 93.9% for the ALND group (hazard ratio [HR] 1.35, 95% confidence interval [CI] 0.70-2.58; p = 0.36). 5 year ipsilateral locoregional recurrence-free survival (LRRFS) was not significantly different between the two groups (95.1% and 98.3% for the SLNB and ALND groups, respectively) [HR 1.86, 95% CI 0.69-5.04; p = 0.21]. In the SLNB group, patients who received radiation therapy (RT) showed superior 5 year LRRFS than patients who did not receive RT (100% vs. 92.9%; p = 0.02). CONCLUSION: Collectively, our findings suggest that SLNB could afford comparable outcomes to ALND in patients with early breast cancer and one to two metastatic SLNs who underwent TM. Importantly, RT could decrease locoregional recurrence in patients who underwent SLNB alone.


Subject(s)
Breast Neoplasms , Lymphadenopathy , Sentinel Lymph Node , Humans , Female , Breast Neoplasms/pathology , Mastectomy, Simple , Mastectomy , Neoplasm Recurrence, Local/pathology , Lymph Node Excision , Sentinel Lymph Node Biopsy , Lymph Nodes/pathology , Lymphadenopathy/surgery , Axilla/pathology , Sentinel Lymph Node/surgery , Sentinel Lymph Node/pathology
17.
Zhonghua Zhong Liu Za Zhi ; 46(2): 140-145, 2024 Feb 23.
Article in Chinese | MEDLINE | ID: mdl-38418188

ABSTRACT

Objectives: This study aims to explore the clinical significance of lateral pelvic sentinel lymph node biopsy (SLNB) using indocyanine green (ICG) fluorescence navigation in laparoscopic lateral pelvic lymph node dissection (LLND) and evaluate the accuracy and feasibility of this technique to predict the status of lateral pelvic lymph nodes (LPLNs). Methods: The clinical and pathological characteristics, surgical outcomes, lymph node findings and perioperative complications of 16 rectal cancer patients who underwent SLNB using ICG fluorescence navigation in laparoscopic LLND in the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College during April 2017 and October 2022 were retrospectively collected and analyzed. The patients did not receive preoperative neoadjuvant radiotherapy and presented with LPLNs but without LPLN enlargement (MRI showed the maximum short axes of the LPLNs were ≥5 mm and <10 mm at first visit). Results: All 16 patients were successfully performed SLNB using ICG fluorescence navigation in laparoscopic LLND. Three patients underwent bilateral LLND and 13 patients underwent unilateral LLND. The lateral pelvic sentinel lymph nodes (SLNs) were clearly fluorescent before dissection in 14 patients and the detection rate of SLNs for these patients was 87.5%. Lateral pelvic SLN metastasis was diagnosed in 2 patients and negative results were found in 12 patients by frozen pathological examinations. Among the 14 patients in whom lateral pelvic SLNs were detected, the dissected lateral pelvic non-SLNs were all negative. All dissected LPLNs were negative in two patients without fluorescent lateral pelvic SLNs. The specificity, sensitivity, negative predictive value, and accuracy was 85.7%, 100%, 100%, and 100%, respectively. Conclusions: This study indicates that lateral pelvic SLNB using ICG fluorescence navigation shows promise as a safe and feasible procedure with good accuracy. This technique may replace preventive LLND for locally advanced lower rectal cancer.


Subject(s)
Laparoscopy , Rectal Neoplasms , Sentinel Lymph Node , Humans , Sentinel Lymph Node Biopsy/methods , Indocyanine Green , Clinical Relevance , Retrospective Studies , Lymph Node Excision , Sentinel Lymph Node/diagnostic imaging , Sentinel Lymph Node/surgery , Sentinel Lymph Node/pathology , Coloring Agents , Lymph Nodes/diagnostic imaging , Lymph Nodes/surgery , Lymph Nodes/pathology , Laparoscopy/methods , Rectal Neoplasms/diagnostic imaging , Rectal Neoplasms/surgery , Rectal Neoplasms/pathology
19.
Int J Gynecol Cancer ; 34(5): 773-776, 2024 May 06.
Article in English | MEDLINE | ID: mdl-38326228

ABSTRACT

BACKGROUND: Nearly 65% of patients with endometrial cancer who undergo primary hysterectomy have concurrent obesity. Retrospective data show advantages in using robotic surgery in these patients compared with conventional laparoscopy, namely lower conversion rate, increased rate of same-day discharge, and reduced blood loss. Nevertheless, to date no prospective randomized controlled trials have compared laparoscopic surgery versus robotic-assisted surgery in morbidly obese patients. PRIMARY OBJECTIVE: The robotic-assisted versus conventional laparoscopic surgery in the management of obese patients with early endometrial cancer in the sentinel lymph node era: a randomized controlled study (RObese) trial aims to find the most appropriate minimally invasive surgical approach in morbidly obese patients with endometrial carcinoma. STUDY HYPOTHESIS: Robotic surgery will reduce conversions to laparotomy in endometrial cancer patients with obesity compared with those who undergo surgery with conventional laparoscopy. TRIAL DESIGN: This phase III multi-institutional study will randomize consecutive obese women with apparent early-stage endometrial cancer to either laparoscopic or robot-assisted surgery. MAJOR INCLUSION/EXCLUSION RITERIA: The RObese trial will include obese (BMI≥30 kg/m2) patients aged over 18 years with apparent 2009 Federation of Gynecology and Obstetrics (FIGO) stage IA-IB endometriod endometrial cancer. PRIMARY ENDPOINT: Conversion rate to laparotomy between laparoscopic surgery versus robot-assisted surgery. SAMPLE SIZE: RObese is a superiority trial. The clinical superiority margin for this study is defined as a difference in conversion rate of -6%. Assuming a significance level of 0.05 and a power of 80%, the study plans to randomize 566 patients. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Patient recruitment will be completed by 2026, and follow-up will be completed by 2029 with presentation of data shortly thereafter. Two interim analyses are planned: one after the first 188 and the second after 376 randomized patients. TRIAL REGISTRATION: NCT05974995.


Subject(s)
Endometrial Neoplasms , Laparoscopy , Robotic Surgical Procedures , Humans , Female , Endometrial Neoplasms/surgery , Endometrial Neoplasms/pathology , Robotic Surgical Procedures/methods , Laparoscopy/methods , Obesity, Morbid/surgery , Obesity, Morbid/complications , Sentinel Lymph Node/pathology , Sentinel Lymph Node/surgery , Obesity/complications , Obesity/surgery , Randomized Controlled Trials as Topic , Middle Aged , Hysterectomy/methods
20.
Int J Gynaecol Obstet ; 165(2): 677-684, 2024 May.
Article in English | MEDLINE | ID: mdl-38226675

ABSTRACT

OBJECTIVE: The aim of this study was to compare patient survival using sentinel lymph node (SLN) procedure and pelvic lymphadenectomy for stating early-stage high risk endometrial cancer. METHODS: Patients who underwent surgery for early-stage high risk endometrial cancer between 2010 and 2017 were extracted from the incidence registry of the SEER program. We identified patients who underwent SLN mapping. Patients who initially underwent pelvic lymphadenectomy were selected as the comparison group. One-to-one matching was performed according to age, ethnicity, histology, extension and grade. The primary outcome was disease-specific survival. The secondary outcome was overall survival. RESULTS: A total of 326 patients who underwent SLN mapping and 326 who underwent pelvic lymphadenectomy initially were included in the study. The three-year analysis did not find a significant difference between the SLN and lymphadenectomy groups on disease-specific survival probability (88.2% vs 82.7, P = 0.07) and on overall survival probability (82.7% vs 78.2%, P = 0.57). Patients who underwent SLN mapping had a lower mean number of lymph nodes removed (mean 3 vs 16, P < 0.001) and there was a higher rate of patients with positive pelvic lymph nodes (18% vs 14%, P = 0.04). Following adjustment for confounding factors, disease-specific survival did not vary according to the lymph node intervention performed (P = 0.056), but the SLN group had better overall survival than those in the lymphadenectomy group (P = 0.047). CONCLUSION: The SLN technique was not associated with poorer disease-specific survival than pelvic lymphadenectomy even after adjustment. These results suggest that SLN is an acceptable and safe procedure in surgical staging for early-stage high-risk endometrial cancer.


Subject(s)
Endometrial Neoplasms , Sentinel Lymph Node , Female , Humans , Sentinel Lymph Node/surgery , Sentinel Lymph Node/pathology , Sentinel Lymph Node Biopsy/methods , Cohort Studies , Lymphatic Metastasis/pathology , Endometrial Neoplasms/surgery , Endometrial Neoplasms/pathology , Neoplasm Staging , Lymph Nodes/surgery , Lymph Nodes/pathology , Lymph Node Excision/methods , Retrospective Studies
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