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The Lancet. Oncology Oct 2010Sentinel-lymph-node (SLN) surgery was designed to minimise the side-effects of lymph-node surgery but still offer outcomes equivalent to axillary-lymph-node dissection... (Comparative Study)
Comparative Study Randomized Controlled Trial
Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 randomised phase 3 trial.
BACKGROUND
Sentinel-lymph-node (SLN) surgery was designed to minimise the side-effects of lymph-node surgery but still offer outcomes equivalent to axillary-lymph-node dissection (ALND). The aims of National Surgical Adjuvant Breast and Bowel Project (NSABP) trial B-32 were to establish whether SLN resection in patients with breast cancer achieves the same survival and regional control as ALND, but with fewer side-effects.
METHODS
NSABP B-32 was a randomised controlled phase 3 trial done at 80 centres in Canada and the USA between May 1, 1999, and Feb 29, 2004. Women with invasive breast cancer were randomly assigned to either SLN resection plus ALND (group 1) or to SLN resection alone with ALND only if the SLNs were positive (group 2). Random assignment was done at the NSABP Biostatistical Center (Pittsburgh, PA, USA) with a biased coin minimisation approach in an allocation ratio of 1:1. Stratification variables were age at entry (≤ 49 years, ≥ 50 years), clinical tumour size (≤ 2·0 cm, 2·1-4·0 cm, ≥ 4·1 cm), and surgical plan (lumpectomy, mastectomy). SLN resection was done with a blue dye and radioactive tracer. Outcome analyses were done in patients who were assessed as having pathologically negative sentinel nodes and for whom follow-up data were available. The primary endpoint was overall survival. Analyses were done on an intention-to-treat basis. All deaths, irrespective of cause, were included. The mean time on study for the SLN-negative patients with follow-up information was 95·6 months (range 70·1-126·7). This study is registered with ClinicalTrials.gov, number NCT00003830.
FINDINGS
5611 women were randomly assigned to the treatment groups, 3989 had pathologically negative SLN. 309 deaths were reported in the 3986 SLN-negative patients with follow-up information: 140 of 1975 patients in group 1 and 169 of 2011 in group 2. Log-rank comparison of overall survival in groups 1 and 2 yielded an unadjusted hazard ratio (HR) of 1·20 (95% CI 0·96-1·50; p=0·12). 8-year Kaplan-Meier estimates for overall survival were 91·8% (95% CI 90·4-93·3) in group 1 and 90·3% (88·8-91·8) in group 2. Treatment comparisons for disease-free survival yielded an unadjusted HR of 1·05 (95% CI 0·90-1·22; p=0·54). 8-year Kaplan-Meier estimates for disease-free survival were 82·4% (80·5-84·4) in group 1 and 81·5% (79·6-83·4) in group 2. There were eight regional-node recurrences as first events in group 1 and 14 in group 2 (p=0·22). Patients are continuing follow-up for longer-term assessment of survival and regional control. The most common adverse events were allergic reactions, mostly related to the administration of the blue dye.
INTERPRETATION
Overall survival, disease-free survival, and regional control were statistically equivalent between groups. When the SLN is negative, SLN surgery alone with no further ALND is an appropriate, safe, and effective therapy for breast cancer patients with clinically negative lymph nodes.
FUNDING
US Public Health Service, National Cancer Institute, and Department of Health and Human Services.
Topics: Axilla; Breast Neoplasms; Canada; Chemotherapy, Adjuvant; Coloring Agents; Disease-Free Survival; Female; Humans; Kaplan-Meier Estimate; Lymph Node Excision; Lymphatic Metastasis; Mastectomy, Modified Radical; Mastectomy, Segmental; Middle Aged; Neoplasm Recurrence, Local; Proportional Hazards Models; Radiopharmaceuticals; Radiotherapy, Adjuvant; Risk Assessment; Risk Factors; Rosaniline Dyes; Sentinel Lymph Node Biopsy; Technetium Tc 99m Sulfur Colloid; Time Factors; Treatment Outcome; United States
PubMed: 20863759
DOI: 10.1016/S1470-2045(10)70207-2 -
Journal of Vascular Surgery. Venous and... Nov 2018
Topics: Humans; Lymphatic Vessels; Postoperative Complications; Rosaniline Dyes
PubMed: 30336902
DOI: 10.1016/j.jvsv.2018.06.004 -
Journal of Vascular Surgery. Venous and... Mar 2019
Topics: Rosaniline Dyes
PubMed: 30771836
DOI: 10.1016/j.jvsv.2018.11.001 -
Surgery Nov 2014We hypothesize that mapping the lymphatic drainage of the arm with blue dye (axillary reverse mapping [ARM]) during axillary lymphadenectomy decreases the likelihood of...
BACKGROUND
We hypothesize that mapping the lymphatic drainage of the arm with blue dye (axillary reverse mapping [ARM]) during axillary lymphadenectomy decreases the likelihood of disruption of lymphatics and subsequent lymphedema.
METHODS
This institutional review board-approved study involved 360 patients undergoing sentinel lymph node biopsy (SLNB) and/or axillary lymph node dissection (ALND) from May 2006 to October 2011. Technetium sulfur colloid (4 mL) was injected subareolarly, and 5 mL of blue dye was injected subcutaneously in the volar surface ipsilateral upper extremity (ARM). Data were collected on variations in lymphatic drainage, successful identification and protection of arm lymphatics, crossover, and occurrence of lymphedema.
RESULTS
A group of 360 patients underwent SLNB and/or ALND, 348 of whom underwent a SLNB. Of those, 237 (68.1%) had a SLNB only, and 111 (31.9%) went on to an ALND owing to a positive axilla. An additional 12 of 360 (3.3%) axilla had ALND owing to a clinically positive axilla/preoperative core needle biopsy. In 96% of patients with SLNB (334/348), breast SLNs were hot but not blue; crossover (SLN hot and blue) was seen in 14 of 348 patients (4%). Blue lymphatics were identified in 80 of 237 SLN incisions (33.7%) and in 93 of 123 ALND (75.4%). Average follow-up was 12 months (range, 3-48) and resulted in a SLNB lymphedema rate of 1.7% (4/237) and ALND of 2.4% (3/123).
CONCLUSION
ARM identified substantial lymphatic variations draining the upper extremities and facilitated preservation. Metastases in ARM-identified lymph nodes were acceptably low, indicating that ARM is safe. ARM added to present-day ALND and SLNB may be useful to lesser rates of lymphedema.
Topics: Axilla; Breast Neoplasms; Coloring Agents; Female; Follow-Up Studies; Humans; Lymph Nodes; Lymphatic Vessels; Lymphedema; Middle Aged; Radiopharmaceuticals; Rosaniline Dyes; Sentinel Lymph Node Biopsy; Technetium Tc 99m Sulfur Colloid
PubMed: 25444319
DOI: 10.1016/j.surg.2014.05.011 -
Oncology (Williston Park, N.Y.) Jan 2004The sentinel node evaluation has revolutionized the modern surgical management of cutaneous melanoma and breast cancer. In gynecologic oncology, sentinel node mapping... (Review)
Review
The sentinel node evaluation has revolutionized the modern surgical management of cutaneous melanoma and breast cancer. In gynecologic oncology, sentinel node mapping has been mainly studied in vulvar and cervical cancer. In vulvar cancer, data from 12 studies including 353 cases indicate that the sentinel node detection rate is 92% and the negative-predictive value is 99%. Three groin recurrences have been documented so far (< 1%). The technique has more recently been studied in cervical cancer. Data from 12 studies including 323 cases indicate a lower sentinel node detection rate of 80% to 86% and a negative-predictive value of 99%. Three false-negative cases have been reported so far (< 1%). Review of the literature suggests that the combined approach with blue dye and lymphoscintigraphy is superior to the blue dye alone for sentinel node detection. It also suggests that the sentinel node mapping technique is feasible in vulvar and cervical cancer and that it may become a valuable alternative to the traditional groin and pelvic lymphadenectomy. However, results have not been duplicated in large multi-institutional trials, and the technique should still be performed in the context of clinical trials. Complications of the sentinel node mapping technique are rare and usually benign but physicians should be aware of the serious risk of anaphylactic reaction to the blue dye (1% to 2%). Before this technique becomes a standard approach in the management of gynecologic malignancies, more data will be needed to clarify some of the related controversies.
Topics: Female; Humans; Laparoscopy; Lymph Node Excision; Lymph Nodes; Lymphatic Metastasis; Radiography; Radionuclide Imaging; Rosaniline Dyes; Sentinel Lymph Node Biopsy; Uterine Cervical Neoplasms; Vulvar Neoplasms
PubMed: 14768408
DOI: No ID Found -
Annals of Surgical Oncology Jul 2016To compare the detection rate (DR) and bilateral optimal mapping (OM) of sentinel lymph nodes (SLNs) in women with endometrial and cervical cancer using indocyanine... (Comparative Study)
Comparative Study
Impact of Indocyanine Green for Sentinel Lymph Node Mapping in Early Stage Endometrial and Cervical Cancer: Comparison with Conventional Radiotracer (99m)Tc and/or Blue Dye.
PURPOSE
To compare the detection rate (DR) and bilateral optimal mapping (OM) of sentinel lymph nodes (SLNs) in women with endometrial and cervical cancer using indocyanine green (ICG) versus the standard technetium-99m radiocolloid ((99m)Tc) radiotracer plus methylene or isosulfan blue, or blue dye alone.
METHODS
From October 2010 to May 2015, 163 women with stage I endometrial or cervical cancer (118 endometrial and 45 cervical cancer) underwent SLN mapping with (99m)Tc with blue dye, blue dye alone, or ICG. DR and bilateral OM of ICG were compared respectively with the results obtained using the standard (99m)Tc radiotracer with blue dye, or blue dye alone.
RESULTS
SLN mapping with (99m)Tc radiotracer with blue dye was performed on 77 of 163 women, 38 with blue dye only and 48 with ICG. The overall DR of SLN mapping was 97, 89, and 100 % for (99m)Tc with blue dye, blue dye alone, and ICG, respectively. The bilateral OM rate for ICG was 85 %-significantly higher than the 58 % obtained with (99m)Tc with blue dye (p = 0.003) and the 54 % for blue dye (p = 0.001). Thirty-one women (19 %) had positive SLNs. Sensitivity and negative predictive value of SLN were 100 % for all techniques.
CONCLUSIONS
SLNs mapping using ICG demonstrated higher DR compared to other modalities. In addition, ICG was significantly superior to (99m)Tc with blue dye in terms of bilateral OM in women with early stage endometrial and cervical cancer. The higher number of bilateral OM may consequently reduce the overall number of complete lymphadenectomies, reducing the duration and additional costs of surgical treatment.
Topics: Adenocarcinoma; Adult; Aged; Aged, 80 and over; Carcinoma, Squamous Cell; Coloring Agents; Endometrial Neoplasms; Female; Follow-Up Studies; Humans; Indocyanine Green; Middle Aged; Prognosis; Radiopharmaceuticals; Retrospective Studies; Rosaniline Dyes; Sentinel Lymph Node; Sentinel Lymph Node Biopsy; Technetium Tc 99m Sulfur Colloid; Uterine Cervical Neoplasms
PubMed: 26714944
DOI: 10.1245/s10434-015-5022-1 -
Journal of Nuclear Medicine : Official... Jul 1999
Comparative Study
Topics: Biopsy; Humans; Lymph Nodes; Lymphatic Metastasis; Melanoma; Radionuclide Imaging; Radiopharmaceuticals; Rosaniline Dyes; Skin Neoplasms; Technetium Tc 99m Aggregated Albumin; Technetium Tc 99m Sulfur Colloid
PubMed: 10405135
DOI: No ID Found -
World Journal of Surgical Oncology Nov 2016Sentinel lymph node biopsy (SLNB) is well accepted to be a standard procedure in breast cancer surgery with clinically negative lymph nodes. Isosulfan blue is the first... (Comparative Study)
Comparative Study
BACKGROUND
Sentinel lymph node biopsy (SLNB) is well accepted to be a standard procedure in breast cancer surgery with clinically negative lymph nodes. Isosulfan blue is the first dye approved by the USA Food and Drug Administration for the localization of the lymphatic system. Few alternative tracers have been investigated. In this study, we aimed to compare the differences between 10 % fluorescein sodium and 1 % isosulfan blue in breast sentinel lymph node biopsy and to investigate the feasibility of using 10 % fluorescein sodium as a new dye for breast sentinel lymph node biopsy.
METHODS
A total of 30 New Zealand rabbits were randomly divided into the fluorescein sodium group and the isosulfan blue group (15 rabbits per group). Fluorescein sodium or isosulfan blue was injected subcutaneously into the second pair of mammary areolas.
RESULTS
The average fading time of the second lymph nodes in the isosulfan blue group was significantly shorter than that in the fluorescein sodium group. Moreover, the detection rates of SLNs were higher in the fluorescein sodium group than in the isosulfan blue group. No significant differences between the fluorescein sodium group and isosulfan blue group were observed regarding the distances between the detected sentinel lymph nodes and second pair of mammary areolas, the distances between the second lymph nodes and second pair of mammary areolas, the number of detected sentinel lymph nodes and second lymph nodes, the average dyeing time of the sentinel and the second lymph nodes, and the average fading time of the second lymph nodes.
CONCLUSIONS
In summary, we first reported that fluorescein sodium is a potential new tracer for breast sentinel lymph node biopsy.
Topics: Animals; Breast Neoplasms; Coloring Agents; Feasibility Studies; Female; Fluorescein; Fluorescent Dyes; Injections, Subcutaneous; Rabbits; Rosaniline Dyes; Sentinel Lymph Node Biopsy
PubMed: 27809854
DOI: 10.1186/s12957-016-1031-1 -
Journal of Investigational Allergology... 2016
Topics: Aged; Aged, 80 and over; Anaphylaxis; Coloring Agents; Drug Hypersensitivity; Female; Humans; Intradermal Tests; Male; Methylene Blue; Middle Aged; Plasma; Predictive Value of Tests; Risk Factors; Rosaniline Dyes; Sentinel Lymph Node Biopsy
PubMed: 27996948
DOI: 10.18176/jiaci.0101 -
Journal of Nuclear Medicine : Official... Jul 1999Sentinel lymph node (SLN) biopsy has emerged as a novel approach for identifying patients with melanoma and regional nodal micrometastasis who may benefit from full... (Comparative Study)
Comparative Study
UNLABELLED
Sentinel lymph node (SLN) biopsy has emerged as a novel approach for identifying patients with melanoma and regional nodal micrometastasis who may benefit from full nodal basin resection. To identify the pattern of tumor lymphatic drainage and the SLN, lymphoscintigraphy has been performed using primarily 99mTc-sulfur colloid (SC). In this study, we compare the efficacy of SLN biopsy using 99mTc-human serum albumin (HSA) with SLN biopsy after SC-based lymphoscintigraphy.
METHODS
One hundred and six patients with localized cutaneous melanoma were studied. Lymphoscintigraphy was performed after intradermal injection of HSA in 85 patients and SC in 21 patients. Four patients underwent lymphoscintigraphy twice, once with SC and once with HSA. Dynamic images were acquired for up to 1 h, followed by high-count images of the SLN in various projections so that the most likely site was marked on the skin for biopsy. Intraoperatively, blue dye was injected around the primary site. Twenty-four patients underwent SLN dissection directed by preoperative lymphoscintigraphy and vital blue dye mapping; in the remaining 80 patients, a gamma probe was added intraoperatively to the localization procedure. Two patients underwent mapping with gamma probe alone.
RESULTS
Draining lymphatic basins and nodes were identified by lymphoscintigraphy in all patients. The SLN was identified in 95% of patients when both blue dye and intraoperative gamma probe were used. When 99mTc-HSA was used for imaging, 98% of the SLNs ultimately identified were radiolabeled, and 82% were both hot and blue. Of the SLN recovered with SC, all the nodes were radiolabeled; however, there was only 58% hot and blue concordance. Greater numbers of SLNs were removed in the SC group (median 2.0 versus 1.0, P = 0.02); however, the incidence of micrometastasis was statistically similar in both HSA and SC cohorts. In the 4 patients examined with both tracers, SLN mapping was similar.
CONCLUSION
Although SC has been the radiotracer of choice for SLN mapping in melanoma, HSA appears to be a suitable alternative, with identical success rates. In fact, the higher concordance between hot and blue nodes using HSA suggests superiority of this tracer for this purpose.
Topics: Biopsy; Female; Humans; Lymph Node Excision; Lymph Nodes; Lymphatic Metastasis; Male; Melanoma; Middle Aged; Radionuclide Imaging; Radiopharmaceuticals; Rosaniline Dyes; Skin Neoplasms; Technetium Tc 99m Aggregated Albumin; Technetium Tc 99m Sulfur Colloid
PubMed: 10405134
DOI: No ID Found