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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 -
Future Oncology (London, England) Feb 2017The combined technique (radioisotope and blue dye) is the gold standard for sentinel lymph node biopsy (SLNB) and there is wide variation in techniques and blue dyes... (Meta-Analysis)
Meta-Analysis Review
The combined technique (radioisotope and blue dye) is the gold standard for sentinel lymph node biopsy (SLNB) and there is wide variation in techniques and blue dyes used. We performed a systematic review and meta-analysis to assess the need for radioisotope and the optimal blue dye for SLNB. A total of 21 studies were included. The SLNB identification rates are high with all the commonly used blue dyes. Furthermore, methylene blue is superior to iso-sulfan blue and Patent Blue V with respect to false-negative rates. The combined technique remains the most accurate and effective technique for SLNB. In order to standardize the SLNB technique, comparative trials to determine the most effective blue dye and national guidelines are required.
Topics: Breast Neoplasms; Coloring Agents; Female; Humans; Lymph Nodes; Lymphatic Metastasis; Melanoma; Neoplasm Recurrence, Local; Sensitivity and Specificity; Sentinel Lymph Node Biopsy
PubMed: 27578614
DOI: 10.2217/fon-2016-0255 -
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 -
Surgical Oncology Mar 2011The sentinel lymph node (SLN) procedure is now used routinely for the staging of clinically node-negative patients with early breast cancer. Two identification... (Review)
Review
The sentinel lymph node (SLN) procedure is now used routinely for the staging of clinically node-negative patients with early breast cancer. Two identification techniques exist: colorimetric and isotopic. These can be used alone or in combination. The combined method is associated with an increased identification rate. However, allergic and adverse reactions to blue dyes have been reported. The objective of this review was to determine the incidence of such events and to discuss alternative approaches. The authors conducted a search of the MEDLINE and EMBASE databases for reports of anaphylactic responses to isosulfan blue dye and patent blue V dye. Allergic reaction to the dyes isosulfan blue and patent blue V is rare and the reported incidence varies between 0.07% and 2.7%. Methylene blue dye appears to be safer, with no cases of allergic events having been reported. However, allergy tests in some patients have proven that there is cross-reactivity between isosulfan blue dye and methylene blue dye. Even though the risk of an anaphylactic response is low, this raises questions about the usefulness of colorimetric detection of SLN and whether alternatives to the use of the isosulfan and patent blue V dyes, such as methylene blue, exist.
Topics: Anaphylaxis; Coloring Agents; Methylene Blue; Rosaniline Dyes; Sentinel Lymph Node Biopsy
PubMed: 21074413
DOI: 10.1016/j.suronc.2010.10.002 -
The Journal of Allergy and Clinical... Oct 2021
Topics: Humans; Hypersensitivity; Rosaniline Dyes; Sentinel Lymph Node Biopsy
PubMed: 34627539
DOI: 10.1016/j.jaip.2021.06.053 -
Military Medicine Nov 2023Anaphylaxis is an acute multisystem syndrome typically resulting from the sudden release of mast cell and basophil-derived mediators into the circulatory system....
Anaphylaxis is an acute multisystem syndrome typically resulting from the sudden release of mast cell and basophil-derived mediators into the circulatory system. Isosulfan blue dye is a rare, but known, mediator of anaphylaxis with an incidence between 0.16% and 2% of cases. We report two cases of anaphylaxis attributed to the use of isosulfan blue dye in the intraoperative setting. Both of the patients we report had grade 3 anaphylactic reactions requiring vasopressors to correct significant hypotension. Both patients required overnight monitoring in the intensive care unit with the second patient also requiring continued vasopressor support.
Topics: Humans; Anaphylaxis; Sentinel Lymph Node Biopsy; Rosaniline Dyes; Hypotension; Vasoconstrictor Agents
PubMed: 36610991
DOI: 10.1093/milmed/usac419 -
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 -
Minerva Ginecologica Dec 2020Endometrial cancer is the most commonly diagnosed gynecological malignancy in developing countries, and the second malignancy after cervical cancer in developing... (Review)
Review
Endometrial cancer is the most commonly diagnosed gynecological malignancy in developing countries, and the second malignancy after cervical cancer in developing countries. The primary treatment is based on surgical and pathologic staging including extrafascial type A radical hysterectomy bilateral salpingo-oophorectomy and pelvic and latero-aortic lymphadenectomy. Minimally invasive surgery is the most widely used technique. Sentinel node biopsy is part of this concept and has reached the management of endometrial cancer. The aim of this review was to describe the history, the different injection techniques and results of sentinel node biopsy, and analyze the future role of this technique in endometrial carcinoma.
Topics: Colorimetry; Coloring Agents; Endometrial Neoplasms; Female; Humans; Hysterectomy; Indocyanine Green; Injections; Lymph Node Excision; Methylene Blue; Radiopharmaceuticals; Rosaniline Dyes; Sentinel Lymph Node; Sentinel Lymph Node Biopsy; Spectroscopy, Near-Infrared; Technetium Tc 99m Aggregated Albumin
PubMed: 32921021
DOI: 10.23736/S0026-4784.20.04626-2 -
Minerva Ginecologica Dec 2020In most cancers, lymph node status is the most critical factor impacting the evolution of the disease and the overall survival. Identifying potential nodal metastasis... (Review)
Review
In most cancers, lymph node status is the most critical factor impacting the evolution of the disease and the overall survival. Identifying potential nodal metastasis allows the oncologist to adjust the stage and, consequently, the patient's treatment. For this reason, a precise evaluation of the regional nodes is mandatory. In gynecological cancers, pelvic, paraaortic, and inguinal nodes are the region most frequently interested by metastasis. In the past years, comprehensive lymphadenectomy was the standard of care for endometrial, cervical, ovarian, and vulvar cancers. However, after introducing the sentinel lymph node (SNL) biopsy in breast cancers, this technique has gained much more interest in gynecology oncology. Several studies have shown that SLN allows an evaluation of the node status without the complications related to the lymphadenectomy that impacts the patient's quality of life. In this review, we discuss the role of SNL biopsy in gynecological cancers and the technique's evolution over the years. Moreover, we debate the OSNA method for SLN analysis that is recently introduced for uterine cancer.
Topics: Coloring Agents; Female; Genital Neoplasms, Female; Humans; Injections; Lymph Node Excision; Lymphatic Metastasis; Methylene Blue; Nucleic Acid Amplification Techniques; RNA, Messenger; Radiopharmaceuticals; Rosaniline Dyes; Sentinel Lymph Node; Sentinel Lymph Node Biopsy; Technetium
PubMed: 33306284
DOI: 10.23736/S0026-4784.20.04707-3