Factors affecting failed localisation and false-negative rates of sentinel node biopsy in breast cancer : results of the ALMANAC validation phase

Despite the widespread application of sentinel lymph node biopsy (SLNB) for early stage breast cancer, there is a wide variation in reported test performance characteristics. A major aim of this prospective multicentre validation study was to quantify detection and false-negative rates of SLNB and e...

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Veröffentlicht in:Breast cancer research and treatment 2006-09, Vol.99 (2), p.203-208
Hauptverfasser: GOYAL, Amit, NEWCOMBE, Robert G, CHHABRA, Alok, MANSEL, Robert E
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CHHABRA, Alok
MANSEL, Robert E
description Despite the widespread application of sentinel lymph node biopsy (SLNB) for early stage breast cancer, there is a wide variation in reported test performance characteristics. A major aim of this prospective multicentre validation study was to quantify detection and false-negative rates of SLNB and evaluate factors influencing them. Eight-hundred and fourty-two patients with clinically node-negative breast cancer underwent SLNB according to a standardised protocol that used a combination of radiopharmaceutical 99mTc-albumin colloid and Patent Blue V dye. SLNB was followed by standard axillary treatment at the same operation in all patients. Sentinel lymph nodes (SLNs) were identified in 803 (96.1%) of 836 evaluable cases. The median number of SLNs removed per patient was 2 (range 1-9). There were 19 false negatives, resulting in a sensitivity of 263/282 (93.3%) and accuracy 782/803 (97.6%). SLNs were successfully identified by blue dye in 698 (85.6%), by isotope in 698 (85.6%), and by the combination of blue dye and isotope in 782 (96.0%) of 815 patients. Among 276 node positive patients, one or more positive SLNs were identified by blue dye in 251 (90.9%), by isotope in 246 (89.1%) and by the combination of blue dye and gamma probe in 258 (93.5%). Obesity, tumor location other than upper outer quadrant and non-visualisation of SLNs on the pre-operative lymphoscintiscan were significantly associated with failed localisation (p
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A major aim of this prospective multicentre validation study was to quantify detection and false-negative rates of SLNB and evaluate factors influencing them. Eight-hundred and fourty-two patients with clinically node-negative breast cancer underwent SLNB according to a standardised protocol that used a combination of radiopharmaceutical 99mTc-albumin colloid and Patent Blue V dye. SLNB was followed by standard axillary treatment at the same operation in all patients. Sentinel lymph nodes (SLNs) were identified in 803 (96.1%) of 836 evaluable cases. The median number of SLNs removed per patient was 2 (range 1-9). There were 19 false negatives, resulting in a sensitivity of 263/282 (93.3%) and accuracy 782/803 (97.6%). SLNs were successfully identified by blue dye in 698 (85.6%), by isotope in 698 (85.6%), and by the combination of blue dye and isotope in 782 (96.0%) of 815 patients. Among 276 node positive patients, one or more positive SLNs were identified by blue dye in 251 (90.9%), by isotope in 246 (89.1%) and by the combination of blue dye and gamma probe in 258 (93.5%). Obesity, tumor location other than upper outer quadrant and non-visualisation of SLNs on the pre-operative lymphoscintiscan were significantly associated with failed localisation (p&lt;0.001, p=0.008, p&lt;0.001, respectively). The false-negative rate in patients with grade 3 tumors was 9.6%, compared with 4.7% in those with grade 2 tumors (p=0.022). The false-negative rate in patients who had one SLN harvested was 10.1%, compared with 1.1% in those who had multiple SLNs (three or more) removed (p=0.010). SLNB can accurately determine whether axillary metastases are present in patients with early stage breast cancer with clinically negative axillary nodes. Both success and accuracy of SLNB are optimised by the combined use of blue dye and isotope. SLNB success decreases with increasing body mass, tumor location other than the upper outer quadrant and non-visualisation of hot nodes on the pre-operative lymphoscintiscan. This study demonstrates reduction in the predictive value of a negative SLNB in grade 3 tumors.</description><identifier>ISSN: 0167-6806</identifier><identifier>EISSN: 1573-7217</identifier><identifier>DOI: 10.1007/s10549-006-9192-1</identifier><identifier>PMID: 16541308</identifier><identifier>CODEN: BCTRD6</identifier><language>eng</language><publisher>Dordrecht: Springer</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Axilla ; Biological and medical sciences ; Biopsy ; Breast cancer ; Breast Neoplasms - diagnostic imaging ; Breast Neoplasms - pathology ; Breast Neoplasms - surgery ; Cancer research ; Cancer therapies ; Carcinoma, Ductal, Breast - secondary ; Carcinoma, Ductal, Breast - surgery ; Carcinoma, Lobular - secondary ; Carcinoma, Lobular - surgery ; Dyes ; False Negative Reactions ; Female ; Gynecology. Andrology. Obstetrics ; Humans ; Lymph Nodes - diagnostic imaging ; Lymph Nodes - pathology ; Lymphatic Metastasis ; Lymphatic system ; Mammary gland diseases ; Medical research ; Medical sciences ; Middle Aged ; Neoplasm Invasiveness ; Neoplasm Recurrence, Local - pathology ; Neoplasm Staging ; Predictive Value of Tests ; Prospective Studies ; Radioisotopes ; Radionuclide Imaging ; Radiopharmaceuticals ; Risk Factors ; Rosaniline Dyes ; Sentinel Lymph Node Biopsy ; Technetium Tc 99m Aggregated Albumin ; Tumors</subject><ispartof>Breast cancer research and treatment, 2006-09, Vol.99 (2), p.203-208</ispartof><rights>2006 INIST-CNRS</rights><rights>Springer Science+Business Media, Inc. 2006</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c356t-cef64aae6b4135245208d51340173ce4932be483d9d956c1dd4c0b70fb7eca753</citedby><cites>FETCH-LOGICAL-c356t-cef64aae6b4135245208d51340173ce4932be483d9d956c1dd4c0b70fb7eca753</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=18090439$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16541308$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>GOYAL, Amit</creatorcontrib><creatorcontrib>NEWCOMBE, Robert G</creatorcontrib><creatorcontrib>CHHABRA, Alok</creatorcontrib><creatorcontrib>MANSEL, Robert E</creatorcontrib><creatorcontrib>ALMANAC Trialists Group</creatorcontrib><creatorcontrib>on behalf of the ALMANAC Trialists Group</creatorcontrib><title>Factors affecting failed localisation and false-negative rates of sentinel node biopsy in breast cancer : results of the ALMANAC validation phase</title><title>Breast cancer research and treatment</title><addtitle>Breast Cancer Res Treat</addtitle><description>Despite the widespread application of sentinel lymph node biopsy (SLNB) for early stage breast cancer, there is a wide variation in reported test performance characteristics. A major aim of this prospective multicentre validation study was to quantify detection and false-negative rates of SLNB and evaluate factors influencing them. Eight-hundred and fourty-two patients with clinically node-negative breast cancer underwent SLNB according to a standardised protocol that used a combination of radiopharmaceutical 99mTc-albumin colloid and Patent Blue V dye. SLNB was followed by standard axillary treatment at the same operation in all patients. Sentinel lymph nodes (SLNs) were identified in 803 (96.1%) of 836 evaluable cases. The median number of SLNs removed per patient was 2 (range 1-9). There were 19 false negatives, resulting in a sensitivity of 263/282 (93.3%) and accuracy 782/803 (97.6%). SLNs were successfully identified by blue dye in 698 (85.6%), by isotope in 698 (85.6%), and by the combination of blue dye and isotope in 782 (96.0%) of 815 patients. Among 276 node positive patients, one or more positive SLNs were identified by blue dye in 251 (90.9%), by isotope in 246 (89.1%) and by the combination of blue dye and gamma probe in 258 (93.5%). Obesity, tumor location other than upper outer quadrant and non-visualisation of SLNs on the pre-operative lymphoscintiscan were significantly associated with failed localisation (p&lt;0.001, p=0.008, p&lt;0.001, respectively). The false-negative rate in patients with grade 3 tumors was 9.6%, compared with 4.7% in those with grade 2 tumors (p=0.022). The false-negative rate in patients who had one SLN harvested was 10.1%, compared with 1.1% in those who had multiple SLNs (three or more) removed (p=0.010). SLNB can accurately determine whether axillary metastases are present in patients with early stage breast cancer with clinically negative axillary nodes. Both success and accuracy of SLNB are optimised by the combined use of blue dye and isotope. SLNB success decreases with increasing body mass, tumor location other than the upper outer quadrant and non-visualisation of hot nodes on the pre-operative lymphoscintiscan. This study demonstrates reduction in the predictive value of a negative SLNB in grade 3 tumors.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Axilla</subject><subject>Biological and medical sciences</subject><subject>Biopsy</subject><subject>Breast cancer</subject><subject>Breast Neoplasms - diagnostic imaging</subject><subject>Breast Neoplasms - pathology</subject><subject>Breast Neoplasms - surgery</subject><subject>Cancer research</subject><subject>Cancer therapies</subject><subject>Carcinoma, Ductal, Breast - secondary</subject><subject>Carcinoma, Ductal, Breast - surgery</subject><subject>Carcinoma, Lobular - secondary</subject><subject>Carcinoma, Lobular - surgery</subject><subject>Dyes</subject><subject>False Negative Reactions</subject><subject>Female</subject><subject>Gynecology. Andrology. 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A major aim of this prospective multicentre validation study was to quantify detection and false-negative rates of SLNB and evaluate factors influencing them. Eight-hundred and fourty-two patients with clinically node-negative breast cancer underwent SLNB according to a standardised protocol that used a combination of radiopharmaceutical 99mTc-albumin colloid and Patent Blue V dye. SLNB was followed by standard axillary treatment at the same operation in all patients. Sentinel lymph nodes (SLNs) were identified in 803 (96.1%) of 836 evaluable cases. The median number of SLNs removed per patient was 2 (range 1-9). There were 19 false negatives, resulting in a sensitivity of 263/282 (93.3%) and accuracy 782/803 (97.6%). SLNs were successfully identified by blue dye in 698 (85.6%), by isotope in 698 (85.6%), and by the combination of blue dye and isotope in 782 (96.0%) of 815 patients. Among 276 node positive patients, one or more positive SLNs were identified by blue dye in 251 (90.9%), by isotope in 246 (89.1%) and by the combination of blue dye and gamma probe in 258 (93.5%). Obesity, tumor location other than upper outer quadrant and non-visualisation of SLNs on the pre-operative lymphoscintiscan were significantly associated with failed localisation (p&lt;0.001, p=0.008, p&lt;0.001, respectively). The false-negative rate in patients with grade 3 tumors was 9.6%, compared with 4.7% in those with grade 2 tumors (p=0.022). The false-negative rate in patients who had one SLN harvested was 10.1%, compared with 1.1% in those who had multiple SLNs (three or more) removed (p=0.010). SLNB can accurately determine whether axillary metastases are present in patients with early stage breast cancer with clinically negative axillary nodes. Both success and accuracy of SLNB are optimised by the combined use of blue dye and isotope. SLNB success decreases with increasing body mass, tumor location other than the upper outer quadrant and non-visualisation of hot nodes on the pre-operative lymphoscintiscan. This study demonstrates reduction in the predictive value of a negative SLNB in grade 3 tumors.</abstract><cop>Dordrecht</cop><pub>Springer</pub><pmid>16541308</pmid><doi>10.1007/s10549-006-9192-1</doi><tpages>6</tpages></addata></record>
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subjects Adult
Aged
Aged, 80 and over
Axilla
Biological and medical sciences
Biopsy
Breast cancer
Breast Neoplasms - diagnostic imaging
Breast Neoplasms - pathology
Breast Neoplasms - surgery
Cancer research
Cancer therapies
Carcinoma, Ductal, Breast - secondary
Carcinoma, Ductal, Breast - surgery
Carcinoma, Lobular - secondary
Carcinoma, Lobular - surgery
Dyes
False Negative Reactions
Female
Gynecology. Andrology. Obstetrics
Humans
Lymph Nodes - diagnostic imaging
Lymph Nodes - pathology
Lymphatic Metastasis
Lymphatic system
Mammary gland diseases
Medical research
Medical sciences
Middle Aged
Neoplasm Invasiveness
Neoplasm Recurrence, Local - pathology
Neoplasm Staging
Predictive Value of Tests
Prospective Studies
Radioisotopes
Radionuclide Imaging
Radiopharmaceuticals
Risk Factors
Rosaniline Dyes
Sentinel Lymph Node Biopsy
Technetium Tc 99m Aggregated Albumin
Tumors
title Factors affecting failed localisation and false-negative rates of sentinel node biopsy in breast cancer : results of the ALMANAC validation phase
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