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Recommendations for use of Sentinel node biopsy

Details of trials or studies

Table 1: Details of trials comparing sentinel node biopsy with axillary dissection3
TRIAL POPULATION PATIENT NUMBERS
SNB ALND
SNB GROUP
(METHOD OF SN DETECTION)
ALND GROUP OUTCOMES MEASURED
MILAN4,5 Women aged 40−75 yrs with primary breast cancer ≤2 cm, and BCT performed before SNB or ALND 259 257 SNB isotope ALND if SN positive SNB ALND Axillary metastases, DFS, OS, detection rate
ALMANAC6,7 Female and male patients aged ≤80 yrs with clinically node negative invasive breast cancer 495 (478 ITT)  496 (476 ITT) SNB (blue due and/or isotope) ALND or axillary radiotherapy if SN positive Standard axillary treatment (ALND or 4-node sampling) Arm and shoulder morbidity, QoL, detection rate
SNAC I 8,22,27 Women with histologically or cytologically confirmed invasive breast cancer ≤3 cm 544 544 SNB (blue dye and or/isotope) ALND if SN positive SNBALND Arm volume, QoL, detection of SN
NSABP B-32 9,20,21 Women with operable invasive breast cancer and clinically negative nodes 2804 2807 SNB (blue dye and isotope) ALND if SN positive SNBALND QoL, FN, detection rate
Cambridge10 Patients with ≤3 cm invasive breast cancer node negative breast cancer 143 155 SNB (blue dye and isotope) ALND if SN positive ALND Physical and psychosocial morbidity
GIVOM 11,12 Patients aged ≤80yrs with ≤3 cm node negative breast cancer 352 345 SNB isotope ALND if SN positive SNBALND Detection, accuracy, QoL, OS, DFS

Notes: ALND=axillary lymph node dissection, BCT=breast conserving therapy, DFS=disease free survival, FN=false negative rate, ITT=intention to treat, OS=overall survival, QoL=quality of life, SN=sentinel node, SNB=sentinel node biopsy

Table 2. Details of trials investigating technique for sentinel node biopsy and treatment following a positive sentinel node3
TRIAL POPULATION TREATMENT OUTCOMES MEASURED
Detection agent used
Radovanovic13 Women clinically T1-2 N0 M0 breast cancer

i) Blue dye only n=50

ii) Blue dye and radioisotope n=100

Accuracy, FN rate, specificity, sensitivity
Hung14 Women ≤70 yrs early breast cancer ≤3 cm

i) Blue dye only n=57

ii) Blue dye and radioisotope n=61

Accuracy, FN rate, detection rate
Meyer-Rochow15 Malignant palpable breast lump stage I or II breast cancer

i) Blue dye alone n=63

ii) Triple modality (preoperative lymphoscintigraphy, intraoperative gamma probe and blue dye) n=41

Accuracy, FN rate, specificity, sensitivity
Injection site
FRANSENODE16 T0-1 invasive breast cancer clinically negative axilla

i) Peritumoral injection of radioisotope and/or blue dye n=224

ii) Periareolar injection of radioisotope and/or blue dye n=225

Detection rate
Povoski17 Females >18 yrs T1-2 N0 M0 breast cancer (invasive or non-invasive) i) Intradermal injection of radioisotope^ n=133
ii) Intraparenchymal injection of radioisotope^ n=134
iii) Subareolar injection of radioisotope^ n=133
^for all patients blue dye was injected intraparenchymally
Detection rate
Treatment following a positive sentinel node
ACOSOG Z001118 Undergoing BCT clinical T1-2 N0 M0 breast cancer 1 or 2 positive SNs i) SNB (blue dye and/or isotope) no further surgery n=445 ii) SNB (blue dye and/or isotope) ALND n=446 QoL, detection rate

Notes: ALND=axillary lymph node dissection, BCT=breast conserving therapy, DFS=disease free survival, FN=false negative rate, QoL=quality of life, SN=sentinel node, SNB=sentinel node biopsy

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