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| 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 | SNB→ALND | 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 | SNB→ALND | 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 | SNB→ALND | 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
| 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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