Table 1.
The characteristics of the included 20 studies reported by 24 papers
| Author publication year | Study design | Lymph bode category | Sample size (n), total (SLNB group/ALND group) | Positive SLN, n (SLNB group/ALND group) | Age (years), total (SLNB group/ALND group) | Tumor size, total (SLNB group/ALND group) | Axillary intervention | Median follow-up, months or specified | Primary outcome(s) |
|---|---|---|---|---|---|---|---|---|---|
| Lucci et al. (2007) ACOSOG Z0011 [30] | RCT | Not specified | 821(417/404) | Range: (1–2/1–2) | Median: not specified for total (54/56) | T2: 252 (120/132) | SLNB alone versus SLNB + complete ALND | Not specified | Adverse surgical effects |
| Bilimoria et al. (2009) [31] | Retrospective cohort study | Micro | 10,259 (3,674/6,585) | Not specified | Median: 56 (58/56) | Median: 2.0 (1.8/2.1) cm | SLNB alone versus SLNB + complete ALND | 63 | Axillary recurrence and survival |
| Macro | 87,055 (16,543/70,512) | ||||||||
| Degnim et al. (2010) [32] | Retrospective cohort study | ITC | 81 (50/31) | Range: (1–3/1–3) | Mean, not specified for total (50/58) | Number of T2 + T3: 29 (15/14) | SLNB alone versus SLNB + complete ALND | 38 | Predicted probability of non-sentinel node metastasis and breast recurrence |
| Giuliano et al. (2010) ACOSOG Z0011 [33] | RCT | Micro | 280 (160/120) | Range: (1–2/1–2) | Median: not specified for total (54/56) | Number of T2: 251 (124/127) | SLNB alone versus SLNB + complete ALND | 6.3 years | Locoregional recurrence |
| Macro | 418 (219/199) | ||||||||
| Unknown | 115 (66/49) | ||||||||
| Yi et al. (2010) [34] | Retrospective cohort study | Micro | 6,838 (2,240/4,598) | Range: (1–24/1–54) | Median: not specified for total (59/56) | Number of T2 + T3: 12,166 (1,430/10,736) | SLNB alone versus SLNB + complete ALND | 50 | OS and breast cancer-specific mortality |
| Macro | 20,148 (2,185/17,963) | ||||||||
| Giuliano et al. (2011) ACOSOG Z0011 [12] | RCT | Not specified | 856 (436/420) | Range: (1–2/1–2) | Median: not specified for total (54/56) | Number of T2: 260 (126/134) | SLNB alone versus SLNB + complete ALND | 6.3 years | OS |
| Gillanders et al. (2012) [35] | Retrospective cohort study | Micro | 78 (31/47) | Not specified | Median: not specified for total (57/51) | Number of T2 + T3: 102 (19/83) | SLNB alone versus SLNB + complete ALND | 73 for SLNB group/ 69 for ALND group | Recurrence and breast cancer-specific mortality |
| Macro | 198 (39/159) | ||||||||
| Galimberti et al. (2013) IBCSG 23–01 [13] | RCT | Micro | 931 (467/464) | Range: (1–2/1–2) | Median: not specified for total (54/53) | Number of > 2 cm: 281 (140/141) | SLNB alone versus SLNB + complete ALND | 5 years | DFS |
| Sola et al. (2013) AATRM 048/13/2000 [36] | RCT | Micro | 233 (121/112) | Not specified | Mean, not specified for total (53.2/ 55.3) | Mean, not specified for total (1.78/1.57) cm | SLNB alone versus SLNB + complete ALND | 62 | DFS |
| Park et al. (2014) [37] | Retrospective cohort study | Not specified | 2545 (197/ 2,348) | 94.9% ≤ 3/ 74.4% ≤ 3 | Mean, not specified for total (47.9/ 48.7) | Number of T2: 101 (67/34) | SLNB alone versus SLNB + complete ALND | 42 | OS |
| Snow et al. (2015) [38] | Retrospective cohort study | Not specified | 318 (60/258) | Range: (1–2/1–10) | Median: 54 (58, 53) | Mean, not specified for total (1.86/ 2.35) cm | SLNB alone versus SLNB + complete ALND | 45.5 | OS and recurrence |
| Tvedskov et al. (2015) [39] | Retrospective cohort study | Micro | 1,673 (136/ 1,537) | Not specified | Mean: 77 (71/ 78) | Number of > 2 cm: 562 (55/507) | SLNB alone versus SLNB + complete ALND | Not specified | Axillary recurrence and OS |
| ITC | 401 (104/ 297) | Number of > 2 cm: 175 (48/127) | |||||||
| Houvenaeghel et al. (2016) [40] | Retrospective cohort study | Micro | 1390 (191/1199) | More than 99% ≤ 2 | Median: 56 (not specified) | Number of > 2 cm: 264 (39/225) | SLNB alone versus SLNB + complete ALND | 60.4 | OS and recurrence-free survival |
| ITC | 619 (147/472) | Number of > 2 cm: 127 (23/104) | |||||||
| Youssef et al. (2016) [41] | Retrospective cohort study | Micro or ITC | 95 (57/38) | Range: (1–2/1–2) | Not specified for median or mean | Number of > 2 cm: 41 (23/18) | SLNB alone versus SLNB + complete ALND | 34.2 | Locoregional recurrence and lymphedema rate |
| Giuliano et al. (2017) ACOSOG Z0011 (Alliance) [42] | RCT | Not specified | 856 (436/420) | Not specified | Median: not specified for total (54/56) | Number of T2: 260 (126/134) | SLNB alone versus SLNB + complete ALND | 9.3 years | 10-year OS |
| Galimberti et al. (2018) IBCSG 23–01 [43] | RCT | Micro | 931 (467/464) | Range: (1–2/1–2) | Median: not specified for total (54/53) | Number of > 2 cm: 85 (36/49) | SLNB alone versus SLNB + complete ALND | 9.7 years | DFS |
| Lee et al. (2018) [44] | Retrospective cohort study | Not specified | 4,442 (1,268/3,174) | Range: (1–2/1–2) | Mean: 49.34 (49.55, 49.26) | Mean: 1.86 (1.81/1.88) | SLNB alone versus SLNB + complete ALND | 47.24 | Disease-specific survival and OS |
| Liu et al. (2018) [45] | Retrospective cohort study | Micro | 5,660 (3,689/1,971) | Range: (1/1) | Not specified for median or mean | 1709 (1072/637) | SLNB alone versus SLNB + complete ALND | Not specified | Breast cancer-specific survival |
| Arisio et al. (2019) [46] | Retrospective cohort study | Macro | 127 (95/32) | Not specified | Median: Median: not specified for total (57/54) | Number of T2 + T3: 278 (83/195) | SLNB alone versus SLNB + complete ALND | 84.4 | OS and relapse-free survival |
| Micro | 199 (115/84) | ||||||||
| Jung et al. (2019) [47] | Retrospective cohort study | Not specified | 1,697 (707/990) | Range: (1–2/1–2) | Median: 49 (50/50) | Mean: 2.1 (2.0/2.2) | SLNB alone versus SLNB + complete ALND | 50 | Disease recurrence |
| Kim et al. (2019) [48] | Retrospective cohort study | Not specified | 1,697 (1,539/158) | Range: (1–3/1–3) | Mean: 47.70 (47.59/48.77) | Mean: 2.8 (2.9/2.4) | SLNB alone versus SLNB + complete ALND | 93 | DFS and OS |
| Jung et al. (2020) [49] | Retrospective cohort study | Not specified | 23,138 (16,518/6,620) | Range: (1–2/1–2) | Median: 60 (62/59) | Number of T2: 9,464 (6,429/3,035) | SLNB alone versus SLNB + complete ALND | 41 | Breast cancer-specific mortality |
| Kim et al. (2020) [50] | Retrospective cohort study | Not specified | 883 (179/704) | Range: (1–2/1–2) | Mean: 50.80 (50.78/50.81) | Number of T2: 474 (96/378) | SLNB alone versus SLNB + complete ALND | 54 | OS |
| Sun et al. (2021) [51] | Retrospective cohort study | Not specified | 329 (128/201) | Range: (1–2/1–2) | Median: 53 (56/51) | Median: 2.3 (2.1/2.5) cm | SLNB alone versus SLNB + complete ALND | 51 | locoregional and distant recurrence and OS |
| Sanvido et al. (2021) [52] | Retrospective cohort study | Mixed with Macro, ITC and Micro | 97 (56/41) | Range (1–2/1–24) | Mean: 57.8 (58.3/56.3) | Mean: 1.7 (1.8/2/2) cm | SLNB alone versus SLNB + complete ALND | 4.3 years | OS and the locoregional recurrence |
| Bartels et al. (2022) EORTC 10981–22023 AMAROS Trial [53] | RCT | Mixed with Macro, ITC and Micro | 1425 (681/744) | Median (2/2) | Median: not specified (55/56) | Median: not specified (18/17) mm | SLNB + ART versus SLNB + complete ALND | 10.0 years | Axillary recurrence rate |
| Gao et al. (2022) [54] | Retrospective cohort study | Mixed with Macro, ITC and Micro | 1050 (245/805) | Range: (1–2/1–2) | Median: 51 (not specified) | Number of T2: 501 (92/409) | SLNB alone versus SLNB + complete ALND | 36 | Locoregional recurrence |
| Houvenaeghel et al. (2022) [55] | Retrospective cohort study | Micro | 1421 (185/1266) | 99.5% of the patients were ≤ 2 | Median: not specified (58.5/55.5) | > 20 mm: 260 (28/232) | SLNB alone versus SLNB + complete ALND | 54 | OS and DFS |
| Tinterri et al. (2022) SINODAR-ONE trial [56] | RCT | Macro | 879 (440/439) | Range: (1–2/1–2) | Mean 56.2 (56.2/56.1) | Not specified | SLNB alone versus SLNB + complete ALND | 34 | OS |
| Zhou et al. (2022) [57] | Retrospective cohort study | Micro | 13848 (1965/ 1883) | Not specified | Mean: 57.95 (58.14/56.77) | Mean 23.64 (22.46/ 31.17) mm | SLNB alone versus SLNB + complete ALND | 48 | OS |
Abbreviation: SLNB sentinel lymph node biopsy, ALND axillary lymph node dissection, ART axillary radiotherapy, IQR interquartile range, RCT randomized controlled trial, OS overall survival, ITC SLN isolated tumor cells, Micro SLN micro-metastases, Macro SLN macro-metastases, DFS disease-free survival