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Table 1 Characteristics of the included studies

From: Axillary surgery in women with sentinel node-positive operable breast cancer: a systematic review with meta-analyses

  ATTRM-048-13-2000 IBCSG-23-01 ACOSOG Z0011 AMAROS OTOASOR
Study years 2001-2008 2001-2010 1999-2004 2001-2010 2002-2009
Comparison SLND + ALND v SLND SLND + ALND v SLND SLND + ALND v SLND ALND v aRT ALND v aRT
ALND intervention Breast conservation therapy or mastectomy + SLND + ”complete ALND” but not otherwise specified Surgical resection of primary tumour + SLND + ALND not otherwise specified Breast conserving surgery + SLND + ALND consisting of removal of all level I and II nodes on affected side with at least 10 identified nodes per surgical specimen Breast-conserving treatment (including whole-breast radiotherapy or mastectomy with/without radiotherapy to the chest wall) + ALND (level I and II; at least 10 nodes) Breast-conserving surgery or mastectomy + ALND (level I and II; at least 6 nodes)
Comparison intervention Breast conservation therapy or mastectomy + SLND Surgical resection of primary tumour + SLND Breast conserving surgery + SLND: After the blue or hot nodes were removed any remaining axillary nodes were palpated and removed as SLNs if suggestive of disease Breast-conserving treatment (including whole-breast radiotherapy or mastectomy with/without radiotherapy to the chest wall) + aRT, including the contents of all three levels of the axilla and the medial part of the supraclavicular fossa; 25 fractions of 2 Gy Breast-conserving surgery or mastectomy + aRT including the contents of all three levels of the axilla and the supraclavicular fossa; 25 fractions of 2 Gy
Country Spain Europe, South America, Australia USA Europe Hungary
Number ALND 112 464 436 744 244
Number Comparison 121 467 420 681 230
Age ALDN (years) Mean = 55.3 (range 29–75) Median = 53 (range 28–81) Median = 56 (range 24–92) Median = 56 (IQR 48–64) Mean = 54.7 (range 26–74)
Age comparison (years) Mean = 53.2 (range 33–75) Median = 54 (range 26–81) Median = 54 (range 25–90) Median = 55 (IQR 48–63) Mean = 55.2 (range 27–74)
Follow up Median = 5.17 (range 2–9.17) years Median = 5 (IQR 3.6–7.3) years Median = 6.3 (IQR 5.2–7.7) years Median = 6.1 (IQR 4.1–8) years Mean = 41.9–42.3 months
Radiotherapy Total breast (not axillary) both arms Intraoperative with/without conventional post-operative RT: SLND alone: N = 410; ALND: N = 413 Whole breast RT. Some patients also received RT to the supraclavicular area (total N = 89). Adjuvant aRT after ALND when ≥ 4 positive nodes were found. Adjuvant RT received to breast/chest wall/internal mammary chain: aRT: N = 546/51/65; ALND: N = 597/34/72. ALND: Postoperative RT to the regional nodes when ≥ 4 positive nodes (pN2a-3a) or 1-3 positive nodes (pN1a) with other high-risk characteristics. 232 patients received RT to the breast/chest wall, 76 patients received RT to the axillary/supraclavicular nodes. aRT: 208 patients received RT to the breast/chest wall, 230 patients received RT to the axillary/supraclavicular nodes.
Chemo-therapy 41 ALND; 42 SLND alone 33 SLND alone; 42 ALND 243 ALND; 253 SLND alone Yes according to local GLs 190 ALND; 159 aRT
Hormone therapy 10 ALND; 7 SLND alone 315 Surgery alone; 292 ALND 195 ALND; 203 SLND alone Yes according to local GLs 213 ALND; 204 aRT
Both chemo- and hormone therapy 51 ALND; 65 SLND alone 103 Surgery alone; 107 ALND Not reported Not reported 159 ALND; 133 aRT
Baseline differences Detection by palpation more in ALND Appear comparable Appear comparable Appear comparable More pT2-3 tumours in ALND
Intention-to-treat analyses 2 SLND alone and 4 ALND patients lost to follow up and not included in analyses Yes for survival and disease-free survival. For the long term adverse events data were analysed per protocol Yes for overall survival and recurrence Yes Unclear
Notes 14/247 randomised patients dropped out Non-inferiority trial; closed early Closed early Non-inferiority trial Equivalence trial
  1. SLND sentinel lymph node dissection, ALND axillary lymph node dissection, aRT axillary radiotherapy, RT radiotherapy, IQR inter-quartile range