Table 1 Characteristics of the included studies

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