Table 1.
Margin status and additional therapies
| Study | Study type | Inclusion period | Comparison | BCS after NACT (vs primary BCS) | Lobular carcinoma (%) | Definition positive margin | Positive margins (%) | Additional boost (%) | Re-excision (%) | Secondary mastectomy (%) | pCR (%) | OCEBM evidence |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Assersohn (1999) [24] | Randomized controlled trial | 1990–1995 | NACT 4x plus adjuvant 4x vs 8x adjuvant chemotherapy | 98 vs 86 | NR | inked margin close < 1 mm | 40% vs 36% | NR | 0% vs 0% | 0% vs 0% | NR | 3 |
| Boughey (2006) [25] | Prospective cohort (RCT data) | 1998–2005 | NACT vs adjuvant chemotherapy | 162 (vs 101) | NR | ≤ 2 mm | NR | NR | 12.3% vs 13.9% | 7.4% vs 9.9% | NR | 3 |
| Waljee (2008) [26] | RSCC | 2002–2006 | NACT vs adjuvant chemotherapy | 65 (vs 211) | NR | NR | NR | NR | 31.3% vs 58.8% (p = 0.001) | 14.1% vs 16.7% (p = 0.001) | NR | 4 |
| Komenaka (2011) [27] | RSCC | 2002–2009 | NACT vs adjuvant chemotherapy | 39 (vs 68) | NR | Inked margin close < 1 mm | 23% vs 46% (close or positive) (p = 0.04) | NR | 18% vs 41% (p = 0.01) | 2.6% vs 8.8% | NR | 4 |
| Tiezzi (2008) [31] | RSCC | 1990–2003 | NACT vs no NACT | 88 (vs 191) | NR | ≤ 1 mm | 19.3% vs 13.1% | NR | 0% vs 0% | 0% vs 0% | NR | 4 |
| Christy (2009) [29] | RSCC | 2002–2007 | NACT vs no NACT | 31 (vs 62) | NR | Positive NR close<1mm | 10% vs 32% (p < 0.01) | NR | 3.2% vs 17.7% (p < 0.01) | 3.2% vs 21.0% (p < 0.01 ) | NR | 4 |
| Karanlik (2015) [28] | RSCC | 2008–2011 | NACT vs no NACT | 80 (vs 116) | NR | < 5 mm | 5% vs15.5%* (p = 0.02) | NR | 3.8% vs 7.8% (p = 0.02) | 1.3% vs 7.8% (p = 0.02) | NR | 4 |
| Volders (2016) [33] | RSCC | 2012–2013 | NACT vs no NACT | 626 (vs 9275) | 11.3% vs 9.0% | Inked margin | 27.3% vs 16.4% (p < 0.001) | NR | 4.0% vs 2.3% (p < 0.001) | 5.1% vs 3.0% (p < 0.001) | 15% | 4 |
| Sadetzki (2005) [34] | RSCC | 1995–2001 | 100 | 9% | < 5 mm invasive < 10 mn DCIS | NR | NR | 10% | 21% | NR | 4 | |
| Fukutomi (2006) [35] | RSCC | NR | 113 | NR | NR | 24.7% | NR | 2nd procedures 11.5% | NR | 4 | ||
| Straver (2010) [36] | RSCC | 2000–2007 | 135 | 15.6% | ≤ 2 mm | 24% | 15.6% | 1.5% | 6.7% | NR | 4 | |
| van Riet (2010) [47] | RSCC | 2003–2008 | 47 | 6.4% | Inked margin | 6.4% | 2.1% | 4.3% | 40.4% | 4 | ||
| Gobardhan (2012) [38] | RSCC | 2009–2010 | 85 | 6% | Inked margin | 8.2% | 4.8% | 0% | 3.5% | 31% | 4 | |
| Mazouni (2013) [39] | RSCC | 2002–2010 | BCS vs OPBS | 259; 214 vs 45 | 6.1%vs 4.4% | NR | 14.1% vs 15.6% | NR | 9% vs 2% | 18% vs 24% | 24.3% vs 22.2% | 4 |
| Donker (2013) [40] | RSCC | 2007–2010 | ROLL vs seed localization | 154; 83 vs 71 | 7% vs 4% | Inked margin | 13% vs 13% | 6.0% vs 4.2% | 1% vs 4% | 6% vs 4% | 30% vs 38% | 4 |
| Gerber (2014) [41] | Multicenter RCT | 2007–2010 |
NACT ECDB vs NACT ECD |
502 | NR | NR | 26.5% | NR | 2nd procedures 26.5% | NR | 3 | |
| Krygh (2014) [30] | RSCC | 2005–2012 | NACT vs no NACT | 83 vs 1252 | NR |
< 5 mm < 2 mm (after Oct 2009) |
NR | NR | 8.8% vs 10.3% | NR | NR | 4 |
| Ramos (2014) [42] | Prospective single center cohort | 2008–2012 | 58 | 5.2% | < 2 mm | 12.1% | 0 (0%) | 6.9% | 5.2% | 31% | 4 | |
| Amabile (2015) [32] | RSCC | 2009–2013 | NACT vs no NACT | 44 vs 85 | 2.3% vs 21.2% | Positive close < 1 mm | 27.3% vs 29.4% positive or close | NR | 2nd procedures 27.3% vs 29.3% | 28.1% | 4 | |
| Truin (2016) [43] | Retrospective national database | 2008–2012 | ILC VS IDC | 1539; 113 vs 1426 | 100% vs 0% | NR | 33.6% vs 8.6% | NR | 7.1% vs 3.9% | 26.5% vs 4.7% | NR | 4 |
| Rubio (2016) [44] | Single center cohort | 2008–2012 | IOUS vs WL | 214; 145 vs 69 | 8.3% vs 2.9% | Inked margin | 3.4% vs 4.3% | NR | 8.9% vs 2.9% | 0.7% vs 5.8% | 22.7% vs 34.7% | 4 |
| Chauhan (2016) [45] | Prospective single center cohort | 2012–2014 | BCS vs OPBS™ | 100; 43 vs 57 | 2% vs 2% | Inked margin | 8% vs 2% | NR | 2% vs 0 | 5% vs 2% | NR | 4 |
NR not reported, NACT neoadjuvant chemotherapy, ILC invasive lobular carcinoma, IDC invasive ductal carcinoma, IOUS intra operative ultrasound, WL wire guided lumpectomy, BCS breast conserving surgery, OPBS oncoplastic breast surgery, RSCC retrospective single center cohort