Table 2.
pCR from key phase II/III neoadjuvant trials of novel HER2 inhibitors.
| Trial/agent | Phase | Regimen | N | pCR (All HER2 +) |
pCR (HER2+ HR +) |
pCR (HER2+ HR−) |
|---|---|---|---|---|---|---|
| Lapatinib | ||||||
| GeparQuinto | III | Chemo + lapatinib | 615 | 22.7% | NR | NR |
| Untch et al.(2012) | Chemo + trastuzumab | 30.3% | ||||
| NeoALTTO | III | Chemo + lapatinib | 455 | 24.7% | 16.1% | 33.7% |
| Baselga et al.(2012b) | Chemo + trastuzumab | 29.5% | 22.7% | 36.5% | ||
| Chemo + lapatinib + trastuzumab | 51.3% | 41.6% | 61.3% | |||
| CHER-LOB | II | Chemo + lapatinib | 121 | 26.3% | NR | NR |
| Guarneri et al.(2012) | Chemo + trastuzumab | 25.0% | ||||
| Chemo + lapatinib + trastuzumab | 46.7% | |||||
| NSABP B-41 | III | Chemo + lapatinib | 519 | 53.2% | 48.0% | 60.6% |
| Robidoux et al.(2013) | Chemo + trastuzumab | 52.5% | 46.7% | 65.5% | ||
| Chemo + lapatinib + trastuzumab | 62.0% | 55.6% | 73.0% | |||
| Neratinib | ||||||
| NSABP FB-7 | II | Chemo + neratinib | 126 | 33.3% | 27.6% | 46.2% |
| Jacobs et al.(2015) | Chemo + trastuzumab | 38.1% | 29.6% | 57.1% | ||
| Chemo + neratinib + trastuzumab | 50.0% | 30.4% | 73.7% | |||
| I-SPY 2 (HER2+ cohort) | II | Chemo + neratinib | 87 | 39% | 30% | 56% |
| Park et al.(2016) | Chemo + trastuzumab | 23% | 17% | 33% | ||
| Pertuzumab | ||||||
| NeoSphere | II | Chemo + trastuzumab | 417 | 29.0% | 20.0% | 36.8% |
| Gianni et al., (2012) | Chemo + pertuzumab + trastuzumab | 45.8% | 26.0% | 63.2% | ||
| Pertuzumab + trastuzumab | 16.8% | 5.9% | 27.3% | |||
| Chemo + pertuzumab | 24.0% | 17.4% | 30.0% | |||
| TRYPHAENA | II | Pertuzumab + trastuzumab + chemo (FEC → docetaxel) | 225 | 61.6% | 46.2% | 79.4% |
| Schneeweiss et al.(2013) | FEC → pertuzumab + trastuzumab + docetaxel | 57.3% | 48.6% | 65.0% | ||
| Chemo + pertuzumab + trastuzumab | 66.2% | 50.0% | 83.8% | |||
| T-DM1 | ||||||
| KRISTINE | III | Chemo + pertuzumab + trastuzumab | 444 | 55.7% | 44.8% | 72.4% |
| Hurvitz et al.(2016) | ||||||
| T-DM1 + pertuzumab | 44.4% | 37.9% | 53.8% | |||
| ADAPT | II | T-DM1 | 375 | NR | 41.0% | NR |
| Harbeck et al. (2016) | T-DM1 + ET | 41.5% | ||||
| Trastuzumab + ET | 15.1% |
Chemo, chemotherapy; ET, endocrine therapy; FEC, 5-fluorouracil, epirubicin, cyclophosphamide; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; NR, not reported; pCR, pathologic complete response; T-DM1, trastuzumab emtansine.