Table 2.
Novel anti-HER2 drugs and dual anti-HER2 blockade in the neoadjuvant setting.
| Study [ref.] |
Phase | n | Neoadjuvant therapy | pCR (%) |
||
|---|---|---|---|---|---|---|
| All | HR+ | HR– | ||||
| Neo-ALTTO [Baselga et al. 2012] | 3 | 455 | Lapatinib + paclitaxel Trastuzumab + paclitaxel Lapatinib + trastuzumab + paclitaxel (anti-HER2 therapy alone 6 weeks → concomitant with weekly paclitaxel × 12 weeks) |
20 28 47 (ypT0/isypN0) |
16 23 42 |
34 36 61 |
| NSABP B-41 [Robidoux et al. 2013] | 3 | 519 | Trastuzumab + CHT Lapatinib + CHT Trastuzumab + lapatinib + CHT [CHT: AC (4C) → weekly P (day 1, 8, 15, 28 × 4C)] |
49 47 60 (ypT0/isypN0) p = 0.056 (combination versus trastuzumab) p = 0.78 (lapatinib versus trastuzumab) |
45 42 55 |
58 55 70 |
| CHER-LOB [Guarneri et al. 2012] | 2 | 121 | Trastuzumab + CHT Lapatinib + CHT Trastuzumab + lapatinib + CHT [CHT: weekly P (12 weeks) → FEC75 (4C)] |
25 26 47 (ypT0/isypN0) |
25 23 36 |
27 36 56 |
| US Oncology [Holmes, 2013] | 2 | 100 | Trastuzumab + CHT Lapatinib + CHT Trastuzumab + lapatinib + CHT [CHT: FEC75 (4C) → weekly P (12 weeks)] |
54 45 74 |
38 23 71 |
69 63 78 |
| CALGB 40601 [Carey et al. 2013] | 3 | 305 | Trastuzumab + paclitaxel Lapatinib + trastuzumab + paclitaxel Lapatinib + paclitaxel (closed early) (16 weeks of neoadjuvant treatment) |
40 51 32 p = 0.11 (ypT0/is) |
||
| NeoSphere [Gianni et al. 2012] | 2 | 417 | Trastuzumab + docetaxel Trastuzumab + pertuzumab + docetaxel Trastuzumab + pertuzumab Pertuzumab + docetaxel (12 weeks of neoadjuvant treatment) |
29 46 17 24 (ypT0/is) |
20 26 6 17 |
37 63 27 30 |
| TRYPHAENA [Schneeweiss et al. 2013] | 2 | 225 | FEC + trastuzumab + pertuzumab × 3 →D + trastuzumab + pertuzumab × 3 FEC × 3 → D + trastuzumab + pertuzumab × 3 D + carboplatin + trastuzumab + pertuzumab × 6 |
62 57 66 (ypT0/is) |
46 48 50 |
79 65 84 |
| TBCRC 006 [Rimawi et al. 2013] | 2 | 64 | Lapatinib + trastuzumab ± letrozol (12 weeks of neoadjuvant treatment) |
27 (ypT0/is) |
21 | 36 |
A, adriamicine; C, cycle; D, docetaxel; FEC, 5 fluorouracil + epirubicin + cyclophosphamide; HER2, human epidermal growth factor receptor 2; P, paclitaxel; pCR, pathological complete response rate.