Table 2.
Randomized trials with neoadjuvant lapatinib versus trastuzumab or lapatinib versus trastuzumab versus lapatinib plus trastuzumab.
| Study (ref.) | No. of pts | Clinical stage | Neoadjuvant chemotherapy | Neoadjuvant anti-HER2 therapy | pCR rate (%) | cCR (%) | Breast-conserving surgery rate (%) |
|---|---|---|---|---|---|---|---|
| NeoALTTO [12], phase III |
455 | T > 2 cm, any N | Weekly P (12 w) | (i) Trastuzumab 4 → 2 mg/kg/w (ii) Lapatinib 1500 mg/d (iii) Lapatinib 1000 mg/d + trastuzumab 2 mg/kg/w |
28% 20% 47% |
NR | 39% 43% 41% |
| GeparQuinto [13], phase III |
615 | cT3/4a–d or HR− or cT2cN+ HR+ or cT1pNSLN+ HR+ | EC (4 c) → Doc (4 c) | (i) Trastuzumab 8 → 6 mg/kg/3 w (ii) Lapatinib 1250 mg/d (adjustment to 1000 mg/d) |
44% 30% |
33% 28.5% |
64% 59% |
| CHER-LOB [14], phase II |
121 | II–IIIA | Weekly P (12 w) → FEC (4 c) | (i) Trastuzumab 4 → 2 mg/kg/w (ii) Lapatinib 1500 mg/d (iii) Lapatinib 1000 mg/d + trastuzumab 2 mg/kg/w |
25% 26% 47% |
NR | 67% 58% 69% |
| NSABP B-41 [15], phase III |
464 | T > 2 cm, any N | AC (4 c) → P (D1, 8, 15, 28; 4 c) | (i) Trastuzumab 4 → 2 mg/kg/w (ii) Lapatinib: 1250 mg/d (iii) Lapatinib 750 mg/d + trastuzumab 2 mg/kg/w |
49% 47% 60% |
82% 70% 77% |
54% 46% 50% |
| Holmes et al. [16], phase II |
100 | II-III | FEC75 (4 c) → weekly P (12 w) | (i) Trastuzumab 4 → 2 mg/kg/w (ii) Lapatinib 1250 mg/d (iii) Lapatinib 750 mg/d + trastuzumab 2 mg/kg |
54% 45% 74% |
NR | NR |
| GEICAM 2006-14 [17], phase II |
99 | T > 2 cm or N+ any T | EC (4 c) → Doc (4 c) | (i) Trastuzumab: 8 → 6 mg/kg/3 w (ii) Lapatinib: 1250 mg/d |
48% 24% |
NR | 58% 58% |
pCR: pathological complete response; cCR: clinical complete response; NR: not reported; HR: hormonal receptors; EC: Epirubicin + Cyclophosphamide; Doc: Docetaxel; FEC: 5fluoro-uracile-epirubicine-cyclophosphamide; AC: adriamycin-cyclophosphamide.