Table 1.
Trials in the neoadjuvant setting.
| Trial | Phase | Treatment | n | pCR | DFS | OS |
|---|---|---|---|---|---|---|
| TRAIN-2 | III | A: FEC + H + P → Pac + CBDA + H + P B: Pac + CBDA |
438 | A: 67 (60–73) B: 68 (61–74) |
A: 3 y EFS: 92.7 (89.3–96.2) B: 3 y EFS: 93.6 (90.4–96.9) |
A: 3 y: 97.7 (95.7–99.7) B: 3 y: 98.2 (96.4–100) |
| WSG-ADAPT | II | A: (H + P) B: (H + P) + Pac |
134 | A: 34.4 (24.7–45.2) B: 90.5 (77.4–97.3) |
||
| KRISTINE | III | A: T-DM1 + P B: TCH + P |
444 | A: 44 B: 56 |
A: 3 y IDFS: 93 (89.4–96.7) B: 3 y IDFS: 92 (86.7–97.3) |
A: 3 y: 97 (94.6–99.4) B: 3 y: 97.6 (95.5–99.7) |
| TBCRC006 | II | Lapatinib + H | 64 | 27 | ||
| TBCRC023 | II | A: Lapatinib + H B: Lapatinib + H |
97 | A: 12 B: 28 |
||
| PER-ELISA | II | A: Letrozole + H + P B: Pac + H + P |
61 | A: 20.5 (11.1–34.5) B: 81 (57–93.4) |
||
| SOLTI-PAMELA | II | Lapatinib + H | 151 | 30 (23–39) | ||
| NeoSphere | II | H + P | 107 | 16.8 (10.3–25.3) | 5 y DFS: 80 (70–86) |
|
| PHERGain | II | A: TCHP B: HP |
356 | A: 57.7 (47.4–69.4) B: 35.4 (29.9–41.3) |
||
| NeoSphere | II | A: H + T B: P + H + T C: P + H D: P + T |
417 | A: 29 (20.6–38.5) B: 45.8 (36.1–55.7) * C: 16.8 (10.3–25.3) † D: 24.0 (15.8–33.7) ‡ * p = 0.0141 vs. A † p = 0.0198 vs. A ‡ p = 0.003 vs. B |
5 y DFS A: 81 (71–87) B: 86 (77–91) C: 73 (64–81) D: 73 (63–81) |
|
| TRYPHAENA | II | A: FEC + H + P→ THP B: FEC→ THP C: TCHP |
225 | A: 56.2 B: 54.7 C: 63.6 |
||
| BERENICE | II | A: ddAC→Pac + H + P B: FEC → THP |
400 | A: 61.8 (54.7–68.6) B: 60.7 (53.6–67.5) |
||
| Meta-analysis (CALGB 40601, Cher-LOB, NSABP-B41, NeoALTTO) | II/III | A: ChT + H B: ChT + H + Lapatinib |
1410 | RFS Pooled HR 0.62 (0.46–0.85) |
OS Pooled HR 0.65 (0.43–0.98) |
|
| Cher-LOB | II | A: ChT + H B: ChT + Lapatinib C: ChT + H + Lapatinib ChT: Pac → FEC |
121 | A: 25 (13.1–36.9) B: 26.3 (14.5–38.1) C: 46.7 (34.4–58.9) |
A: 5 y RFS: 77.8 B: 5 y RFS: 77.1 C: 5 y RFS: 85.5 HR 0.52 (0.23–1.15) (A vs. C) |
HR 1.00 (0.31–3.27) (A vs. C) |
| NSABP-B41 | III | A: ChT + H B: ChT + Lapatinib C: ChT + H + Lapatinib ChT: AC → Pac |
529 | A: 52.5 (44.9–59.5) B: 53.2 (45.4–60.3) C: 62 (54.3–68.8) |
A: 5 y RFI: 84.3 B: 5 y RFI: 78.6 C: 5 y RFI: 90 EFS: HR 0.66 (0.34–1.25) (A vs. C) |
A: 5 y: 94.5 B: 5 y: 89.4 C: 5 y: 95.7 HR 1.00 (0.24–1.67) (A vs. C) |
| NeoALTTO | III | A: H + ChT B: Lapatinib + ChT C: H + Lapatinib + ChT ChT: Pac |
455 | 29.5 (22.4–37.5) 24.7 (18.1–32.3) 51.3 (43.1–59.5) |
6 y EFS: 67 6 y EFS: 67 6 y EFS: 74 EFS: HR 0.98 (0.64–1.91) (A vs. C) |
6 y: 82 6 y: 79 6 y: 85 HR 0.85 (0.49–1.86) (A vs. C) |
| CALGB 40601 | III | A: H + ChT B: Lapatinib + ChT C: H + Lapatinib + ChT ChT: Pac |
305 | 46 (37–55) 32 (22–45) 56 (47–65) |
7 y EFS: 79 7 y EFS: 69 7 y EFS: 93 EFS: HR 0.32 (0.14–0.71) (A vs. C) |
7 y: 88 7 y: 84 7 y: 96 HR 0.34 (0.12–0.94) (A vs. C) |
T-DM1: trastuzumab-emtansine; ChT: chemotherapy; Pac: paclitaxel; H: trastuzumab; P: Pertuzumab: T: docetaxel; A: adriamycin; C: cyclophosphamide; dd: dose dense; CBDA: carboplatin; F: 5-fluorouracil; E: epirubicin; pCR: pathologic complete response; DFS: disease-free survival; OS: overall survival; EFS: events free survival; RFI: relapse free interval; RFS: relapse free survival; IDFS invasive disease-free survival; y: year. pCR, DFS and OS are % (95% CI).