Table 2.
Trials in the adjuvant setting.
| Trial | Phase | Treatment | n | DFS | OS |
|---|---|---|---|---|---|
| HERA | III | A: 1 y H B: 2 y H C: Observation |
3389 | A: 2 y DFS: 85.8 C: 2 y DFS: 77.4 p < 0.0001 A: 10 y DFS: 69 B: 10 y DFS: 69 C: 10y DFS: 63 HR 0.76 (0.68–0.86) (A vs. C) |
A: 2 y: 96 C: 2 y: 95.1 p = 0.26 A: 12 y: 79 B: 12 y: 80 C: 12 y: 73 HR 0.74 (0.64–0.86) (A vs. C) |
| BCIRG-006 | III | A: AC →T B: AC → T → 1 y H C: TC → 1 y H |
3222 | A: 5 y DFS: 75 B: 5 y DFS: 84 C: 5 y DFS: 81 p < 0.001 (A vs. B) p = 0.04 (A vs. C) A: 10 y DFS: 67.9 B: 10 y DFS: 74.6 C: 10 y DFS: 73 p < 0.0001 (A vs. B) p = 0.0011 (A vs. C) |
A: 5 y: 87 B: 5 y: 92 C: 5 y: 91 p < 0.001 (A vs. B) p = 0.04 (A vs. C) A: 10 y: 78.7 B: 10 y: 85.9 C: 10 y: 83.3 p < 0.0001 (A vs. B) p = 0.0075 (A vs. C) |
| NSABP B-31 | III | A: AC →Pac B: AC → Pac + 1 y H |
3351 | A: 10 y DFS: 62.2 B/C: 10 y DFS: 73.7 p ≤ 0.001 HR 0.6 (0.53–0.68) |
A: 10 y OS: 75.2 B/C: 10 y OS: 85 p = 0.001 HR 0.63 (0.54–0.73) |
| NCCTG N9831 | III | A: AC → Pac B: AC → Pac + 1 y H C: AC → Pac → 1 y H |
|||
| Short-HER | III | A: AC or EC → T or Pac → 1 y H B: T → FEC → 9 w H |
1254 | A: 5 year-DFS: 88.5 B: 5 year-DFS: 85.5HR 1.13 (90% CI, 0.89–1.42) 8.7 y DFS: HR 1.09 (90% CI, 0.88–1.35) |
A: 5 y: 95.2 B: 5 y: 95 HR 1.07 (CI 90%, 0.74–1.56) A: 9 y: 90 B: 9 y: 91 HR 1.18 (CI 90%, 0.86–1.62) |
| SOLD | III | A: T + 9 w H →FEC B: T → FEC → 1 y H |
2174 | A: 5 y DFS: 88 B: 5 y DFS: 90.5 HR 1.39 (CI 90%, 1.12–1.72) |
A: 5 y: 94.7 B: 5 y: 95.9 HR 1.36 (CI 90%, 0.98–1.89) |
| PHARE | III | A: 6 m H B: 12 m H |
3384 | A: 7.5 y DFS: 78.8 B: 7.5 y DFS: 79.6 p = 0.39 HR 1.08 (0.93–1.25) |
7.5 y OS: HR 1.13 (0.92–1.39) |
| PERSEPHONE | III | A: ChT + 6 m H B: ChT + 1 y H |
4089 | A: 4 y DFS: 89.4 B: 4 y DFS: 89.8 p = 0.011 HR 1.07 (CI 90%, 0.93–1.24) |
A: 4 y: 93.8 B: 4 y: 94.8 HR 1.14 (CI 90%, 0.95–1.37) |
| APT | II | Pac + 12 w H → 9 m H | 406 | 7 y DFS: 93.3 (90.4–96.2) |
7 y: 95 (92.4–97.7) |
| APHINITY | III | A: ChT + 1 y H B: ChT + H + 1 y P |
4800 | A: 6 y DFS: 88 B: 6 y DFS: 91 HR 0.76 (0.64–0.91) |
A: 6 y: 94 B: 6 y: 95 p = 0.17 Immature data |
| ALTTO | III | A: ChT + H → lapatinib B: ChT + H + lapatinib C: ChT + H |
8381 | A: 6.9 y DFS: 84 B: 6.9 y DFS: 85 C: 6.9 y DFS: 82 HR 0.86 (0.74–1.0) (B vs. C) HR 0.93 (0.81–1.08) (A vs. C) |
A: 6 y: 92 B: 6 y: 93 C: 6 y: 91 HR 0.86 (0.7–1.06) (B vs. C) HR 0.88 (0.71–1.08) (A vs. C) |
| KAITLIN | III | A: AC →T-DM1 + P B: AC → P + H + P |
1846 | A: 3 y DFS: 93 B: 3 y DFS: 94 p = 0.827 HR 0.98 (0.72–1.32) |
Immature data for OS |
| ExteNET | III | A: Neratinib 1 y after H-based therapy B: Observation after H-based therapy |
2840 | 5 y DFS in HR+/≤ 1 y post-H: A: 90.8 B: 85.7 HR 0.58 (0.41–0.82) 5 y DFS in HR+/>1 y post-H and residual disease after NA: benefit of 7.4% in group A vs. B HR 0.60 (0.33–1.07) |
8y OS in HR+/≤ 1 y post-H: A: 91.5 B: 89.4 HR 0.79 (0.55–1.13) 8y OS in HR+/>1 y of prior H and residual disease after NA: benefit of 9.1% in group A vs. B HR 0.47 (0.23–0.92) |
| KATHERINE | III | A: T-DM1 × 14 cycles B: H × 14 cycles |
1486 | A: 3 y DFS: 88.3 B: 3 y DFS: 77 HR 0.5 (0.39–0.64) |
Immature data for OS |
T-DM1: trastuzumab-emtansine; T: docetaxel; Pac: paclitaxel; H: trastuzumab; P: pertuzumab; F: 5-fluorouracil; E: epirubicin; A: adriamycin; C: cyclophosphamide; ChT: chemotherapy; pCR: pathologic complete response; DFS: disease-free survival; OS: overall survival; y: year; m: month; w: week; NA: neoadjuvant treatment; HR+: hormone receptor positive pCR, DFS and OS are % (95% CI).