Table 3.
Response to treatment (intention-to-treat population)
| Response | Overall population (n = 24) | HER2 IHC 1 (n = 3) | HER2 IHC 2 (n = 9) | HER2 IHC 3 (n = 12) | HER2 GCN < 5 (n = 9) | HER2 GCN 5–10 (n = 8) | HER2 GCN ≥ 10 (n = 4) | |||
|---|---|---|---|---|---|---|---|---|---|---|
| Type of response | ||||||||||
| Complete | 1 | 0 | 0 | 1 | 0 | 0 | 1 | |||
| Partial | 10 | 0 | 3 | 7 | 2 | 4 | 3 | |||
| Stable disease ≥6 weeks | 4 | 1 | 2 | 1 | 3 | 0 | 0 | |||
| Progression | 8 | 1 | 4 | 3 | 3 | 4 | 0 | |||
| Death | 1 | 1 | 0 | 0 | 1 | 0 | 0 | |||
| Objective response rate (95% CI) | 46% (26–67%) | 0% (0–71%) | 33% (7–70%) | (35–90%) | (3–60%) | 50% (16–84%) | 100% (40–100%) | |||
| Disease control rate after 6 weeks (95% CI) | 63% (41–81%) | 33% (1–91%) | 56% (21–86%) | 75% (43–95%) | 56% (21–86%) | 50% (16–84%) | 100% (40–100%) | |||
| Duration of response | ||||||||||
| Median no. of months | 5.6 | n.a. | 5.6 | 4.2 | 2.8 | 3.0 | 4.2 | |||
| (95% CI) | (3.8–7.3) | (1.1–10.1) | (2.0–6.4) | n.a. | (0.3–5.7) | (1.5–6.9) | ||||
| Progression-free survival | ||||||||||
| Median no. of months | 2.3 | 1.4 | 1.7 | 5.4 | 1.7 | 1.4 | 5.6 | |||
| 95% CI | (0–5.8) | (0–3.3) | (0.2–3.1) | (4.0–6.7) | (0–3.3) | (0–5.6) | (1.9–9.3) | |||
GCN gene copy number