Table 2.
Best overall response (Japanese ITT population) a
|
Dacomitinib n = 40 |
Gefitinib n = 41 |
|
|---|---|---|
| Type of response, n (%) | ||
| Complete response | 1 (2.5) | 1 (2.4) |
| Partial response | 29 (72.5) | 30 (73.2) |
| Stable disease | 9 (22.5) | 5 (12.2) |
| Progressive disease | 1 (2.5) | 2 (4.9) |
| Not evaluable | 0 (0.0) | 3 (7.3) |
| Objective response rate (95% CI) | 75.0 (58.8‐87.3) | 75.6 (59.7‐87.6) |
| 2‐sided P b | 0.9493 | |
| Duration of response in responders, mo | ||
| Median (95% CI) | 17.5 (10.2‐34.3) | 8.3 (5.6‐12.9) |
| HR (95% CI) | 0.435 (0.224‐0.843) | |
| 2‐sided P c | 0.0112 | |
Cutoff date: July 29, 2016.
Abbreviations: CI, confidence interval; HR, hazard ratio; ITT, intention‐to‐treat.
a
By blinded independent review committee.
b
P (2‐sided) is from Pearson’s chi‐square test.
c
P (2‐sided) is from log‐rank test.