Table 2.
Efficacy in patients with CNS metastases at baseline
| Endpoint | N + C (n = 51) | L + C (n = 50) |
|---|---|---|
| Progression‐free survival a | ||
| Restricted mean (95% CI), b mo | 7.8 (5.6–10.1) | 5.5 (3.8–7.2) |
| Median (95% CI), mo | 5.6 (3.7–7.1) | 4.3 (2.8–5.6) |
| Hazard ratio (95% CI) | 0.66 (0.41–1.05) | |
| p value (Log‐rank) | .074 | |
| Overall survival | ||
| Restricted mean (95% CI), b mo | 16.4 (13.4–19.5) | 15.4 (12.1–18.8) |
| Median (95% CI), mo | 13.9 (8.9–17.5) | 12.4 (9.7–16.9) |
| Hazard ratio (95% CI) | 0.90 (0.59–1.38) | |
| p value (Log‐rank) | .635 | |
| Time to intervention for CNS disease | ||
| 12‐month cumulative incidence (95% CI), % | 25.5 (14.4–38.1) | 36.0 (22.9–49.3) |
| p value (Gray's test) | .430 | |
| Progressive CNS disease c | ||
| 12‐month cumulative incidence (95% CI), % | 26.2 (13.8–40.3) | 41.6 (25.4–57.1) |
| p value (Gray's test) | .364 | |
| CNS progression‐free survival c | ||
| Median (95% CI), mo | 12.4 (5.6–17.9) | 8.3 (4.3–NE) |
| Hazard ratio (95% CI) | 0.62 (0.32–1.18) | |
| p value (Log‐rank) | .143 | |
| Objective response, a n (%) | 10/35 (28.6) | 11/39 (28.2) |
| Objective response rate (95% CI), % | 28.6 (14.6–46.3) | 28.2 (15.0–44.9) |
| p value (CMH test) | .972 | |
| Duration of response a , d | ||
| Median (95% CI), mo | 8.3 (2.7–8.3) | 5.3 (4.1–6.8) |
| Hazard ratio (95% CI) | 0.47 (0.10–1.60) | |
| p value (Log‐rank) | .252 | |
| Clinical benefit,a no. (%) | 14/35 (40.0) | 12/39 (30.8) |
| Clinical benefit rate (95% CI), % | 40.0 (23.9–57.9) | 30.8 (17.0–47.6) |
| p value (CMH test) | .410 | |
a
Independently adjudicated.
b
At 24 months (progression‐free survival) and 48 months (overall survival).
c
Scans read centrally.
d
Assessed in 10 and 11 patients in the N + C and L + C groups, respectively.
Abbreviations: CI, confidence interval; CMH, Cochran Mantel‐Haenszel; CNS, central nervous system; L + C, lapatinib plus capecitabine; N + C, neratinib plus capecitabine; NE, not estimable.