Table 2.
CNS efficacy of alectinib in patients with symptomatic or large CNS metastases at baseline.
| Response | Measurable baseline CNS disease (N=15)* | Measurable and/or nonmeasurable baseline CNS disease (N=18)* |
|---|---|---|
| CNS response rate | ||
| Responders, No. | 11 | 13 |
| CORR, % (95% CI) | 73.3 (44.9 to 92.2) | 72.2 (46.5 to 90.3) |
| Best overall response, No. (%) | ||
| Complete response | 1 (6.7) | 3 (16.7) |
| Partial response | 10 (66.7) | 10 (55.6) |
| Stable disease | 4 (26.7) | 5 (27.8) |
| Progressive disease | 0 | 0 |
| CNS disease control rate (DCR) | ||
| No. | 15 | 18 |
| CDCR, % (95% CI) | 100.0 (78.2 to 100.0) | 100.0 (81.5 to 100.0) |
| Median CDOR, months (95% CI) | 19. 3 (14.3 to not evaluable) | 17.1 (14.3 to not evaluable) |
| Patients included in analysis, No. (%) | 11 (100.0) | 13 (100.0) |
| Patients with event, No. (%) | 7 (63.6) | 8 (61.5) |
| Cumulative incidence rate for CNS PD, % (95% CI) | ||
| Patients included in analysis, No. | 16 | 19 |
| 6 months | 12.5 (1.9–33.7) | 15.8 (3.7–35.6) |
| 12 months | 12.5 (1.9–33.7) | 21.1 (6.2–41.7) |
| 18 months | 39.4 (15.1–63.2) | 45.3 (20.6–61.2) |
| 24 months | 66.9 (34.3–86.0) | 70.5 (39.6–87.7) |
*
One patient with baseline measurable CNS disease could not be evaluated for CNS disease response due to missing scans.
Abbreviations: CNS, central nervous system; CORR, CNS objective response rate; CDOR, CNS duration of response; PD, progressive disease; 95% CI, 95% confidence interval.