Table 2.
Response rates (FAS)
| ASP8273 | Erlotinib/gefitinib | |
|---|---|---|
| n = 267 | n = 263 | |
| Best overall response, n (%) | ||
| Complete response | 0 | 0 |
| Partial response | 88 (33.0) | 126 (47.9) |
| Stable disease | 78 (29.2) | 48 (18.3) |
| Progressive disease | 17 (6.4) | 9 (3.4) |
| Overall response rate, n (%) | 88 (33.0) | 126 (47.9) |
| 95% CI, % | 27.4, 39.0 | 41.7, 54.1 |
| Stratified one-sided P valuea | 1.0 | NA |
| Disease control rate,bn (%) | 166 (62.2) | 174 (66.2) |
| 95% CI, % | 56.1, 68.0 | 60.1, 71.9 |
| Stratified one-sided P valuea | 0.839 | NA |
| Duration of responseb | ||
| Events, n (%) | 16/88 (18.2) | 24/126 (19.0) |
| Censored, n (%) | 72 (81.8) | 102 (81.0) |
| Median (95% CI), months | 9.17 (5.45, NE) | 9.03 (7.39, NE) |
| Range,c months | 0.03+, 9.46+ | 0.03+, 11.10+ |
| Stratified one-sided P valuea,d | 0.780 | NA |
| Hazard ratioe (95% CI) | 1.298 (0.661, 2.548) | NA |
a
Stratification factors were ECOG PS (0 and 1 versus 2), EGFR mutation type (exon 19 deletion versus exon 21 L8598R), and chosen TKI (erlotinib versus gefintinib).
b
Based on the Kaplan–Meier estimate.
c
Plus sign (+) indicates censoring.
d
P value was based on the log-rank test.
e
Based on the Cox proportional hazards model.
CI, confidence interval; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; FAS, full analysis set; NA, not applicable; NE, not evaluable; TKI, tyrosine kinase inhibitor.