Table 5.
Summary of efficacy by first-line treatment (TKI or chemotherapy) and TKI type (gefitinib or erlotinib) in the evaluable population
| Endpoint | First-line treatment | TKI subtype | |||
|---|---|---|---|---|---|
| TKI | CT | CT + TKI maintenance | Gefitinib | Erlotinib | |
| Evaluable | 124 | 18 | 8 | 100 | 22 |
| Response, n (%) | |||||
| CR | 3 (2.2) | 2 (11.1) | 0 (0.0) | 2 (2.0) | 1 (4.5) |
| PR | 55 (44.4) | 2 (11.1) | 2 (25.9) | 48 (48.0) | 7 (31.8) |
| SD | 51 (41.1) | 10 (55.6) | 6 (75.0) | 36 (36.0) | 13 (59.1) |
| PD | 15 (12.1) | 4 (22.2) | 0 (0.0) | 14 (14.0) | 1 (4.5) |
| ORR, n (%) | 58 (46.8) | 4 (22.2) | 2 (25.0) | 50 (50.0) | 8 (36.4) |
| 95% CI | 37.8–55.9 | 6.4–47.6 | 3.2–65.1 | 39.8–60.2 | 17.2–59.3 |
| DCR, n (%) | 109 (87.9) | 14 (77.8) | 8 (100) | 86 (86.0) | 21 (95.5) |
| 95% CI | 80.8–93.1 | 52.4–93.6 | 63.1–100.0 | 77.6–92.1 | 77.2–99.9 |
| Median PFS (95% CI), months | 9.9 (8.3–11.5) | 5.2 (3.8–7.1) | 7.6 (6.1–17.4) | 9.9 (8.3–11.7) | 9.9 (4.8–15.0) |
| One-year PFS, n (%) | 37.3 | 0.0 | 12.5 | 36.6 | 34.1 |
| Median OS (95% CI), months | 17.2 (13.5–21.4) | 12.7 (9.3–21.0) | 16.6 (10.6–26.7) | 16.7 (12.4–20.1) | 23.7 (15.2–31.5) |
| One-year OS, n (%) | 61.7 | 50 | 37.5 | 59.8 | 66.6 |
CI: Confidence interval; CR: Complete response; DCR: Disease control rate; ORR: Overall response rate; OS: Overall survival; PR: Partial response; PD: Progressive disease; PFS: Progression-free survival; SD: Stable disease