Table 2.
Response to treatment by RECIST 1.1.
| Best Response | No. of Patients (%) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Full-analysis set | Treatment-naïve | Exon19 deletion | L858R mutation | With baseline CNS metastasis | No. baseline CNS metastasis | |||||||
| Erlotinib (n = 74) | Gefitinib (n = 83) | Erlotinib (n = 55) | Gefitinib (n = 60) | Erlotinib (n = 46) | Gefitinib (n = 45) | Erlotinib (n = 27) | Gefitinib (n = 36) | Erlotinib (n = 29) | Gefitinib (n = 30) | Erlotinib (n = 45) | Gefitinib (n = 53) | |
| Partial response | 46 (62) | 44 (53) | 38 (69) | 33 (55) | 31 (67) | 26 (58) | 15 (56) | 17 (47) | 16 (55) | 13 (43) | 30 (67) | 31 (58) |
| Stable disease | 21 (28) | 33 (40) | 14 (25) | 23 (38) | 13 (28) | 18 (40) | 8 (30) | 15 (42) | 10 (34) | 14 (47) | 11 (24) | 19 (36) |
| Progressive disease | 7 (9) | 6 (7) | 3 (5) | 4 (7) | 2 (4) | 1 (2) | 4 (15) | 4 (11) | 3 (10) | 3 (10) | 4 (9) | 3 (6) |
| ORR | 46 (62) | 44 (53) | 38 (69) | 33 (55) | 31 (67) | 26 (58) | 15 (56) | 17 (47) | 16 (55) | 13 (43) | 30 (67) | 31 (58) |
| 95% CI | (50.8–72.4) | (42.4–63.4) | (56.0–79.7) | (42.5–66.9) | (53.0–79.1) | (43.3–71.0) | (37.3–72.4) | (32.0–63.0) | (37.5–71.6) | (27.3–60.8) | (52.1–78.6) | (45.1–70.7) |
| P-value | 0.247 | 0.120 | 0.343 | 0.513 | 0.363 | 0.405 | ||||||
| DCR | 67 (91) | 77 (93) | 52 (95) | 56 (93) | 44 (96) | 44 (98) | 23 (85) | 32 (89) | 26 (90) | 27 (90) | 41 (91) | 50 (94) |
| 95% CI | (81.7–95.3) | (85.1–96.6) | (85.1–98.1) | (84.1–97.4) | (85.5–98.8) | (88.4–99.6) | (67.5–94.1) | (74.7–95.6) | (73.6–96.4) | (74.4–96.5) | (79.3–96.5) | (84.6–98.1) |
| P-value | 0.613 | 1.000 | 1.000 | 0.715 | 1.000 | 0.670 | ||||||
95% CI, 95% confidence interval; ORR, objective response rate; DCR, disease control rate.