Table 2.
All (N = 134) | Gefitinib (N = 62) | Erlotinib (N = 49) | Afatinib (N = 23) | p value | |
---|---|---|---|---|---|
Treatment response | .053 | ||||
PR | 100 (74.6%) | 49 (79.4%) | 34 (69.4%) | 17 (73.9%) | |
SD | 26 (19.4%) | 12 (19.0%) | 12 (24.5%) | 2 (8.7%) | |
PD | 8 (6.0%) | 1 (1.6%) | 3 (6.1%) | 4 (17.4%) | |
Intracranial response | .208 | ||||
CR | 56 (41.8%) | 21 (33.9%) | 23 (46.9%) | 12 (52.2%) | |
PR | 26 (19.4%) | 12 (19.4%) | 11 (22.4%) | 3 (13.0%) | |
SD | 48 (35.8%) | 28 (45.2%) | 14 (28.6%) | 6 (26.1%) | |
PD | 4 (3.0%) | 1 (1.6%) | 1 (2.0%) | 2 (8.7%) | |
PD location | .055 | ||||
Intracranial only | 32 (23.9%) | 16 (27.0%) | 10 (20.4%) | 6 (26.1%) | |
Extracranial only | 73 (54.5%) | 40 (63.5%) | 22 (44.9%) | 11 (47.8%) | |
Both | 13 (9.7%) | 4 (6.3%) | 6 (12.2%) | 3 (13.0%) | |
Common adverse effects (≥ grade 2) | |||||
Skin rash or itching | 4 (3.0%) | 1 (1.6%) | 1 (2.0%) | 2 (8.7%) | .164 |
Diarrhea | 1 (0.7%) | 0 (0.0%) | 0 (0.0%) | 1 (4.3%) | .115 |
Paronychia | 2 (1.5%) | 0 (0.0%) | 1 (2.0%) | 1 (4.3%) | .005 |
Median PFS (months) [95% CI] | 11.4 [9.30 to 13.30] | 12.1 [9.00 to 14.50] | 10.6 [8.80 to 40.60] | 10.4 [7.50 to 17.20] | .783a |
Time to intracranial PD (months) [95% CI] | 23.6 [17.20 to 30.10] | 23.6 [17.00 to 30.10] | 27.8 [11.30 to 27.80] | 17.2 [10.40 to 19.00] | .729a |
Median OS (months) [95% CI) | 36.9 [29.10 to 60.00] | 38.2 [29.10 to 60.00] | NAb | 29.6 [24.80 to 33.00] | .695a |
aLog-rank test
bThe median overall survival (OS) of the erlotinib group could not be computed. Instead, the median OS of the erlotinib group was 36.9 months (95% CI 19.90 to 36.90) if the Kaplan-Meier survival curves for 60 months were calculated