Table 1. Patient demographics and clinical characteristics.
Characteristics | All patients (n=170) | Post RECIST-PD regimens | P | |
---|---|---|---|---|
Chemo alone (n=91) | Chemo + gefitinib (n=79) | |||
Age, median (range), No. (%) (years) | 59 [30–84] | 0.286 | ||
≥65 | 43 (25.3) | 20 (22.0) | 23 (29.1) | |
<65 | 127 (74.7) | 71 (78.0) | 56 (70.9) | |
Gender, No. (%) | 0.029 | |||
Male | 71 (41.8) | 45 (49.5) | 26 (32.9) | |
Female | 99 (58.2) | 46 (50.5) | 53 (67.1) | |
Smoking status, No. (%) | 0.234 | |||
Never | 133 (78.2) | 68 (74.7) | 65 (82.3) | |
Former/current | 37 (21.8) | 23 (25.3) | 14 (17.1) | |
EGFR mutation, No. (%) | 0.806 | |||
Exon 19 deletion | 82 (48.2) | 41 (45.1) | 31 (39.2) | |
Exon 21 L858R mutation | 65 (38.2) | 29 (31.9) | 31 (39.2) | |
Other (exon 18/20) | 8 (4.7) | 5 (5.5) | 3 (3.8) | |
Wild type | 8 (4.7) | 5 (5.5) | 3 (3.8) | |
Unknown | 7 (4.1) | 11 (12.1) | 11 (13.9) | |
Histologic subtype, No. (%) | 0.729 | |||
Adenocarcinoma | 158 (92.9) | 84 (92.3) | 74 (93.7) | |
Non-adenocarcinoma | 12 (7.2) | 7 (7.7) | 5 (6.3) | |
ECOG PS, No. (%) | 0.472 | |||
0 | 1 (0.6) | 0 (0.0) | 1 (1.3) | |
1 | 160 (94.1) | 87 (95.6) | 73 (92.4) | |
≥2 | 9 (5.3) | 4 (4.4) | 5 (6.4) | |
Disease stage, No. (%) | 0.664 | |||
IIIB | 9 (5.3) | 4 (4.4) | 5 (6.3) | |
IV | 138 (81.2) | 73 (80.2) | 65 (82.3) | |
Recurrent | 23 (13.5) | 14 (15.4) | 9 (11.4) | |
Brain metastasis at baseline | 0.277 | |||
Yes | 47 (27.6) | 22 (24.2) | 25 (31.6) | |
No | 123 (72.4) | 69 (75.8) | 54 (68.4) | |
Previous response to gefitinib | 0.707 | |||
Partial response | 93 (54.7) | 51 (56.0) | 42 (53.2) | |
Stable disease | 77 (45.3) | 40 (44.0) | 37 (46.8) | |
Time to progression after initial gefitinib treatment (months) | 0.206 | |||
≤10 | 82 (48.2) | 48 (52.7) | 34 (43.0) | |
>10 | 88 (51.8) | 43 (47.3) | 45 (57.0) | |
Lines of initial gefitinib treatment | 0.085 | |||
1 | 99 (58.2) | 54 (59.3) | 45 (57.0) | |
2 | 50 (29.4) | 22 (24.2) | 28 (35.4) | |
≥3 | 21 (12.4) | 15 (16.5) | 6 (7.6) | |
Progression mode, No. (%) | 0.122 | |||
Gradual | 69 (40.6) | 32 (35.2) | 37 (46.8) | |
Dramatic | 101 (59.4) | 59 (64.8) | 42 (53.2) | |
T790M status, No. (%) | 0.917 | |||
Negative | 78 (45.9) | 41 (45.1) | 37 (46.8) | |
Positive | 42 (24.7) | 22 (24.2) | 20 (25.3) | |
Unknown | 50 (29.4) | 28 (30.8) | 22 (27.8) | |
Rebiopsy sites, No. (%) | 0.454 | |||
Primary site | 74 (43.5) | 42 (46.2) | 32 (40.5) | |
Metastasis site | 46 (27.1) | 21 (23.1) | 25 (31.6) | |
Not Performed | 50 (29.4) | 28 (30.8) | 22 (27.8) |
EGFR, epidermal growth factor receptor; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR-TKIs, EGFR tyrosine kinase inhibitors; Post-RECIST PD, post-Response Evaluation Criteria in Solid Tumors-progressive disease.