Table 1.
Patient characteristics
| Characteristic | All (n = 199) | Training cohort (n = 159) | Validation cohort (n = 40) | p value |
|---|---|---|---|---|
| Age, yr, median (range) | 55 (14–88) | 54 (25–79) | 56 (14–87) | 0.323 |
| Sex | ||||
| Male | 80 (40.2) | 68 (42.8) | 12 (30) | |
| Female | 119 (59.8) | 91 (57.2) | 28 (70) | 0.141 |
| ECOG | ||||
| 0 | 34 (17.1) | 29 (18.2) | 5 (12.5) | |
| 1 | 145 (72.9) | 114 (71.7) | 31 (77.5) | |
| 2 | 18 (9.0) | 16 (10.1) | 2 (5) | |
| 3 | 2 (1.0) | 0 | 2 (5) | 0.022 |
| Smoking | ||||
| Never smoker | 147 (73.9) | 115 (72.3) | 32 (80) | |
| Current or ex-smoker | 52 (26.1) | 44 (27.7) | 8 (20) | 0.323 |
| Pathology | ||||
| Adenocarcinoma | 196 (98.5) | 156 (98.1) | 40 (100) | |
| Large cell carcinoma | 2 (1.0) | 2 (1.3) | 0 | |
| Poorly-differentiated carcinoma | 1 (0.5) | 1 (0.6) | 0 | 0.682 |
| Palliative reason | ||||
| Initial stage IIIB-IV | 160 (80.4) | 127 (79.9) | 33 (82.5) | |
| Recurred after surgery | 39 (19.6) | 32 (20.1) | 7 (17.5) | 0.708 |
| No. of metastatic organs, mean ± SE | 2.75 ± 0.09 | 2.77 ± 0.10 | 2.70 ± 0.19 | 0.763 |
| Metastatic organ | ||||
| CNS | 81 (40.7) | 73 (45.9) | 8 (20) | 0.003 |
| Lung-to-lung | 120 (60.3) | 95 (59.8) | 25 (62.5) | 0.751 |
| Bone | 77 (38.7) | 63 (39.6) | 14 (35) | 0.592 |
| Liver | 47 (23.6) | 34 (21.4) | 13 (32.5) | 0.139 |
| Lymph node | 108 (54.3) | 87 (54.7) | 21 (52.5) | 0.801 |
| Pleura | 78 (39.2) | 61 (38.4) | 17 (42.5) | 0.632 |
| Crizotinib line | ||||
| First line | 39 (19.6) | 26 (16.4) | 13 (32.5) | |
| ≥ Second line | 160 (80.4) | 133 (83.6) | 27 (67.5) | 0.021 |
| Crizotinib response | ||||
| CR | 5 (2.5) | 4 (2.5) | 1 (2.5) | |
| PR | 155 (77.9) | 124 (78) | 31 (77.5) | |
| SD | 27 (13.6) | 25 (15.7) | 2 (5) | |
| PD | 7 (3.5) | 4 (2.5) | 3 (7.5) | |
| Not evaluable | 5 (2.5) | 2 (1.3) | 3 (7.5) | 0.042 |
| ORR | 160 (82.5) | 128 (81.5) | 32 (86.5) | 0.475 |
| PFS, mon, median (95% CI) | 12.4 (10.2–15.6) | 12.4 (10.2–15.6) | 15.6 (7.1–16.8) | 0.439 |
| OSa, mon, median (95% CI) | 31.3 (26.7–42.3) | 31.3 (26.2–42.3) | NR (17.3–NR) | 0.987 |
| Follow-up, mon, median (range) | 38.3 (2.1–74.5) | 43.5 (3.9–74.5) | 14.7 (2.1–54) | < 0.001 |
Values are presented as number (%) unless otherwise indicated.
ECOG, Eastern Cooperative Oncology Group; SE, standard error of mean; CNS, central nervous system; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; ORR, objective response rate; PFS, progression-free survival; CI, confidential interval; OS, overall survival; NR, not reached.
a
Overall survival from the initiation of crizotinib to death or last follow-up.