TABLE 1.
Characteristic | Patients (n=214) |
Age years (n=211) | 58 (19–90) |
Sex (n=214) | |
Female | 111 (51.9) |
ECOG performance status (n=205) | |
0–1 | 145 (70.7) |
≥2 | 60 (28.9) |
Histology (n=207) | |
Adenocarcinoma | 199 (96.1) |
Undifferentiated carcinoma | 2 (1.0) |
Other | 6 (2.9) |
Number of metastatic sites (n=177) | |
0–2 | 117 (66.1) |
≥3 | 60 (33.9) |
Metastatic localizations (n=210) | |
Brain | 105 (50.0) |
ALK test method (n=203) | |
FISH only | 107 (52.7) |
IHC only | 19 (9.4) |
FISH and IHC | 74 (36.5) |
Other | 3 (1.5) |
Time from initial diagnosis to inclusion in TAU months (n=206) | 23.2 (1.7–192.8) |
Prior medication regimens (including crizotinib) (n=213) | |
1 (crizotinib only) | 15 (7.0) |
2 | 97 (45.5) |
>2 | 101 (47.4) |
Median | 2 |
Treatment line for crizotinib administration# (n=213) | |
1 | 27 (12.7) |
2 | 130 (61.0) |
3 | 35 (16.4) |
>4 | 37 (17.4) |
Crizotinib as last prior regimen# (n=213) | |
Yes | 156 (73.2) |
Duration of crizotinib treatment months (n=208) | 9.1 (0.1–52.0) |
25%–75% | 5.0–15.0 |
Reason to stop crizotinib# (n=222) | |
Disease progression | 203 (91.4) |
Toxicity | 16 (7.2) |
Other | 3 (1.4) |
Data are presented as n (%) or median (range) unless otherwise stated. ECOG: Eastern Cooperative Oncology Group; FISH: fluorescent in situ hybridisation; IHC: immunohistochemistry; TAU: temporary authorisation for use. #: crizotinib could be administered as more than one line/regimen for the same patient.