Table 1.
Patient Characteristics by Dose Level
Characteristics | Dose Level 1 (n = 7) | Dose Level –1 (n = 20) | All Patients (N = 27) |
---|---|---|---|
Sex, n (%) | |||
Male | 1 (14) | 7 (35) | 8 (30) |
Female | 6 (86) | 13 (65) | 19 (70) |
Median age (range), y | 55 (43–68) | 63 (47–79) | 60 (43–79) |
Mean weight (SD), kg | 69 (7) | 65 (13) | 66 (11) |
Mean height (SD), cm | 164 (8) | 163 (11) | 163 (10) |
Race, n (%) | |||
White | 4 (57) | 13 (65) | 17 (63) |
Asian | 1 (14) | 4 (20) | 5 (19) |
Black | 2 (29) | 1 (5) | 3 (11) |
Other | 0 | 2 (10) | 2 (7) |
ECOG PS, n (%) | |||
0 | 3 (43) | 6 (30) | 9 (33) |
1 | 4 (57) | 13 (65) | 17 (63) |
2 | 0 | 1 (5) | 1 (4) |
Smoking status, n (%) | |||
Never | 2 (29) | 12 (60) | 14 (52) |
Former | 5 (71) | 8 (40) | 13 (48) |
Histologic type, n (%) | |||
Adenocarcinoma | 7 (100) | 14 (70) | 21 (78) |
Bronchioloalveolar carcinoma | 0 | 5 (25) | 5 (19) |
Papillary adenocarcinoma | 0 | 1 (5) | 1 (4) |
Stage, n (%) | |||
Locally advanced | 1 (14) | 1 (5) | 2 (7) |
Metastatic | 6 (86) | 19 (95) | 25 (93) |
Number of prior systemic therapies, n (%) | |||
1 | 5 (71) | 9 (45) | 14 (52) |
2 | 2 (29) | 10 (50) | 12 (44) |
3 | 0 | 1 (5) | 1 (4) |
Prior EGFR TKI, n (%) | 0 | 7 (35) | 7 (26) |
Note: Dose level of 1: crizotinib, 150 mg twice daily, plus erlotinib, 100 mg once daily. Dose level of 1: crizotinib, 200 mg twice daily, plus erlotinib, 100 mg once daily.
ECOG PS, Eastern Cooperative Oncology Group performance status; TKI, tyrosine kinase inhibitor.