TABLE 1.
Baseline Characteristics for patients with ALK+ NSCLC in ALTA‐1L and ALTA
| Continuous covariates, median (range) |
ALTA−1L n = 123 |
ALTA n = 201 |
|---|---|---|
| Age, years | 57 (27–85) | 53 (18–82) |
| Albumin, g/L a | 41 (24–48) | 36 (20–47) |
| ALT, U/L | 20 (5–118) | 30 (5–129) |
| AST, U/L | 20 (9–111) | 26 (10–88) |
| Bilirubin, μmol/L | 8 (3–34) | 9 (1–22) |
| Body weight, kg | 67 (43–111) | 70 (41–172) |
| eGFR, mL/min/1.73 m2 | 92 (40–178) | 83 (37–278) |
| Log sum target lesions at baseline, mm b | 3.92 (2.34–5.4) c | _ |
| Categorical covariates, n (%) | ||
| Sex | ||
| Male | 63 (51.2) | 85 (42.3) |
| Female | 60 (48.8) | 116 (57.7) |
| Race | ||
| White | 68 (55.3) | 133 (66.2) |
| Asian | 53 (43.1) | 64 (31.8) |
| Other | 2 (1.6) | 4 (2.0) |
| ECOG status, b 0/1/2 | 49 (39.8)/69 (56.1)/5 (4.1) | _ |
| Prior chemotherapy, b No/Yes | 88 (71.5)/35 (28.5) | _ |
| Brain metastases at baseline, b No/Yes | 87 (70.7)/36 (29.3) | _ |
Abbreviations: ALK+, anaplastic lymphoma kinase positive; ALT, alanine aminotransferase; ALTA‐1L, Anaplastic Lymphoma Kinase in Lung Cancer Trial of brigAtinib in First Line; AST, aspartate aminotransferase; ECOG, Eastern Cooperative Oncology Group; eGFR, estimated glomerular filtration rate; NSCLC, non‐small cell lung cancer; PK, pharmacokinetic; U/L, units per liter.
Three patients in the ALTA‐1L trial were missing data on albumin.
Sum of target lesions at baseline, ECOG status, prior chemotherapy status, presence of brain metastases, and smoking status were included as covariates only in the exposure‐response analyses and are therefore not reported for the ALTA population (which was included only for assessment of the population PK model).
One patient in ALTA‐1L had missing data for log sum of target lesions at baseline.