Table 4.
Exploratory variables Criterion variable Evaluation variable |
Total number of patients | Incidence of ILD, % | Univariate analysisa | Multivariate analysisb | ||||
---|---|---|---|---|---|---|---|---|
HR | 95% CI | P-value | HR | 95% CI | P-value | |||
Overall | 829 | 6.3 | ||||||
Gender | 1.3 | 0.7–2.2 | 0.4033 | |||||
Female | 346 | 5.5 | ||||||
Male | 483 | 6.8 | ||||||
Age, years | ||||||||
<75 | 722 | 5.7 | 1.8 | 0.9–3.6 | 0.0719 | |||
≥75 | 107 | 10.3 | ||||||
Previous or concurrent lung disease | ||||||||
No | 746 | 5.8 | 1.9 | 0.9–3.9 | 0.0849 | 2.2 | 1.0–4.5 | 0.0365 |
Yes | 83 | 10.8 | ||||||
Smoking history | ||||||||
No | 460 | 4.6 | 1.8 | 1.1–3.2 | 0.0298 | |||
Yes | 369 | 8.4 | ||||||
ECOG PS | ||||||||
0 | 572 | 6.1 | 1.5 | 0.9–2.7 | 0.1495 | |||
≥1 | 257 | 6.6 | ||||||
Number of chemotherapy regimens for primary disease: two categories | ||||||||
≥1 | 162 | 2.5 | 2.6 | 0.9–7.2 | 0.0667 | |||
0 | 667 | 7.2 | ||||||
Number of affected organs: two categories | ||||||||
0 or ≤2 | 748 | 5.3 | 3.9 | 2.1–7.5 | <0.0001 | 4.2 | 2.2–8.2 | <0.0001 |
≥3 | 81 | 14.8 |
CI, confidence interval; HR, hazard ratio.
aFourteen patients for whom not all exploratory variable data were obtained were excluded from the univariate and multivariate analyses.
bExploratory variables included: gender, age, number of organs affected by metastases (categorical variable <3 vs. ≥3), previous/concurrent lung disease, smoking history, ECOG PS and previous chemotherapy regimens. These baseline demographics were selected as ILD risk factors because they were previously reported as ILD risk factors in Japan (26) or were statistically different with a P-value of <0.05 in univariate analyses. 75 years was selected as the exploratory variable for age because it had a higher univariate HR compared with 65 years.