Table 4. Univariate and multivariate analyses of clinical factors for progression-free survival in a real-world cohort.
| Clinical factor | Patients (n) | Univariate analysis | Multivariate analysis | ||
|---|---|---|---|---|---|
| HR (95.0% CI) | P-value | HR (95.0% CI) | P-value | ||
| Age (years) | |||||
| < 65 | 87 | 1 | – | ||
| ≥ 65 | 53 | 1.39 (0.89–2.19) | 0.153 | – | – |
| Sex | |||||
| M | 53 | 1.07 (0.68–1.69) | 0.776 | – | – |
| F | 87 | 1 | – | ||
| Smoking status | |||||
| Never smoked | 98 | 1 | – | ||
| Ex-smoker | 19 | 1 | – | ||
| Current smoker | 23 | 1.18 (0.86–1.60) | 0.304 | – | – |
| BMI | |||||
| < 20 | 18 | 1.33 (0.72–2.46) | 0.371 | – | – |
| ≥ 20 | 119 | 1 | – | ||
| Weight loss at diagnosis | |||||
| ≤ 10.0% | 109 | 1 | 1 | ||
| > 10.0% | 31 | 1.73 (1.04–2.88) | 0.035* | 1.75 (1.05–2.93) | 0.033* |
| ECOG PS | |||||
| 0–1 | 129 | 1 | 1 | ||
| 2–4 | 11 | 2.15 (1.02–4.52) | 0.043* | 1.48 (0.69–3.16) | 0.310 |
| BMs | |||||
| Present | 42 | 2.29 (1.46–3.60) | < 0.001* | 2.09 (1.32–3.32) | 0.002* |
| Absent | 98 | 1 | 1 | ||
| EGFR mutation status | |||||
| Group 1a | 108 | 0.68 (0.41–1.13) | 0.130 | 0.67 (0.41–1.12) | 0.125 |
| Group 2–3b,c | 32 | 1 | 1 | ||
| Tumor response to afatinib treatment | |||||
| PR | 94 | 0.49 (0.31–0.77) | 0.002* | 0.49 (0.31–0.79) | 0.003* |
| SD/PD | 46 | 1 | 1 | ||
| Afatinib dose during the first 6 months of treatment (mg) | |||||
| 40 | 81 | 0.84 (0.53–1.31) | 0.435 | – | – |
| < 40 | 59 | 1 | – | ||
* P < 0.05
aClassical mutation(s)
bComplex mutation with classical mutation
cRare mutation with or without complex mutation
BM, brain metastasis; BMI, body mass index; CI, confidence interval; ECOG, Eastern Cooperative Oncology Group; F, female; HR, hazard ratio; M, male; PD, progressive disease; PR, partial response; PS, performance status; SD, stable disease