Summary of the multivariate analysis (MVA) with Cox proportional-hazards of progression-free survival (PFS)
| Variable (comparator) | Pembrolizumab cohort—MVA PFS | Chemotherapy cohort—MVA PFS | ||
| aHR (95% CI); p value | aHR (95% CI); p value | aHR (95% CI); p value | aHR (95% CI); p value | |
| BMI (normal weight) | ||||
| Underweight | 1.46 (0.98–2.20); p=0.0625 | 0.97 (0.56–1.69); p=0.9332 | ||
| Overweight | 1.04 (0.85–1.26); p=0.6736 | 0.95 (0.76–1.20); p=0.7239 | ||
| Obese | 0.61 (0.45–0.82); p=0.0012 | 1.37 (1.01–1.87); p=0.0477 | ||
| ΔBMI | ||||
| ≥1.4% vs <1.4% | – | 0.39 (0.29–0.51); p<0.0001 | – | 0.78 (0.62–0.99); p=0.0341 |
| Gender | ||||
| Male vs female | 0.97 (0.81–1.16); p=0.7896 | 0.85 (0.69–1.05); p=0.1378 | 1.30 (1.03–1.63); p=0.0219 | 1.33 (1.06–1.66); p=0.0132 |
| Age | ||||
| Elderly vs non-elderly | 1.08 (0.91–1.28); p=0.3606 | 1.13 (0.92–1.37); p=0.2190 | 1.20 (0.97–1.48); p=0.0810 | 1.14 (0.92–1.41); p=0.2221 |
| CNS metastases | ||||
| Yes vs no | 1.25 (1.01–1.55); p=0.0366 | 1.18 (0.92–1.51); p=0.1881 | 1.15 (0.86–1.54); p=0.3222 | 1.12 (0.85–1.49); p=0.4139 |
| Bone metastases | ||||
| Yes vs no | 1.62 (1.36–1.94); p<0.0001 | 1.74 (1.42–2.13); p<0.0001 | 1.25 (1.01–1.57); p=0.0460 | 1.22 (0.98–1.53); p=0.0729 |
| Liver metastases | ||||
| Yes vs no | 1.80 (1.46–2.23); p<0.0001 | 1.80 (1.42–2.29); p<0.0001 | 1.47 (1.09–1.98); p=0.0101 | 1.47 (1.10–1.97); p=0.0083 |
| ECOG-PS | ||||
| ≥2 vs (0–1) | 2.48 (2.03–3.03); p<0.0001 | 2.16 (1.69–2.76); p<0.0001 | 2.23 (1.49–3.32); p=0.0001 | 2.27 (1.52–3.41); p=0.0001 |
aHR, adjusted HR; BMI, body mass index; CNS, central nervous system; ECOG-PS, Easter Cooperative Oncology Group—Performance Status.