Table 5.

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.