Table 3.

Univariate analysis of prognostic factors for PFS and OS (exploratory cohort)

	Progression-free survival				Overall survival
	Events	HR	95%CI	p value*	Events	HR	95%CI	p value*
Age (years)
< 65	27/44	1			25/44	1
≥ 65	24/48	0.67	[0.38–1.2]	0.15	20/48	0.67	[0.37–1.2]	0.18
Sex
Women	19/33	1			17/33	1
Men	32/59	0.69	[0.39–1.2]	0.20	28/59	0.85	[0.46–1.6]	0.60
ECOG performance status
0	11/24	1			9/24	1
1	33/58	1.6	[0.77–3.2]		29/58	1.8	[0.81–3.9]
2	7/10	2.2	[0.83–5.8]	0.25	6/10	3.3	[1.1–10]	0.08
Tumor histology
Adenocarcinoma	38/72	1			33/72	1
Squamous cell carcinoma	9/16	1.1	[0.54–2.3]	0.75	8/16	1.3	[0.59–2.8]	0.53
Current or former smoker
No	12/18	1			11/18	1
Yes	22/45	0.6	[0.3–1.2]	0.15	22/45	1.1	[0.52–2.3]	0.80
Previous chemotherapy
No	12/24	1			11/24	1	[0.45–1.8]
Yes	39/68	1.2	[0.61–2.2]	0.65	34/68	0.89	[0.45–1.8]	0.75
PD-L1 tumor expression
0%	5/10	1			4/10	1
1–49%	13/21	0.52	[0.18–1.5]		12/21	1	[0.33–3.2]
≥ 50%	22/42	0.39	[0.14–1.1]	0.17	21/42	0.89	[0.3–2.6]	0.90
Treatment
Pembrolizumab	28/50	1			27/50
Nivolumab	22/39	1	[0.58–1.8]	0.86	18/39	0.65	[0.35–1.2]	0.17
iPERCIST (PETInterim1)
CMR/PMR/SMD	8/33	1			7/33	1
uPMD	43/59	5.5	[2.6–12]	< 0.0001	38/59	4.6	[2.1–10.0]	< 0.0001
Inflammation on PETInterim1/2 (all organs)
No	14/25	1			13/25	1
Yes	37/67	1.1	[0.59–2.0]	0.79	32/67	0.92	[0.48–1.8]	0.79
Immuno-induced gastritis on PETInterim1/2
No	41/72	1			39/72	1
Yes	10/20	1.5	[0.74–2.19]	0.13	6/20	2.6	[1.1–6.1]	0.026

^*Log-rank test

HR, hazard ratio; CI, confidence interval