Table 2.

Univariate and multivariate analyses for progression-free survival after anti-PD-1/PD-L1 immunotherapy (n=375). Variables with p<0.10 in the univariate analyses were entered into the multivariate analysis

Characteristics	Progression-free survival
	Univariate analysis		Multivariate analysis
	Median, months	P value	HR (95% CI)	P value
Age, years*
≥63 (n=195) vs <63 (n=180)	4.6 vs 4.0	0.57	–	–
Gender
Female (n=167) vs male (n=208)	3.8 vs 5.1	0.08	1.16 (0.91 to 1.47)	0.23
Diagnosis
NSCLC (n=111) vs not (n=264)	4.9 vs 4.1	0.99	–	–
Colorectal (n=49) vs not (n=326)	2.9 vs 4.6	0.02	1.38 (0.98 to 1.97)	0.07
Melanoma (n=97) vs not (n=278)	7.8 vs 3.7	<0.001	0.69 (0.50 to 0.95)	0.02
Endometrial (n=23) vs not (n=352)	3.7 vs 4.2	0.64	–	–
Number of characterized alteration in tissue DNA†
≥6 (n=195) vs <6 (n=180)	4.2 vs 4.2	0.03	1.09 (0.84 to 1.41)	0.51
MSI-status
MSI-high (n=16) vs not‡ (n=359)	12.3 vs 4.0	0.01	0.74 (0.33 to 1.64)	0.46
TMB, mutations/mb
TMB-high (≥20) (n=65) vs not‡ (n=310)	13.6 vs 3.7	<0.001	0.47 (0.31 to 0.71)	<0.001
ARID1A status
ARID1A-altered (n=46) vs wild type (n=329)	10.9 vs 3.9	0.006	0.61 (0.39 to 0.94)§	0.02
Regimen of anti-PD-1/PD-L1 immunotherapy
Administered as 1st line (n=121) vs ≥2nd line (n=254)	7.4 vs 3.7	0.001	0.80 (0.60 to 1.07)	0.13

All p-values <0.05 are listed in bold.

*Age at tissue DNA analysis. Dichotomized by the median.

†Dichotomized by the median.

‡Including patients whose data were not reported.

§The HR (95% CI) was similar (0.55 (0.34 to 0.88), p=0.01) even if patients with MS-unknown or TMB-unknown (n=70) were excluded.

ARID1A, AT-Rich Interactive Domain-containing protein 1A gene; CI, confidence interval; HR, hazard ratio; MSI, microsatellite instability; NSCLC, non-small cell lung cancer; PD-1/PD-L1, programmed cell death-1 and its ligand; TMB, tumor mutational burden.