Table 1.

Patient characteristics (N = 155)a

VariablesAll (N = 155)TTF <2 months (N = 49)TTF ≥2 months (N = 106)ORb (95% CI; Univariate)Pb (Univariate)ORc (95% CI; Multivariate)Pc (Multivariate)Pd (Bootstrap)
Age ≤65 years104 (67.1%)32 (65.3%)72 (67.9%)0.89 (0.44–1.80)0.85
Age >65 years51 (32.9%)17 (34.7%)34 (32.1%)
Cancer diagnosis
Melanoma51 (32.9%)6 (12.2%)45 (42.5%)0.19 (0.08–0.48)0.00020.12 (0.01–0.74)0.020.004
Non–small cell lung cancer38 (24.5%)18 (36.7%)20 (18.9%)2.50 (1.17–5.32)0.031.33 (0.44–4.00)0.750.56
Squamous cell carcinoma of head and neck11 (7.1%)4 (8.2%)7 (6.6%)1.26 (0.39–4.25)0.74
Cutaneous squamous cell carcinoma9 (5.8%)0 (0)9 (8.5%)<0.26 (0.02–1.77)e0.060.85 (0–7.36)0.910.001
Renal cell carcinoma6 (3.9%)3 (6.1%)3 (2.8%)2.24 (0.50–9.82)0.38
Colorectal cancer5 (3.2%)2 (4.1%)3 (2.8%)1.46 (0.25–7.33)0.65
Types of immunotherapy
Anti–PD-1 or PD-L1102 (65.8%)39 (79.6%)63 (59.4%)2.66 (1.19–5.72)0.020.37 (0.05–2.50)0.390.19
Anti-CTLA-4 alone or in combination with anti–PD-1f35 (22.6%)5 (10.2%)30 (28.3%)0.29 (0.12–0.76)0.010.84 (0.12–7.40)1.000.74
High-dose IL210 (6.5%)3 (6.1%)7 (6.6%)0.92 (0.25–3.66)>0.9999
Investigational agents8 (5.2%)2 (4.1%)6 (5.7%)0.71 (0.14–2.95)>0.9999
Genomic alterations
TP5365 (41.9%)24 (49.0%)41 (38.7%)1.52 (0.78–2.99)0.29
CDKN2A/B46 (29.7%)12 (24.5%)34 (32.1%)0.69 (0.31–1.50)0.45
TERT37 (23.9%)7 (14.3%)30 (28.3%)0.42 (0.16–1.05)0.071.68 (0.43–6.62)0.570.47
BRAF28 (18.1%)8 (16.3%)20 (18.9%)0.84 (0.35–1.99)0.82
LRP1B19 (12.3%)4 (8.2%)15 (14.2%)0.54 (0.19–1.67)0.43
PTEN16 (10.3%)2 (4.1%)14 (13.2%)0.28 (0.06–1.14)0.100.26 (0.02–1.54)0.190.06
MYC15 (9.7%)5 (10.2%)10 (9.4%)1.09 (0.40–3.20)>0.9999
NF114 (9.0%)1 (2.0%)13 (12.3%)0.15 (0.01–0.85)0.070.26 (0.01–2.27)0.370.17
PIK3CA14 (9.0%)6 (12.2%)8 (7.5%)1.71 (0.54–5.50)0.37
KRAS12 (7.7%)3 (6.1%)9 (8.5%)0.70 (0.20–2.79)0.75
MLL212 (7.7%)2 (4.1%)10 (9.4%)0.41 (0.09–1.66)0.34
NOTCH111 (7.1%)0 (0)11 (10.4%)<0.19 (0.02–1.22)e0.020.55 (0–3.67)0.630.003
NRAS11 (7.1%)1 (2.0%)10 (9.4%)0.20 (0.02–1.24)0.18
ARID210 (6.5%)1 (2.0%)9 (8.5%)0.22 (0.02–1.46)0.17
EGFR10 (6.5%)8 (16.3%)2 (1.9%)10.2 (2.28–48.3)0.0028.36 (1.28–98.5)0.020.004
CTNNB19 (5.8%)3 (6.1%)6 (5.7%)1.09 (0.29–4.08)>0.9999
APC8 (5.2%)3 (6.1%)5 (4.7%)1.32 (0.34–5.29)0.71
ARID1A8 (5.2%)2 (4.1%)6 (5.7%)0.71 (0.14–2.95)>0.9999
ASXL18 (5.2%)1 (2.0%)7 (6.6%)0.29 (0.03–1.74)0.44
BRCA28 (5.2%)2 (4.1%)6 (5.7%)0.71 (0.14–2.95)>0.9999
CCND18 (5.2%)2 (4.1%)6 (5.7%)0.71 (0.14–2.95)>0.9999
FGFR18 (5.2%)4 (8.2%)4 (3.8%)2.27 (0.63–8.02)0.26
PTCH18 (5.2%)1 (2.0%)7 (6.6%)0.29 (0.03–1.74)0.44
SETD28 (5.2%)2 (4.1%)6 (5.7%)0.71 (0.14–2.95)>0.9999
ATM7 (4.5%)2 (4.1%)5 (4.7%)0.86 (0.17–4.25)>0.9999
NOTCH27 (4.5%)2 (4.1%)5 (4.7%)0.86 (0.17–4.25)>0.9999
RB17 (4.5%)3 (6.1%)4 (3.8%)1.66 (0.40–6.38)0.68
RET7 (4.5%)3 (6.1%)4 (3.8%)1.66 (0.40–6.38)0.68
SMAD47 (4.5%)2 (4.1%)5 (4.7%)0.86 (0.17–4.25)>0.9999
BAP16 (3.9%)3 (6.1%)3 (2.8%)2.24 (0.50–9.82)0.38
CREBBP6 (3.9%)0 (0)6 (5.7%)<0.42 (0.04–3.24)e0.18
ERBB26 (3.9%)2 (4.1%)4 (3.8%)1.09 (0.20–4.79)>0.9999
FAT16 (3.9%)1 (2.0%)5 (4.7%)0.42 (0.04–3.24)0.67
GNAS6 (3.9%)1 (2.0%)5 (4.7%)0.42 (0.04–3.24)0.67
MCL16 (3.9%)2 (4.1%)4 (3.8%)1.09 (0.20–4.79)>0.9999
MDM2/46 (3.9%)6 (12.2%)0 (0)>11.9 (1.53–141.6)e0.00110.8 (1.88-infinity)0.020.001
PDGFRA6 (3.9%)1 (2.0%)5 (4.7%)0.42 (0.04–3.24)0.67
SOX26 (3.9%)4 (8.2%)2 (1.9%)4.62 (1.04–24.7)0.081.56 (0.14–22.0)1.000.49
STK116 (3.9%)1 (2.0%)5 (4.7%)0.42 (0.04–3.24)0.67
CD274 (PD-L1)5 (3.2%)0 (0)5 (4.7%)<0.53 (0.04–3.36)e0.18
DNMT3A5 (3.2%)4 (8.2%)1 (0.9%)9.33 (1.46–115.1)0.0313.9 (1.11–783.2)0.040.04
ERBB45 (3.2%)0 (0)5 (4.7%)<0.53 (0.04–3.36)e0.18
FBXW75 (3.2%)3 (6.1%)2 (1.9%)3.39 (0.67–19.4)0.33
FGF195 (3.2%)2 (4.1%)3 (2.8%)1.46 (0.25–7.33)0.65
FGF35 (3.2%)2 (4.1%)3 (2.8%)1.46 (0.25–7.33)0.65
FGF45 (3.2%)2 (4.1%)3 (2.8%)1.46 (0.25–7.33)0.65
FGF65 (3.2%)2 (4.1%)3 (2.8%)1.46 (0.25–7.33)0.65
JAK25 (3.2%)0 (0)5 (4.7%)<0.53 (0.04–3.36)e0.18
KDM6A5 (3.2%)0 (0)5 (4.7%)<0.53 (0.04–3.36)e0.18
MET5 (3.2%)2 (4.1%)3 (2.8%)1.46 (0.25–7.33)0.65
PBRM15 (3.2%)2 (4.1%)3 (2.8%)1.46 (0.25–7.33)0.65
PDCD1LG25 (3.2%)0 (0)5 (4.7%)<0.53 (0.04–3.36)e0.18
ZNF2175 (3.2%)0 (0)5 (4.7%)<0.53 (0.04–3.36)e0.18
Absolute lymphocyte count (mm3; N = 152)gAll (N = 152)TTF <2 months (N = 48)TTF ≥2 months (N = 104)ORcPb (Univariate)
<1,00048 (31.6%)18 (37.5%)30 (28.8%)1.48 (0.73–3.09)0.35
≥1,000104 (68.4%)30 (62.5%)74 (71.2%)
Royal Marsden Hospital score (N = 133) hAll (N = 133)TTF <2 months (N = 40)TTF ≥2 months (N = 93)ORbPb (Univariate)
0 or 186 (64.7%)22 (55%)64 (68.8%)0.55 (0.26–1.20)0.17
2 or 147 (35.3%)18 (45%)29 (31.2%)
MD Anderson Cancer Center prognostic score (N = 133)hAll (N = 133)TTF <2 months (N = 40)TTF ≥2 months (N = 93)ORbPb (Univariate)
0 or 131 (23.3%)7 (17.5%)24 (25.8%)0.61 (0.24–1.51)0.37
2 to 5102 (76.7%)33 (82.5%)69 (74.2%)
  • Abbreviations: CI, confidence interval; IL2, interleukin-2; TTF, time-to-treatment failure.

  • aIncluded variables with N ≥5.

  • bOR and P value by the Fisher's exact test.

  • cOR and P value by exact conditional logistic regression (multivariate) analysis. Included characteristics with P value ≤0.1 from univariate analysis.

  • dBootstrapping with multiple logistic regression analysis was conducted on characteristics with P value ≤0.1 from univariate analysis. p-value based on 982 bootstrap samples.

  • eIf a variable dichotomized as N versus zero, and the odds ratio was thus zero or infinity, we adjusted the events to be 1 (instead of zero) versus N-1. This produces a numerical odds ratio, which is less than the actual infinite odds ratio. For example, for MDM2/4, where there were N = 6 versus zero patients with TTF <2 versus ≥2 months, the actual odds ratio is infinity. Using the adjustment above, the numeric odds ratio for N = 5 versus one patient is 11.9, and we list it as “>11.9.” The P value shown is the actual P value for the unadjusted numbers.

  • fAnti–CTLA-4 alone; N = 19, anti-CTLA-4 in combination with ant-PD-1; N = 16. Among patients who received anti–CTLA-4 alone, 3 patients had TTF <2 months. Among patients receiving combination of anti–CTLA-4/PD-1, 2 patients had TTF <2 months.

  • gTotal of N = 152 were tested for lymphocyte count within 4 weeks of starting the immunotherapy.

  • hN = 133 were evaluable for Royal Marsden Hospital score and MD Anderson Cancer Center prognostic score. For Royal Marsden Hospital score, each point was counted when albumin was <3.5 (g/dl), LDH > upper limit of normal (175 U/L) and number of organ metastases >2. For MD Anderson Cancer Center prognostic score, each point was counted when albumin was <3.5 (g/dl), LDH > upper limit of normal (175 U/L), number of organ metastases >2, gastrointestinal tumor type, and ECOG PS ≥1.