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Table 2 Univariate analysis of factors affecting outcome for patients treated with immune checkpoint blockade (N = 83)

From: MHC-I genotype and tumor mutational burden predict response to immunotherapy

 

Rate of SD ≥ 6 month/PR/CR1

PFS

OS

Variable

N (%)

P value2

Median, months

HR (95% CI)

P value3

Median, months

HR (95% CI)

P value3

Sex

 Male (N = 46) vs. female (N = 37)

23 (51%) vs. 13 (35%)

0.18

6.3 vs. 4.1

0.63 (0.38–1.04)

0.07

NR (MFU, 19.1) vs. 12.0

0.51 (0.27–0.95)

0.03

Ethnicity

 Caucasian (N = 71) vs. others4 (N = 12)

32 (45%) vs. 4 (36%)

0.75

4.9 vs. 2.9

0.52 (0.26–1.00)

0.045

18.5 vs. 8.2

0.45 (0.19–1.06)

0.004

Age5, years

 < 60 (N = 17) vs. ≥ 60 (N = 66)

6 (35%) vs. 30 (46%)

0.58

3.5 vs. 5.1

1.29 (0.70–2.39)

0.41

12.0 vs. 14.9

0.86 (0.36–2.06)

0.73

Tumor type

 Head and neck SCC (N = 9) vs. not (N = 74)

4 (44%) vs. 32 (44%)

> 0.99

4.8 vs. 4.9

1.01 (0.46–2.22)

0.99

12.9 vs. 16.6

1.11 (0.43–2.84)

0.83

 NSCLC (N = 26) vs. not (N = 57)

8 (31%) vs. 28 (50%)

0.15

3.0 vs. 6.0

1.67 (0.99–2.81)

0.05

9.3 vs. 16.6

1.37 (0.71–2.64)

0.34

 Cutaneous SCC (N = 10) vs. not (N = 73)

7 (70%) vs. 29 (40%)

0.10

26.8 vs. 4.7

0.43 (0.17–1.08)

0.06

NR (median follow-up, 21.7) vs. 13.9 14.9 vs. 17.1

0.43 (0.13–1.40)

0.15

 Others6 (N = 38) vs. head and neck SCC, NSCLC, and cutaneous SCC (N = 45)

17 (46%) vs. 19 (42%)

0.82

5.1 vs. 4.8

0.91 (0.55–1.52)

0.72

1.02 (0.54–1.93)

0.95

TMB7, mutations/mb

 ≥ 50 (N = 12) vs. < 50 (N = 65)

9 (75%) vs. 25 (39%)

0.03

26.8 vs. 4.4

0.40 (0.17–0.94)

0.03

NR (median follow-up, 17.5) vs. 12.9

0.39 (0.12–1.27)

0.10

 ≥ 20 (N = 21) vs. < 20 (N = 56)

14 (67%) vs. 20 (36%)

0.02

14.1 vs. 4.2

0.45 (0.23–0.85)

0.01

NR (median follow-up, 22.4) vs. 12.0

0.42 (0.19–0.96)

0.03

 ≥ 10 (N = 39) vs. < 10 (N = 38)

23 (59%) vs. 11 (29%)

0.01

6.9 vs. 4.0

0.40 (0.23–0.68)

0.001

37.1 vs. 10.1

0.42 (0.21–0.82)

0.009

PHBR

 < 0.5 (N = 32) vs. ≥ 0.5 (N = 51)

17 (53%) vs. 19 (38%)

0.25

5.1 vs. 4.4

0.58 (0.34–0.99)

0.04

NR (median follow-up, 21.7) vs. 14.9

0.66 (0.34–1.27)

0.21

PD-1/L1 therapy

 Monotherapy (N = 66) vs. combination (N = 17)

25 (39%) vs. 11 (65%)

0.06

4.1 vs. 6.3

1.17 (0.63–2.16)

0.63

17.1 vs. 11.3

0.78 (0.37–1.66)

0.51

  1. 1Thirty-six patients achieved SD with ≥ 6 months/PR/CR. One patient attained ongoing SD, but has not yet reached 6-month follow-up and is therefore not considered evaluable for this parameter; only 82 patients were evaluable for this comparison
  2. 2Calculated using Fisher’s exact test
  3. 3Calculated using the log-rank test
  4. 4Others: African American (N = 2), Asian (N = 4), Hispanic (N = 5), and unknown (N = 1)
  5. 5At time of initiation of treatment with immunotherapy
  6. 6Others: adrenal (N = 1), appendix (N = 4), basal cell carcinoma (N = 3), breast cancer (N = 6), cervical (N = 1), cholangiocarcinoma (N = 1), colorectal (N = 2), duodenal (N = 1), gastroesophageal (N = 5), glioblastoma (N = 2), thyroid (N = 1), prostate (N = 1), rectal squamous cell carcinoma (N = 1), renal cell carcinoma (N = 1), sarcoma (N = 3), urothelial (N = 4), and urethral squamous cell carcinoma (N = 1)
  7. 7Seventy-seven patients with TMB were evaluable for the response rate, PFS, and OS
  8. Abbreviations: HR hazard ratio, NR not reached to 50%, NSCLC non-small cell lung cancer, OS overall survival, PFS progression-free survival, PHBR Patient Harmonic-mean Best Rank, SCC squamous cell carcinoma, TMB tumor mutational burden
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