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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