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Table 2 Impact of patients’ and disease characteristics on treatment response and overall survival since the beginning of combined immunotherapy

From: Tumor mutation burden and circulating tumor DNA in combined CTLA-4 and PD-1 antibody therapy in metastatic melanoma – results of a prospective biomarker study

  Total n = 35 Responder n = 15 Non-Responder n = 20 Response P value Overall survival P value
TMB [Mut/Mb]
 > 23 6 6 0 0.002 1* 0.062
 ≤ 23 24 6 18
ctDNA [copies/ml] detection5
 Not detectable 14 10 4 0.011 1* 0.006 2*
 Detectable 18 4 14
ctDNA [copies/ml] increase5
 Not increasing 20 12 8 0.008 1* 0.03 2*
 Increasing 11 1 10
Cell-free DNA [ng/ml]6
 Decrease > 50% 7 5 2 0.022 3* 0.005 4*
 Stable 15 7 8
 Increase > 50% 9 1 8
LDH baseline elevated
 No 21 11 10 0.2961 0.001 2*
 Yes 14 4 10
Targeted therapy before
 No 25 12 13 0.4581 0.001 2*
 Yes 10 3 7
Sex
 Male 19 11 8 0.0871 0.005 2*
 Female 16 4 12
Liver metastasis baseline
 No 25 14 11 0.022 1* 0.013 2*
 Yes 10 1 9
PD-L1 Expression
 ≥ 1% 10 6 4 0.0801 0.7722
 < 1% 11 2 9
  1. * significant (in bold).
  2. 1Exact Test of Fisher
  3. 2Log rank test
  4. 3Exact Chi-Square Test for Trend (Monte Carlo Simulation)
  5. 4Log rank test for Trend
  6. 5ctDNA measured by tumor-specific variant [copies/ml plasma] at first follow-up after start of combined immunotherapy
  7. 6Cell-free DNA [ng/ml plasma] at first follow-up after start of combined immunotherapy