Table 2.

Sample size calculation for assessment of correlation between immune monitoring results and clinical end points (two-sided χ2 test, α error 0.05, β error 0.8)

ExampleImmunologic response rate (%)Clinical end pointClinical response rate in patients with T-cell response (%)Clinical response rate in patients without T-cell response (%)Expected overall clinical response rate (%)Required sample size
125CR/PR50012.532
225CR/PR2506.2574
325CR/PR1002.5203
450CR/PR5002529
550CR/PR25012.569
650CR/PR1005190
780CR/PR5004051
880CR/PR25020132
980CR/PR1008378
1025CR/PR/SD70*2032.546
1125CR/PR/SD45*2026.25157
1225CR/PR/SD30*2022.5811
1350CR/PR/SD70*2047.537
1450CR/PR/SD45*2032.5124
1550CR/PR/SD30*2025626
1680CR/PR/SD70*206063
1780CR/PR/SD45*2040228
1880CR/PR/SD30*20281,158
  • Abbreviations: CR, complete response; PR, partial response; SD, stable disease.

  • * Including the 20% spontaneous stabilization rate.