Table 2.
Patient no. | Doses (mg) | Times | AE | DTH (mm) 235/332 | WT1 tetramer+CD8* T cells/ CD8*T cells (%)a | IFN-y-producing CD8*T cells/ CD8*T cells (%)a | TNF-a-producing CD4+T cells/CD4*T cells (%)a | Clinical responses | Outcome | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pre | 4–8 weeks | 10 months–1 year 3 months | Pre | 4–8 weeks | 10 months–1 year 3 months | Pre | 4–8 weeks | 10 months–1 year 3 months | 6 weeks | 12 weeks | PFS (weeks) | OS (weeks) | |||||
1 | 0.75 | 30 | (−) | –/3 | 0.03 | 1.25 | 1.3 | 1.05 | 0.33 | 6.72 | SD | SD | 58.4 | 58.4 | |||
2 | 0.75 | 21 | (−) | –/– | 0.76 | 43.9 | 0 | 39.8 | 0 | 48.3 | PD | PD | 4 | 28.5 | |||
3 | 0.75 | 11 | (−) | 4/6 | 0.09 | 2.55 | 0 | 2.2 | 0 | 26.7 | PD | PD | 4 | 18.4 | |||
4 | 1.5 | 10 | (−) | –/– | 0.29 | 0.31 | 0 | 0.03 | 0.33 | 0.39 | PD | PD | 4 | 22.2 | |||
5 | 1.5 | 35 | (−) | 3/– | 0.05 | 1.06 | 0.14 | 0 | 2 | 0.68 | 0.87 | 3.7 | 1.96 | SD | SD | 23.7 | 77.1 |
6 | 1.5 | 49 | (−) | –/3 | 0.02 | 2.50 | 0.36 | 0.25 | 12.11 | 2.18 | 0.16 | 12.69 | 8.73 | SD | SD | 84.5 | 144.5 |
7 | 1.5 | 63 | (−) | –/– | 0.04 | 11.6 | 28.00 | 0.16 | 4.79 | 21.33 | 0.04 | 41.4 | 41.5 | SD | SD | > 320.1 | > 320.1 |
8 | 3 | g | (−) | –/– | 0.03 | 0.27 | 0 | SD | PD | 8.8 | 15.7 | ||||||
9 | 3 | 49 | (−) | –/– | 0.09 | 0.50 | 0.14 | 0 | 0.15 | 0.2 | 0.17 | 2.34 | 10.23 | SD | SD | 105.3 | 165.8 |
10 | 3 | 7 | (−) | 4/– | 0.1 | 5.42 | 0.23 | 6.08 | 0.01 | 17.21 | PD | PD | 4 | 13.9 | |||
11 | 3 | 25 | (−) | 3/3 | 0.08 | 2.03 | 0 | 0.53 | 0.04 | 7.52 | PD | PD | 4.2 | 24.7 |
DTH delayed-type hypersensitivity, Doses doses of WT1 class II peptide, Times times of WT1 vaccine, AE adverse effect, SD stable disease, PD progressive disease
aFrequencies of WT1 tetramer+ CD8+ T cells, IFN-γ-producing CD8+ T cells, and IFN-α-producing CD4+ T cells were analyzed after 1-week culture of PBMCs