Table 1.
Patient characteristics: A. Characteristics at baseline
| Characteristics | N (%) |
|---|---|
| Age (years) | |
| Median | 51 |
| Range | 20–79 |
| Sex | |
| Male | 37 (62.7) |
| Female | 22 (37.3) |
| KPS | |
| ∼70 | 17 (28.8) |
| 80 | 7 (11.9) |
| 90 | 20 (33.9) |
| 100 | 9 (15.3) |
| Unknown | 6 (10.2) |
| Time to entry (days) | |
| Median | 459.5 |
| Range | 89–5,116 |
| Number of chemotherapy | |
| None | 10 (16.9) |
| 1 | 36 (61.0) |
| ≧2 | 13 (22.0) |
| Number of surgery | |
| 1 | 38 (64.4) |
| ≧2 | 21 (35.6) |
| Number of radiotherapy | |
| 1 | 44 (74.6) |
| ≧2 | 15 (25.4) |
| KPS; Karnofsky performance status score, time to entry; days from diagnosis to entry to the trial. | |
| B. WT1‐specific immune responses and clinical responses | |
|---|---|
| Responses | N (%) |
| Production of WT1‐235 IgG antibody a | |
| Positive | 28 (56.0) |
| Negative | 22 (44.0) |
| Delayed type hypersensitivity (DTH) to WT1 peptide skin test a | |
| Positive | 30 (60.0) |
| Negative | 18 (36.0) |
| NE | 2 (4.0) |
| Response during the first 3 months of vaccination | |
| PR | 2 (3.4) |
| SD | 20 (33.9) |
| PD | 36 (61.0) |
| NE | 1 (1.7) |
| Best response | |
| CR | 2 (3.4) |
| PR | 2 (3.4) |
| SD | 18 (30.5) |
| PD | 36 (61.0) |
| NE | 1 (1.7) |
| PFS (days) | |
| Median | 83 |
| Range | 24–2,583+ |
| OS (days) | |
| Median | 252 |
| Range | 35–2,583+ |
| Frequencies of WT1‐specific CD8+ CTLs before vaccination (%) | |
| Median: | 0.49 |
| Range: | 0.052–1.95 |
| Frequencies of WT1‐specific CD8+ CTLs at 1 month (%) | |
| Median | 0.27 |
| Range | 0.085–1.01 |
| Frequencies of WT1‐specific CD8+ CTLs at 3 months (%) | |
| Median | 0.31 |
| Range | 0.085–1.07 |
a
Positivity at 3 months of vaccination in patients who underwent 12 or more vaccinations, NE; not evaluated. Frequencies of WT1‐specific CD8+ CTLs were obtained from 15 patients including 10 responders and five nonresponders.35