Table 2.
Listing of CTL responses, percentage of regulatory T cells, lymphocyte count, injection site reaction, efficacy and post‐treatment therapy for each patient
| Patient no. | Dose (mg/body) | No. vaccinations | CTL responses | Tregs (%) | Baseline lymphocyte count (/mm3) | Occurrence of injection site reaction (Yes/No) | OR | TTF (months) | OS (months) | Post‐treatment therapy | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ELISpot | ICS | |||||||||||||||||
| RNF43 | TOMM34 | RNF43 | TOMM34 | |||||||||||||||
| B | C1 | B | C1 | B | C1 | B | C1 | B | C1 | |||||||||
| 1 | 0.3 | 8 | 0 | 0 | 0 | 0 | 0 | 0.002 | 0 | 0 | 0.50 | 1.81 | 1420.4 | No | PD | 1.9 | 3.6 | Radiotherapy |
| 2 | 0.3 | 8 | 64 | 0 | 0 | 0 | 0.005 | 0 | 0.007 | 0 | 2.36 | 2.57 | 2053.2 | No | PD | 2.1 | 7.5 | Regorafenib |
| 3 | 0.3 | 8 | 0 | 20 | 0 | 0 | 0 | 0.003 | 0 | 0.006 | 1.34 | 2.05 | 1937.5 | No | PD | 1.8 | 8.2 | S‐1, calcium folinate, bevacizumab |
| 4 | 0.3 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0.006 | 0 | 1.04 | 1.51 | 1301.5 | Yes | PD | 0.9 | 8.6 | Bevacizumab, thermotherapy, capecitabine, oxaliplatin |
| 5 | 0.3 | 8 | 0 | 191 | 21 | 11 | 0 | 0.001 | 0 | 0 | 1.31 | 2.64 | 1956.0 | No | PD | 1.8 | 9.3 | Radiotherapy |
| 6 | 0.3 | 4 | 0 | 0 | 0 | 0 | 0.002 | 0.01 | 0 | 0 | 1.36 | 0.75 | 1392.4 | No | PD | 0.7 | 2.5 | – |
| 7 | 1 | 8 | 0 | 44 | 22 | 31 | 0.063 | 0.062 | 0 | 0.006 | 4.70 | 3.16 | 1341.6 | No | PD | 0.7 | 17.1 | Regorafenib |
| 8 | 1 | 4 | 0 | 41 | 13 | 126 | 0.038 | 0.117 | 0.009 | 0.011 | 3.13 | 3.21 | 1958.5 | Yes | PD | 0.9 | 16.6 | UFT, calcium folinate, bevacizumab |
| 9 | 1 | 8 | 12 | 0 | 6 | 31 | 0.018 | 0.043 | 0 | 0.012 | 6.62 | 5.67 | 1237.3 | No | SD | 2.3 | 6.5 | Regorafenib |
| 10 | 1 | 4 | 13 | 0 | 8 | 0 | 0.03 | 0.019 | 0 | 0.005 | 1.91 | 1.93 | 984.0 | No | PD | 0.9 | Censored | Regorafenib, cetuximab, panitumumab |
| 11 | 1 | 4 | 0 | NA | 0 | NA | 0.465 | NA | 0 | NA | 4.65 | NA | 830.8 | No | PD | 0.9 | 3.0 | – |
| 12 | 1 | 4 | 9 | 14 | 29 | 0 | 0.025 | 0.075 | 0 | 0.004 | 4.32 | 3.76 | 1992.0 | No | PD | 0.9 | 1.3 | – |
| 13 | 3 | 11 | 0 | 24 | 0 | 0 | 0.005 | 0.029 | 0.005 | 0.013 | 1.81 | 3.09 | 2198.7 | Yes | PD | 1.7 | 11.1 | Regorafenib |
| 14 | 3 | 7 | 0 | 0 | 0 | 11 | 0.002 | 0.027 | 0 | 0 | 2.81 | 1.79 | 1054.0 | Yes | PD | 1.8 | 4.0 | Regorafenib |
| 15 | 3 | 11 | 0 | 0 | 20 | 0 | 0 | 0 | 0 | 0.016 | 2.75 | 4.85 | 1072.1 | Yes | SD | 2.8 | 9.3 | Radiotherapy, 5‐FU |
| 16 | 3 | 14 | 1 | 86 | 0 | 17 | 0.011 | 0 | 0.005 | 0 | 2.86 | 2.80 | 1477.0 | No | SD | 3.5 | 15.5 | BBI608 |
| 17 | 3 | 15 | 174 | 0 | 24 | 52 | 0 | 0.001 | 0 | 0 | 3.04 | 8.15 | 1555.2 | No | SD | 3.6 | 7.5 | – |
| 18 | 3 | 4 | 0 | 435 | 26 | 0 | 0 | 0.032 | 0 | 0.001 | 3.63 | 2.32 | 1467.9 | No | PD | 0.9 | 4.5 | – |
| 19 | 6 | 7 | 5 | 3 | 2 | 18 | 0 | 0 | 0.001 | 0 | 2.87 | 3.13 | 732.1 | No | PD | 0.9 | 3.2 | – |
| 20 | 6 | 7 | 11 | 0 | 3 | 10 | 0 | 0 | 0.001 | 0.003 | 3.08 | 2.54 | 1181.3 | No | PD | 1.8 | Censored | S‐1, calcium folinate, bevacizumab |
| 21 | 6 | 6 | 0 | 9 | 0 | 3 | 0 | 0 | 0 | 0 | 4.39 | 3.64 | 1490.6 | No | PD | 1.4 | 4.8 | TAS‐102 |
| 22 | 6 | 10 | NA | 60 | NA | 3 | 0 | 0 | 0 | 0 | NA | 4.70 | 1144.0 | No | SD | 2.8 | 11.9 | – |
| 23 | 6 | 3 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 717.4 | No | PD | 0.7 | 2.8 | TAS‐102 |
| 24 | 6 | 15 | 4 | 47 | 6 | 0 | 0 | 0 | 0 | 0 | 3.23 | 2.45 | 2439.6 | Yes | SD | 3.9 | 10.0 | Nintedanib |
B, baseline; C1, cycle 1; CTL, cytotoxic T lymphocyte; ELISpot, Enzyme‐linked Immunospot; 5‐FU, fluorouracil; ICS, intracellular cytokine staining; NA, not available; OR, overall response; OS, overall survival; PD, progressive disease; RNF43, ring finger protein 43; S‐1, tegafur/gimeracil/oteracil; SD, stable disease; TOMM34, translocase of outer mitochondrial membrane 34; Tregs, regulatory T cells; TTF, time to treatment failure; UFT, tegafur/uracil; –, no post‐treatment therapy.