Table 1.
Characteristics of included studies
| Study | Country | Design | Clinical number | Phase | Sample size | ICIs | Lines of immunotherapy | Target | Resistance | ORR | DCR | 1-year OS rate | 1-year PFS rate | Incidence of grade 3-4 AEs |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Jeong Eun Kim, 2022 | Korea | RCT | NCT03435107 | II | 33 | Durvalumab | ≥ 2 | PD-L1 | 27.3% | 42.4% | 66.7% | 68.3% | 58.2% | 36.4% |
| Lin Shen, 2021 | China | RCT | NCT03667170 | II | 24 | Envafolimab | 2 | PD-L1 | – | 62.5% | 66.7% | – | – | – |
| 41 | Envafolimab | ≥ 3 | PD-L1 | – | 31.7% | 58.5% | – | – | – | |||||
| L.A. Diaz, Jr, 2020 | U.S.A | RCT | NCT02563002 | III | 153 | Pembrolizumab | 1 | PD-1 | 29.4% | 43.8% | 70.6% | - | 55.3% | 56.0% |
| Thierry André, 2020 | French | RCT | NCT03350126 | II | 57 | Nivolumab + ipilimumab | ≥ 2 | PD-1+CTLA-4 | – | 59.6% | 89.5% | 84.0% | 72.9% | 29.8% |
| Eric Van Cutsem, 2019 | U.S.A | RCT | NCT02460198 | II | 124 | Pembrolizumab | ≥ 2 | PD-1 | 43.0% | 33.0% | 54.0% | 74.0% | 37.6% | 14.5% |
| Michael J. Overman, 2018 | U.S.A | RCT | NCT02060188 | II | 119 | Nivolumab + ipilimumab | ≥ 2 | PD-1+CTLA-4 | 12.0% | 55.0% | 80.0% | 85.0% | 71.0% | 32.0% |
| Michael Overman, 2017* | U.S.A | RCT | NCT02060188 | II | 53 | Nivolumab | ≥ 2 | PD-1 | 21.0% | 36.0% | 74.0% | 73.0% | 50.0% | 20.0% |
*CheckMate 142 is the phase 2 study performed to assess the activity and safety of nivolumab monotherapy or nivolumab in combination with ipilimumab in patients with microsatellite instability-high colorectal cancer. ICIs: Immune checkpoint inhibitors; Resistance: Rate of intrinsic resistance during immunotherapy; ORR: Objective response rate; DCR: Disease control rate; OS: Overall survival; PFS: Progression-free survival; AEs: Adverse events; RCT: Randomized controlled trial; CTLA-4: Cytotoxic T lymphocyte-associated antigen 4; PD-1: Programmed cell death protein 1; PD-L1: Programmed death ligand 1.