Table 1.
The baseline characteristics of included studies.
| study | Years | Country | Trail Name | Study type | Stage | Cancer type | Medicines | Target point | TMB methods | TMB cut-off | High | Low |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alborelli [23] | 2019 | Switzerland | NR | RCS | Stage Ⅰ- IV | NSCLC | Nivolumab / pembrolizumab / atezolizumab | PD-(L)1 | NGS | 9 | 25 | 51 |
| Yang [24] | 2020 | USA | NR | Clinical trial | recurrent /refractory | pan-cancer | anti–PD-(L)1/CTLA-4 | CTLA-4, PD-(L)1 | NGS | 6.88 | 9 | 94 |
| Shim [25] | 2020 | Korea | NR | PCS | advanced | NSCLC | anti-PD-(L)1 | PD-(L)1 | WES* | 272 | 47 | 151 |
| Li [26] | 2020 | China | NR | RCS | stage III | melanoma | pembrolizumab | PD-(L)1 | NR | 2 | 10 | 11 |
| Kim [27] | 2020 | Korea | NR | RCS | advanced | Gastric cancer | Nivolumab / pembrolizumab | PD-(L)1 | NGS | 14.31 | 8 | 55 |
| Huang [28] | 2020 | China | NR | RCS | advanced | NSCLC | anti-PD-(L)1 | PD-(L)1 | NGS | 10 | 14 | 20 |
| Fang A [29] | 2019 | China | NR | Clinical trial | Advanced /recurrent | NSCLC | Anti–PD-(L)1 | PD-(L)1 | WES* | 157 | 25 | 48 |
| Fang B [29] | NGS* | 10 | 26 | 49 | ||||||||
| Ricciuti [30] | 2019 | USA | NR | RCS | Limited | SCLC | anti–PD-1 / CTLA-4 | PD-1/CTLA-4 | NGS | 9.68 | 26 | 26 |
| Chae [31] | 2019 | USA | NR | RCS | 75.6% metastasis | NSCLC | anti-PD-(L)1 | PD-(L)1 | FoundationOne | 15 | 11 | 23 |
| Heeke A [32] | 2019 | France | NR | RCS | NR | NSCLC | anti-PD-(L)1 | PD-(L)1 | FoundationOne | 15 | 15 | 21 |
| Heeke B [32] | melanoma | anti-PD-(L)1 | PD-(L)1 | FoundationOne | 18 | 15 | 17 | |||||
| Ready [33] | 2019 | USA | CheckMate-568 | Clinical trial | IV/recurrent IIIB | NSCLC | anti-PD-(L)1 / CTLA-4 | PD-(L)1, CTLA-4 | FoundationOne | 10 | 48 | 50 |
| Singnal [34] | 2019 | NR | RCS | NR | NSCLC | Anti-PD-(L)1 | PD-(L)1 | FoundationOne | 20 | 161 | 1116 | |
| Samsteina [35] | 2019 | USA | NR | Clinical trial | advanced | pan-cancer | ICIs | ICP | MSK-IMPACT | 52.2 | 合计1662 | |
| Cristescu A [36] | 2018 | USA | KEYNOTE-028/ KEYNOTE-012 | Clinical trial | NR | pan-cancer | pembrolizumab | PD-(L)1 | WES* | 102.5 | 37 | 82 |
| Cristescu B [36] | 2018 | USA | KEYNOTE-012 B1/B2 | Clinical trial | NR | HNSCC | pembrolizumab | PD-(L)1 | WES* | 86 | 54 | 53 |
| Cristescu C [36] | 2018 | USA | KEYNOTE-001/ KEYNOTE-006 | Clinical trial | NR | melanoma | pembrolizumab | PD-(L)1 | WES* | 191.5 | 59 | 30 |
| Rizvia [37] | 2018 | USA | NR | RCS | advanced | NSCLC | anti–PD-(L)1 / CTLA-4 | PD-(L)1, CTLA-4 | MSK-IMPACT | 7.4 | 380 | 379 |
| Hellmann 1 [38] | 2018 | Europe and America | CheckMate-012 (NCT01454102) | Clinical trial | Stage IIIB/IV | NSCLC | Nivolumab / ipilimumab | PD-1, CTLA-4 | WES* | 158 | 47 | 48 |
| Hellmann 2A [39] | 2018 | Europe and America | CheckMate-032 (NCT01928394) | Clinical trial | NR | SCLC | Nivolumab | PD-1 | FoundationOne* | tertile | 42 | 47 |
| Hellmann 2B [39] | Nivolumab + Ipilimumab | PD-1, CTLA-4 | FoundationOne* | tertile | 26 | 27 | ||||||
| Janjigiana [40] | 2018 | NR | PCS | advanced | esophagogastric cancer | ICIs | ICP | MSK-IMPACT | 9.7 | 10 | 30 | |
| Goodman [41] | 2017 | USA | NR | RCS | locally/advanced/metastatic | pan-cancer | immunotherapy | PD-(L)1, CTLA4, IL2, Other | FoundationOne | 20 | 38 | 113 |
| Johnson [42] | 2016 | USA | NR | RCS | Stage IV | melanoma | Nivolumab / pembrolizumab / atezolizumab | PD-(L)1 | NGS | 23.1 | 27 | 14 |
| Synder A [43] | 2014 | USA | Not reported | Clinical trial | metastatic | melanoma | Ipilimumab / tremelimumab | CTLA4 | WES* | 100 | 17 | 8 |
| Synder B [43] | 30 | 9 | ||||||||||
| Daniel [44] | 2021 | Canada | NR | RCS | metastatic | solid tumor | investigational immunotherapy | NR | NGS | 12 | 7 | 15 |
| Chen [45] | 2021 | China | NR | PCS | IIIB-IV | NSCLC | anti-PD-1 / PD-L1 therapy | PD-(L)1 | OncoScreen | 7 | 14 | 18 |
| Hana [46] | 2021 | Korea | NR | PCS | advanced | pan-cancer | ICIs | ICP | NGS | 10 | 58 | 443 |
| Gogas [47] | 2020 | Europe and America | NCT03273153 | Clinical trial | advanced or metastatic | melanoma | pembrolizumab | PD-(L)1 | FoundationOne | 10 | Total 224 | |
| Hyojin [48] | 2021 | Korea | NR | RCS | surgically resected | NSCLC | ICIs | ICP | NGS | 5.29 | 15 | 15 |
| Wang [49] | 2021 | china | NCT02915432 | Clinical trial | recurrent or Metastatic | nasopharyngeal cancer | Toripalimab | PD-(L)1 | WES | 2.9 | 17 | 157 |
| Alexandra [50] | 2021 | Canada | NCT02155621 | Clinical trial | advanced or metastatic | pan-cancer | ICIs | ICP | NGS | 10 | 19 | 63 |
| Michele [51] | 2021 | UK | NCT02563002 | Clinical trial | surgical resected | colorectal cancer | Nivolumab / pembrolizumab / ipilimumab | PD-(L)1, CTLA4 | WES | 12 | 26 | 6 |
| Keigo [52] | 2021 | Japan | NR | PCS | Advanced/metastatic | gastrointestinal cancer | Pembrolizumab / Nivolumab | PD-(L)1 | WES/NGS | 10 | 41 | 4 |
| Goodman [53] | 2020 | USA | NR | RCS | NR | pan-cancer | anti-PD-1/L1 | PD-(L)1 | NGS | 10 | 39 | 38 |
| Goodman [54] | 2019 | USA | NCT02478931 | RCS | NR | pan-cancer | ICIs | ICP | FoundationOne | 20 | 15 | 45 |
| Yelena [55] | 2021 | USA | NCT01693562 | Clinical trial | Advanced /metastatic | pan-cancer | Durvalumab | PD-(L)1 | NGS | tertile | 13 | 24 |
| Schrock [56] | 2019 | USA | NR | RCS | Stage Ⅱ- IV | colorectal cancer | anti-PD-(L)1 | PD-(L)1 | NGS | 37.4 | 13 | 9 |
| Carl [57] | 2018 | USA | NR | Clinical trial | metastatic | melanoma | Nivolumab / pembrolizumab / ipilimumab | PD-(L)1, CTLA4 | WES | 7.1 | 39 | 119 |
| Chester [58] | 2021 | USA | NR | RCS | advanced | NSCLC | Nivolumab / pembrolizumab / atezolizumab | PD-(L)1, CTLA4 | FoundationOne | 10 | 35 | 53 |
| Tang [59] | 2019 | China | NCT02836795 | Clinical trial | metastatic | melanoma or urologic cancers | Toripalimab | PD-(L)1 | NGS | 6 | 11 | 12 |
| Wang [13] | 2019 | China | NCT02915432 | Clinical trial | chemorefractory | gastric cancer | Toripalimab | PD-(L)1 | WES | 12(20%) | 12 | 42 |
| Hodi A [60] | 2021 | Europe and America | checkmate067 | Clinical trial | advanced | melanoma | Nivolumab | PD-(L)1 | WES* | 203.5 | 87 | 89 |
| Hodi B [60] | Nivolumab + ipilimumab | PD-(L)1, CTLA-4 | 203.5 | 88 | 96 | |||||||
| Hodi C [60] | Nivolumab | PD-(L)1 | 203.5 | 94 | 84 | |||||||
| Hugo [61] | 2016 | USA | NR | RCS | metastatic | melanoma | Pembrolizumab / Nivolumab | PD-(L)1 | WES* | top third | 12 | 27 |
| Rizvia [62] | 2015 | USA | NR | RCS | NR | NSCLC | pembrolizumab | PD-(L)1 | WES* | 200 | 17 | 17 |
A, B and C represent different datasets from the same study; 1 and 2 represent different studies from the same first author; * represents that non-synonymous mutations were used to replace TMB in the study. RCS retrospective cohort study; PCS prospective cohort study, NR not report, ICIs immune checkpoint inhibitors, ICP Immune checkpoint, NES next generation sequencing, WES whole exome sequencing.