Table 1.
The characteristics of the studies included in the meta-analysis.
| Study | Year | Country | Study Type | Tumor Type | Immunotherapy Drug | Sample Source | TMB Detection Method | TMB Cutoff (mut/MB) | No. Patients | Outcome | QA | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| H | L | |||||||||||
| Li et al. (24) | 2020 | China | RCS | Melanoma | P | NR | NR | ≥2 | 10 | 11 | PFS | 4 |
| Aggarwal et al. (25) | 2020 | USA | Clinical trial | NSCLC | P | Blood | NGS | ≥16 | Total 26 | OS; PFS | 11 | |
| Alborelli et al. (26) | 2020 | Switzerland | RCS | NSCLC | ICIs | Tissue | NGS | ≥9 | 25 | 51 | OS; PFS | 6 |
| Joshi et al. (27) | 2020 | USA | PCS | Urothelial cancer | Anti–PD-1/L1 | NR | FoundationOne | NR | Total 34 | OS | 6 | |
| Wang et al. (28) | 2020 | China | PCS | NSCLC | Anti–PD-1/L1 | Blood | FoundationOne | ≥6 | 28 | 36 | OS | 9 |
| ≥16 | 103 | 326 | OS | |||||||||
| Wang, Z et al. (29) | 2019 | China | PCS | NSCLC | Anti–PD-1/L1 | Blood | CGP | ≥6 | 28 | 22 | PFS | 8 |
| Chae et al. (8) | 2019 | USA | RCS | NSCLC | Anti–PD-1/L1 | Blood | NGS | Median | Total 20 | OS; PFS | 7 | |
| Total 22 | OS; PFS | |||||||||||
| Gogas et al. (5) | 2020 | Greece | PCS | Melanoma | P | Tissue | FoundationOne | ≥10 | Total 224 | PFS | 7 | |
| Fang et al. (30) | 2019 | China | RCS | NSCLC | Anti–PD-1/L1 | Tissue | WES | 157 | 25 | 48 | PFS | 6 |
| NGS | 10 | 26 | 49 | PFS | ||||||||
| Goodman et al. (31) | 2019 | USA | PCS | Multiple tumors | Anti–PD-1/L1 or anti-CTLA4 | Tissue | FoundationOne | ≥20 | 15 | 45 | OS; PFS | 7 |
| B-S et al. (11) | 2020 | USA | Clinical trial | Breast cancer | ICIs | Tissue | OncoPanel | 6 | 12 | 50 | OS; PFS | 12 |
| Goodman et al. (32) | 2017 | USA | RCS | Multiple tumors | Multi-Immunotherapy | Tissue | FoundationOne | ≥20 | 38 | 113 | OS; PFS | 8 |
| Hodi et al. (33) | 2019 | USA | RCS | Melanoma | N | Tissue | NR | NR | 23 | 30 | OS; PFS | / |
| N | 95 | 97 | OS; PFS | |||||||||
| I | 101 | 93 | OS; PFS | |||||||||
| N + I | 94 | 103 | OS; PFS | |||||||||
| D'Angelo et al. (13) | 2020 | USA | Clinical trial | MCC | Avelumab | Blood and Tissue | WES | ≥2 | 11 | 25 | OS; PFS | 9 |
| Davis et al. (34) | 2018 | USA | RCS | NSCLC | ICIs | Blood | NGS | NR | Total 19 | OS | / | |
| Total 18 | PFS | |||||||||||
| Kowanetz et al. (9) | 2016 | USA | Clinical trial | NSCLC | A | Tissue | FM1 panel | 16.6 | Total 367 | OS; PFS | / | |
| Ricciuti et al. (35) | 2018 | USA | RCS | SCLC | Anti–PD-1 ± anti–CTLA-4 | Tissue | NGS | 9.29 | 21 | 23 | OS; PFS | 9 |
| Griesinger et al. (10) | 2017 | Germany | Clinical trial | NSCLC | A | Tissue | FoundationOne | ≥13.5 | Total 102 | OS; PFS | / | |
| ≥17.1 | Total 371 | OS; PFS | ||||||||||
| He et al. (36) | 2020 | China | RCS | NSCLC | Anti–PD-1/L1 | Tissue | TMBRB | ≥10 | 84 | 243 | OS; PFS | 6 |
| Yang et al. (37) | 2020 | USA | Clinical trial | Multiple tumors | ICIs | Tissue | NGS | ≥6.88 | 9 | 94 | OS | 10 |
| Shim et al. (38) | 2020 | Korea | PCS | NSCLC | Anti–PD-1/L1 | Tissue | WES | top 25% | 47 | 151 | PFS | 7 |
| Li et al. (39) | 2020 | NR | Clinical trial | HNSCC | D ± T | Tissue | WES | ≥upper tertile | Total 153 | OS | / | |
| D and D+T | NR | Total 76 | OS | |||||||||
| Kim et al. (12) | 2020 | Korea | RCS | Gastric cancer | P/N | Tissue | NGS | ≥14.31 | 8 | 55 | PFS | 8 |
| Huang et al. (40) | 2020 | China | RCS | NSCLC | Anti–PD-1/L1 | Tissue | NGS | ≥10 | 14 | 20 | OS; PFS | 7 |
| 7 | 7 | OS; PFS | ||||||||||
| Wang, F et al. (41) | 2019 | China | PCS | Gastric cancer | Toripalimab | Blood | WES | ≥12 | 12 | 42 | OS; PFS | 6 |
| Ohue et al. (42) | 2019 | Japan | PCS | NSCLC | Anti–PD-1 | Tissue | NGS | NR | Total 13 | OS; PFS | 6 | |
| Ricciuti et al. (43) | 2019 | USA | RCS | SCLC | Anti–PD-1 and/or anti–CTLA-4 | Tissue | NGS | >9.68 | 26 | 26 | OS; PFS | / |
| >9.78 | Total 52 | OS | ||||||||||
| Lai et al. (44) | 2019 | USA | PCS | SCLC | Anti–PD-1 ± anti–CTLA-4 | Tissue | NGS | upper tertile | Total 57 | PFS | / | |
| Kim et al. (45) | 2018 | USA | Clinical trial | NSCLC | A | Blood | NR | ≥20 | 19 | 100 | PFS | / |
| Heeke et al. (46) | 2019 | France | RCS | NSCLC | Anti–PD-1/L1 | Tissue | FoundationOne | ≥15 | 15 | 21 | PFS | 7 |
| Melanoma | 15 | 17 | PFS | |||||||||
| Higgs et al. (47) | 2018 | USA | Clinical trial | NSCLC | D+T | Tissue | FoundationOne | ≥11.41 | 37 | 69 | PFS | 8 |
| Samstein et al. (4) | 2019 | USA | Clinical trial | Multiple tumors | ICIs | Tissue | NGS | top 20% | 1662 | OS | 9 | |
TMB, tumor mutation burden; H, high TMB; L, low TMB; OS, overall survival; RFS, progression-free survival; HR, hazard ratio; CI, confidence interval; PCS, prospective cohort study; RCS, retrospective cohort study; P, pembrolizumab; NR, not reported; NSCLC, non-small cell lung cancer; NGS, next-generation sequencing; ICIs, immune checkpoint inhibitors; N, nivolumab; A, atezolizumab; CGP, cancer gene panel; WES, whole-exome sequencing; I, ipilimumab; MCC, Merkel cell carcinoma; SCLC, small cell lung cancer; D, durvalumab; T, tremelimumab; TMBRB,TMB radiomic biomarker; HNSCC, head and neck squamous cell carcinoma.