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Association details:
Biomarker:TMB-H
Cancer:Colorectal Cancer
Drug Class:Immunotherapy
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Assessment of Tumor Mutational Burden and Outcomes in Patients With Diverse Advanced Cancers Treated With Immunotherapy

Published date:
05/02/2023
Excerpt:
In this cohort study of patients with advanced solid tumors treated with ICIs in diverse clinics, TMB-H cancers were significantly associated with improved clinical outcomes compared with TMB-L cancers....Our results were generally consistent with our pancancer cohort, with the 1-year survival probability of TMB-H patients being higher than that of TMB-L patients with NSCLC, bladder, melanoma, and CRC (Figure 3).
DOI:
10.1001/jamanetworkopen.2023.11181
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Anti PD-1 monoclonal antibody in patients with MSI-high and/or high tumor mutational burden for solid malignancies.

Published date:
05/26/2022
Excerpt:
Retrospective analysis of 16 patients (pts) who received 18 CPI-based therapies between October 2017 and February 2022. MSI-H and TMB status was assessed by CARIS, Guardant360 or INVITAE genetic testing…. 15 pts were evaluable for response with an ORR of 33%, including 33% among pts with CRC and 27% for non-CRC malignancies....We identify a higher incidence of SD rates among CRC pts (67% vs. 18% non-CRC).
DOI:
10.1200/JCO.2022.40.16_suppl.e15539
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Tumor Mutational Burden Predicting the Efficacy of Immune Checkpoint Inhibitors in Colorectal Cancer: A Systematic Review and Meta-Analysis

Published date:
09/29/2021
Excerpt:
...we aim to verify the effect of TMB as a biomarker in predicting the efficacy of ICIs in colorectal cancer….The TMB-high patient group had a longer OS than the TMB-low patient group (HR = 0.68, 95% CI: 0.51, 0.92, p = 0.013) among colorectal cancer patients receiving ICIs. In addition, the TMB-high patient group was superior in terms of ORR (OR = 19.25, 95% CI: 10.06, 36.82, p < 0.001) compared to the TMB-low patient group.
DOI:
10.3389/fimmu.2021.751407
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Age, sex, and specific gene mutations affect the effects of immune checkpoint inhibitors in colorectal cancer.

Published date:
05/13/2020
Excerpt:
Mutation count > 11 (tumor mutation burden (TMB)-high), age > 65, male, RNF43, CREBBP, NOTCH3, PTCH1, CIC, DNT1, and SPEN mutant (MT) were associated with longer OS, while APC-mMT and TP53-MT were significantly correlated with shorter OS….Our study is the first to elucidate comprehensive prognostic factors for the treatment of ICIs in CRC patients, from clinical characteristics such as age and sex to specific gene mutations, providing new ideas for immunotherapy in CRC.
DOI:
10.1200/JCO.2020.38.15_suppl.e16103
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

The predictive efficacy of tumor mutation burden in immunotherapy across multiple cancer types: A meta-analysis and bioinformatics analysis

Excerpt:
Compared with low TMB patients receiving ICIs, high TMB yielded a better ORR (RR = 2.73; 95% CI: 2.31–3.22; P = 0.043) and DCB (RR = 1.93; 95% CI: 1.64–2.28; P = 0.356), and a significantly increased OS (HR =0.24; 95% CI: 0.21–0.28; P < 0.001) and PFS (HR = 0.38; 95% CI: 0.34–0.42; P < 0.001)....We found that after immunotherapy for colorectal cancer, gastric cancer, lung cancer, melanoma and pan-cancer, the OS improvement in the high TMB group was significantly better than non-ICIs.
DOI:
https://doi.org/10.1016/j.tranon.2022.101375