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Tumor Mutational Burden - Usage Guide
Overview
Calculate tumor mutational burden from somatic VCFs with Friends of Cancer Research (Vega 2021) harmonization equations for per-assay calibration to the FDA pembrolizumab 10 mut/Mb pan-tumor threshold (TSO500 = 7.8, Oncomine = 8.4 per Ramos-Paradas 2021). Covers FoundationOne CDx convention of including synonymous variants, hypermutator / ultra-hypermutator tiering (POLE+MMR), tumor-type-specific cutoffs per McGrail 2021 (poor TMB performance in breast / prostate / glioma), blood TMB caveats (BFAST Cohort C failed), and integration with MSI-H, HLA-LOH (LOHHLA / DASH), and neoantigen quality (Luksza fitness, McGranahan clonality).
Prerequisites
pip install cyvcf2 pandas numpy
# VEP for annotation (or snpEff / Funcotator)
# Ensembl VEP: docker pull ensemblorg/ensembl-vep
# Or: conda install -c bioconda ensembl-vep
# HLA-LOH
# LOHHLA: https://github.com/mskcc/lohhla
# DASH: https://github.com/RamratnamLab/DASH
# Friends of Cancer Research TMB harmonization tool
# https://friendsofcancerresearch.org/tmb/
Quick Start
Tell the agent what to do:
- "Calculate TMB from this FoundationOne-style somatic VCF using 0.8 Mb scored region (NOT 1.1 Mb panel total)"
- "Apply cross-panel calibration: report TMB-H equivalent thresholds for TSO500 (7.8), Oncomine (8.4) per Ramos-Paradas 2021"
- "For this MSK-IMPACT cohort, compute TMB excluding synonymous (vs FoundationOne which includes them); document convention"
- "Integrate TMB + MSI-H + HLA-LOH (LOHHLA) for ICI eligibility decision"
- "For breast / prostate / glioma cohorts, apply tumor-type-specific Samstein 2019 cutoff (NOT universal 10/Mb; McGrail 2021)"
Example Prompts
Standard TMB Calculation
"Compute TMB from this VEP-annotated Mutect2 VCF. Use FoundationOne CDx conventions: scored region 0.8 Mb, include synonymous, VAF >= 5%, exclude hotspots, gnomAD grpmax FAF95 < 0.5%."
"For my TSO500 panel cohort, compute TMB with 1.3 Mb scored region; apply the TSO500 equivalent threshold of 7.8/Mb (Ramos-Paradas 2021) for TMB-H classification."
Cross-Panel Comparison
"Reconcile TMB values across FoundationOne CDx (0.8 Mb scored, includes synonymous), TSO500 (1.3 Mb scored), MSK-IMPACT v4 (1.22 Mb scored). Document counting conventions."
"Audit these published TMB values: are they comparable across studies using different panels?"
Cancer-Type-Specific Cutoffs
"For this breast cancer cohort, do NOT apply universal 10/Mb cutoff. Use tumor-type-specific cutoff per Samstein 2019 (top 20% within tumor type). Cite McGrail 2021 for the breast / prostate / glioma limitation."
MSI + HLA-LOH Integration
"For each tumor: compute TMB, run MSI testing, run LOHHLA. Report ICI eligibility with: MSI-H supersedes TMB-H; TMB-H + HLA-LOH-positive has reduced neoantigen presentation."
Blood TMB
"Compute bTMB from cfDNA panel; flag low tumor fraction (BFAST Cohort C failure mechanism); recommend tissue TMB confirmation."
Hypermutator Characterization
"For samples with TMB > 100 mut/Mb, identify mechanism: MMR-D (SBS6/15/26/44 + ID1/2) vs POLE-exo (SBS10a/10b). For TMB > 500 mut/Mb, suspect POLE+MMR concurrent."
What the Agent Will Do
- Verify VCF has VEP / snpEff / Funcotator consequence annotations.
- Apply filters: PASS-only, VAF >= 5% (FoundationOne) or higher, depth >= 100, tumor-only germline filter gnomAD grpmax FAF95 <= 0.5%, exclude COSMIC hotspots.
- Count nonsynonymous coding variants (configurable to include synonymous for FoundationOne CDx compatibility).
- Divide by SCORED region in Mb (NOT total panel size).
- Apply Vega 2021 calibration: assay-specific equivalent threshold for FoundationOne 10/Mb sensitivity.
- Classify: TMB-low; TMB-H (>= cutoff); hypermutator (>= 100); ultra-hypermutator (>= 500).
- For breast / prostate / glioma, apply tumor-type-specific Samstein 2019 cutoff and document the McGrail 2021 tumor-type limitation.
- Integrate MSI status: MSI-H is the primary biomarker (Sha 2020); TMB-H is not additive.
- Run LOHHLA / DASH for HLA-LOH; flag tumors with reduced neoantigen presentation.
- For research-grade neoantigen quality, compute Luksza fitness + McGranahan clonality.
Tips
- FoundationOne CDx SCORED region is 0.8 Mb (NOT the 1.1 Mb total panel). Using panel total inflates TMB ~37%.
- FoundationOne CDx INCLUDES synonymous variants in TMB; MSK-IMPACT and most academic pipelines exclude. Match the comparison reference.
- Cross-panel TMB is not directly comparable without per-assay calibration. The FoundationOne 10/Mb = TSO500 7.8 = Oncomine 8.4 equivalences are from the TMB2 project (Ramos-Paradas 2021).
- bTMB is research-grade in tissue-naive contexts; BFAST Cohort C failed primary endpoint due to low ctDNA shed.
- TMB-H does not enrich ICI response in breast, prostate, glioma per McGrail 2021. Use tumor-type-specific cutoffs.
- MSI-H + TMB-H is statistical tautology (MSI-H is uniformly hypermutator). MSI-H is primary biomarker.
- HLA-LOH (~17% pan-cancer; >30% HNSCC / NSCLC / cervical) abolishes neoantigen presentation; run LOHHLA / DASH for high-TMB tumors.
- Hypermutator (>=100/Mb) signature stratification: MMR-D = SBS6/15/26/44 + ID1/2; POLE-exo = SBS10a/10b + SBS28.
- Ultra-hypermutator (>=500/Mb) is typically POLE+MMR concurrent; ICI excellent response.
- COSMIC hotspots (BRAF V600E, KRAS G12C) excluded by convention (not random; biases TMB upward).
- Population-stratified gnomAD AF (grpmax FAF95) for ancestry-diverse cohorts; EUR-only filter inflates AFR/EAS TMB.
- Tumor purity floor: FoundationOne >= 20%, MSK-IMPACT >= 30%; below this, VAF-based filtering unreliable.
- Panel size minimum: >= 0.8 Mb workable; >= 1.0 Mb preferred; < 0.5 Mb unreliable (Predicine ATLAS borderline).
- clinical-databases/somatic-signatures - Mutational signatures (SBS3 HRD, MMR-D, POLE)
- clinical-databases/msi-detection - MSI-H related ICI biomarker
- clinical-databases/hla-typing - HLA typing for neoantigen + LOH
- variant-calling/variant-calling - Mutect2 / Strelka2 somatic upstream
- variant-calling/clinical-interpretation - ACMG/AMP cancer framework