# Tumor-Infiltrating Lymphocytes in Triple-Negative Breast Cancer

Source: https://onco.cc/key-papers/paper-leon-ferre-tils-tnbc-no-chemotherapy-jama-2024/  
OnCo record `paper-leon-ferre-tils-tnbc-no-chemotherapy-jama-2024` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A pooled study of 1,966 women with early triple-negative breast cancer treated with surgery and radiotherapy but no chemotherapy, in which those whose tumours were half or more immune cells had 94 percent five-year freedom from distant relapse in stage I disease against 78 percent for immune-poor tumours.

## Summary

Leon-Ferre, Jonas, Salgado, Loi and colleagues pooled individual patient data from 13 centres in North America, Europe and Asia for 1,966 patients diagnosed with triple-negative breast cancer between 1979 and 2017 who received surgery with or without radiotherapy but no adjuvant or neoadjuvant chemotherapy (median age 56; 55 percent stage I). Median tumour-infiltrating lymphocyte level was 15 percent; 417 (21 percent) had 50 percent or more (median age 41) and 1,300 (66 percent) less than 30 percent. In stage I disease five-year distant recurrence-free survival was 94 percent (95 percent confidence interval 91 to 96) with lymphocytes of 50 percent or more versus 78 percent (75 to 80) below 30 percent, and five-year overall survival 95 versus 82 percent. At a median follow-up of 18 years each 10 percent increment in lymphocytes was independently associated with better invasive disease-free survival (hazard ratio 0.92), recurrence-free survival (0.90), distant recurrence-free survival (0.87) and overall survival (0.88).

## Fields

- Kind: Key paper
- Last checked: 2026-09-24
- Tags: tnbc-evidence
- Journal: JAMA
- Year: 2024
- DOI: 10.1001/jama.2024.3056
- Authors: Leon-Ferre RA, Jonas SF, Salgado R, et al.
- Findings: Stage I, lymphocytes 50 percent or more vs under 30 percent: five-year distant recurrence-free survival 94 vs 78 percent; five-year overall survival 95 vs 82 percent.; Each 10 percent increase in lymphocytes: hazard ratios 0.92 (invasive disease-free), 0.90 (recurrence-free), 0.87 (distant recurrence-free), 0.88 (overall survival), adjusted for age, size, nodes, grade and radiotherapy.
- What it means: The evidence behind the stage I de-escalation statement on the triple-negative page: an ordinary haematoxylin and eosin slide identifies a fifth of patients whose outcome without chemotherapy matches treated cohorts. A prospective trial of chemotherapy omission is the missing step.
- Caveats: Retrospective; patients were untreated for historical or clinical reasons that may confound.; Lymphocyte scoring reproducibility between pathologists is imperfect; digital scoring is under evaluation.

## Sources

- JAMA 2024: https://doi.org/10.1001/jama.2024.3056
- PubMed: https://pubmed.ncbi.nlm.nih.gov/38563834/

## Connected records

- key papers: [Tumor-Infiltrating Lymphocytes in Triple-Negative Breast Cancer](https://onco.cc/key-papers/paper-leon-ferre-jama/)
- cancers: [Early triple-negative breast cancer](https://onco.cc/cancers/tnbc-early/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Digital pathology & AI](https://onco.cc/technologies/digital-pathology-ai/)
- institutions: [Mayo Clinic](https://onco.cc/institutions/mayo-clinic/)
- terms: [De-escalation, escalation and response-adapted therapy](https://onco.cc/terms/de-escalation/), [Hazard ratio (HR)](https://onco.cc/terms/hazard-ratio/), [Tumour-infiltrating lymphocytes (TILs)](https://onco.cc/terms/tils/)
- people: [Giuseppe Curigliano](https://onco.cc/people/giuseppe-curigliano/), [Sherene Loi](https://onco.cc/people/loi-sherene/)
- bottlenecks: [Biomarkers are not validated or standardised](https://onco.cc/bottlenecks/b-biomarker-validation/), [Toxicity and quality of life are undervalued](https://onco.cc/bottlenecks/b-toxicity-qol/)
- journals: [JAMA](https://onco.cc/journals/jama/)
- roadmaps: [Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem](https://onco.cc/roadmaps/tnbc-roadmap/)
- ideas: [Give exceptional responders less: pembrolizumab omission after complete response, anthracycline-free regimens and chemotherapy omission in lymphocyte-rich stage I disease](https://onco.cc/ideas/idea-tnbc-de-escalation-for-exceptional-responders/)

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