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This study evaluated prognostic value using both visual scoring and computational assessment in a randomized phase 2 trial comparing preoperative cisplatin versus paclitaxel in BRCA1/2-proficient stage I–III disease. Results assessed response, residual cancer burden, and related biomarker 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141–149  \n[https://doi.org/10.1093/jnci/djaf289](https://doi.org/10.1093/jnci/djaf289)  \nAdvance Access Publication Date: October 11, 2025  \nArticle  \nPrognostic value of visually and computationally assessed tumor-infiltrating lymphocytes in early-stage triple-negative breast cancer (TBCRC-030)  \nGuilherme Nader-Marta , MD􀀃 ,1 ,2 , Xiangying Chu , MS3, Satabhisa Mukhopadhyay, PhD4, Vandana G. Abramson , MD5, Adam Brufsky , MD, PhD6, Erica Michelle Stringer-Reasor , MD7, Susan Faye Dent , MD8, Tiffany A. Traina, MD9,  \nLisa A. Carey , MD, ScM10, Mothaffar F. Rimawi , MD11, Jennifer M. Specht , MD12, Kathy D. Miller , MD13,  \nCesar Augusto Santa-Maria , MD, MSCI14, Tathagata Dasgupta, PhD4, Busem Binboa Kurt, MD1, 2, Michelle DeMeo , BS1, Ian E. Krop , MD, PhD15, Nadine M. Tung , MD16, Stuart J. Schnitt, MD17, Nabihah Tayob , PhD2,3, Erica L. Mayer , MD, MPH1, 2  \n1Breast Oncology Program, Dana-Farber Cancer Institute, Boston, MA, United States 2Harvard Medical School, Boston, MA, United States  \n3Data Science, Dana-Farber Cancer Institute, Boston, MA, United States 44D Path Inc, Newton, MA, United States  \n5Vanderbilt University Medical Center, Nashville, TN, United States 6University of Pittsburgh, Pittsburgh, PA, United States  \n7O’Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, Birmingham, AL, United States 8Duke Cancer Institute, Durham, NC, United States  \n9Memorial Sloan Kettering Cancer Center, New York, NY, United States  \n10Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States 11Baylor College of Medicine, Houston, TX, United States  \n12University of Washington, Seattle, WA, United States  \n13Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, IN, United States 14Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Medicine, Baltimore, MD, United States 15Yale Cancer Center, New Haven, CT, United States  \n16Beth Israel Deaconess Medical Center, Boston, MA, United States 17Brigham and Women’s Hospital, Boston, MA, United States  \n􀀃 Corresponding author: Guilherme Nader-Marta, MD, Department of Medical Oncology, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA, United States ([guilherme_nadermarta@dfci.harvard.edu](guilherme_nadermarta@dfci.harvard.edu)) .  \nAbstract  \nBackground: Tumor-infiltrating lymphocytes (TILs), assessed by visual examination, are prognostic and predictive in early-stage triple-negative breast cancer. Computational assessment may provide a complementary approach. We evaluated the prognostic value of TILs by visual examination and computational assessment.  \nMethods: Cisplatin vs Paclitaxel for Triple Negative Breast Cancer (TBCRC030; [ClinicalTrials.gov](ClinicalTrials.gov) identifier NCT01982448) was a randomized phase 2 trial enrolling patients with BRCA1/2-proficient stage I to III triple-negative breast cancer to receive preoperative cisplatin or paclitaxel. The primary endpoint was pathological response at surgery. The TILs were visually scored on digitized pretreatment biopsies per International TILS Working Group recommendations. Computational assessment used the 4D Path QPOR platform to generate TILs, an immune heterogeneity index, and a combined immune/cell cycle biomarker (CmbI) . Predictive performance for residual cancer burden 0/1 was assessed using receiver operating characteristic curves and odds ratios (ORs) with 95% CIs; all statistical tests were 2-sided.  \nResults: Of 139 response-evaluable patients, 121 had matched visual examination and computational assessment data (59 on cisplatin, 62 on paclitaxel) . Median visual examination TILs were higher in responders (40.0% vs. 10.0%; P ¼ .002) and predicted response (OR ¼ 1.86, 95% CI ¼ 1.24 to 2.87; area under the curve ¼ 0.69, 95% CI ¼0.57 to 0.80) . Computational assessment CmbI differed by response group and predicted residual can","cbCaiknN9w0qpYZJ","https://ap.wps.com/l/cbCaiknN9w0qpYZJ","pdf",736365,"English","# Background\n# Methods\n# Results\n# Conclusion","[{\"question\":\"What was the study’s goal regarding tumor-infiltrating lymphocytes (TILs)?\",\"answer\":\"To evaluate the prognostic value of TILs using both visual examination and computational assessment in early-stage triple-negative breast cancer.\"},{\"question\":\"Which treatments and patient population were included?\",\"answer\":\"A randomized phase 2 trial compared preoperative cisplatin versus paclitaxel in BRCA1/2-proficient stage I–III triple-negative breast cancer patients.\"},{\"question\":\"How did computational assessment compare with visual scoring for prediction?\",\"answer\":\"Computational assessment of CmbI was associated with response but did not outperform visual assessment, and computational TILs and the immune heterogeneity index were not predictive.\"}]","Prognostic value of visually and computationally assessed tumor-infiltrating lymphocytes in early-stage triple-negative breast cancer (TBCRC-030) | PDF",1790133635,23]