| Title: |
Tumor-Infiltrating Lymphocytes and Survival Outcomes in Early ERBB2-Positive Breast Cancer: 10-Year Analysis of the ShortHER Randomized Clinical Trial. |
| Authors: |
Dieci MV; Bisagni G; Bartolini S; Schirone A; Cavanna L; Musolino A; Giotta F; Rimanti A; Garrone O; Bertone E; Cagossi K; Sarti S; Ferro A; Piacentini F; Orvieto E; Sanders M; Miglietta F; Massa D; Balduzzi S; Conte P; D'Amico R; Guarneri V. |
| Contributors: |
Dieci, Mv; Bisagni, G; Bartolini, S; Schirone, A; Cavanna, L; Musolino, A; Giotta, F; Rimanti, A; Garrone, O; Bertone, E; Cagossi, K; Sarti, S; Ferro, A; Piacentini, F; Orvieto, E; Sanders, M; Miglietta, F; Massa, D; Balduzzi, S; Conte, P; D'Amico, R; Guarneri, V. |
| Publication Year: |
2026 |
| Collection: |
Archivio della ricerca dell'Università di Modena e Reggio Emilia (Unimore: IRIS) |
| Description: |
Importance: For patients with early ERBB2 (formerly HER2)-positive breast cancer, there is a need to identify biomarkers to guide treatment de-escalation. Objective: To evaluate the association of tumor-infiltrating lymphocytes (TILs) with distant disease-free (DDFS) and overall survival (OS) for patients with ERBB2-positive early breast cancer. Design, setting, and participants: The ShortHER randomized clinical trial was a multicentric trial in Italy that enrolled patients with ERBB2-positive breast cancer from December 2007 to October 2013. Patients received 9 weeks or 1 year of adjuvant trastuzumab combined with chemotherapy. Tumor samples were evaluated for TILs. Herein, patients were evaluated at a median follow-up of 9 years, and data were analyzed from February 2023 to August 2024. Intervention: Four cycles of anthracycline-based chemotherapy followed by 4 courses of taxanes combined with trastuzumab for 1 year (long arm) or 3 courses of taxanes combined with trastuzumab for 9 weeks followed by reduced-dose anthracycline-based chemotherapy for 3 courses (short arm). Main outcomes and measures: The association of TILs with DDFS and OS was assessed with Cox models. Results: Of 1253 patients enrolled in the ShortHER trial, 866 women (median [IQR] age, 56 [48-64] years) had evaluable TILs. In Cox models with relevant factors, each 5% TIL increment was associated with improved DDFS (hazard ratio [HR], 0.87; 95% CI, 0.80-0.95; P = .001) and OS (HR, 0.89; 95% CI, 0.81-0.98; P = .01). The 10-year OS rate was 91.3% for patients with TILs 20% or higher, 93.3% for patients with TILs 30% or higher, and 98.1% for patients with TILs 50% or higher, resulting higher vs lower TIL counterparts. Patients with TILs lower than 20% showed a better outcome with the long vs short treatment (10-year DDFS, 88.7% vs 81.0%), whereas patients with TILs 20% or higher showed the opposite (10-year DDFS, 87.1% vs 92.2%; P for interaction = .01). Similarly, patients with TILs 20% or higher had a 10-year OS rate of 89.3% in the long arm vs ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/39946142; firstpage:386; lastpage:393; journal:JAMA ONCOLOGY; https://hdl.handle.net/11380/1391749 |
| DOI: |
10.1001/jamaoncol.2024.6872 |
| Availability: |
https://hdl.handle.net/11380/1391749; https://doi.org/10.1001/jamaoncol.2024.6872 |
| Rights: |
info:eu-repo/semantics/openAccess |
| Accession Number: |
edsbas.BAF8FF87 |
| Database: |
BASE |