Abstract 27P
Background
The optimal systemic treatment for stage I TNBC remains unclear, given the lack of well-designed randomized trials. sTILs have emerged as a prognostic biomarker in early TNBC. We aimed to study the impact of (neo)adjuvant CT use and sTILs in the prognosis of pts with stage I TNBC.
Methods
Pts with stage I TNBC (ER<10% and HER2-0/low) treated at Vall d’Hebron Hospital between 2006 and 2021 were reviewed. sTILs were evaluated at the surgery specimen and/or at the diagnostic biopsy, as per the international immuno-oncology working group guidelines. The effect of (neo)adjuvant CT and sTILs on invasive disease-free survival (iDFS), distant disease-free survival (DDFS), and overall survival (OS) was evaluated. Statistical significance (p<0.05) was determined using the log-rank test.
Results
108 patients were identified (median age 56, 35% pre-menopausal). The majority of patients had tumors ≥10mm (75%), grade 3 (61%), and received CT (79%). Patients not receiving CT had a median age of 75, 17% were pT1a tumors and 30% had favorable histotypes. sTILs could be assessed in 79/108 (73%); 34% had sTILs >50%, which associated with higher grade and Ki67. With a median follow-up of 7.2 years (IC: 3.0 – 21.8), 19/108 (18%) had a progression event, 9 (8%) distant metastases. 5y iDFS, DDFS, and OS rates are presented in the table. (Neo)adjuvant CT was not associated with better iDFS (p=.53), DDFS (p=.66) or OS (p=.89). In multivariate analyses for the survival endpoints, no interaction was observed between sTILs (both as categorical and continuous variables) and CT use. Table: 27P
| 5-year rates | N | iDFS (%) | DDFS (%) | OS (%) |
| Overall population | 108 | 83.6 | 91.2 | 98.9 |
| sTILs >50% | 27 | 88.7 | 100 | 100 |
| sTILs <50% | 52 | 85.6∗ | 93.8† | 97.6‡ |
| CT, overall | 85 | 83.1 | 91.3 | 100 |
| CT and sTILs>50% | 23 | 87 | 100 | 100 |
| CT and sTILs<50% | 36 | 89 | 97 | 100 |
| No CT, overall | 23 | 86.1 | 90.9 | 95.2 |
| No CT and sTILs>50% | 4 | 100 | 100 | 100 |
| No CT and sTILs<50% | 16 | 80 | 87 | 93 |
∗p=.63.
†p=.34.
‡p=.68.
Conclusions
In this retrospective cohort, a high proportion of patients with stage I TNBC received CT, which was not associated with better outcomes, irrespectively of the abundance of sTILs. The role of (neo)adjuvant CT in stage I TNBC should be studied in prospective trials to identify patients that can be spared systemic treatment.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
E. Zamora Adelantado: Financial Interests, Personal, Invited Speaker, Review session for medical oncologists: Eisai, Lilly; Financial Interests, Personal, Invited Speaker, Manegement of iCDK toxicities to oncologist nurses: Novartis; Other, Registration to ESMO Congress 2022 (virtual): Novartis; Other, Registration to: Eisai; Other, Virtual registration to ASCO Congress 2023: Novartis; Other, Registration to SEOM Congress 2023: Lilly; Other, Registration to ESMO Breast Cancer Congress 2023: MSD; Other, Registration to ESMO Congress (virtual): Roche. I. Pimentel: Financial Interests, Personal, Invited Speaker: MSD, Novartis, AstraZeneca; Non-Financial Interests, Member, ASCO member: ASCO; Other, travel and accommodations expenses: Phyzer. M. Bellet Ezquerra: Financial Interests, Personal, Advisory Board: Pfizer, Novartis, Lilly, Stemline-Menarini; Other, Speaker'sBureau and Travel Expenses: Pfizer; Other, Speaker's Bureau: Novartis, Lilly. L. Sanz Gomez: Financial Interests, Institutional, Invited Speaker: Pfizer, AstraZeneca, Daiichi Sankyo. S. Escrivá-De-Romaní: Financial Interests, Personal, Advisory Board: Roche, Daiichi Sankyo/AstraZeneca, Seagen, Pierre-Fabre; Financial Interests, Personal, Invited Speaker: Roche, Daiichi Sankyo/AstraZeneca, Pfizer, Seagen, Novartis; Financial Interests, Personal, Other, Travel grants: Pfizer, Kern; Financial Interests, Personal, Expert Testimony: COR2ED; Financial Interests, Institutional, Invited Speaker: Roche, Synthon, Byondis, Lilly, MedSIR, Zymeworks, Daiichi Sankyo/AstraZeneca, SOLTI. M. Cruellas Lapena: Financial Interests, Institutional, Invited Speaker: Roche. V. Peg Cámara: Financial Interests, Advisory Board: Sysmex, Roche, Bayer; Financial Interests, Sponsor/Funding: MSD, AstraZeneca, exact science, Daiichi Sankyo. C. Saura Manich: Financial Interests, Personal, Advisory Board: AstraZeneca, Daiichi Sankyo, Eisai, Exact Sciences, Exeter Pharma, F. Hoffmann - La Roche Ltd., Gilead, Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Philips, Pierre Fabre, PintPharma, Puma, Roche Farma, Sanofi Avenits, Seagen, Zymeworks, Pharmalex Spain SLU; Financial Interests, Personal, Expert Testimony: Boehringer Ingelheim, Bristol Meyers Squibb, Genentech, Innoup, Millenium; Financial Interests, Personal, Other, SC: Byondis B.V., GSK, Macrogenics, Menarini, Merus, Synthon Biopharpaceuticals; Financial Interests, Institutional, Research Grant: AstraZeneca, Bayer Pharma, Boehringer Ingelheim, Bristol Myers Squibb (BMS), Cytomx Therapeutics, Daiichi Sankyo, Eli Lilly and Company, F. Hoffmann-La Roche Ltd., Genentech, GSK, Immunomedics, Innoup Farma, Macrogenics, Menarini Ricerche, Merus, Novartis, Pfizer, Puma, Roche, Sanofi-Aventis, Seattle Genetics; Financial Interests, Institutional, Invited Speaker: Byondis B.V.; Non-Financial Interests, Member: Spanish Society of Medical Oncology (SEOM), American Society for Clinical Oncology (ASCO), Geicam (Spanish Breast Cancer Research Group), European Society for Medical Oncology (ESMO), Sinology Society of the Official College of Physicians of Barcelona (COMB); Non-Financial Interests, Member, Junta Directiva y Comité Científico: SOLTI group (Academic research group in breast cancer). M. Oliveira: Financial Interests, Personal, Advisory Board: AstraZeneca, Daiichi Sankyo / AstraZeneca, Gilead, Lilly, MSD, Relay Therapeutics, Roche, Seagen, Cureo Science, iOne, Pfizer; Financial Interests, Personal, Invited Speaker: Eisai, Gilead, Pfizer, Roche, Seagen, AstraZeneca, Lilly, Medscape, AstraZeneca, AstraZeneca; Financial Interests, Personal, Other, Educational activity: Libbs; Financial Interests, Institutional, Invited Speaker: AstraZeneca, Boehringer-Ingelheim, GSK, Roche, Seattle Genetics, Zenith Epigenetics, Gilead, Ayala Pharmaceuticals, Pfizer; Financial Interests, Invited Speaker: Roche; Non-Financial Interests, Member of Board of Directors, Head: SOLTI Breast Cancer Research; Other, Travel Grant: Pierre Fabre, Eisai, Gilead, AstraZeneca. All other authors have declared no conflicts of interest.