Abstract 253P
Background
TNT is a standard treatment for LARC. However, use and outcome of the different TNT regimens in real-world practice are largely unknown.
Methods
This is an ongoing, international, multicentre, retrospective study by The International Real-World TNT Study Consortium. Eligibility is limited to patients treated with TNT outside of clinical trials. The primary objective is to describe real-word practice across international centres. Secondary objectives include treatment safety and efficacy overall and by TNT regimen. Logistic mixed models for binary outcomes, and Kaplan-Meier analysis and Cox proportional hazards models for time-to-event outcomes were used after propensity-score matching.
Results
1,585 patients treated between 2013 and 2023 were included in this analysis. Baseline characteristics: 63% males, median age 60 years (IQR 53-68), 46% low rectum, 26% cT4, 47% cN2, 32% EMVI+, 44% CRM+. TNT regimens: RAPIDO 33%, PRODIGE 23 18%, OPRA with induction chemotherapy 12%, OPRA with consolidation chemotherapy 16%, other 21%. The median follow-up was 24 months. In the entire population, pathological complete response (pCR) was 21%, with CR (pCR + sustained clinical CR at 1 year) 23%. Local or distant progression as first site of treatment failure occurred in 7% and 16% of cases, respectively. 3-year event-free survival (EFS) and overall survival (OS) were 66% and 89%, respectively. Serious adverse events were reported for 16% of patients. 948 patients were included in the matched analysis (see table). Table: 253P
| TNT regimen | pCR | CR | Local progression as first event | Distant progression as first event | EFS | OS | ||||||
| OR | p | OR | p | OR | p | OR | p | HR | p | HR | p | |
| RAPIDO (n = 318 ) | Ref | Ref | Ref | Ref | Ref | Ref | ||||||
| PRODIGE 23 (n = 237) | 1.13 (0.65-1.95) | 0.67 | 1.01 (0.64-1.60) | 0.96 | 0.39 (0.14-1.03) | 0.07 | 1 (0.58-1.73) | 1 | 0.77 (0.44-1.32) | 0.34 | 0.87 (0.35-2.14) | 0.76 |
| OPRA induction (n= 178) | 0.83 (0.49-1.42) | 0.50 | 0.70 (0.44-1.12) | 0.14 | 1.14 (0.55-2.31) | 0.71 | 0.88 (0.50-1.53) | 0.65 | 0.90 (0.57-1.41) | 0.64 | 1.53 (0.75-3.13) | 0.24 |
| OPRA consolidation (n=215) | 0.92 (0.55-1.55) | 0.76 | 0.92 (0.59-1.42) | 0.7 | 1.07 (0.53-2.12) | 0.85 | 1.21 (0.74-2.00) | 0.45 | 1.15 (0.74-1.79) | 0.53 | 1.34 (0.64-2.81) | 0.43 |
Conclusions
This is the largest real-world study of TNT for LARC to date. Our findings show substantial variation in the choice of the TNT regimen. Efficacy results are overall in line with those reported in clinical trials, and confirm the efficacy of TNT in a real-world setting regardless of the specific regimen. Data reported by the authors on behalf of The International Real-World TNT Study Consortium.
Legal entity responsible for the study
Institut Jules Bordet.
Funding
Has not received any funding.
Disclosure
E. Ruiz: Financial Interests, Personal, Advisory Board: Roche, Amgen, BMS, Bayer, Pfizer; Financial Interests, Personal, Invited Speaker: Roche, Merck, Astellas; Non-Financial Interests, Member: ASCO. M.C. Riesco Martinez: Financial Interests, Personal, Advisory Role: Ferrer; Financial Interests, Personal, Invited Speaker: Servier, Pfizer; Financial Interests, Institutional, Research Grant: MSD Oncology; Financial Interests, Personal, Other: Servier. J. Dekervel: Financial Interests, Personal, Invited Speaker: Amgen, Bayer, Eisai, Ipsen, Lilly, Merck, MSD, Roche, Servier; Financial Interests, Personal, Advisory Board: BMS, Eisai, Novartis, Roche; Financial Interests, Institutional, Research Grant: Bayer. I. Kirac: Financial Interests, Institutional, Research Grant: Polypid. J. Hernando Cubero: Financial Interests, Personal, Expert Testimony: Eisai, Ipsen, Novartis, AAA, Angelini, Pfizer, Roche. M. Artaç: Financial Interests, Personal, Royalties: Amgen, Bayer, Merck, Pfizer, Roche; Financial Interests, Personal, Advisory Role: Roche. J.M.R. O'Connor: Financial Interests, Personal, Invited Speaker: Merck Serono, BMS, Bayer, Servier, Pfizer; Financial Interests, Personal, Advisory Board: MSD. A.I. Shamseddine: Financial Interests, Personal, Royalties: AstraZeneca, Merck, MSD, Servier; Financial Interests, Personal, Advisory Role: AstraZeneca, Bayer; Financial Interests, Personal, Speaker’s Bureau: Amgen, Bayer, Merck, MSD, Novartis, Pfizer, Sanofi; Financial Interests, Personal, Research Grant: Bristol Myers Squibb, Bristol Myers Squibb/Medarex, Merck; Financial Interests, Personal, Other: Algorithm SAL. F. Sclafani: Financial Interests, Personal, Advisory Board: AMAL Therapeutics, Bayer, BMS, Dragonfly Therapeutics, GSK, Nordic Pharma, Roche; Financial Interests, Personal, Invited Speaker: Amgen, Merck, Servier; Financial Interests, Institutional, Research Grant: Amgen, Astellas, AstraZeneca, Bayer, BMS, Merck, MSD, Pierre Fabre, Roche, Sanofi; Non-Financial Interests, Leadership Role, Secretary of the EORTC Gastrointestinal Tract Cancer Group: EORTC Gastrointestinal Tract Cancer Group; Other, Travel grants: Amgen, Bayer, Lilly, Merck, Roche, Servier. All other authors have declared no conflicts of interest.