Abstract 443P
Background
Limited third-line options exist for mGEA. In this setting, trifluridine/tipiracil (FTD/TPI) is a standard treatment thanks to improved overall survival (OS) in a phase III study. FOLFIRI is another widely adopted regimen based on non-randomized, mainly single-arm or retrospective studies. To our knowledge, no data comparing these two are available. We aim to evaluate their outcomes as third lines in a real-world cohort of patients (pts) treated at our institution.
Methods
In this retrospective monocentric study pts with mGEA who progressed after two lines of therapy containing fluoropyrimidines, platinum derivatives and taxanes and were treated in third line with FOLFIRI or FTD/TPI at our institution from January 2020 to March 2024 were included. Outcomes in terms of overall response rate (ORR), progression-free survival (PFS), OS and toxicity were evaluated.
Results
Among a total of 350 pts treated for mGEA in the selected timeframe, 156 received third-line treatment and 74 pts were deemed eligible according to inclusion criteria. Median age was 62 years, 72% had synchronous metastatic disease and 45% an ECOG PS≥1. Primary tumor site was GEJ in 38%. 72% received FOLFIRI and 28% FTD/TPI as third-line therapy. ORR was 7% vs 0% (p=0.313) and mPFS 2.5 vs 2.3 months (mo) (p=0.122) in FOLFIRI and FTD/TPI treated pts, respectively. Grade 3-4 toxicity was reported in 18% vs 12% (p=0.160) of pts, respectively. In the overall population 39% received subsequent fourth-line treatment: 22% vs 18% among FOLFIRI and FTD/TPI treated pts (p=0.017). Fourth line was FOLFIRI in 33% and FTD/TPI in 10% of pts. Median follow up was 21.9 mo in the whole population (44.2 mo in FOLFIRI and 12.6 mo in the FTD/TPI population, p=0.015). In this selected cohort, mOS from diagnosis of metastatic disease was 21.4 mo and mOS from third-line start was 5.9 mo. Third-line mOS in FOLFIRI compared to FTD/TPI pts was 5.3 mo vs 9.5 mo (p=0.182). A positive effect of third-line FTD/TPI treatment was noticed at multivariate analysis (HR 0.497, 95%CI 0.252 – 0.978, p=0.043).
Conclusions
Our data suggest that FTD/TPI, despite slightly lower response rates and similar mPFS, may have a positive impact on OS and lower toxicity compared to FOLFIRI, confirming its mainstay role as third-line therapy.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
L. Procaccio: Financial Interests, Advisory Board: AstraZeneca. M.D. Rizzato: Financial Interests, Invited Speaker: AstraZeneca. F. Bergamo: Financial Interests, Personal, Invited Speaker: Lilly, BMS, MSD, Eisai, Bayer, Amgen; Financial Interests, Personal, Advisory Board: Servier, AAA; Other, congress: Bayer, Ipsen, AAA. S. Lonardi: Financial Interests, Personal, Advisory Board: Amgen, Merck Serono, Lilly, Servier, AstraZeneca, MSD, Incyte, Daiichi Sankyo, Bristol Myers Squibb, Astellas, GSK, Takeda, Bayer; Financial Interests, Personal, Invited Speaker: Pierre Fabre, GSK, Roche, Servier, Amgen, Bristol Myers Squibb, Incyte, Lilly, Merck Serono, MSD; Financial Interests, Institutional, Invited Speaker: Amgen, Merck Serono, Bayer, Roche, Lilly, AstraZeneca, Bristol Myers Squibb; Non-Financial Interests, Member of Board of Directors, Italian No-Profit Oncology Research Foundation supporting academic Clinical trials: GONO Foundation. All other authors have declared no conflicts of interest.