AUTHOR=Sur Daniel , Lungulescu Cristina , Spînu Ștefan , Gorzo Alecsandra , Dumitrescu Elena-Adriana , Gheonea Dan Ionut , Lungulescu Cristian-Virgil 

TITLE=Trifluridine/tipiracil as a therapeutic option in real life setting of metastatic colorectal cancer: An efficacy and safety analysis

JOURNAL=Frontiers in Pharmacology

VOLUME=13

YEAR=2022

URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.1041927

DOI=10.3389/fphar.2022.1041927

ISSN=1663-9812

ABSTRACT=<p><bold>Background:</bold> In the phase III RECOURSE trial, the orally administered combination trifluridine/tipiracil (FTD/TPI) demonstrated a survival benefit and an acceptable safety profile, earning approval as a third-line therapy in metastatic colorectal cancer (mCRC). This study aimed to assess the efficacy and safety of FTD/TPI in daily clinical practice in Romanian population.</p><p><bold>Methods:</bold> A single-center, retrospective, and observational study analyzed patients with mCRC that received chemotherapy with trifluridine/tipiracil between May 2019 and May 2022 at the Oncology Institute Prof. Dr. Ion Chiricuță in Cluj-Napoca, Romania. Study endpoints included safety, and median progression-free survival (PFS).</p><p><bold>Results:</bold> In this Romanian cohort (<italic>n</italic> = 50) the most common treatment-emergent adverse event was haematological toxicity (76%): anemia (50%), leucopenia (38%), neutropenia (34%), and thrombocytopenia (30%), followed by fatigue (60%), and abdominal pain (18%). Overall, the median progression-free survival was 3.85 months (95% CI: 3.1–4.6 months). PFS was significantly correlated with the number of FTD/TPI administrations and prior surgery.</p><p><bold>Conclusion</bold>: Our study corroborated the previously described safety profile for FTD/TPI in the third-line setting, and demonstrated relatively superior mPFS.</p>