Bachet, Jean-BaptisteWyrwicz, LucjanPrice, TimothyCremolini, ChiaraPhelip, Jean-MarcPortales, FabienneOzet, Ahmet2024-06-122024-06-1220202059-7029https://doi.org/10.1136/esmoopen-2020-000698https://hdl.handle.net/20.500.14551/19952Background In RECOURSE (, trifluridine/tipiracil significantly improved overall survival and progression-free survival (PFS) versus placebo in patients with pretreated metastatic colorectal cancer (mCRC). PRECONNECT was designed to further characterise safety and clinical use of trifluridine/tipiracil. Methods In this ongoing, international, multicentre, open-label trial, patients with pretreated mCRC received oral trifluridine/tipiracil 35 mg/m(2) twice daily on days 1-5 and 8-12 of each 28-day cycle. The primary endpoint was safety; secondary endpoints included PFS and quality of life (QoL). Results 793 patients (median age 62 years) from 13 countries received trifluridine/tipiracil for a median of 2.84 months (IQR 2.64). Adverse events (AEs) were experienced by 96.7%; the most common (>= 20% of patients) were neutropaenia, asthenia/fatigue, nausea, anaemia and diarrhoea. Grade >= 3 AEs occurred in 73.9% of patients, with the most common being neutropaenia (39.1% of patients), anaemia (9.8%) and asthenia/fatigue (5.0%). Median PFS was 2.8 months (95% CI 2.7 to 2.9). Median time to Eastern Cooperative Oncology Group performance status deterioration (>= 2) was 8.9 months (range 0.03-14.72). There was no clinically relevant change from baseline in QoL. Conclusions PRECONNECT showed consistent results with the previously demonstrated safety and efficacy profile of trifluridine/tipiracil, with no new safety concerns identified. QoL was maintained during treatment.en10.1136/esmoopen-2020-000698info:eu-repo/semantics/openAccessColorectal CancerMetastaticQuality Of LifeSafetyTrifluridine TipiracilTas-102 MonotherapyCost-EffectivenessDouble-BlindPlaceboRegorafenibTrialArticle53Q1WOS:0005738550000022-s2.0-8508590924232487542Q1