Author:

Keywords:

Science & Technology, Life Sciences & Biomedicine, Oncology, colorectal cancer, metastatic, quality of life, safety, trifluridine tipiracil, TAS-102 MONOTHERAPY, COST-EFFECTIVENESS, DOUBLE-BLIND, PLACEBO, REGORAFENIB, TRIAL, Aged, Antineoplastic Combined Chemotherapy Protocols, Colorectal Neoplasms, Female, Humans, Male, Middle Aged, Patient Reported Outcome Measures, Pyrrolidines, Quality of Life, Thymine, Trifluridine, Vascular Endothelial Growth Factor A, 3211 Oncology and carcinogenesis

Abstract:

BACKGROUND: 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/m2 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. TRIAL REGISTRATION NUMBER: NCT03306394.