Safety, efficacy and patient-reported outcomes with trifluridine/tipiracil in pretreated metastatic colorectal cancer: results of the PRECONNECT study

ESMO Open

article

Jean-Baptiste Bachet¹  Lucjan Wyrwicz³  Timothy Price⁴  Chiara Cremolini⁵  Jean-Marc Phelip⁶  Fabienne Portales⁷  Ahmet Ozet⁸  Irfan Cicin⁹  Dan Atlan^1,10  Martin Becquart^1,10  Loick Vidot^1,11  Nadjat Mounedji^1,10  Eric Van Cutsem^1,12  Julien Taieb^1,13  Alfredo Falcone⁵ 

[1] Department of Hepatogastroenterology, University Hospital Pitié Salpêtrière;Sorbonne Universite;Department of Oncology and Radiotherapy, Maria Skłodowska Curie Memorial Cancer Centre and Institute of Oncology Warsaw;Department of Medical Oncology, The Queen Elizabeth Hospital;Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa;Department of Gastroenterology, Centre Hospitalier Universitaire de Saint-Etienne;Department of Medical Oncology, Institut régional du Cancer de Montpellier;Department of Medical Oncology, Gazi University Faculty of Medicine;Department of Medical Oncology, Trakya University;Global Medical Affairs;Institut de Recherches Internationales Servier;Department of Digestive Oncology, KU Leuven University Hospitals Leuven;Department of Gastroenterology and Digestive Oncology, European Hospital Group Georges-Pompidou

关键词: colorectal cancer;    metastatic;    quality of life;    safety;    trifluridine tipiracil;   

DOI  :  10.1136/esmoopen-2020-000698

学科分类：社会科学、人文和艺术（综合）

来源: BMJ Publishing Group

【 摘 要 】

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.

【 授权许可】

CC BY|CC BY-NC-ND