Safety, efficacy and patient-reported outcomes with trifluridine/tipiracil in pretreated metastatic colorectal cancer: results of the PRECONNECT study.
作者： Jean-Baptiste Bachet , Lucjan Wyrwicz , Timothy Price , Chiara Cremolini , Jean-Marc Phelip
DOI: 10.1136/ESMOOPEN-2020-000698
关键词: Clinical endpoint 、 Quality of life 、 Adverse effect 、 Internal medicine 、 Medicine 、 Trifluridine 、 Tipiracil 、 Placebo 、 Colorectal cancer 、 Nausea
摘要: ABSTRACT Background In RECOURSE (, trifluridine/tipiracil significantly improved overall survival and progression-free (PFS) versus placebo in patients with pretreated metastatic colorectal cancer (mCRC). PRECONNECT was designed to further characterise safety clinical use of trifluridine/tipiracil. Methods this ongoing, international, multicentre, open-label trial, mCRC received oral 35 mg/m2 twice daily on days 1–5 8–12 each 28-day cycle. The primary endpoint safety; secondary endpoints included PFS quality life (QoL). Results 793 (median age 62 years) from 13 countries for a median 2.84 months (IQR 2.64). Adverse events (AEs) were experienced by 96.7%; the most common (≥20% patients) neutropaenia, asthenia/fatigue, nausea, anaemia diarrhoea. Grade ≥3 AEs occurred 73.9% patients, being neutropaenia (39.1% patients), (9.8%) asthenia/fatigue (5.0%). Median 2.8 (95% CI 2.7 2.9). time Eastern Cooperative Oncology Group performance status deterioration (≥2) 8.9 (range 0.03–14.72). There no clinically relevant change baseline QoL. Conclusions showed consistent results previously demonstrated efficacy profile trifluridine/tipiracil, new concerns identified. QoL maintained during treatment. Trial registration number NCT03306394 .
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