Evidence map›Paper›PMID 32487542›Full record

Trial reportESMO open2020

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

Jean-Baptiste Bachet, Lucjan Wyrwicz, Timothy Price, Chiara Cremolini, Jean-Marc Phelip, Fabienne Portales, Ahmet Ozet, Irfan Cicin, Dan Atlan, Martin Becquart and 5 more

Registry-linked trialOpen access · goldAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in ESMO open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03306394 (An Open-label Early Access Phase IIIb Study of Trifluridine / Tipiracil), which is not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03306394 phase3completednot on this map

An Open-label Early Access Phase IIIb Study of Trifluridine / Tipiracil (S 95005/TAS-102) in Patients With a Pretreated Metastatic Colorectal Cancer (PRECONNECT)

TypeinterventionalSponsorInstitut de Recherches Internationales ServierRan2016 to 2020Enrolled907ConditionsMetastatic Colorectal CancerArmsTrifluridine/Tipiracil hydrochloride (S95005)
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 45 citations in OpenAlex.

  1. Efficacy and safety of trifluridine/tipiracil (TAS-102) in patients with metastatic colorectal cancer: a systematic review and meta-analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
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  6. Targeted therapy combined with immunotherapyWorld journal of gastroenterology · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 11 institutions in 6 countries.

Jean-Baptiste BachetDepartment of Hepatogastroenterology, University Hospital Pitié Salpêtrière, Paris, Île-de-France, France; Sorbonne Universite, Paris, Île-de-France, France. Electronic address: jean-baptiste.bachet@aphp.fr.
Lucjan WyrwiczDepartment of Oncology and Radiotherapy, Maria Skłodowska Curie Memorial Cancer Centre and Institute of Oncology Warsaw, Warszawa, Poland.
Timothy PriceDepartment of Medical Oncology, The Queen Elizabeth Hospital, Woodville South, South Australia, Australia.
Chiara CremoliniDepartment of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Toscana, Italy.
Jean-Marc PhelipDepartment of Gastroenterology, Centre Hospitalier Universitaire de Saint-Etienne, Saint-Etienne, Rhône-Alpes, France.
Fabienne PortalesDepartment of Medical Oncology, Institut régional du Cancer de Montpellier, Montpellier, France.
Ahmet OzetDepartment of Medical Oncology, Gazi University Faculty of Medicine, Ankara, Turkey.
Irfan CicinDepartment of Medical Oncology, Trakya University, Edirne, Turkey.
Dan AtlanGlobal Medical Affairs, Servier Médical, Suresnes, Île-de-France, France.
Martin BecquartGlobal Medical Affairs, Servier Médical, Suresnes, Île-de-France, France.
Loick VidotInstitut de Recherches Internationales Servier, Suresnes, France.
Nadjat MounedjiGlobal Medical Affairs, Servier Médical, Suresnes, Île-de-France, France.
Eric Van CutsemDepartment of Digestive Oncology, KU Leuven University Hospitals Leuven, Leuven, Belgium.
Julien TaiebDepartment of Gastroenterology and Digestive Oncology, European Hospital Group Georges-Pompidou, Paris, Île-de-France, France.
Alfredo FalconeDepartment of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Toscana, Italy.
Servier (France) · FRUniversity of Pisa · ITCentre Hospitalier Universitaire de Saint-Étienne · FRGazi University · TRHôpital Européen Georges-Pompidou · FRInstitut de Recherche en Cancérologie de Montpellier · FRKU Leuven · BEQueen Elizabeth Hospital · AUSorbonne Université · FRThe Maria Sklodowska-Curie National Research Institute of Oncology · PLTrakya University · TR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn 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.

methodsIn this ongoing, international, multicentre, open-label trial, patients with pretreated mCRC received oral trifluridine/tipiracil 35 mg/m

results793 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.

conclusionsPRECONNECT 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.

Indexed as

Colorectal NeoplasmsQuality of LifeAgedAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansMaleMiddle AgedPatient Reported Outcome MeasuresPyrrolidinesThymineTrifluridineVascular Endothelial Growth Factor APyrrolidinesThyminetipiracilTrifluridineVascular Endothelial Growth Factor Acolorectal cancermetastaticquality of lifesafetytrifluridine tipiracil

Identifiers

PMID32487542
PMCPMC7264999
OpenAlexW3030149115

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.