Evidence map›Paper›PMID 36707808›Full record

Trial reportBMC cancer2023

Safety and efficacy of trifluridine/tipiracil in previously treated metastatic colorectal cancer: final results from the phase IIIb single-arm PRECONNECT study by duration of therapy.

Julien Taieb, Timothy Price, Loïck Vidot, Bénédicte Chevallier, Lucjan Wyrwicz, Jean-Baptiste Bachet

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase III
In one paragraph

Trial report in BMC cancer, 2023. 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 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
3.0field-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

11 citing papers in PubMed, 13 citations in OpenAlex.

  1. Article
  2. Targeted therapy combined with immunotherapyWorld journal of gastroenterology · 2025
    Article
  3. Observational
  4. Review
  5. Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
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

6 authors at 5 institutions in 4 countries.

Julien TaiebDepartment of Gastroenterology and Digestive Oncology, European Hospital Group Georges-Pompidou, Paris, France. jtaieb75@gmail.com.ORCID https://orcid.org/0000-0002-9955-4753
Timothy PriceDepartment of Medical Oncology, The Queen Elizabeth Hospital and University of Adelaide, Woodville South, South Australia, Australia.ORCID https://orcid.org/0000-0002-3922-2693
Loïck VidotServier, Suresnes, Paris, France.
Bénédicte ChevallierServier, Suresnes, Paris, France.
Lucjan WyrwiczDepartment of Oncology and Radiotherapy, Maria Skłodowska Curie Memorial Cancer Centre and Institute of Oncology, Warsaw National Cancer Research Institute, Warsaw, Poland.ORCID https://orcid.org/0000-0003-0808-6892
Jean-Baptiste BachetDepartment of Hepatogastroenterology, University Hospital Pitie Salpetriere, Paris, France.ORCID https://orcid.org/0000-0003-4337-286X
Servier (France) · FRHôpital Européen Georges-Pompidou · FRQueen Elizabeth Hospital · AUSorbonne Université · FRThe Maria Sklodowska-Curie National Research Institute of Oncology · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPRECONNECT was an international, phase IIIb trial evaluating the safety and efficacy of trifluridine/tipiracil (FTD/TPI) for metastatic colorectal cancer (mCRC).

methodsPatients with mCRC received FTD/TPI 35 mg/m PRIMARY ENDPOINT: safety and time to deterioration of Eastern Cooperative Oncology Group performance status [ECOG PS] to ≥2). Secondary endpoints included progression-free survival (PFS). Potential prognostic factors for PFS were explored.

resultsOf 914 patients, 69% completed 0-3, 24% completed 4-7, and 7% completed ≥8 cycles of FTD/TPI. Drug-related grade ≥ 3 adverse events included neutropenia (38.1%), anaemia (7.2%) and asthenia (3.4%). Median [95% CI] time to ECOG PS deterioration was 8.7 [8.1-not calculable] months and increased with duration of treatment (DoT). Median PFS was 2.8 [2.7-3.0] months and increased with duration of treatment DoT. Prognostic factors associated with longer PFS included time since diagnosis of first metastasis, number of metastatic sites, baseline ECOG PS, presence/absence of liver metastasis or previous regorafenib treatment, and laboratory variables.

conclusionsNo new safety concerns for FTD/TPI were identified and PFS increased with DoT. These data provide confidence for the use of FTD/TPI, including the use of multiple cycles, in routine practice.

trial registrationEudraCT Number: 2016-002311-18; registered 19/09/2016. https://clinicaltrials.gov/ct2/show/NCT03306394 ; registered 11/10/2017.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsDrug CombinationsDuration of TherapyHumansPyrrolidinesThymineTrifluridineDrug CombinationsPyrrolidinesThyminetipiracilTrifluridine

Identifiers

PMID36707808
PMCPMC9881327
OpenAlexW4318200407

What OpenQuestion holds

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LicenceCC BY
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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.