Evidence map›Paper›PMID 31912801›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2020

Neutropenia and survival outcomes in metastatic colorectal cancer patients treated with trifluridine/tipiracil in the RECOURSE and J003 trials.

T Yoshino, J M Cleary, E Van Cutsem, R J Mayer, A Ohtsu, E Shinozaki, A Falcone, K Yamazaki, T Nishina, R Garcia-Carbonero and 22 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01607957 (Randomized, Double-blind, Phase 3 Study of TAS-102 Plus Best Supportive Care), which is not on this map. Cited by 42 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 4 pooled it
4.0field-weighted citation impact, top 5% 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.

NCT01607957 phase3completednot on this map

Randomized, Double-blind, Phase 3 Study of TAS-102 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies

TypeinterventionalSponsorTaiho Oncology, Inc.Ran2012 to 2016Enrolled800ConditionsColorectal CancerArmsTAS-102, Placebo
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 4 syntheses or guidelines pooled it, 64 citations in OpenAlex.

  1. Pooled it
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  3. 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
    Pooled it
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

32 authors at 20 institutions in 6 countries.

T YoshinoDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan. Electronic address: tyoshino@east.ncc.go.jp.
J M ClearyDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA.
E Van CutsemDivision of Digestive Oncology, University Hospitals Leuven and KU Leuven, Leuven, Belgium.
R J MayerDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA.
A OhtsuDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
E ShinozakiDepartment of Gastroenterology, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
A FalconeDepartment of Translational Medicine, University of Pisa, Pisa, Italy.
K YamazakiDivision of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
T NishinaDepartment of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
R Garcia-CarboneroOncology Department, University Hospital 12 de Octubre, IIS imas12, UCM, CNIO, CIBERONC, Madrid, Spain.
Y KomatsuDepartment of Cancer Chemotherapy, Hokkaido University Hospital, Sapporo, Japan.
H BabaDepartment of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University Hospital, Kumamoto, Japan.
G ArgilésUniversity Hospital Vall d'Hebrón, Barcelona, Spain.
A TsujiDepartment of Medical Oncology, Kochi Health Sciences Center, Kochi, Japan.
A SobreroDepartment of Oncology, IRCCS AOU San Martino IST, Genoa, Italy.
K YamaguchiDepartment of Gastroenterology, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan; Division of Gastroenterology, Saitama Cancer Center, Saitama, Japan.
M PeetersDepartment of Oncology, Antwerp University Hospital, Edegem, Belgium.
K MuroDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
A ZaniboniDepartment of Oncology, Fondazione Poliambulanza, Brescia, Italy.
N SugimotoDepartment of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan.
Y ShimadaDepartment of Clinical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Y TsujiDepartment of Medical Oncology, KKR Sapporo Medical Center Tonan Hospital, Sapporo, Japan.
H S HochsterDepartment of Gastrointestinal Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick, USA.
T MoriwakiDivision of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
B TranDepartment of Medical Oncology, The Royal Melbourne Hospital, Victoria, Australia.
T EsakiDepartment of Gastrointestinal and Medical Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
C HamadaFaculty of Engineering, Tokyo University of Science, Tokyo, Japan.
T TanaseDepartment of Data Science, Taiho Pharmaceutical Co., Ltd., Tokyo, Japan.
F BenedettiDepartment of Clinical Development, Taiho Pharmaceutical Co., Ltd., Tokyo, Japan.
L MakrisStatistical Consultant, Stathmi, Inc., New Hope, USA.
F YamashitaDepartment of Bioanalytics and Drug Metabolism and Pharmacokinetics, Taiho Oncology, Inc., Princeton, USA.
H-J LenzDivision of Medical Oncology, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, USA.
Dana-Farber Cancer Institute · USNational Cancer Center Hospital East · JPTaiho Pharmaceutical (Japan) · JPThe Cancer Institute Hospital · JPAichi Cancer Center · JPAntwerp University Hospital · BECentro de Investigación Biomédica en Red de Cáncer · ESFondazione Poliambulanza Istituto Ospedaliero · ITHokkaido University Hospital · JPKochi Medical School Hospital · JPKU Leuven · BEKumamoto University Hospital · JPNational Hospital Organization Kyushu Cancer Center · JPOsaka Medical Center for Cancer and Cardiovascular Diseases · JPOspedale Policlinico San Martino · ITRutgers, The State University of New Jersey · USShikoku Cancer Center · JPShizuoka Cancer Center · JPTaiho Oncology (United States) · USThe Royal Melbourne Hospital · AU

Funding

USC/NORRIS COMPREHENSIVE CANCER CENTER (CORE) SUPPORTP30CA014089 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI Fumito Ito · 1985 to 2026
$181.4M
NCI NIH HHS P30 CA014089
6 · The paper itself

Abstract

backgroundThe phase II J003 (N = 169) and phase III RECOURSE (N = 800) trials demonstrated a significant improvement in survival with trifluridine (FTD)/tipiracil (TPI) versus placebo in patients with refractory metastatic colorectal cancer. This post hoc analysis investigated pharmacokinetic data of FTD/TPI exposure and pharmacodynamic markers, such as chemotherapy-induced neutropenia (CIN) and clinical outcomes. PATIENTS AND

methodsA total of 210 patients from RECOURSE were enrolled in this substudy. A limited sampling approach was used, with three pharmacokinetic samples drawn on day 12 of cycle 1. Patients were categorized as being above or below the median area under the plasma concentration-time curve (AUC) for FTD and TPI. We conducted a post hoc analysis using the entire RECOURSE population to determine the correlations between CIN and clinical outcome. We then carried out a similar analysis on the J003 trial to validate the results.

resultsIn the RECOURSE subset, patients in the high FTD AUC group had a significantly increased CIN risk. Analyses of the entire population demonstrated that FTD/TPI-treated patients with CIN of any grade in cycles 1 and 2 had significantly longer median overall survival (OS) and progression-free survival (PFS) than patients who did not develop CIN and patients in the placebo group. Patients who required an FTD/TPI treatment delay had increased OS and PFS versus those in the placebo group and those who did not develop CIN. Similar results were obtained in the J003 cohort.

conclusionsIn RECOURSE, patients with higher FTD drug exposure had an increased CIN risk. FTD/TPI-treated patients who developed CIN had improved OS and PFS versus those in the placebo group and those who did not develop CIN. Similar findings were reported in the J003 cohort, thus validating the RECOURSE results. The occurrence of CIN may be a useful predictor of treatment outcomes for FTD/TPI-treated patients. CLINICALTRIALS. GOV IDENTIFIER: NCT01607957 (RECOURSE). JAPAN PHARMACEUTICAL INFORMATION CENTER NUMBER: JapicCTI-090880 (J003).

Indexed as

Colorectal NeoplasmsNeutropeniaDrug CombinationsHumansJapanPyrrolidinesThymineTrifluridineUracilDrug CombinationsPyrrolidinesThyminetipiracilTrifluridineUracilchemotherapy-induced neutropeniaFTD/TPIJ003metastatic colorectal cancerRECOURSE

Identifiers

PMID31912801
PMCPMC7491979
OpenAlexW2999325656

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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.