Evidence map›Paper›PMID 35897060›Full record

ArticleBMC cancer2022

Study protocol of the FIRE-8 (AIO-KRK/YMO-0519) trial: a prospective, randomized, open-label, multicenter phase II trial investigating the efficacy of trifluridine/tipiracil plus panitumumab versus trifluridine/tipiracil plus bevacizumab as first-line treatment in patients with metastatic colorectal cancer.

G Sommerhäuser, A Kurreck, S Stintzing, V Heinemann, L Fischer von Weikersthal, T Dechow, F Kaiser, M Karthaus, I Schwaner, M Fuchs and 11 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05007132 (Prospective, Randomized, Open, Multicenter Phase II Trial to Investigate the Efficacy of Trifluridine/Tipiracil Plus Panitumumab Versus Trifluridine/Tipiracil Plus Bevacizumab as First-line Treatment of Metastatic Colorectal Cancer), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 23% 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.

NCT05007132 phase2recruitingnot on this map

Prospective, Randomized, Open, Multicenter Phase II Trial to Investigate the Efficacy of Trifluridine/Tipiracil Plus Panitumumab Versus Trifluridine/Tipiracil Plus Bevacizumab as First-line Treatment of Metastatic Colorectal Cancer: FIRE-8; AIO-KRK/YMO-0519

TypeinterventionalSponsorDominik Paul ModestRan2021 to 2032Enrolled153ConditionsMetastatic Colorectal CancerArmsPanitumumab 20 milligram/ML, Bevacizumab, Trifluridine/Tipiracil Hydrochloride
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Observational
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

21 authors at 13 institutions in 1 country.

G SommerhäuserDepartment of Hematology, Oncology, and Cancer Immunology (CVK/CCM), Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
A KurreckDepartment of Hematology, Oncology, and Cancer Immunology (CVK/CCM), Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
S StintzingDepartment of Hematology, Oncology, and Cancer Immunology (CVK/CCM), Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
V HeinemannGerman Cancer Consortium (DKTK), DKFZ, Heidelberg, Germany.
L Fischer von WeikersthalGesundheitszentrum St. Marien, Amberg, Germany.
T DechowOncological Practice, Ravensburg, Germany.
F KaiserOncological Practice, Landshut, Germany.
M KarthausDepartment of Hematology and Oncology, Klinikum Neuperlach/ Klinikum Harlaching, Munich, Germany.
I SchwanerOncological Practice Kurfuerstendamm, Berlin, Germany.
M FuchsDepartment of Gastroenterology, Hepatology, and Gastrointestinal Oncology, München Klinik Bogenhausen, Munich, Germany.
A KönigDepartment of Gastroenterology and Gastrointestinal Oncology Goettingen, University Medical Center Goettingen, Goettingen, Germany.
C RoderburgDepartment of Gastroenterology, Hepatology, and Infectiology, University Medical Center Duesseldorf, Duesseldorf, Germany.
I HoyerDepartment of Hematology, Oncology, and Cancer Immunology (CVK/CCM), Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
M QuanteDepartment of Gastroenterology, Hepatology, Endocrinology, and Infectiology, Albert-Ludwigs-Universität Freiburg, Freiburg, Germany.
A KianiDepartment of Medicine IV, Klinikum Bayreuth GmbH, Bayreuth, Germany.
S FruehaufDepartment of Hematology, Oncology, and Palliative Care, Klinik Dr. Hancken GmbH, Stade, Germany.
L MüllerOnkologie UnterEms, Leer, Germany.
A Reinacher-SchickDepartment of Hematology, Oncology and Palliative Care, Ruhr-University Bochum, Bochum, Germany.
T J EttrichDepartment of Internal Medicine, University Hospital Ulm, Ulm, Germany.
A StahlerDepartment of Hematology, Oncology, and Cancer Immunology (CVK/CCM), Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
D P ModestDepartment of Hematology, Oncology, and Cancer Immunology (CVK/CCM), Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany. dominik.modest@charite.de.ORCID http://orcid.org/0000-0002-6853-0599
Humboldt-Universität zu Berlin · DEGerman Cancer Research Center · DEBayreuth Medical Center · DEDüsseldorf University Hospital · DEKlinikum St. Marien Amberg · DEMünchen Klinik Bogenhausen · DEMünchen Klinik Harlaching · DEMVZ - Kurfürstendamm · DEPraxis für Hämatologie und Onkologie · DERuhr University Bochum · DEUniversity Hospital Ulm · DEUniversity of Applied Sciences Landshut · DEUniversity of Freiburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInitial systemic therapy for patients with metastatic colorectal cancer (mCRC) is usually based on two- or three-drug chemotherapy regimens with fluoropyrimidine (5-fluorouracil (5-FU) or capecitabine), oxaliplatin and/or irinotecan, combined with either anti-VEGF (bevacizumab) or, for RAS wild-type (WT) tumors, anti-EGFR antibodies (panitumumab or cetuximab). Recommendations for patients who are not eligible for intensive combination therapies are limited and include fluoropyrimidine plus bevacizumab or single agent anti-EGFR antibody treatment. The use of a monochemotherapy concept of trifluridine/ tipiracil in combination with monoclonal antibodies is not approved for first-line therapy, yet. Results from the phase II TASCO trial evaluating trifluridine/ tipiracil plus bevacicumab in first-line treatment of mCRC patients and from the phase I/II APOLLON trial investigating trifluridine/ tipiracil plus panitumumab in pre-treated mCRC patients suggest favourable activity and tolerability of these new therapeutic approaches.

methodsFIRE-8 ( NCT05007132 ) is a prospective, randomized, open-label, multicenter phase II study which aims to evaluate the efficacy of first-line treatment with trifluridine/tipiracil (35 mg/m DISCUSSION: To the best of our knowledge, this is the first phase II trial to evaluate the efficacy of trifluridine/tipiracil plus panitumumab in first-line treatment of RAS WT mCRC patients. The administration of anti-EGFR antibodies rather than anti-VEGF antibodies in combination with trifluridine/tipiracil may result in an increased initial efficacy.

trial registrationEU Clinical Trials Register (EudraCT) 2019-004223-20 . Registered October 22, 2019, ClinicalTrials.gov NCT05007132 . Registered on August 12, 2021.

Indexed as

Colorectal NeoplasmsTrifluridineAngiogenesis InhibitorsAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBody WeightClinical Trials, Phase II as TopicFluorouracilHumansMulticenter Studies as TopicPanitumumabProspective StudiesPyrrolidinesRandomized Controlled Trials as TopicThymineAngiogenesis InhibitorsAntibodies, MonoclonalBevacizumabFluorouracilPanitumumabPyrrolidinesThyminetipiracilTrifluridineBevacizumabFirst-line treatmentMetastatic Colorectal CancerPanitumumabTrifluridine/tipiracil

Identifiers

PMID35897060
PMCPMC9327141
OpenAlexW4288726101

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.