Evidence map›Paper›PMID 25165041›Full record

Trial reportCancer medicine2015

Eltrombopag with gemcitabine-based chemotherapy in patients with advanced solid tumors: a randomized phase I study.

Eric S Winer, Howard Safran, Boguslawa Karaszewska, Donald A Richards, Lee Hartner, Frederic Forget, Rodryg Ramlau, Kirushna Kumar, Bhabita Mayer, Brendan M Johnson and 2 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04600960 (Eltrombopag for Chemotherapy-induced Thrombocytopenia), which is not on this map. Cited by 28 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 7 pooled it
–field-weighted citation impact
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.

NCT04600960 phase2recruitingnot on this mapstarted 2020, after this paper: background citation

Eltrombopag for Chemotherapy-induced Thrombocytopenia: a Prospective Multi-center One-arm Study in Solid Tumors

TypeinterventionalSponsorInstitute of Hematology & Blood Diseases Hospital, ChinaRan2020 to 2025Enrolled50ConditionsChemotherapy-induced Thrombocytopenia, EltrombopagArmsEltrombopag
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 7 syntheses or guidelines pooled it.

  1. Pooled it
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  18. Successful Management of Ibrutinib-Induced Thrombocytopenia with Eltrombopag in a Patient with Waldenström MacroglobulinemiaTurkish journal of haematology : official journal of Turkish Society of Haematology · 2022
    Article
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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

12 authors.

Eric S WinerRhode Island Hospital, Providence, Rhode Island.
Howard Safran
Boguslawa Karaszewska
Donald A Richards
Lee Hartner
Frederic Forget
Rodryg Ramlau
Kirushna Kumar
Bhabita Mayer
Brendan M Johnson
Conrad A Messam
Yasser Mostafa Kamel

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Preventing chemotherapy-induced thrombocytopenia could avoid chemotherapy dose reductions and delays. The safety and maximum tolerated dose of eltrombopag, an oral thrombopoietin receptor agonist, with gemcitabine-based therapy was evaluated. Patients with advanced solid tumors and platelets ≤300 × 10(9) /L receiving gemcitabine plus cisplatin or carboplatin (Group A) or gemcitabine monotherapy (Group B) were randomized 3:1 to receive eltrombopag or placebo at a starting dose of 100 mg daily administered on days -5 to -1 and days 2-6 starting from cycle 2 of treatment. Nineteen patients (Group A, n = 9; Group B, n = 10) received eltrombopag 100 mg and seven (Group A, n = 3; Group B, n = 4) received matching placebo. Nine eltrombopag patients in Group A and eight in Group B had 38 and 54 occurrences of platelet counts ≥400 × 10(9) /L, respectively. Mean platelet nadirs across cycles 2-6 were 115 × 10(9) /L and 143 × 10(9) /L for eltrombopag-treated patients versus 53 × 10(9) /L and 103 × 10(9) /L for placebo-treated patients in Groups A and B, respectively. No dose-limiting toxicities were reported for eltrombopag; however, due to several occurrences of thrombocytosis, a decision was made not to dose-escalate eltrombopag to >100 mg daily. In Groups A and B, 14% of eltrombopag versus 50% of placebo patients required chemotherapy dose reductions and/or delays for any reason across cycles 3-6. Eltrombopag 100 mg once daily administered 5 days before and after day 1 of chemotherapy was well tolerated with an acceptable safety profile, and will be further tested in a phase II trial. Fewer patients receiving eltrombopag required chemotherapy dose delays and/or reductions compared with those receiving placebo.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBenzoatesDeoxycytidineDrug Administration ScheduleFemaleGemcitabineHumansHydrazinesMaleMiddle AgedNeoplasmsNeoplasm StagingPlatelet CountBenzoatesDeoxycytidineeltrombopagGemcitabineHydrazinesPyrazolesBlood plateletscancereltrombopagthrombocytopeniathrombosis

Identifiers

PMID25165041
PMCPMC4312114

What OpenQuestion holds

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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.