Evidence map›Paper›PMID 24687088›Full record

Trial reportBlood2014

Phase 2 trial of CPX-351, a fixed 5:1 molar ratio of cytarabine/daunorubicin, vs cytarabine/daunorubicin in older adults with untreated AML.

Jeffrey E Lancet, Jorge E Cortes, Donna E Hogge, Martin S Tallman, Tibor J Kovacsovics, Lloyd E Damon, Rami Komrokji, Scott R Solomon, Jonathan E Kolitz, Maureen Cooper and 3 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Blood, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 162 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
162citing papers in PubMed, 3 pooled it
20.7field-weighted citation impact, top 1% 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.

NCT00788892 phase2completednot on this map

Phase IIB, Multicenter, Randomized, Open Label Trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection Versus Cytarabine and Daunorubicin in Patients With Untreated AML 60-75 Years of Age.

TypeinterventionalSponsorJazz PharmaceuticalsRan2008 to 2011Enrolled126ConditionsAcute Myeloid LeukemiaArmsCPX-351, Cytarabine, Daunorubicin
NCT04230239 phase2completednot on this mapstarted 2019, after this paper: background citation

A Phase II, Multicentre, Open Label Clinical Trial to Assess the Efficacy and Toxicity of Induction and Consolidation With CPX-351 for Patients Aged 60 to 75 Years With Secondary or High-risk Acute Myeloid Leukemia

TypeinterventionalSponsorPETHEMA FoundationRan2019 to 2021Enrolled59ConditionsNewly Diagnosed Secondary or High Risk AMLArmsCPX-351
3 · Its place in the literature

Who cites it

162 citing papers in PubMed, 3 syntheses or guidelines pooled it, 334 citations in OpenAlex.

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102 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 11 institutions in 2 countries.

Jeffrey E LancetH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL;
Jorge E CortesUniversity of Texas MD Anderson Cancer Center, Houston, TX;
Donna E HoggeBritish Columbia Cancer Agency, Vancouver, BC, Canada;
Martin S TallmanMemorial Sloan-Kettering Cancer Center and Weill Cornell Medical College, New York, NY;
Tibor J KovacsovicsOregon Health & Science University, Knight Cancer Institute, Portland, OR;
Lloyd E DamonUniversity of California, San Francisco, San Francisco, CA;
Rami KomrokjiH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL;
Scott R SolomonBlood & Marrow Transplant at Northside Hospital, Atlanta, GA;
Jonathan E KolitzHofstra North Shore-Long Island Jewish School of Medicine, Lake Success, NY;
Maureen CooperSt. Francis Hospital and Health Centers, Indianapolis, IN;
Andrew M YeagerUniversity of Arizona, Tucson, AZ;
Arthur C LouieCelator Pharmaceuticals, Inc., Princeton, NJ; and.
Eric J FeldmanWeill Medical College of Cornell University and New York Presbyterian Hospital, New York, NY.
University of South Florida · USBC Cancer Agency · CACornell University · USFranciscan Health Indianapolis · USHofstra University · USNew York Hospital Queens · USNorthside Hospital · USOregon Health & Science University · USThe University of Texas MD Anderson Cancer Center · USUniversity of Arizona · USUniversity of California, San Francisco · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
6 · The paper itself

Abstract

CPX-351 is a liposomal formulation of cytarabine:daunorubicin designed to deliver synergistic drug ratios to leukemia cells. In this phase 2 study, newly diagnosed older acute myeloid leukemia (AML) patients were randomized 2:1 to first-line CPX-351 or 7+3 treatment. The goal was to determine efficacy and identify patient subgroups that may benefit from CPX-351 treatment. Response rate (complete remission + incomplete remission) was the primary end point, with event-free survival (EFS) and overall survival (OS) as secondary end points. The 126 patients entered were balanced for disease and patient-specific risk factors. Overall, CPX-351 produced higher response rates (66.7% vs 51.2%, P = .07), meeting predefined criteria for success (P < .1). Differences in EFS and OS were not statistically significant. A planned analysis of the secondary AML subgroup demonstrated an improved response rate (57.6% vs 31.6%, P = .06), and prolongation of EFS (hazard ratio [HR] = 0.59, P = .08) and OS (HR = 0.46, P = .01). Recovery from cytopenias was slower after CPX-351 (median days to absolute neutrophil count ≥1000: 36 vs 32; platelets >100 000: 37 vs 28) with more grade 3-4 infections but without increase in infection-related deaths (3.5% vs 7.3%) or 60-day mortality (4.7% vs 14.6%), indicating acceptable safety. These results suggest a clinical benefit with CPX-351, particularly among patients with secondary AML, and provide the rationale for a phase 3 trial currently underway in newly diagnosed secondary AML patients. This study is registered at Clinicaltrials.gov as #NCT00788892.

Indexed as

AgedAntibiotics, AntineoplasticAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsCytarabineDaunorubicinDisease-Free SurvivalFemaleHumansLeukemia, Myeloid, AcuteLiposomesMaleMiddle AgedAntibiotics, AntineoplasticAntimetabolites, AntineoplasticCytarabineDaunorubicinLiposomes

Identifiers

PMID24687088
PMCPMC4624448
OpenAlexW2055884944

What OpenQuestion holds

Textmetadata
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.