Evidence map›Paper›PMID 33724305›Full record

Trial reportBlood advances2021

Older adults with newly diagnosed high-risk/secondary AML who achieved remission with CPX-351: phase 3 post hoc analyses.

Tara L Lin, David A Rizzieri, Daniel H Ryan, Gary J Schiller, Jonathan E Kolitz, Geoffrey L Uy, Donna E Hogge, Scott R Solomon, Matthew J Wieduwilt, Robert J Ryan and 3 more

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

Trial report in Blood advances, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01696084 (Phase III, Multicenter, Randomized, Trial of CPX-351), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 11% 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.

NCT01696084 phase3completednot on this map

Phase III, Multicenter, Randomized, Trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection Versus Cytarabine and Daunorubicin in Patients 60-75 Years of Age With Untreated High Risk (Secondary) AML

TypeinterventionalSponsorJazz PharmaceuticalsRan2012 to 2015Enrolled309ConditionsHigh Risk Acute Myeloid LeukemiaArmsCPX-351, 7+3 (cytarabine and daunorubicin)
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

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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

13 authors at 12 institutions in 2 countries.

Tara L LinUniversity of Kansas Medical Center, Kansas City, KS.
David A RizzieriDuke Comprehensive Cancer Center, Durham, NC.
Daniel H RyanDepartment of Pathology and Laboratory Medicine, University of Rochester, Rochester, NY.
Gary J SchillerDavid Geffen School of Medicine at UCLA, Los Angeles, CA.
Jonathan E KolitzMonter Cancer Center, Northwell Health System, Lake Success, NY.
Geoffrey L UyWashington University School of Medicine, St Louis, MO.
Donna E HoggeLeukemia/Bone Marrow Transplant Program of British Columbia, Vancouver, BC, Canada.
Scott R SolomonLeukemia Program, Northside Hospital Cancer Institute, Atlanta, GA.
Matthew J WieduwiltUniversity of California-San Diego Moores Cancer Center, La Jolla, CA.
Robert J RyanJazz Pharmaceuticals, Inc, Philadelphia, PA.
Stefan FaderlJazz Pharmaceuticals, Inc, Palo Alto, CA.
Jorge E CortesUniversity of Texas MD Anderson Cancer Center, Houston, TX.
Jeffrey E LancetH. Lee Moffitt Cancer Center & Research Institute, Tampa, FL.
Jazz Pharmaceuticals (United States) · USDuke Medical Center · USLeukemia & Lymphoma Society of Canada · CAMoffitt Cancer Center · USNorthside Hospital · USNorthwell Health · USThe University of Texas MD Anderson Cancer Center · USUniversity of California, Los Angeles · USUniversity of California San Diego · USUniversity of Kansas Medical Center · USUniversity of Rochester · USWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

CPX-351, a dual-drug liposomal encapsulation of daunorubicin/cytarabine in a synergistic 1:5 molar ratio, is approved for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). In a pivotal phase 3 study, patients aged 60 to 75 years with newly diagnosed, high-risk/secondary AML were randomized to receive CPX-351 or conventional 7+3 chemotherapy. In the primary endpoint analysis, CPX-351 demonstrated significantly prolonged median overall survival (OS) vs 7+3. These exploratory post hoc subgroup analyses evaluated the impact of achieving complete remission (CR) or CR with incomplete neutrophil or platelet recovery (CRi) with CPX-351 (73/153 [48%]) vs conventional 7+3 (52/56 [33%]) on outcomes. CPX-351 improved median OS vs 7+3 in patients who achieved CR or CRi (25.43 vs 10.41 months; hazard ratio = 0.49; 95% confidence interval, 0.31, 0.77). Improved median OS was seen across AML subtypes (t-AML, AML-MRC), age subgroups (60 to 69 vs 70 to 75 years), patients with prior hypomethylating agent exposure, and patients who did not undergo transplantation. Patients who achieved CR or CRi with CPX-351 also had a higher rate of transplantation, a longer median OS landmarked from the date of transplantation (not reached vs 11.65 months; hazard ratio = 0.43; 95% confidence interval, 0.21, 0.89), and a safety profile that was consistent with the known safety profile of 7+3. These results suggest deeper remissions may be achieved with CPX-351, leading to improved OS. This study was registered at www.clinicaltrials.gov as #NCT01696084.

Indexed as

Leukemia, Myeloid, AcuteMyelodysplastic SyndromesAgedCytarabineDaunorubicinHumansMiddle AgedCPX-351CytarabineDaunorubicin

Identifiers

PMID33724305
PMCPMC7993093
OpenAlexW3138496492

What OpenQuestion holds

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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.