Evidence map›Paper›PMID 25223583›Full record

Trial reportCancer2015

Phase II, multicenter, randomized trial of CPX-351 (cytarabine:daunorubicin) liposome injection versus intensive salvage therapy in adults with first relapse AML.

Jorge E Cortes, Stuart L Goldberg, Eric J Feldman, David A Rizzeri, Donna E Hogge, Melissa Larson, Arnaud Pigneux, Christian Recher, Gary Schiller, Krzysztof Warzocha and 3 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05628623 (Eradicating Measurable Residual Disease in Patients With Acute Myeloid Leukemia), which is not on this map. Cited by 67 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 1 pooled it
8.9field-weighted citation impact, top 2% 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.

NCT05628623 phase2not yet recruitingnot on this mapstarted 2024, after this paper: background citation

Eradicating Measurable Residual Disease in Patients With Acute Myeloid Leukemia (AML) Prior to StEm Cell Transplantation (ERASE): A MyeloMATCH Treatment Trial

TypeinterventionalSponsorEastern Cooperative Oncology GroupRan2024 to 2027Enrolled184ConditionsLeukemia, Myeloid, AcuteArmsCytarabine, Venetoclax, CPX-351, Azacitidine
3 · Its place in the literature

Who cites it

67 citing papers in PubMed, 1 synthesis or guideline pooled it, 171 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Venetoclax Combined With FLAG-IDA Induction and Consolidation in Newly Diagnosed and Relapsed or Refractory Acute Myeloid Leukemia.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021
    Trial
  5. Trial
  6. Trial
  7. Article
  8. Article
  9. Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Smart nanoparticles for cancer therapy.Signal transduction and targeted therapy · 2023
    Review
  15. Article
  16. Review
  17. Review
  18. Review
  19. Article
  20. Article

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

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 11 institutions in 4 countries.

Jorge E CortesThe MD Anderson Cancer Center, Houston, Texas.
Stuart L Goldberg
Eric J Feldman
David A Rizzeri
Donna E Hogge
Melissa Larson
Arnaud Pigneux
Christian Recher
Gary Schiller
Krzysztof Warzocha
Hagop Kantarjian
Arthur C Louie
Jonathan E Kolitz
The University of Texas MD Anderson Cancer Center · USBC Cancer Agency · CADuke Medical Center · USHackensack University Medical Center · USHofstra University · USHôpital Cardiologique du Haut-Lévêque · FRHôpital Purpan · FRInstytut Hematologii i Transfuzjologi · PLNewYork–Presbyterian Hospital · USRush University · USUniversity of California, Los Angeles · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
TOLERANCE INDUCTION BY MEGADOSE STEM CELL TRANSPLANTS IN CML--GVHD AND GVLP01CA049639 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI THALL, PETER F · 1990 to 2014
$41.8M
THE THERAPY OF AMLP01CA055164 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI THOMAS, MATTIE J · 1992 to 2011
$25.3M
NCI NIH HHS P01 CA049639NCI NIH HHS P01 CA055164NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundCPX-351 is a liposome-encapsulated fixed-molar-ratio formulation of cytarabine and daunorubicin that exploits molar ratio-dependent drug-drug synergy to enhance antileukemic efficacy.

methodsThis phase II study randomized 125 patients 2:1 to CPX-351 or investigators' choice of first salvage chemotherapy. Patients with acute myeloid leukemia (AML) in first relapse after initial Complete Remission (CR) lasting ≥1 month were stratified per the European Prognostic Index (EPI) into favorable, intermediate, and poor-risk groups based on duration of first CR, cytogenetics, age, and transplant history. Control salvage treatment was usually based on cytarabine and anthracycline, often with 1 or more additional agents. Survival at 1 year was the primary efficacy end point.

resultsPatient characteristics were well balanced between the 2 study arms. Improvements in efficacy outcomes were observed following CPX-351, but did not meet prospectively defined statistical criteria for 1-year survival improvement in the overall population. Subset analyses of the EPI-defined poor-risk strata demonstrated higher response rates (39.3% vs 27.6%) and improvements in event-free survival (HR, 0.63; P = .08) and overall survival (HR, 0.55; P = .02). Also, 60-day mortality was lower in the CPX-351 study arm for poor-risk patients (16.1% vs 24.1%).

conclusionsTaken together, the data suggest possible improved outcomes in CPX-351-treated first relapse AML patients with EPI-defined poor-risk disease.

Indexed as

AdultAgedAminoglycosidesAmsacrineAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCladribineCytarabineDaunorubicinDisease-Free SurvivalEtoposideFemaleGemtuzumabHumansInjectionsKaplan-Meier EstimateAminoglycosidesAmsacrineAntibodies, Monoclonal, HumanizedCladribineCytarabineDaunorubicinEtoposidefludarabineGemtuzumabLiposomesMitoxantroneVidarabineAcute Myeloid LeukemiaChemotherapy InterventionFirst RelapsePhase II

Identifiers

PMID25223583
PMCPMC5542857
OpenAlexW1568498224

What OpenQuestion holds

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LicenceTDM
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.