Evidence map›Paper›PMID 26993758›Full record

Trial reportClinical lymphoma, myeloma & leukemia2016

Evaluating the Impact of a Switch to Nilotinib on Imatinib-Related Chronic Low-Grade Adverse Events in Patients With CML-CP: The ENRICH Study.

Jorge E Cortes, Jeffrey H Lipton, Carole B Miller, Lambert Busque, Luke P Akard, Javier Pinilla-Ibarz, Christopher Keir, Ghulam Warsi, Felice P Lin, Michael J Mauro

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Clinical lymphoma, myeloma & leukemia, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00980018 (An Exploratory Trial to Assess the Improvement of Chronic Low-grade Non-hematologic Adverse Events Experienced by Patients With Philadelphia Chromosome Positive), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
4.8field-weighted citation impact, top 5% 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.

NCT00980018 phase4completednot on this map

An Exploratory Trial to Assess the Improvement of Chronic Low-grade Non-hematologic Adverse Events Experienced by Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Treated With Imatinib When Switched to Nilotinib Treatment

TypeinterventionalSponsorNovartis PharmaceuticalsRan2009 to 2012Enrolled52ConditionsChronic Myelogenous LeukemiaArmsNilotinib
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 35 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Quality of life among chronic myeloid leukemia patients in the second-line treatment with nilotinib and influential factors.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2022
    Article
  8. Article
  9. Review
  10. Article
  11. Review
  12. [Patient-reported outcome and its application in hematological neoplasm].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2019
    Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Chronic myeloid leukemia: sequencing of TKI therapies.Hematology. American Society of Hematology. Education Program · 2016
    Review
  18. Review
  19. Article
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

10 authors at 7 institutions in 2 countries.

Jorge E CortesThe University of Texas MD Anderson Cancer Center, Houston, TX. Electronic address: jcortes@mdanderson.org.
Jeffrey H LiptonPrincess Margaret Cancer Center, University of Toronto, Toronto, ON, Canada.
Carole B MillerSt. Agnes Hospital, Baltimore, MD.
Lambert BusqueUniversity of Montreal, Maisonneuve-Rosemont Hospital, Montreal, QC, Canada.
Luke P AkardIndiana Blood and Marrow Transplantation, Indianapolis, IN.
Javier Pinilla-IbarzH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.
Christopher KeirNovartis Pharmaceuticals Corporation, East Hanover, NJ.
Ghulam WarsiNovartis Pharmaceuticals Corporation, East Hanover, NJ.
Felice P LinNovartis Pharmaceuticals Corporation, East Hanover, NJ.
Michael J MauroMemorial Sloan Kettering Cancer Center, New York, NY.
Indiana Cancer Consortium · USMemorial Sloan Kettering Cancer Center · USMoffitt Cancer Center · USPrincess Margaret Cancer Centre · CASt. Agnes Hospital · USThe University of Texas MD Anderson Cancer Center · USUniversité de Montréal · CA

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
NCI NIH HHS P01 CA049639NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundMany patients with chronic myeloid leukemia in chronic phase experience chronic treatment-related adverse events (AEs) during imatinib therapy. These AEs can impair quality of life and lead to reduced treatment adherence, which is associated with poor clinical outcomes. PATIENTS AND

methodsIn the phase II ENRICH (Exploring Nilotinib to Reduce Imatinib Related Chronic Adverse Events) study (N = 52), the effect of switching patients with imatinib-related chronic low-grade nonhematologic AEs from imatinib to nilotinib was evaluated.

resultsThree months after switching to nilotinib, 84.6% of the patients had overall improvement in imatinib-related AEs (primary endpoint). Of 210 imatinib-related AEs identified at baseline, 62.9% had resolved within 3 months of switching to nilotinib. Of evaluable patients, most had improvements in overall quality of life after switching to nilotinib. At screening, 65.4% of evaluable patients had a major molecular response (BCR-ABL1 ≤ 0.1% on the International Scale). After switching to nilotinib, the rate of the major molecular response was 76.1% at 3 months and 87.8% at 12 months. Treatment-emergent AEs reported with nilotinib were typically grade 1 or 2; however, some patients developed more serious AEs, and 8 patients discontinued nilotinib because of new or worsening AEs.

conclusionOverall, results from the ENRICH study demonstrated that switching to nilotinib can mitigate imatinib-related chronic low-grade nonhematologic AEs in patients with chronic myeloid leukemia in chronic phase, in conjunction with acceptable safety and achievement of molecular responses. This trial was registered at www.clinicaltrials.gov as NCT00980018.

Indexed as

Drug SubstitutionAdultAgedAged, 80 and overAntineoplastic AgentsFemaleHumansImatinib MesylateLeukemia, Myeloid, Chronic-PhaseMaleMiddle AgedProtein Kinase InhibitorsPyrimidinesQuality of LifeTreatment OutcomeAntineoplastic AgentsImatinib MesylatenilotinibProtein Kinase InhibitorsPyrimidinesChronic myeloid leukemiaClinical trialsImatinib-related chronic adverse eventsNilotinibSwitch

Identifiers

PMID26993758
PMCPMC4965237
OpenAlexW2283642020

What OpenQuestion holds

Textmetadata
LicenceTDM
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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.