Evidence map›Paper›PMID 30290003›Full record

Observational studyAmerican journal of hematology2019

Tyrosine kinase inhibitor interruptions, discontinuations and switching in patients with chronic-phase chronic myeloid leukemia in routine clinical practice: SIMPLICITY.

Rüdiger Hehlmann, Jorge E Cortes, Teresa Zyczynski, Carlo Gambacorti-Passerini, Stuart L Goldberg, Michael J Mauro, Mauricette Michallet, Bengt Simonsson, Loretta A Williams, Srikanth Gajavelli and 3 more

Registry-linked trialAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in American journal of hematology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01244750 (Studying Interventions for Managing Patients With Chronic Myeloid Leukemia), which is not on this map. Cited by 29 papers.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed
–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.

NCT01244750 completednot on this map

Studying Interventions for Managing Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase: The 5-Year Prospective Cohort Study (SIMPLICITY)

TypeobservationalSponsorBristol-Myers SquibbRan2010 to 2020Enrolled1,494ConditionsChronic Myeloid Leukemia
3 · Its place in the literature

Who cites it

29 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Non-coding RNA research · 2025
    Article
  7. Article
  8. Article
  9. Real World Outcomes with Treatment Free Remission in Chronic Myeloid Leukemia-Experience from a Tertiary Care Cancer Centre.Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion · 2024
    Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Real-world Management of CML: Outcomes and Treatment Patterns.Current hematologic malignancy reports · 2023
    Review
  15. Article
  16. Review
  17. Article
  18. Review
  19. Review
  20. 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

13 authors.

Rüdiger HehlmannUniversität Heidelberg and ELN-Foundation, Weinheim, Germany.ORCID 0000-0002-3107-485X
Jorge E CortesThe University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-8636-1071
Teresa ZyczynskiBristol-Myers Squibb, Princeton, New Jersey.
Carlo Gambacorti-PasseriniUniversity of Milano Bicocca, San Gerardo Hospital, Monza, Italy.
Stuart L GoldbergJohn Theurer Cancer Center, Hackensack University Medical Center, Hackensack, New Jersey.ORCID 0000-0002-5996-1055
Michael J MauroMemorial Sloan-Kettering Cancer Center, New York, New York.
Mauricette MichalletCentre Hospitalier Lyon-Sud, Pierre-Bénite, France.
Bengt SimonssonUppsala Universitet, Uppsala, Sweden.
Loretta A WilliamsThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Srikanth GajavelliBristol-Myers Squibb, Princeton, New Jersey.
Irene DeGutisBristol-Myers Squibb, Princeton, New Jersey.
Ginny P SenICON Clinical Research LLC, South San Francisco, California.
Ron L PaquetteUCLA Medical Centre, Los Angeles, California.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
Bristol-Myers SquibbNCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

SIMPLICITY (NCT01244750) is an observational study exploring tyrosine kinase inhibitor (TKI) use and management patterns in patients with chronic phase-chronic myeloid leukemia in the US and Europe in routine clinical practice. Herein we describe interruptions, discontinuations and switching of TKI therapy during the initial 2 years of treatment among 1121 patients prospectively enrolled between October 1, 2010 and March 7, 2017. Patient characteristics were broadly similar between the imatinib (n = 370), dasatinib (n = 376), and nilotinib (n = 375) cohorts. Treatment interruptions occurred in 16.4% (year 1) and 4.0% (year 2) of patients, mainly attributed to hematologic intolerances. Treatment discontinuations occurred in 21.8% (year 1) and 10.2% (year 2) of patients, with the highest rate within the first 3 months for intolerance. Switching of TKI was seen in 17.8% (year 1) and 9.5% (year 2) of patients. Significant associations were found between TKI switching and female gender (year 1), age ≥65 years at diagnosis (year 2) and treatment with imatinib (year 2). Intolerance was the most common reason given for patients discontinuing and for switching TKI therapy; however resistance was also cited. Lack of response monitoring in routine clinical practice may have resulted in lower identification of resistance in this dataset. Data from SIMPLICITY suggest that, in routine clinical practice, intolerance and resistance to TKIs influence decisions to change treatment. Changes in TKI therapy are frequent, with nearly a third of patients discontinuing their first-line TKI.

Indexed as

Molecular Targeted TherapyAgedAntineoplastic AgentsDasatinibDisease ManagementDrug Administration ScheduleDrug Resistance, NeoplasmDrug SubstitutionEuropeFemaleHematologic DiseasesHumansImatinib MesylateLeukemia, Myeloid, Chronic-PhaseMaleMusculoskeletal DiseasesAntineoplastic AgentsDasatinibImatinib MesylatenilotinibProtein Kinase InhibitorsPyrimidines

Identifiers

PMID30290003
PMCPMC6587733

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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.