Evidence map›Paper›PMID 31502383›Full record

Observational studyCancer medicine2019

Efficacy and safety of generic imatinib after switching from original imatinib in patients treated for chronic myeloid leukemia in the United States.

Iman Abou Dalle, Hagop Kantarjian, Jan Burger, Zeev Estrov, Maro Ohanian, Srdan Verstovsek, Farhad Ravandi, Gautam Borthakur, Guillermo Garcia-Manero, Elias Jabbour and 1 more

Registry-linked trialOpen access · goldAbstract readObservational Study
In one paragraph

Observational study in Cancer medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05282108 (Efficacy and Safety of Generic Imatinib), which is not on this map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
2.5field-weighted citation impact, top 10% 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.

NCT05282108 recruitingnot on this mapstarted 2022, after this paper: background citation

Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia; a Multicenter, Observational Study

TypeobservationalSponsorHikma Pharmaceuticals LLCRan2022 to 2026Enrolled240ConditionsChronic Myeloid LeukemiaArmsCarcemia, Glivec
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 35 citations in OpenAlex.

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  14. Current status and novel strategy of CML.International journal of hematology · 2021
    Review
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  18. Observational
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

11 authors at 1 institution in 1 country.

Iman Abou DalleDepartment of leukemia, MD Anderson Cancer Center, The University of Texas, Houston, Texas.ORCID 0000-0002-6520-9134
Hagop KantarjianDepartment of leukemia, MD Anderson Cancer Center, The University of Texas, Houston, Texas.ORCID 0000-0002-1908-3307
Jan BurgerDepartment of leukemia, MD Anderson Cancer Center, The University of Texas, Houston, Texas.
Zeev EstrovDepartment of leukemia, MD Anderson Cancer Center, The University of Texas, Houston, Texas.ORCID 0000-0002-1623-3613
Maro OhanianDepartment of leukemia, MD Anderson Cancer Center, The University of Texas, Houston, Texas.
Srdan VerstovsekDepartment of leukemia, MD Anderson Cancer Center, The University of Texas, Houston, Texas.
Farhad RavandiDepartment of leukemia, MD Anderson Cancer Center, The University of Texas, Houston, Texas.
Gautam BorthakurDepartment of leukemia, MD Anderson Cancer Center, The University of Texas, Houston, Texas.
Guillermo Garcia-ManeroDepartment of leukemia, MD Anderson Cancer Center, The University of Texas, Houston, Texas.
Elias JabbourDepartment of leukemia, MD Anderson Cancer Center, The University of Texas, Houston, Texas.
Jorge CortesDepartment of leukemia, MD Anderson Cancer Center, The University of Texas, Houston, Texas.
The University of Texas MD Anderson Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionImatinib is standard therapy for patients with chronic myeloid leukemia (CML). In February 2016, a generic formulation entered the US market. Physicians and patients are frequently concerned about whether switching from original to generic drugs may affect the efficacy and/or safety. MATERIALS AND

methodsThis is an observational retrospective study using medical charts of patients diagnosed with CML in the chronic phase who were treated with original imatinib from the year 2000 to 2017 and who were subsequently switched to generic imatinib.

resultsIn this study, 38 patients have switched to generic imatinib. Before the switch, responses were assessed on all patients, all of them were in CCyR and 36 (95%) were in MMR, including 28 (74%) with MR4.5. Patients have received generic imatinib for a median of 19.4 (range, 3.4-46.3) months. Molecular responses after switching were stable in 89%, improved in 8%, and worsened in 3% of patients. After switching, 15 (39%) patients reported new or worsening adverse events, including 5 (13%) patients with edema, 8 (21%) muscle cramps, 7 (18%) nausea, 6 (16%) diarrhea, and 5 (13%) fatigue. DISCUSSION: Bioequivalence studies demonstrated the same rate and extent of absorption of generic imatinib compared to the original form, which led to the FDA approval. In our observational series, most of the patients maintained their responses and none lost MMR. Adverse events noted were mild and well tolerated.

conclusionA change from original to generic imatinib appears to maintain efficacy and be generally safe. More patients and longer follow-up are required to confirm these observations.

Indexed as

AdultAgedAntineoplastic AgentsChildDrugs, GenericFemaleHumansImatinib MesylateLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMaleMiddle AgedRetrospective StudiesTherapeutic EquivalencyTreatment OutcomeUnited StatesYoung AdultAntineoplastic AgentsDrugs, GenericImatinib Mesylatebioequivalencegenericimatinibleukemiasafety

Identifiers

PMID31502383
PMCPMC6825993
OpenAlexW2972586553

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.