Evidence map›Paper›PMID 32319737›Full record

ArticleCancer medicine2020

How many chronic myeloid leukemia patients who started a frontline second-generation tyrosine kinase inhibitor have to switch to a second-line treatment? A retrospective analysis from the monitoring registries of the italian medicines agency (AIFA).

Massimo Breccia, Pier Paolo Olimpieri, Odoardo Olimpieri, Fabrizio Pane, Alessandra Iurlo, Paolo Foggi, Alessia Cirilli, Antonietta Colatrella, Marcello Cuomo, Lucia Gozzo and 4 more

Open access · goldAbstract read
In one paragraph

Article in Cancer medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
3.7field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 38 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

14 authors at 6 institutions in 1 country.

Massimo BrecciaDepartment of Translational and Precision Medicine, Az. Policlinico Umberto I-Sapienza University, Rome, Italy.ORCID 0000-0003-1163-6162
Pier Paolo OlimpieriItalian Medicines Agency, Rome, Italy.ORCID 0000-0001-7934-9034
Odoardo OlimpieriItalian Medicines Agency, Rome, Italy.
Fabrizio PaneUniversità degli Studi di Napoli Federico II, Naples, Italy.
Alessandra IurloFoundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.ORCID 0000-0002-4401-0812
Paolo FoggiItalian Medicines Agency, Rome, Italy.
Alessia CirilliItalian Medicines Agency, Rome, Italy.
Antonietta ColatrellaItalian Medicines Agency, Rome, Italy.
Marcello CuomoItalian Medicines Agency, Rome, Italy.
Lucia GozzoItalian Medicines Agency, Rome, Italy.
Valentina SummaItalian Medicines Agency, Rome, Italy.
Paolo CorradiniUniversità degli Studi di Milano & Divisione Ematologia, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milano, Italy.
Pierluigi RussoItalian Medicines Agency, Rome, Italy.
AIFA’s Monitoring Registries GroupUniversità degli Studi di Milano & Divisione Ematologia, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milano, Italy.
Italian Medicines Agency · ITFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITFondazione IRCCS Istituto Nazionale dei Tumori · ITPoliclinico Umberto I · ITUniversity of Milan · ITUniversity of Naples Federico II · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The frequency of patients who switch to a second-line therapy from a frontline second-generation (2gen) tyrosine kinase inhibitor (TKI) such as dasatinib and nilotinib, is still substantially unknown. We retrospectively investigated a large series of chronic phase chronic myeloid leukemia (CP-CML) patients initially treated with 2gen TKIs monitored through the Italian Medicines Agency (AIFA Agenzia Italiana del farmaco) registries. Overall, 2420 patients were analyzed over a period of 6 years. One hundred and fifty-seven patients (16.3%) treated with dasatinib and 164 treated with nilotinib (11.3%) have switched to another drug, with an overall frequency of 13.2%. In the dasatinib cohort, 39.4% of patients changed treatment for failure and 36.3% for intolerance as compared to 45.7% and 27.4% respectively in the nilotinib cohort. Overall, the median time to switch due to resistance was 293 days, whereas it was 317 days in case of intolerance. Resistance was observed mainly in younger male patients with high-risk features, while intolerance was not related to any baseline parameter. After resistance/intolerance to nilotinib, the majority of patients switched to dasatinib (53.8%) whereas in case of frontline dasatinib to ponatinib (43.2%). To the best of our knowledge these data provide the first report on the frequency of discontinuation of frontline 2gen TKIs and on the main causes and pattern of choice to a second-line therapy in the real-life setting.

Indexed as

Decision MakingDrug Resistance, NeoplasmSalvage TherapyAdultAgedAged, 80 and overFamily CharacteristicsFemaleFollow-Up StudiesHumansItalyLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMaleMiddle AgedPrognosisProtein Kinase InhibitorsProtein Kinase Inhibitorschronic myeloid leukemiafailureintolerancesecond-generation TKIs

Identifiers

PMID32319737
PMCPMC7300412
OpenAlexW3016793632

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.