Evidence map›Paper›PMID 37079069›Full record

ArticleAnnals of hematology2023

Efficacy and safety of nilotinib as frontline treatment in elderly (> 65 years) chronic myeloid leukemia patients outside clinical trials.

Luigia Luciano, Roberto Latagliata, Gabriele Gugliotta, Mario Annunziata, Mario Tiribelli, Bruno Martino, Antonello Sica, Maria Rosaria Esposito, Monica Bocchia, Sara Galimberti and 11 more

Open access · hybridAbstract read
In one paragraph

Article in Annals of hematology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.6field-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.

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

6 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
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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

21 authors at 16 institutions in 1 country.

Luigia LucianoHematology Unit, Federico II" University of Naples, Naples, Italy. lulucian@unina.it.ORCID http://orcid.org/0000-0003-2255-9190
Roberto LatagliataDepartment of Cellular Biotechnologies and Hematology, University "La Sapienza" of Rome, Rome, Italy.
Gabriele GugliottaInstitute of Hematology "L. and A. Seràgnoli", Department of Experimental, Diagnostic and Specialty Medicine, "S. Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy.
Mario AnnunziataHematology Unit, Cardarelli Hospital, Naples, Italy.
Mario TiribelliDivision of Hematology and BMT, Azienda Ospedaliero - Universitaria Di Udine, Udine, Italy.
Bruno MartinoHematology Unit, Bianchi Melacrino Morelli Hospital, Reggio Calabria, Italy.
Antonello SicaHematologyunit, "L Vanvitelli" University of Campania, Naples, Italy.
Maria Rosaria EspositoHematologyunit, Ascalesi Hospital, Naples, Italy.
Monica BocchiaHematology Unit, Azienda Ospedaliera Universitaria Senese and University of Siena, Siena, Italy.
Sara GalimbertiDepartment of Clinical and Experimental Medicine, Section of Hematology, University of Pisa, Pisa, Italy.
Federica SoràDepartment of Diagnostic Imaging, Oncological Radiotherapy and Hematology, A. Gemelli, IRCCS University Hospital Foundation, Rome, Italy.
Francesco AlbanoHematology and Transplants Unit, University of Bari, Bari, Italy.
Raffaele PalmieriHematology Unit,"S. Giuseppe Moscati" Hospital, Avellino, Italy.
Patrizia PregnoHematology Unit, Azienda Ospedaliero Universitaria Città Della Salute E Della Scienza, Turin, Italy.
Matteo DraganiHematology, San Luigi Gonzaga Hospital, Orbassano, Italy.
Maria IovineHematology Unit, AO "S. Anna E S. Sebastiano", Caserta, Italy.
Simona SicaDepartment of Diagnostic Imaging, Oncological Radiotherapy and Hematology, A. Gemelli, IRCCS University Hospital Foundation, Rome, Italy.
Alessandra IurloOncohematology Division, IRCCS Ca' Granda - Maggiore Policlinico Hospital Foundation, University of Milan, Milan, Italy.
Fausto CastagnettiInstitute of Hematology "L. and A. Seràgnoli", Department of Experimental, Diagnostic and Specialty Medicine, "S. Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy.
Gianantonio RostiInstitute of Hematology "L. and A. Seràgnoli", Department of Experimental, Diagnostic and Specialty Medicine, "S. Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy.
Massimo BrecciaDepartment of Cellular Biotechnologies and Hematology, University "La Sapienza" of Rome, Rome, Italy.
IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola · ITAgostino Gemelli University Polyclinic · ITSapienza University of Rome · ITAzienda ospedaliera "Bianchi-Melacrino-Morelli" · ITAzienda Ospedaliera Citta' della Salute e della Scienza di Torino · ITAzienda Ospedaliera S.Giuseppe Moscati · ITFatebenefratelli Hospital · ITFederico II University Hospital · ITI.R.C.C.S. Oasi Maria SS · ITOspedale San Luigi Gonzaga · ITOspedale Santa Maria della Misericordia di Udine · ITUniversity of Bari Aldo Moro · ITUniversity of Campania "Luigi Vanvitelli" · ITUniversity of Milan · ITUniversity of Pisa · ITUniversity of Siena · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Here, we report real-world evidence on the safety and efficacy of nilotinib as a first-line treatment in elderly patients with chronic phase CML, treated in 18 Italian centers. Sixty patients aged > 65 years (median age 72 years (65-84)) were reported: 13 patients were older than 75 years. Comorbidities were recorded at baseline in 56/60 patients. At 3 months of treatment, all patients obtained complete hematological response (CHR), 43 (71.6%) an early molecular response (EMR), while 47 (78%) reached a complete cytogenetic response (CCyR). At last follow-up, 63.4% of patients still had a deep molecular response (MR4 or better), 21.6% reached MR3 as best response and 11.6% persisted without MR. Most patients (85%) started the treatment at the standard dose (300 mg BID), maintained at 3 months in 80% of patients and at 6 months in 89% of them. At the last median follow-up of 46.3 months, 15 patients discontinued definitively the treatment (8 due to side effects, 4 died for unrelated CML causes, 1 for failure, 2 were lost to follow-up). One patient entered in treatment-free remission. As to safety, 6 patients (10%) experienced cardiovascular events after a median time of 20.9 months from the start. Our data showed that nilotinib could be, as first-line treatment, effective and relatively safe even in elderly CML patients. In this setting, more data in the long term are needed about possible dose reduction to improve the tolerability, while maintaining the optimal molecular response.

Indexed as

Antineoplastic AgentsLeukemia, Myelogenous, Chronic, BCR-ABL PositiveAgedHumansImatinib MesylateProtein Kinase InhibitorsPyrimidinesTreatment OutcomeAntineoplastic AgentsImatinib MesylateProtein Kinase InhibitorsPyrimidinesChronic myeloid leukemiaEfficacy and safetyElderlyNilotinib

Identifiers

PMID37079069
PMCPMC10182159
OpenAlexW4366463991

What OpenQuestion holds

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Registered trials

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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.