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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
Multicenter independent assessment of outcomes in chronic myeloid leukemia patients treated with imatinib
Journal of the National Cancer Institute, Volume 103, No. 7, Year 2011
Notification
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Description
BackgroundImatinib slows development of chronic myeloid leukemia (CML). However, available information on morbidity and mortality is largely based on sponsored trials, whereas independent long-term field studies are lacking.Patients and MethodsConsecutive CML patients who started imatinib treatment before 2005 and who were in complete cytogenetic remission (CCyR) after 2 years (±3 months) were eligible for enrollment in the independent multicenter Imatinib Long-Term (Side) Effects (ILTE) study. Incidence of the first serious and nonserious adverse events and loss of CCyR were estimated according to the Kaplan-Meier method and compared with the standard log-rank test. Attainment of negative Philadelphia chromosome hematopoiesis was assessed with cytogenetics and quantitative polymerase chain reaction. Cumulative incidence of death related or unrelated to CML progression was estimated, accounting for competing risks, according to the Kalbleisch-Prentice method. Standardized incidence ratios were calculated based on population rates specific for sex and age classes. Confidence intervals were calculated by the exact method based on the χ2 distribution. All statistical tests were two-sided.ResultsA total of 832 patients who were treated for a median of 5.8 years were enrolled. There were 139 recorded serious adverse events, of which 19.4% were imatinib-related. A total of 830 nonserious adverse events were observed in 53% of patients; 560 (68%) were imatinib-related. The most frequent were muscle cramps, asthenia, edema, skin fragility, diarrhea, tendon, or ligament lesions. Nineteen patients (2.3%) discontinued imatinib because of drug-related toxic effects. Forty-five patients lost CCyR, at a rate of 1.4 per 100 person-years. Durable (>1 year) negative Philadelphia chromosome hematopoiesis was attained by 179 patients. Twenty deaths were observed, with a 4.8% mortality incidence rate (standardized incidence ratio = 0.7; 95% confidence interval = 0.40 to 1.10, P =. 08), with only six (30%) associated with CML progression.ConclusionsIn this study, CML-related deaths were uncommon in CML patients who were in CCyR 2 years after starting imatinib, and survival was not statistically significantly different from that of the general population. © 2011 The Author.
Authors & Co-Authors
Gambacorti Passerini, Carlo B.
Italy, Monza
Azienda Ospedaliera San Gerardo Monza
Antolini, Laura
Italy, Milan
Università Degli Studi Di Milano-bicocca
Mahon, François Xavier
France, Talence
Centre Hospitalier Universitaire de Bordeaux
Guilhot, François
France, Paris
Inserm
Deininger, Michael Werner Nikolaus
United States, Salt Lake City
Huntsman Cancer Institute
Fava, Carmen
Unknown Affiliation
Nagler, Arnon
Israel, Tel Hashomer Tel Aviv
Chaim Sheba Medical Center Israel
Della Casa, Chiara Maria
Italy, Bergamo
Ospedali Riuniti Di Bergamo
Morra, Enrica
Italy, Milan
Asst Grande Ospedale Metropolitano Niguarda
Abruzzese, Elisabetta
Italy, Rome
Università Degli Studi Di Roma Tor Vergata
D'Emilio, Anna
Italy, Vicenza
Ospedale San Bortolo
Stagno, Fabio
Italy, Catania
Università Degli Studi Di Catania
Le Coutre, Philipp D.
Germany, Berlin
Charité – Universitätsmedizin Berlin
Hurtado-Monroy, Rafael
Mexico, Mexico
Hospital Angeles Del Pedregal
Santini, Valeria
Italy, Florence
Azienda Ospedaliera Careggi
Martino, Bruno
Italy, Reggio Calabria
Azienda Ospedaliera Bianchi-melacrino-morelli
Pane, Fabrizio
Italy, Naples
Università Degli Studi Di Napoli Federico Ii
Piccin, Andrea
Italy, Bolzano
San Maurizio Regional Hospital
Giraldo, Pilar
Spain, Zaragoza
Hospital Miguel Servet
Assouline, Sarit E.
Canada, Montreal
Sir Mortimer B. Davis Jewish General Hospital
Durosinmi, Muheez Alani
Nigeria, Ife
Obafemi Awolowo University
Leeksma, Onno
Unknown Affiliation
Pogliani, Enrico Maria
Italy, Monza
Azienda Ospedaliera San Gerardo Monza
Puttini, Miriam
Italy, Monza
Azienda Ospedaliera San Gerardo Monza
Jang, Eunjung
South Korea, Bucheon-si
The Catholic University of Korea
Reiffers, Jossy J.
France, Bordeaux
Institut Bergonie
Valsecchi, Maria Grazia
Italy, Milan
Università Degli Studi Di Milano-bicocca
Kim, Dong-wook
South Korea, Bucheon-si
The Catholic University of Korea
Statistics
Citations: 399
Authors: 28
Affiliations: 22
Identifiers
Doi:
10.1093/jnci/djr060
ISSN:
00278874
e-ISSN:
14602105
Research Areas
Environmental
Study Design
Cross Sectional Study
Cohort Study
Study Approach
Quantitative