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Haematologica. 2017 Sep;102(9):1530-1536. doi: 10.3324/haematol.2017.169532. Epub 2017 Jun 1.

Incidence of second primary malignancies and related mortality in patients with imatinib-treated chronic myeloid leukemia.

Author information

1
Institute of Hematology "L. and A. Seràgnoli", "S. Orsola-Malpighi" University Hospital, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Italy gabriele.gugliotta@unibo.it.
2
Institute of Hematology "L. and A. Seràgnoli", "S. Orsola-Malpighi" University Hospital, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Italy.
3
Division of Cellular Biotechnologies and Hematology, University Sapienza, Rome, Italy.
4
Chair of Hematology, University of Bari, Italy.
5
Oncohematology Division, IRCCS Ca' Granda -Maggiore Policlinico Hospital Foundation, Milan, Italy.
6
Hematology Unit, Azienda Ospedaliera "Papa Giovanni XXIII", Bergamo, Italy.
7
Hematology Unit, "S. Eugenio" Hospital, Rome, Italy.
8
Hematology Unit, "Pugliese-Ciaccio" Hospital, Catanzaro, Italy.
9
Hematology Unit, Azienda Ospedaliera "Spedali Civili", Brescia, Italy.
10
Hematology Unit, Azienda Ospedaliero Universitaria "Città della Salute e della Scienza", Torino, Italy.
11
Chair of Hematology, Azienda Ospedaliero Universitaria Arcispedale "S. Anna", University of Ferrara, Italy.
12
Chair and Division of Hematology, Azienda Ospedaliero Universitaria Policlinico - V. Emanuele, University of Catania, Italy.
13
Hematology Unit, Azienda Ospedaliera "Bianchi-Melacrino-Morelli", Reggio Calabria, Italy.
14
Department of Hematology, "Spirito Santo" Hospital, Pescara, Italy.
15
Chair of Hematology, "Cattolica del Sacro Cuore" University, Fondazione Policlinico Universitario Agostino Gemelli, Rome, Italy.
16
Division of Hematology and Bone Marrow Transplantation, Azienda Sanitaria Universitaria Integrata di Udine, Italy.
17
Hematology Unit, "C. e G. Mazzoni" Hospital, Ascoli Piceno, Italy.
18
Hematology Unit, Azienda Ospedaliera di Padova, University of Padova, Italy.
19
Department of Medicine, Section of Hematology, University of Verona, Italy.
20
Hematology Unit, "P. Giaccone" Hospital, Palermo, Italy.
21
Department of Biochemistry and Medical Biotechnologies, "Federico II" University, Napoli, Italy.
22
Chair of Hematology, Department of Clinical and Biological Sciences, "S Luigi Gonzaga" University Hospital, University of Torino, Orbassano, Italy.
23
Department of Hematology and Oncology "L. and A. Seràgnoli", University of Bologna, Italy.

Abstract

The majority of patients with chronic myeloid leukemia are successfully managed with life-long treatment with tyrosine kinase inhibitors. In patients in chronic phase, other malignancies are among the most common causes of death, raising concerns on the relationship between these deaths and the off-target effects of tyrosine kinase inhibitors. We analyzed the incidence of second primary malignancies, and related mortality, in 514 chronic myeloid leukemia patients enrolled in clinical trials in which imatinib was given as first-line treatment. We then compared the observed incidence and mortality with those expected in the age- and sex-matched Italian general population, calculating standardized incidence and standardized mortality ratios. After a median follow-up of 74 months, 5.8% patients developed second primary malignancies. The median time from chronic myeloid leukemia to diagnosis of the second primary malignancies was 34 months. We did not find a higher incidence of second primary malignancies compared to that in the age- and sex-matched Italian general population, with standardized incidence ratios of 1.06 (95% CI: 0.57-1.54) and 1.61 (95% CI: 0.92-2.31) in males and females, respectively. Overall, 3.1% patients died of second primary malignancies. The death rate in patients with second primary malignancies was 53% (median overall survival: 18 months). Among females, the observed cancer-related mortality was superior to that expected in the age- and sex-matched Italian population, with a standardized mortality ratio of 2.41 (95% CI: 1.26 - 3.56). In conclusion, our analysis of patients with imatinib-treated chronic myeloid leukemia did not reveal a higher incidence of second primary malignancies; however, the outcome of second primary malignancies in such patients was worse than expected. Clinicaltrials.gov: NCT00514488, NCT00510926.

PMID:
28572163
PMCID:
PMC5685244
DOI:
10.3324/haematol.2017.169532
[Indexed for MEDLINE]
Free PMC Article

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