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ISSN 1527-3172 (Electronic)

2011, Number 1

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MEDICC Review 2011; 13 (1)

Introduction of imatinib as first-line therapy for chronic myeloid leukemia in Cuba

Pavón V, Gómez R, Jaime JC, Hernández P, Arencibia A, Espinosa-Martínez E, Ávila OM, Hernández C, González A, Carnot J, Espinosa-Estrada E, Lam RM, Amor AM, Lavauth K, Hernández A

Language: English
References: 33
Page: 35-40
PDF size: 86.42 Kb.


ABSTRACT

Introduction: Chronic myeloid leukemia is the  first malignant disease to be associated with a genetic lesion and is the  first leukemia to provide a genotype model conducive to targeted molecular therapy. It is a chronic clonal myeloproliferative disorder, originating in a pluripotent stem cell common to all three hematopoietic lineages, characterized by overproduction of myeloid cells in all stages of maturation.
Approval of the use of imatinib in the United States in 2001 and its introduction in the treatment of chronic myeloid leukemia changed the evolution and prognosis of the disease and began the era of molecular therapy for malignancies. Imatinib is highly effective and causes fewer adverse reactions than earlier treatments based on interferon and hydroxyurea.
In Cuba, chronic myeloid leukemia has been treated with interferon since 1998. Starting in 2003, imatinib was gradually introduced for use in newly-diagnosed chronic myeloid leukemia patients.
Objective: Evaluate the use of imatinib as  first-line therapy for chronic myeloid leukemia in a group of Cuban patients, based on hematologic, cytogenetic, and molecular response; overall and eventfree survival rates; and most frequency and severity of adverse reactions.
Methods: During May 2003 to May 2008, 33 newly-diagnosed chronic myeloid leukemia patients (25 adults, 8 children; ‹ 6 months from diagnosis) received a single daily oral dose of imatinib 400 mg from the time of study enrollment. Variables used: (1) to evaluate treatment eficacy: hematologic, cytogenetic, and molecular response; overall and event-free survival; and (2) to evaluate safety: presence of adverse reactions leading to de nitive interruption of treatment or death.
Results: Complete hematologic response occurred in 100% of patients, major cytogenetic response in 90.9%, and complete cytogenetic response in 48.5%. Molecular response occurred in 36.4% of patients. With a mean follow-up of 39 months, overall survival was 96% and estimated  five-year event-free survival was 85%. No adverse reactions occurred in 39.5% of patients. Adverse reactions most frequently observed were myelosuppression (24.2%) and digestive disorders (21.2%). These were followed, in decreasing order, by edema, primarily orbital (9.1%), skin depigmentation (3%), and cardiac arrhythmias (3%).
Conclusions: In the present study, imatinib was effective  first-line therapy for patients with newly-diagnosed chronic myeloid leukemia, as determined by overall and event-free survival rates. No severe adverse reactions were observed.


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