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Evaluation of tolerability and efficacy of imatinib mesylate in elderly patients with chronic phase CML: ELDERGLI study.

Abstract：

:Imatinib mesylate (IM) is the treatment of choice in patients with newly diagnosed chronic myeloid leukemia (CML), irrespectively of their age. Nevertheless, information regarding tolerability and responses in advanced-age patients, a subgroup in which co-morbidities and other factors may influence outcome, is scarce, since they were excluded from most clinical trials. In this observational study (ELDERGLI), information regarding demographics, concomitant medication, physical examination, performance status, hemogram, biochemistry, hematologic, cytogenetic and molecular responses, time to progression, adverse events (AE) and severe adverse events (SAE) were prospectively recorded in a series of 36 elderly patients with CML, with a median age of 76.6 years. Most patients had cardiovascular co-morbidities, especially hypertension. Regarding IM toxicity, around one third of patients required treatment interruptions because of adverse events, especially hematologic toxicity (66% of cases that needed dose interruptions). When analyzing non hematologic adverse events, the most frequent ones were superficial edemas and GI symptoms. Of note, 9 of patients experienced an infection episode during the follow-up, and 4 were diagnosed during the study period of another type of cancer. Finally, cardiovascular events were reported in 7 patients, most of them with prior cardiovascular risk factors. Regarding responses, after 12 months of imatinib therapy, the rate of complete hematologic response (CHR), complete cytogenetic response (CCyR) and major molecular response (MMolR) were 89%, 72% and 55% respectively. In summary, IM display, in advanced-age patients with chronic phase CML, an efficacy and safety profile comparable to younger patients.

journal_name

Leuk Res

journal_title

Leukemia research

authors

Sánchez-Guijo FM,Durán S,Galende J,Boqué C,Nieto JB,Balanzat J,Gracia A,García I,Avellaneda-Molina C,Moreno MV,Luño-Fernandez E,Hermosilla M,Sanchez-Varela JM,Dios A,López-Garrido P,Giraldo P,Bargay J,Domingo JM,Soler

doi

10.1016/j.leukres.2011.01.017

subject

Has Abstract

pub_date

2011-09-01 00:00:00

pages

1184-7

issue

9

eissn

0145-2126

issn

1873-5835

pii

S0145-2126(11)00027-0

journal_volume

35

pub_type

临床试验,杂志文章,多中心研究

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