Abstract:
AIM:Clinical and pharmacokinetic effects of azacitidine in higher-risk myelodysplastic syndromes were established in mainly Caucasian populations. Because of inter-ethnic genotype variability of drug-metabolizing enzymes, it is important to evaluate azacitidine in populations expected to use the drug. METHODS:In this single-arm study, Taiwanese patients with higher-risk myelodysplastic syndromes received azacitidine 75 mg/m2 /day for 7 days/28-day cycle for up to six cycles. Response-evaluable patients had baseline and cycle 6 marrow assessments. Clinical outcomes are compared descriptively with those from a phase 3 study comprising mainly Caucasian patients (N = 179). Pharmacokinetics in a subgroup of Taiwanese patients are descriptively compared with a historical control of North American patients (N = 45). RESULTS:Median age of Taiwanese patients (N = 44) was 64 years (range 36-90), and 46% had poor cytogenetics. Median number of azacitidine cycles was six (1-6). No response-evaluable patient (n = 33) achieved complete or partial remission; however, 22 patients (50%) achieved hematologic improvement, 12 of 32 patients attained RBC transfusion independence and 7 of 18 attained platelet transfusion independence. Most common grade 3-4 treatment-emergent adverse events were neutropenia (52%) and leukopenia (39%). Pharmacokinetic profiles were similar for Taiwanese (N = 12) and North American (N = 45) patients. Maximum plasma concentration was higher in Taiwanese patients; however, mean azacitidine exposure was within the range for North American patients. CONCLUSION:These data confirm the safety and efficacy of azacitidine in Taiwanese patients with higher-risk myelodysplastic syndromes. Clinical outcomes were generally comparable with those for Caucasian patients. No meaningful differences in azacitidine pharmacokinetics were observed for Taiwanese patients, and no initial dose adjustment is necessary.
journal_name
Asia Pac J Clin Oncoljournal_title
Asia-Pacific journal of clinical oncologyauthors
Chou WC,Yeh SP,Hsiao LT,Lin SF,Chen YC,Chen TY,Laille E,Galettis A,Dong Q,Songer S,Beach CLdoi
10.1111/ajco.12659subject
Has Abstractpub_date
2017-10-01 00:00:00pages
e430-e439issue
5eissn
1743-7555issn
1743-7563journal_volume
13pub_type
杂志文章abstract::The rationale for certain patterns of metastatic spread seen in melanoma is not well understood. Currently, there is no clear experimental evidence to support the potential for metastases to form metastases in this disease. We report a case of a 31-year-old woman, with metastatic melanoma, who developed axillary lymph...
journal_title:Asia-Pacific journal of clinical oncology
pub_type: 杂志文章
doi:10.1111/ajco.12169
更新日期:2014-12-01 00:00:00
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journal_title:Asia-Pacific journal of clinical oncology
pub_type: 杂志文章,多中心研究
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journal_title:Asia-Pacific journal of clinical oncology
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abstract::Cancer, its therapy, and related adverse effects have been associated with reduced work performance, including absenteeism (i.e. absence from scheduled work due to health problems) and presenteeism (i.e. impaired on-the-job performance due to health problems) among cancer survivors. This review aimed to compare the wo...
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journal_title:Asia-Pacific journal of clinical oncology
pub_type: 杂志文章
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更新日期:2013-06-01 00:00:00
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更新日期:2020-10-30 00:00:00
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journal_title:Asia-Pacific journal of clinical oncology
pub_type: 杂志文章,meta分析,评审
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更新日期:2015-06-01 00:00:00
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更新日期:2021-02-01 00:00:00
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pub_type: 临床试验,杂志文章
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更新日期:2011-06-01 00:00:00
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pub_type: 杂志文章,多中心研究
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pub_type: 杂志文章
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journal_title:Asia-Pacific journal of clinical oncology
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pub_type: 杂志文章
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journal_title:Asia-Pacific journal of clinical oncology
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