Abstract:
BACKGROUND:Azacitidine safety and efficacy were established in studies of mainly Caucasian patients. Differences in drug metabolism enzymes between Caucasian and East Asian populations prevent extrapolation of drug effects between these groups. This phase 2 study evaluated azacitidine safety, efficacy and pharmacokinetics in patients with higher-risk myelodysplastic syndromes (HR-MDS) in mainland China. METHODS:Patients aged ≥18 years with HR-MDS were to receive subcutaneous azacitidine 75 mg/m2 /day for 7 days per 28-day cycle, for ≥6 cycles. Pharmacokinetic blood samples were collected in cycle 1 predose on days 5-7, and postdose on day 7. Pharmacokinetic outcomes are descriptively compared with those of a historical North American cohort. RESULTS:Of 72 participants, 46 (64%) completed ≥6 cycles. Response rate was 96%, driven primarily by stable disease (94%); one patient achieved complete remission. Hematologic improvement was attained by 53% of patients. Azacitidine mean plasma concentration versus time profiles were similar in shape for Chinese (n = 12) and North American (n = 45) patients. Maximum plasma concentration (Cmax ) was higher in Chinese patients; however, mean azacitidine exposure (1190 ng·h/mL) was similar to the North American cohort (1021 ng·h/mL). Most common grade 3-4 treatment-emergent adverse events (TEAEs) were thrombocytopenia (69%) and neutropenia (67%). CONCLUSIONS:Azacitidine was safe and effective in Chinese patients with HR-MDS. Clinical outcomes were comparable to those for primarily Caucasian patients in the phase 3 AZA-001 study. Cmax differences between Chinese and North American patients were not associated with differences in TEAE frequency or severity. No initial azacitidine dose adjustment is required for Chinese patients with HR-MDS.
journal_name
Asia Pac J Clin Oncoljournal_title
Asia-Pacific journal of clinical oncologyauthors
Du X,Lai YY,Xiao Z,Liu T,Hu Y,Sun A,Li X,Shen ZX,Jin J,Yu L,Laille E,Dong Q,Songer S,Beach CLdoi
10.1111/ajco.12835subject
Has Abstractpub_date
2018-06-01 00:00:00pages
270-278issue
3eissn
1743-7555issn
1743-7563journal_volume
14pub_type
杂志文章,多中心研究abstract:AIM:This study examined pathological quality-of-surgery indicators in laparoscopic and open rectal cancer resection specimens. METHODS:Retrospective analysis of consecutive, prospectively recorded laparoscopic (LR) or open (OR) resections for rectal cancer. Indicators included integrity of the perirectal fascial envel...
journal_title:Asia-Pacific journal of clinical oncology
pub_type: 杂志文章
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更新日期:2018-04-01 00:00:00
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journal_title:Asia-Pacific journal of clinical oncology
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journal_title:Asia-Pacific journal of clinical oncology
pub_type: 历史文章,杂志文章
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journal_title:Asia-Pacific journal of clinical oncology
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journal_title:Asia-Pacific journal of clinical oncology
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journal_title:Asia-Pacific journal of clinical oncology
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journal_title:Asia-Pacific journal of clinical oncology
pub_type: 杂志文章,多中心研究,评审
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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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journal_title:Asia-Pacific journal of clinical oncology
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