Abstract:
:To determine the maximum-tolerated dose (MTD), dose-limiting toxicities and pharmacokinetic of semisynthetic homoharringtonine (ssHHT), given as a twice daily subcutaneous (s.c.) injections for 9 days, in patients with advanced acute leukaemia, 18 patients with advanced acute myeloid leukaemia were included in this sequential Bayesian phase I dose-finding trial. A starting dose of 0.5 mg m(-2) day(-1) was explored with subsequent dose escalations of 1, 3, 5 and 6 mg m(-2) day(-1). Myelosuppression was constant. The MTD was estimated as the dose level of 5 mg m(-2) day(-1) for 9 consecutive days by s.c. route. Dose-limiting toxicities were hyperglycaemia with hyperosmolar coma at 3 mg m(-2), and (i) one anasarque and haematemesis, (ii) one life-threatening pulmonary aspergillosis, (iii) one skin rash and (iv) one scalp pain at dose level of 5 mg m(-2) day(-1). The mean half-life of ssHHT was 11.01+/-3.4 h, the volume of distribution at steady state was 2+/-1.4 l kg(-1) and the plasma clearance was 11.6+/-10.4 l h(-1). Eleven of the 12 patients with circulating leukaemic cells had blood blast clearance, two achieved complete remission and one with blast crisis of CMML returned in chronic phase. The recommended daily dose of ssHHT on the 9-day schedule is 5 mg m(-2) day(-1).
journal_name
Br J Cancerjournal_title
British journal of cancerauthors
Lévy V,Zohar S,Bardin C,Vekhoff A,Chaoui D,Rio B,Legrand O,Sentenac S,Rousselot P,Raffoux E,Chast F,Chevret S,Marie JPdoi
10.1038/sj.bjc.6603265subject
Has Abstractpub_date
2006-08-07 00:00:00pages
253-9issue
3eissn
0007-0920issn
1532-1827pii
6603265journal_volume
95pub_type
杂志文章,随机对照试验abstract::Pancreatic cancer is a highly lethal malignancy with a dismal 5-year survival of less than 5%. The scarcity of early biomarkers has considerably hindered our ability to launch preventive measures for this malignancy in a timely manner. Neutrophil gelatinase-associated lipocalin (NGAL), a 24-kDa glycoprotein, was repor...
journal_title:British journal of cancer
pub_type: 杂志文章
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journal_title:British journal of cancer
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abstract::Early detection of relapse has been advocated to improve survival in children with recurrent medulloblastoma. However, the prognostic factors and the longer term outcome of these patients remains unclear. Pattern of recurrences were analysed in three consecutive protocols of the Société Française d'Oncologie Pédiatriq...
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pub_type: 临床试验,杂志文章,多中心研究
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pub_type: 杂志文章,随机对照试验
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journal_title:British journal of cancer
pub_type: 杂志文章,多中心研究
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pub_type: 临床试验,杂志文章
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journal_title:British journal of cancer
pub_type: 杂志文章
doi:10.1038/bjc.1994.173
更新日期:1994-05-01 00:00:00
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pub_type: 临床试验,杂志文章,随机对照试验
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pub_type: 杂志文章
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pub_type: 杂志文章
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