每周给予4'-脱氧阿霉素的I期试验。
Phase I trial of 4'-deoxydoxorubicin given weekly.
作者信息
Sessa C, Bosia L, Kaplan S, Pusterla C, Varini M, Cavalli F
出版信息
Invest New Drugs. 1984;2(4):369-73. doi: 10.1007/BF00171587.
Twenty-six patients with various solid tumors entered a Phase I trial with 4'-Deoxydoxorubicin (Esorubicin, IMI-58), a new doxorubicin analogue. The drug was administered weekly i.v. for 3-4 weeks. Leukopenia proved to be dose limiting. The maximum tolerated dose (MTD) was reached at 20 mg/m2 weekly for 3 weeks. For Phase II trials, a weekly dose of 15 and 17.5 mg/m2 can be proposed for poor and good risk patients respectively. Non-hematologic toxicity was minimal. Phase II trials with this new anthracycline are warranted.
26例患有各种实体瘤的患者进入了一项使用新型阿霉素类似物4'-脱氧阿霉素（表柔比星，IMI-58）的I期试验。该药物通过静脉注射每周给药一次，持续3至4周。白细胞减少被证明是剂量限制性毒性。每周20mg/m²，持续3周时达到了最大耐受剂量（MTD）。对于II期试验，对于低风险和高风险患者，可分别建议每周剂量为15mg/m²和17.5mg/m²。非血液学毒性极小。有必要对这种新型蒽环类药物进行II期试验。
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