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卡铂输注治疗复发难治性急性髓系白血病——西南肿瘤协作组试验

Carboplatin infusion in relapsed and refractory acute myeloid leukemia--a Southwest Oncology Group trial.

作者信息

Welborn J L, Kopecky K J, Meyers F J, Veith R, Shurafa M, Doroshow J H, Balcerzak S P, Appelbaum F R

机构信息

University of California, Davis, Division of Hematology and Oncology, UC Davis Cancer Center, Sacramento 95817, USA.

出版信息

Leukemia. 1995 Jul;9(7):1126-9.

PMID:7630183
Abstract

Carboplatin (CBDCA) is an active agent in the treatment of acute leukemia and is associated with limited extramedullary toxicity. Simultaneous phase II trials were conducted by the Southwest Oncology Group in adult patients with relapsed or refractory acute myeloid leukemia (AML). CBDCA was given as a continuous infusion at a dose of 300 mg/m2 daily for 5 days. Three (8%) of the 37 eligible patients in the relapsed group achieved complete remissions (CRs) lasting 3, 4, and 26 months. Entry of patients was stopped early in the refractory group due to slow accrual and in the relapsed group due to low CR rate. For both groups combined, the CR rate was 3/45 or 7% (95% confidence interval 3-18%). There were 12 fatal toxicities. Four patients died of intracerebral hemorrhage, three of infection, and five of hepatic and/or renal failure. Nonhematologic grade 4 toxicity included diarrhea in three patients, hyperbilirubinemia in four, and mucositis and renal toxicity in one each. These results suggest that CBDCA should not be considered for treatment of relapsed or refractory AML patients with prior high-dose therapy.

摘要

卡铂(CBDCA)是治疗急性白血病的一种有效药物,且髓外毒性有限。西南肿瘤协作组对复发或难治性急性髓系白血病(AML)成年患者进行了同步II期试验。卡铂以300mg/m²的剂量每日持续输注,共5天。复发组37例符合条件的患者中有3例(8%)实现完全缓解(CR),缓解持续时间分别为3个月、4个月和26个月。难治组因入组缓慢提前停止入组患者,复发组因CR率低提前停止入组患者。两组合并后,CR率为3/45或7%(95%置信区间3-18%)。有12例致命毒性反应。4例患者死于脑出血,3例死于感染,5例死于肝和/或肾衰竭。非血液学4级毒性反应包括3例患者出现腹泻,4例出现高胆红素血症,1例出现粘膜炎,1例出现肾毒性。这些结果表明,对于之前接受过高剂量治疗的复发或难治性AML患者,不应考虑使用卡铂进行治疗。

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