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异环磷酰胺/美司钠与米托蒽醌用于既往治疗过的非霍奇金淋巴瘤患者的II期试验:癌症与白血病B组研究8753

Phase II trial of ifosfamide/mesna and mitoxantrone in previously treated patients with non-Hodgkin's lymphoma: cancer and leukemia group B study 8753.

作者信息

Case D C, Santarelli M T, Carey R W, Anderson J, Gottlieb A

机构信息

Department of Medicine, Maine Medical Center, Portland 04102.

出版信息

Med Pediatr Oncol. 1992;20(4):325-9. doi: 10.1002/mpo.2950200411.

DOI:10.1002/mpo.2950200411
PMID:1608355
Abstract

Ifosfamide (2.0 g/m2 intravenously/day x 3) with mesna (400 mg/m2 intravenously q 4 h daily x 3) was combined with mitoxantrone (14 mg/m2 intravenously x 1) and given on a 3 week schedule to patients with previously treated non-Hodgkin's lymphoma. In 45 eligible/evaluable patients, a 47% response rate (95% confidence interval: 32%, 62%) was achieved of which 25% were complete responses and 22% were partial responses. Median duration of remission was 10 months with 42% of patients in remission at 18 months. Hematologic toxicity (granulocytopenia) was the dose-limiting toxicity with severe or life-threatening granulocytopenia in 98% of patients at full protocol doses. Nausea/vomiting was seen in 73% of patients but was usually mild/moderate. Three patients had significant hematuria secondary to ifosfamide. Two patients had severe changes in the left ventricular ejection fraction (LVEF) secondary to mitoxantrone; and one patient had acute neurologic dysfunction secondary to ifosfamide. Ifosfamide/mesna can be safely combined with mitoxantrone at full doses in previously treated patients with non-Hodgkin's lymphoma. This combination should be considered for other trials in lymphoma.

摘要

异环磷酰胺(2.0 g/m²,静脉注射,每日1次,共3天)联合美司钠(400 mg/m²,静脉注射,每4小时1次,每日共3次)与米托蒽醌(14 mg/m²,静脉注射,1次)联合使用,按照3周方案给药,用于治疗既往接受过治疗的非霍奇金淋巴瘤患者。在45例符合条件/可评估的患者中,总缓解率为47%(95%置信区间:32%,62%),其中完全缓解率为25%,部分缓解率为22%。缓解持续时间的中位数为10个月,18个月时42%的患者仍处于缓解状态。血液学毒性(粒细胞减少)是剂量限制性毒性,在全方案剂量下,98%的患者出现严重或危及生命的粒细胞减少。73%的患者出现恶心/呕吐,但通常为轻/中度。3例患者因异环磷酰胺出现显著血尿。2例患者因米托蒽醌导致左心室射血分数(LVEF)严重改变;1例患者因异环磷酰胺出现急性神经功能障碍。异环磷酰胺/美司钠可与米托蒽醌全剂量安全联合用于既往接受过治疗的非霍奇金淋巴瘤患者。在淋巴瘤的其他试验中应考虑这种联合方案。

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