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顺二氯二氨铂(II)持续5天输注治疗非小细胞肺癌的II期研究。

Phase II study of 5-day continuous infusion of cis-diamminedichloroplatinum(II) in the treatment of non-small-cell lung cancer.

作者信息

Saito Y, Mori K, Tominaga K, Yokoi K, Miyazawa N

机构信息

Division of Thoracic Disease, Tochigi Cancer Center, Utsunomiya, Japan.

出版信息

Cancer Chemother Pharmacol. 1990;26(6):389-92. doi: 10.1007/BF02994086.

DOI:10.1007/BF02994086
PMID:2171793
Abstract

cis-Diamminedichloroplatinum(II) (CDDP) was given as a single agent at a dose of 25 mg/m2 daily for 5 days by continuous infusion; treatment was repeated every 4 weeks in 30 previously untreated patients with advanced non-small-cell lung cancer (NSCLC). The median age of the patients was 61 years; 13 patients had limited disease and 17, extensive disease. The overall response rate was 40% (12/30; 95% confidence limits, 23-58%), with a median survival of 8 months. Vomiting was observed in 37% of patients; elevated serum creatinine levels (greater than 1.5 mg/dl), in 7%; leukopenia (less than 3,000/mm3), in 39%; thrombocytopenia (less than 70,000/mm3), in 26%; and anemia (hemoglobin less than 9.5 g/dl), in 60% of patients. In all cases, these toxicities were mild and transient, requiring no dose modification. The exposure to filterable platinum, determined from the area under the concentration-time curve, was 9.08 +/- 3.21 micrograms h ml-1. We conclude that CDDP given by 5-day continuous i.v. infusion is safe and effective for treatment of NSCLC.

摘要

顺二氯二氨铂(II)(CDDP)作为单一药物,以25mg/m²的剂量连续输注,每日一次,共5天;30例先前未接受过治疗的晚期非小细胞肺癌(NSCLC)患者每4周重复进行一次治疗。患者的中位年龄为61岁;13例患者疾病局限,17例患者疾病广泛。总缓解率为40%(12/30;95%置信区间,23-58%),中位生存期为8个月。37%的患者出现呕吐;7%的患者血清肌酐水平升高(大于1.5mg/dl);39%的患者出现白细胞减少(低于3000/mm³);26%的患者出现血小板减少(低于70000/mm³);60%的患者出现贫血(血红蛋白低于9.5g/dl)。在所有病例中,这些毒性均为轻度且短暂,无需调整剂量。根据浓度-时间曲线下面积确定的可滤过铂暴露量为9.08±3.21μg h ml⁻¹。我们得出结论,5天连续静脉输注CDDP治疗NSCLC是安全有效的。

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