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表柔比星治疗广泛期小细胞肺癌:一项针对既往未接受治疗患者的II期研究:加拿大国家癌症研究所临床试验组研究

Epirubicin in extensive small-cell lung cancer: a phase II study in previously untreated patients: a National Cancer Institute of Canada Clinical Trials Group Study.

作者信息

Blackstein M, Eisenhauer E A, Wierzbicki R, Yoshida S

机构信息

Mount Sinai Hospital, Toronto, Canada.

出版信息

J Clin Oncol. 1990 Mar;8(3):385-9. doi: 10.1200/JCO.1990.8.3.385.

Abstract

The Clinical Trials Group of the National Cancer Institute of Canada (NCIC) studied single-agent epirubicin in 40 previously untreated patients with extensive small-cell lung cancer (SCLC). The starting dose of epirubicin was 100 (eight patients) or 120 (32 patients) mg/m2 administered intravenously every 3 weeks. Twenty patients (50%) achieved an objective response (95% confidence limits, 33% to 66%) and three of the 20 had complete responses (CRs). The median survival of all 40 patients was 8.3 months (35.4 weeks). Myelosuppression, mild or moderate nausea and vomiting, and hair loss were commonly seen. There was one chemotherapy-related death. This drug is active and well tolerated in SCLC and the use of it as first-line therapy did not appear to compromise survival in this group of patients.

摘要

加拿大国立癌症研究所(NCIC)临床试验小组对40例既往未接受过治疗的广泛期小细胞肺癌(SCLC)患者进行了表柔比星单药研究。表柔比星的起始剂量为100mg/m²(8例患者)或120mg/m²(32例患者),每3周静脉给药一次。20例患者(50%)获得客观缓解(95%置信区间,33%至66%),其中20例中有3例完全缓解(CR)。40例患者的中位生存期为8.3个月(35.4周)。常见的不良反应有轻至中度骨髓抑制、恶心和呕吐以及脱发。有1例与化疗相关的死亡。该药物在SCLC中具有活性且耐受性良好,在这组患者中作为一线治疗使用似乎并未影响生存。

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