A phase I study of a 24 hour infusion of gemcitabine in previously untreated patients with inoperable non-small-cell lung cancer.
A phase I study of a 24 hour infusion of gemcitabine in previously untreated patients with inoperable non-small-cell lung cancer.
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DOI：
10.1038/bjc.1996.382
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发表时间：
1996-08
影响因子：
8.8
通讯作者：
Hansen H
中科院分区：
文献类型：
--
作者：
Anderson H;Thatcher N;Walling J;Hansen H
一项确定吉西他滨24小时输注治疗不可手术的非小细胞肺癌（NSCLC）患者的最大耐受剂量和毒性的I期研究。共有24例不可切除的IIIa-IV期NSCLC患者入组研究。吉西他滨在第0、7和14天24小时输注给药。每28天重复治疗一次。有16名男性和8名女性，中位年龄为51岁（范围40-73岁）。WHO体能评分为1分（21例患者）或2分（3例患者）。TNM分期：IIIa期6例，IIIb期10例，IV期8例。每个剂量水平入组3例患者，最大耐受剂量（MTD）入组6例患者。剂量水平为10、20、40、80、120、180和210 mg m-2。MTD为180 mg m-2，剂量限制性毒性为中性粒细胞减少和嗜睡。在5例（21%）患者（95% CI 7-42%）中观察到部分缓解，持续10、14、18、47和51 +周。吉西他滨24小时输注给药的最大耐受剂量为180 mg m-2。
A phase I study to determine the maximum tolerated dose and toxicity of gemcitabine when given as a 24 h infusion to patients with inoperable non-small-cell lung cancer (NSCLC). A total of 24 patients with unresectable stage IIIa-IV NSCLC were entered into the study. Gemcitabine was administered as a 24 h infusion on days 0, 7 and 14. Courses of therapy were repeated every 28 days. There were 16 males and 8 females with a median age of 51 years (range 40-73 years). The WHO performance score was 1 (21 patients) or 2 (3 patients). The TNM stage was IIIa (6), IIIb (10) and IV (8). Three patients were entered at each dose level with six at the maximum tolerated dose (MTD). Dose levels were 10, 20, 40, 80, 120, 180 and 210 mg m-2. The MTD was 180 mg m-2 and dose-limiting toxicity was neutropenia and lethargy. Partial response was observed in five (21%) patients (95% CI 7-42%) lasting 10, 14, 18, 47 and 51 + weeks. The maximum tolerated dose of gemcitabine given as a 24 h infusion was 180 mg m-2.