Oral etoposide for patients with metastatic gastric adenocarcinoma.

J A Ajani, P F Mansfield, P Dumas
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Abstract

Purpose: Oral administration of etoposide represents a pharmacokinetic advantage over the traditional intermittent intravenous usage of this drug. This phase II trial was undertaken to determine its activity against gastric adenocarcinoma in chemotherapy-naive patients.

Patients and methods: Patients with measurable, unresectable, metastatic gastric carcinoma with performance status < or = 2 by Zubrod scale were eligible. Patients had to have normal liver, renal, and bone marrow functions. Written informed consent was obtained from all patients. The starting dose of etoposide was 50 mg/m2/day, given orally daily for 21 days, followed by a 7-day rest period. Oral etoposide was repeated every 28 days. Response was evaluated after two courses.

Results: Twenty-eight patients were registered. The median number of courses was two (range, 1 to 12; total, 69 courses). Twenty-six patients were evaluable for response and toxicity. Five patients (19%; 95% confidence interval, 3% to 35%) achieved a partial response. The median duration of response was 3.5 months. There was no treatment-related death. Toxic effects were mild to moderate.

Conclusions: Oral etoposide is modestly active against gastric carcinoma. It is well tolerated by patients. Further studies in combination with other active agents against gastric carcinoma may be warranted.

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口服依托泊苷治疗转移性胃腺癌。
目的:口服依托泊苷的药代动力学优势优于传统的间歇性静脉注射。这项II期试验是为了确定其对首次化疗的胃腺癌患者的活性。患者和方法:可测量的、不可切除的、转移性胃癌患者,按Zubrod评分评分<或= 2。患者必须有正常的肝、肾和骨髓功能。所有患者均获得书面知情同意。起始剂量为依托泊苷50 mg/m2/天,每日口服21天,休息7天。口服依托泊苷每28天重复一次。两个疗程后评估患者的反应。结果:28例患者入组。课程数的中位数为2(范围为1到12;总共69门课程)。26例患者可评估反应和毒性。5例患者(19%;95%置信区间(3%至35%)达到部分反应。中位反应持续时间为3.5个月。没有治疗相关的死亡。毒性作用为轻度至中度。结论:口服依托泊苷对胃癌有一定的抑制作用。患者耐受性良好。进一步的研究与其他活性药物联合抗胃癌可能是必要的。
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