J A Ajani1, P F Mansfield, P Dumas. 1. Department of Gastrointestinal Oncology, University of Texas M. D. Anderson Cancer Center, Houston 77030, USA.
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.
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.