The cancer journal from Scientific American · 1998
Phase II study of Taxol in patients with advanced gastric carcinoma.
Клиническое исследованиеКлиническое исследование II фазыСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Ajani J A, Fairweather J, Dumas P, Patt Y Z, Pazdur R, Mansfield P F
Аннотация
PURPOSE: Taxol (paclitaxel) represents a new class of anticancer agent with activity against a wide variety of solid tumors. It has been found to be active in patients with adenocarcinoma and squamous cell carcinoma of the esophagus. To determine its activity against gastric adenocarcinoma, we conducted a phase II trial of Taxol in chemotherapy-naive patients with advanced disease.
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 Taxol was 200 mg/m2 infused over either 3 hours (in the first 15 patients) or 24 hours (in the subsequent 18 patients). Taxol was repeated every 21 days. Response was evaluated after two courses.
RESULTS: Thirty-three patients were registered. The median number of courses was two (range, 1 to 12; total, 112 courses). Thirty patients were evaluable for response and toxicity. Among the first 15 patients (two inevaluable) receiving Taxol over 3 hours, there were one partial response (PR) (one of 13 patients, or 8%; 95% confidence interval, 0% to 36%) and three minor responses (MRs). However, among the 18 patients (one inevaluable) receiving Taxol over 24 hours, there were four PRs (four of 17 patients or 23%; 95% confidence interval, 7% to 50%) and three MRs. The overall PR rate was 17% (five of 30 patients; 95% confidence interval, 6% to 35%). The median duration of PR was 6.5 months (range, 2.3 months to 11.3+ months. There were no treatment-related deaths. Myelosuppression was more severe with the 24-hour schedule than with the 3-hour schedule.
CONCLUSIONS: Taxol has a modest degree of activity against gastric carcinoma. It is well tolerated by the patients. Further studies of Taxol in combination with other active agents against gastric carcinoma should be considered.
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 Taxol was 200 mg/m2 infused over either 3 hours (in the first 15 patients) or 24 hours (in the subsequent 18 patients). Taxol was repeated every 21 days. Response was evaluated after two courses.
RESULTS: Thirty-three patients were registered. The median number of courses was two (range, 1 to 12; total, 112 courses). Thirty patients were evaluable for response and toxicity. Among the first 15 patients (two inevaluable) receiving Taxol over 3 hours, there were one partial response (PR) (one of 13 patients, or 8%; 95% confidence interval, 0% to 36%) and three minor responses (MRs). However, among the 18 patients (one inevaluable) receiving Taxol over 24 hours, there were four PRs (four of 17 patients or 23%; 95% confidence interval, 7% to 50%) and three MRs. The overall PR rate was 17% (five of 30 patients; 95% confidence interval, 6% to 35%). The median duration of PR was 6.5 months (range, 2.3 months to 11.3+ months. There were no treatment-related deaths. Myelosuppression was more severe with the 24-hour schedule than with the 3-hour schedule.
CONCLUSIONS: Taxol has a modest degree of activity against gastric carcinoma. It is well tolerated by the patients. Further studies of Taxol in combination with other active agents against gastric carcinoma should be considered.