Ohtsu A, Boku N, Tamura F, Muro K, Shimada Y, Saigenji K, Akazawa S, Kitajima M, Kanamaru R, Taguchi T
Department of Gastrointestinal Oncology/Gastroenterology, National Cancer Center Hospital East, Kashiwanoha, Kashiwa, Japan.
Am J Clin Oncol. 1998 Aug;21(4):416-9. doi: 10.1097/00000421-199808000-00021.
The purpose of this study was to evaluate the feasibility and efficacy of 3-hour infusional paclitaxel for the treatment of advanced gastric cancer with measurable metastatic diseases. Eligibility criteria included no more than one regimen of prior chemotherapy. Paclitaxel was administered as an intravenous infusion over 3 hours at a dose of 210 mg/m2 every 3 weeks. Premedication of dexamethazone, ranitidine, and diphenhydramine were given to all patients. Sixteen patients were registered in the study. One patient did not receive paclitaxel because of gastrointestinal bleeding before the initiation of drug's administration. Thirteen of the 15 patients had a prior history of chemotherapy. Although 10 patients (67%) developed grade 4 neutropenia, no serious infections occurred during the study. Nonhematologic toxicities were generally mild. Three (20%) patients who showed evidences of resistance to the previous intensive regimen achieved a partial response. In conclusion, a 3-hour infusion of paclitaxel is a safe and promising treatment for advanced gastric cancer. Paclitaxel appears to be non-cross resistant to other agents that are commonly used for gastric cancer. A large-scale phase II study is now underway.
本研究的目的是评估3小时输注紫杉醇治疗伴有可测量转移性疾病的晚期胃癌的可行性和疗效。入选标准包括既往化疗不超过一种方案。紫杉醇以210mg/m²的剂量每3周静脉输注3小时给药。所有患者均给予地塞米松、雷尼替丁和苯海拉明进行预处理。16例患者登记参加本研究。1例患者因在开始给药前出现胃肠道出血而未接受紫杉醇治疗。15例患者中有13例有化疗史。尽管10例患者（67%）出现4级中性粒细胞减少，但研究期间未发生严重感染。非血液学毒性一般较轻。3例（20%）对既往强化方案耐药的患者获得部分缓解。总之，3小时输注紫杉醇治疗晚期胃癌是一种安全且有前景的治疗方法。紫杉醇似乎与其他常用于胃癌的药物无交叉耐药性。一项大规模的II期研究正在进行中。
