Emi Yasunori, Yamamoto Manabu, Takahashi Ikuo, Orita Hiroyuki, Kakeji Yoshihiro, Kohnoe Shunji, Maehara Yoshihiko
Department of Surgery and Science, Graduate School of Medical Science, Kyushu University, and Department of Surgery, Saiseikai Yahata Hospital, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
Surg Today. 2008;38(11):1013-20. doi: 10.1007/s00595-008-3769-8. Epub 2008 Oct 29.
A phase clinical II trial was conducted to determine the antitumor activity and toxicity of weekly paclitaxel administered to patients with advanced gastric cancer.
Sixty-eight patients with advanced gastric cancer and performance status 0-2 were treated with 80 mg/m2 paclitaxel over 1 h following a short course of premedication with dexamethasone, diphenhydramine, and ranitidine administered 30 min prior to the delivery of the paclitaxel. In principle, the treatment was repeated weekly for three courses, followed by a 1-week rest.
Objective responses were observed in 12 of 68 patients (17.6%; 95% confidence interval: 9.5%-28.8%). Two of fourteen (14.2%) patients with no prior chemotherapy and 10 of 54 (18.5%) patients previously treated for metastatic disease developed a partial response. The median therapeutic duration and the median survival time were 96 days and 222 days, respectively. In 212 (85.5%) of 248 total cycles, the original dose of 80 mg/m2 of paclitaxel was administered and was well tolerated. Fourteen of 68 patients (20.1%) experienced grade 3 or 4 neutropenia. Grade 1 or 2 peripheral neuropathy occurred in 10 patients (14.7%).
Weekly paclitaxel therapy is an active and safe treatment for advanced gastric cancer.
开展一项II期临床试验，以确定每周给予晚期胃癌患者紫杉醇的抗肿瘤活性和毒性。
68例晚期胃癌且体能状态为0 - 2级的患者，在给予紫杉醇前30分钟，先接受地塞米松、苯海拉明和雷尼替丁的短程预处理，然后用80mg/m²紫杉醇静脉滴注1小时。原则上，每周重复治疗3个疗程，随后休息1周。
68例患者中有12例（17.6%；95%置信区间：9.5% - 28.8%）观察到客观缓解。14例未接受过化疗的患者中有2例（14.2%）出现部分缓解，54例先前接受过转移性疾病治疗的患者中有10例（18.5%）出现部分缓解。中位治疗持续时间和中位生存时间分别为96天和222天。在248个总疗程中的212个疗程（85.5%）中给予了80mg/m²的初始紫杉醇剂量，且耐受性良好。68例患者中有14例（20.1%）出现3级或4级中性粒细胞减少。10例患者（14.7%）出现1级或2级周围神经病变。
每周紫杉醇治疗是晚期胃癌的一种有效且安全的治疗方法。
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