Department of Clinical Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Aichi, Japan.
Jpn J Clin Oncol. 2011 Feb;41(2):287-90. doi: 10.1093/jjco/hyq206. Epub 2010 Nov 9.
Weekly paclitaxel is an effective and widely used regimen for patients with advanced gastric cancer, with main dose-limiting toxicities of neutropenia and neurotoxicity. Neutropenia during weekly paclitaxel administration was reported to be associated with better survival. The aim of this study is to evaluate prospectively whether dosing adjustments based on the occurrence of neutropenia may improve chemotherapy efficacy. A total of 90 patients will be randomized to receive either a standard dose of weekly paclitaxel (80 mg/m(2)) or an escalated dose of weekly paclitaxel (80 mg/m(2) initially followed by 100 and 120 mg/m(2) unless severe toxicity is observed). The primary endpoint is overall survival. Secondary endpoints include progression-free survival, response rate, disease control rate and adverse events.
每周紫杉醇是一种有效的、广泛应用于治疗晚期胃癌的方案，主要剂量限制毒性为中性粒细胞减少和神经毒性。有报道称，每周紫杉醇治疗期间发生中性粒细胞减少与更好的生存相关。本研究旨在前瞻性评估基于中性粒细胞减少发生情况的剂量调整是否可以提高化疗疗效。共 90 例患者将被随机分配接受标准剂量的每周紫杉醇（80mg/m(2)）或递增剂量的每周紫杉醇（80mg/m(2)，最初剂量为 100 和 120mg/m(2)，除非观察到严重毒性）。主要终点为总生存期。次要终点包括无进展生存期、缓解率、疾病控制率和不良事件。
