Tominaga T, Nomura Y, Adachi I, Takashima S, Kimura M, Koyama H, Toge T, Tamura K, Hayasaka H, Kunii Y
Dept. of Surgery, Tokyo Metropolitan Komagome Hospital.
Gan To Kagaku Ryoho. 1994 May;21(6):801-8.
A multi-institutional early phase II study of KW-2307 (vinorelbine), a new vinca alkaloid derivative, in advanced or recurrent breast cancer was conducted in 15 nationwide hospitals. KW-2307 was intravenously administered once weekly at doses of 15 to 25 mg/m2. Sixty-five among the enrolled 69 patients were eligible. Response rates were 11.8% (2/17) with 15 mg/m2, 28.0% (7/25) with 20 mg/m2 and 17.4% (4/23) with 25 mg/m2, and the overall response rate was 20.0%. Once-weekly intravenous administration of 20 mg/m2 was estimated to be the optimal dose of KW-2307 from the results. The major side effect was leucopenia, which was the dose-limiting factor in this study. Other subjective or objective side effects included anorexia, nausea-vomiting, phlebitis, fever, general fatigue and stomatitis, but none of them was serious.
一项关于新型长春花生物碱衍生物KW-2307（长春瑞滨）治疗晚期或复发性乳腺癌的多机构II期早期研究在全国15家医院开展。KW-2307以15至25mg/m²的剂量每周静脉给药一次。入组的69例患者中有65例符合条件。15mg/m²剂量组的缓解率为11.8%（2/17），20mg/m²剂量组为28.0%（7/25），25mg/m²剂量组为17.4%（4/23），总缓解率为20.0%。根据研究结果，每周一次静脉注射20mg/m²被认为是KW-2307的最佳剂量。主要副作用是白细胞减少，这是本研究中的剂量限制因素。其他主观或客观副作用包括厌食、恶心呕吐、静脉炎、发热、全身乏力和口腔炎，但均不严重。
