Taguchi T, Hirata K, Kunii Y, Tabei T, Suwa T, Kitajima M, Adachi I, Tominaga T, Shimada H, Sano M
Dept. of Surgery, Hospital Attached to the Research Institute for Microbial Disease, Osaka University.
Gan To Kagaku Ryoho. 1994 Oct;21(14):2453-60.
An early phase II clinical study of RP56976 (docetaxel), a new anticancer agent of plant origin, was conducted in patients with breast cancer at 20 Japanese collaborative institutions. Docetaxel was administered at two or more doses of 60 mg/m2 by intravenous infusion with dose-free intervals of 3-4 weeks, and the efficacy and safety was evaluated. Of the 51 patients enrolled, 50 patients completed the scheduled course of treatment. Two patients showed a complete response (CR) and 19 showed a partial response (PR) with a response rate of 42.0%. The response rates based on the efficacy for metastatic lesions in soft tissue, liver and lung, were 46.2% (18/39), 37.5% (3/8), and 38.5% (5/13), respectively. Of the 50 patients who completed the study, 48 patients had previously been treated for the present malignancy. Forty-seven patients had previously been treated with chemotherapy and showed a response rate of 40.4% (19/47). The response rate in those who had received chemotherapy composed of anthracyclines and other agents was 44.1% (15/34). Grade 3 or more severe leukopenia and neutropenia developed in 43 patients (84.3%) and 48 patients (94.1%), respectively. Other adverse reactions which occurred in a Grade 3 or more severe form included nausea/vomiting (1 patient), anorexia (5 patients), diarrhea (4 patients), fatigue (2 patients), and alopecia (20 patients). Except for alopecia, most adverse reactions were generally transient and reversible without any specific treatment.
在20家日本合作机构对患有乳腺癌的患者开展了一项关于新型植物源抗癌药物RP56976（多西他赛）的II期早期临床研究。多西他赛以60mg/m²的两种或更多剂量通过静脉输注给药，给药间隔为3 - 4周，同时对疗效和安全性进行评估。在入组的51例患者中，50例患者完成了预定的治疗疗程。2例患者出现完全缓解（CR），19例患者出现部分缓解（PR），缓解率为42.0%。基于软组织、肝脏和肺部转移病灶疗效的缓解率分别为46.2%（18/39）、37.5%（3/8）和38.5%（5/13）。在完成研究的50例患者中，48例患者此前曾接受过针对当前恶性肿瘤的治疗。47例患者此前接受过化疗，缓解率为40.4%（19/47）。接受过由蒽环类药物和其他药物组成的化疗方案的患者缓解率为44.1%（15/34）。43例患者（84.3%）出现3级或更严重的白细胞减少，48例患者（94.1%）出现3级或更严重的中性粒细胞减少。以3级或更严重形式出现的其他不良反应包括恶心/呕吐（1例患者）、厌食（5例患者）、腹泻（4例患者）、疲劳（2例患者）和脱发（20例患者）。除脱发外，大多数不良反应通常是短暂的且可逆转，无需任何特殊治疗。
