Kudo S, Hino M, Fujita A, Igarashi T, Arita K, Niitani H, Taguchi T
4th Internal Medicine, Nippon Medical School.
Gan To Kagaku Ryoho. 1994 Nov;21(15):2617-23.
A late phase II clinical study of RP56976 (Docetaxel) was conducted in patients with non-small cell lung cancer. Patients with non-small cell lung cancer in Stage IIIB and Stage IV not previously treated were enrolled. Docetaxel was administered at a dose of 60 mg/m2 based on the results of a phase I and an early phase II clinical study, and the efficacy and safety were examined. Of the 77 patients enrolled, 72 patients were evaluated to have completed the scheduled course of treatment by the Evaluation Committee. A partial response (PR) was seen in 18 patients, and the overall response rate was 25.0%. The response rate classified by clinical stage was 28.0% (7/25) in patients with Stage IIIB and 23.4% (11/47) in patients with Stage IV. Hematological adverse reactions included leukopenia of Grade III or more in 53.3% (40/75) and neutropenia of Grade III or more in 86.7% (65/75) as specified in the Adverse Event Reporting Form proposed by the Japan Society for Cancer Therapy. Other major adverse reactions included alopecia, asthenia, and fever, all of which were tolerable. From these results, the efficacy of docetaxel for the treatment of non-small cell lung cancer was confirmed.
对RP56976（多西他赛）进行了一项晚期II期临床研究，研究对象为非小细胞肺癌患者。纳入了之前未接受过治疗的IIIB期和IV期非小细胞肺癌患者。根据I期和早期II期临床研究的结果，多西他赛的给药剂量为60mg/m²，并对疗效和安全性进行了检查。在纳入的77例患者中，评估委员会评估有72例患者完成了预定的治疗疗程。18例患者出现部分缓解（PR），总缓解率为25.0%。按临床分期分类的缓解率在IIIB期患者中为28.0%（7/25），在IV期患者中为23.4%（11/47）。血液学不良反应包括日本癌症治疗学会提出的不良事件报告表中规定的III级或以上白细胞减少症，发生率为53.3%（40/75），III级或以上中性粒细胞减少症发生率为86.7%（65/75）。其他主要不良反应包括脱发、乏力和发热，所有这些不良反应均可耐受。根据这些结果，证实了多西他赛治疗非小细胞肺癌的疗效。
