Yokoyama A, Kurita Y, Watanabe K, Negoro S, Ogura T, Nakano M, Minoda S, Niitani H, Taguchi T
Dept. of Internal Medicine, Niigata Cancer Center.
Gan To Kagaku Ryoho. 1994 Nov;21(15):2609-16.
An early phase II clinical study of RP56976 (Docetaxel), a new anticancer agent of plant origin, was conducted in patients with primary pulmonary cancer as a multicentered study involving 28 Japanese institutions. Docetaxel was administered at an intravenous dose of 60 mg/m2 based on the results of a phase I clinical study, and efficacy and safety were examined. Of the 65 patients enrolled, 57 patients were evaluated to have completed the scheduled course of treatment by the Evaluation Committee. The antitumor effect in patients with non-small cell lung cancer was 21.4% (9/42). In patients not previously treated, the antitumor effect was 30.0% (6/20), in patients previously treated the antitumor effect was 13.6% (3/22), and in 13.3% (2/15) of patients with small cell lung cancer. This shows that docetaxel had an efficacy for non-small cell lung cancer. Hematological adverse reactions included leukopenia and neutropenia of Grade III or more as specified in the Adverse Event Reporting Form proposed by the Japan Society for Cancer Therapy in 53.3% (32/60) and 78.3% (47/60) patients, respectively. Other major adverse reactions included alopecia and anorexia. Neurological symptoms developed at a low frequency and were mild in severity.
对一种新的植物源抗癌药物RP56976（多西他赛）进行了一项II期早期临床研究，该研究以原发性肺癌患者为对象，是一项涉及28家日本机构的多中心研究。根据I期临床研究结果，多西他赛的静脉给药剂量为60mg/m²，并对疗效和安全性进行了检查。在入组的65例患者中，评估委员会评估57例患者完成了预定的治疗疗程。非小细胞肺癌患者的抗肿瘤效果为21.4%（9/42）。在未经治疗的患者中，抗肿瘤效果为30.0%（6/20），在既往接受过治疗的患者中，抗肿瘤效果为13.6%（3/22），在小细胞肺癌患者中的抗肿瘤效果为13.3%（2/15）。这表明多西他赛对非小细胞肺癌有效。血液学不良反应包括白细胞减少和中性粒细胞减少，分别在53.3%（32/60）和78.3%（47/60）的患者中出现日本癌症治疗学会提出的不良事件报告表中规定的III级或更高级别。其他主要不良反应包括脱发和厌食。神经症状出现频率低，严重程度较轻。
