Tsukagoshi S
Cancer Institute, Japanese Foundation for Cancer Research.
Gan To Kagaku Ryoho. 1997 Jul;24(9):1167-74.
A new semi-synthetic taxoid, docetaxel (taxotere) was recently developed in Japan. The phase I study was initiated in 1991, and the MTD was determined as 70-90 mg/m2, dose-limiting factor as leukopenia, and recommended dose for the phase II study as 60 mg/m2, every 3-4 weeks. The early and late phase II studies were conducted based on above dose schedule. After the late phase II studies, appreciable responses were obtained against advanced recurrent breast (50.4%) and inoperable lung (22.4%) cancers, and the results were accepted by MHW of the Japanese Government. Docetaxel possesses an unique tubulin-interacting activity (promotion of assembly of stable microtubules) and currently combination studies with other anticancer drugs or radiotherapy are ongoing.
一种新的半合成紫杉烷类药物多西他赛(泰索帝)最近在日本研制成功。I期研究于1991年启动,确定最大耐受剂量为70 - 90mg/m²,剂量限制因素为白细胞减少,II期研究的推荐剂量为60mg/m²,每3 - 4周一次。早期和晚期II期研究均按照上述剂量方案进行。晚期II期研究之后,在晚期复发性乳腺癌(50.4%)和不可切除肺癌(22.4%)患者中获得了显著疗效,该结果得到了日本厚生省的认可。多西他赛具有独特的与微管蛋白相互作用的活性(促进稳定微管的组装),目前正在进行与其他抗癌药物或放疗的联合研究。