多西他赛注射液治疗晚期非小细胞肺癌和乳腺癌的随机对照临床研究

A randomized control clinical trial of docetaxel in treatment of advanced non-small cell lung cancer or breast cancer

目的：观察福州三先药物研究所和南京振华医药科技开发有限公司联合开发的多西他赛注射液治疗晚期非小细胞肺癌和乳腺癌的疗效和毒性。方法：随机入组患者共220例，其中试验组111例，对照组109例。试验组接受新开发的多西他赛注射液，对照组应用艾素。两组非小细胞肺癌采用．rP方案：多西他赛注射液70mg／m^2，第1天，顺铂70mg／m^2，第2天。乳腺癌患者可采用上述的联合方案，也可选用多西他赛单药治疗，100mg／m^2，第1天。所有治疗均每3周重复1次。结果：试验组和对照组治疗晚期非小细胞肺癌／乳腺癌可评价病例共200例，其中试验组100例（肺癌49例，乳腺癌51例），对照组100例（肺癌48例，乳腺癌52例），总缓解率分别为31．00％（肺癌28．57％，乳腺癌33．33％）和32．00％（肺癌25．00％，乳腺癌38．46％），两组比较均无统计学差异（P〉0．05）。试验组和对照组发生与化疗药物相关的毒副反应总发生率分别为93．64％和92．66％，其中Ⅲ～Ⅳ度发生率分别为75．45％和76．15％，两组比较亦均无统计学差异（P〉0．05）。主要毒副反应有白细胞下降、呕吐、肌肉酸痛、腹泻、发热、感染等。结论：新研发的多西他赛注射液治疗晚期非小细胞肺癌和乳腺癌安全有效。

Objective：Docetaxel is one of the major effective drugs for the advanced non-small cell lung cancer and breast cancer in clinical use. The study was to evaluate the efficacy and tolerability of a new domestic docetaxel in the treatment of non-small cell lung cancer and breast cancer. Methods：Two hundred and twenty patients were randomized into two groups. There were 111 pa- tients in the study group and 109 patients in the control group. In the study group, patients received the new domestic docetaxel; while in the control group, docetaxel （ made in Jiangsu） was administrated. All the non-small cell lung cancer patients in both groups re- ceived docetaxel 70mg/m2 plus cisplatin 70mg/m2. The breast cancer patients were either administrated the above regimen or treated with single docetaxel 100mg/m2 ,which was repeated every 3 weeks. All the patients had to receive at least 2 cycles of chemotherapy. Results：The objective responses in the study and control group were 31.00% （non-small cell lung cancer was 28. 57% , breast cancer was 33.33% ） and 32.00% （non-small cell lung cancer was 25.00% , breast cancer was 38. 46% ） respectively, with no statistical difference （ P 〉 0. 05 ）. The incidences of adverse events related to chemotherapy in the study and control groups were 93. 64% and 92. 66% respectively and those of grade [U and IV adverse events were 75.45% and 76. 15% respectively, with no statistical differ- ence （P 〉 0. 05 ）. The major adverse events included leukopenia, vomiting, myalgia, diarrhea, fever, infection and etc. Conclusion： The new domestic Doceetaxel is an effective chemotherapy drug in advanced non-small cell lung cancer and breast cancer treatment, which has the similar efficacy and toxicity to docetaxel made in Jiangsu.