国产紫杉醇治疗恶性肿瘤的Ⅱ期临床研究

A phase Ⅱ clinical study of China made paclitaxel in the treatment of cancer patients

目的考察国产紫杉醇治疗各种晚期恶性肿瘤的疗效及其毒副作用。方法紫杉醇每次剂量１７５ｍｇ／ｍ２，３小时静脉输注，每３周重复疗程。在紫杉醇化疗前常规给予地塞米松、苯海拉明和西米替丁预防过敏反应。结果共１１４例患者接受了２～３个疗程的化疗。各种恶性肿瘤的总有效率如下：卵巢癌４６．７％，乳腺癌５６．４％，非小细胞肺癌２５．０％，小细胞肺癌６６．７％，鼻咽癌４１．７％。过去化疗失败的晚期恶性肿瘤患者，接受了本试验所用的紫杉醇剂量治疗后，也取得了较好疗效，有效率如下：卵巢癌４２．９％，乳腺癌５７．６％，非小细胞肺癌３３．３％，小细胞肺癌２５．０％，鼻咽癌４０．０％。临床观察表明，紫杉醇与阿霉素及顺铂无明显交叉抗药性，上述紫杉醇剂量的毒副反应主要为白细胞减少、肌肉及关节疼痛、手足麻木和脱发，未见发生严重的过敏反应。结论本研究所用的紫杉醇制剂及剂量安全有效，患者能耐受。

Objective To evaluate the efficacy and toxicity of China made paclitaxel in patients with a variety of advanced malignacies. Methods Paclitaxel was administered by iv infusion at a dose of 175 mg/m 2 in 3 hour every three weeks. All patients received premedication(dexamethasone, diphenhydramine and cimetidine) to prevent allergic reactions. Results Of 116 patients, 114 patients received 2 to 3 courses of therapy and were evaluable for response. The overall response rate for ovarian cancer was 46.7%, for breast cancer 56.4%, for non small cell lung cancer 25.0%, for small cell lung cancer 66.7%, and for nasopharyngeal cancer 41.7%.Responses were also achieved in patients who had failed to respond to prior chemotherapy, with the overall reponse rate of 42.9% for ovarian cancer, 57.6% for breast cancer, 33.3% for non small cell lung cancer, 25.0% for small cell lung cancer, and 40.0% for nasopharyngeal cancer. Paclitaxel did not show cross resistance with doxorubicin and cisplatin. The major toxicity associated with paclitaxel included neutropenia, arthralgia, myalgia, numbness of hands and feet and alopecia. No severe hypersensitivity reactions were observed.Conclusion At the above mentioned dose and schedule, paclitaxel is effective with tolerable side effects.