国产紫杉醇治疗恶性肿瘤的Ⅲ期临床研究报告

A PHASE Ⅲ CLINICAL STUDY OF PACLITAXEL IN THE TREATMENT OF CANCER PATIENTS

目的考察紫杉醇治疗多种恶性肿瘤的疗效及毒副作用。方法紫杉醇单药化疗每次剂量１７５ｍｇ／ｍ２，联合化疗紫杉醇每次剂量１３５ｍｇ／ｍ２，３ｈ静脉输注，每３周重复，在紫杉醇治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３３３例进入了临床研究。１６７例接受了紫杉醇单药化疗，１６６例接受了紫杉醇加顺铂或阿霉素或其他药物联合化疗。紫杉醇单药化疗的有效率如下：卵巢癌３７％，乳腺癌３９％，非小细胞肺癌３１％，小细胞肺癌４０％，鼻咽癌６７％。紫杉醇联合化疗的有效率如下：卵巢癌３８％，乳腺癌４４％，非小细胞肺癌３１％，小细胞肺癌４０％，鼻咽癌４４％。患者毒副反应主要为白细胞减少、肌肉及关节疼痛、感觉异常和脱发。结论本研究所用的紫杉醇制剂及剂量安全有效，患者能够耐受。紫杉醇可与其他化疗药物联合应用，治疗恶性肿瘤病人。

Objective:To evaluate the efficacy and toxicity of paclitaxel in patients with a variety of malignancies.Methods:Paclitaxel was administered as a single agent at a dose of 175 mg/m 2 or in combination chemotherapy at a dose of 135 mg/m 2 by 3 hour iv infusion every three weeks.All patients received premedication (dexamethasone,diphenhydramine,and cimetidine)to prevent hypersensitivity reactions.Results:Three hundred and thirty three patients were entered into this study.167 patients were treated with paclitaxel single agent therapy and 166 patients were treated with paclitaxel combined with cisplatin or doxorubicin or other chemotherapeutic agents.Responses were observed in patients receiving paclitaxel treatment alone,with the overall response rate for ovarian cancer being 37%,breast cancer 39%,non small cell lung cancer 31%,small cell lung cancer 40%, and nasopharyngeal cancer 67%.Responses were also achieved in patients receiving paclitaxel combination chemotherapy,with the overall response rate for ovarian cancer being 38%,breast cancer 44%,non small cell lung cancer 31%,small cell lung cancer 40%,and nasopharyngeal cancer 44%.The major toxicity associated with paclitaxel included neutropenia,myalgia and arthralgia,peripheral neuropathy,and alopecia.Conclusion:At this dose and schedule,paclitaxel is well tolerated and has notable antitumor activity.Paclitaxel may be combined with other chemotherapeutic agents for the treatment of cancer patients.