紫杉醇治疗中晚期恶性肿瘤121例

CLINICAL TRIAL RESULTS OF PACLITAXEL IN MANGEMENT OF 121 PATIENTS WITH ADVANCED CANCER

用从我国红豆杉中提取的紫杉醇对１２１例中晚期病人进行了临床试用。单药治疗：紫杉醇１５０～１７５ｍｇ／ｍ２，静滴，３～５ｈ，每３～４周一次，２～３周期为一疗程。联合化疗：紫杉醇１３５ｍｇ／ｍ２，ｉｖ，卵巢癌加顺铂８０ｍｇ／ｍ２；乳腺癌加阿霉素４０ｍｇ／ｍ２；肺癌加顺铂８０ｍｇ／ｍ２或卡铂３５０ｍｇ／ｍ２，ｉｖ；食管癌加顺铂８０ｍｇ／ｍ２，ｉｖ，（第１周）和平阳霉素８ｍｇ，肌注２次／周（第１，２周），均每３周一次，２～３周期为一疗程。近期疗效：完全缓解３例，部分缓解５１列，无变化５１例，进展１６例，总有效率为４４．６％。单药治疗６９例，有效率４４．９％；联合化疗５２例，有效率４４．２％。卵巢癌单药治疗有效率为４０％（６／１５），与顺铂联用有效率６０％（９／１５）；乳腺癌单药治疗５４．２％（１３／２３），与阿霉素联用４１．７％（５／１２）；食管癌单用有效率３３．３％（３／９），与顺铂及平阳霉素联用５８．３％（７／１２）；肺癌单用有效率３５．３％（６／１７）；与顺铂联用１５．４％（２／１３）。主要不良反应为消化道反应、肌肉痛无力、脱发和骨髓抑制。未发现有严重过敏的病人。

The phaseⅡ clinical trials were conducted on 121 in patients with advanced cancer of various kinds confirmed by pathological or cytological examinations using paclitaxel developed by Institute of Materia Medica,Chinese Academy of Medical Sciences.In monotherapy ,paclitaxel was given to patients in a dose of 150～175 mg/m 2 per 3～4 weeks and one couse consisted of 2～3 cycles.In combination regimens,advanced refractory or recurrent patients after surgery,irradiation or chemotherapy were treated with paclitaxel in a dose of 135 mg/m 2 in combination with:iv cisplatin 80 mg/m 2 for ovarin or lung cancer patients;iv adriamycin 40 mg/m 2for breast cancer patients;iv cisplatin 80mg/m 2 and pingyangmycin(bleomycin A5)8 mg im twice a week for 2 weeks for esophageal cancer patients;drugs are given every 3 weeks and one course consisted of 2～3 cycles.After 2～3 cycles treatment,the total response rate(RR) in 121 patients was 44.6% ,with 3 complete remission,51 partial remission,51 stable disease and 16 progression;and the RR in four group cancer patients are listed below:RR in monotherapy RR in combination regimens (%)(%)Ovarin cancer 40.0(6/5) 60.0(9/15) Breast cancer 54.2(13/23) 41.7(5/12) Esophageal cancer 33.3(3/9) 58.3(13/23) Lung cancer 35.3(6/17) 15.4(2/13) Analysis of factors influencing prognosis showed that performens status,pathology,and stage of patients were most important.The major ADRs were GI tract reactions,myopathy,alopecia,and bone marrow suppression. About 10% patients experienced mild abnormal liver function when received paclitaxel in combination with adriamycin.For comparision,taxol was given to 41 patients at the same period,and no significant differnces were observed in efficacy and ADRs.