羟基喜树碱冻干粉针(拓僖)单药治疗晚期恶性肿瘤临床研究的初步报告  

Preliminary Study of Lyophilized 10-Hydroxycamptothecin in Advanced or Recurrent Malignancies

作　　者：黄慧强[1] 姜文奇[1] 胡晓桦[2] 林旭滨[1] 刘魁凤[3] 李宇红[1] 林忠[3] 申维玺 陈强[5] 何友兼[1] 管忠震[1] 

机构地区：[1]中山大学肿瘤防治中心内科,广东广州510060 [2]广西医科大学肿瘤医院内科,广西南宁530027 [3]广州铁路中心医院肿瘤科,广东广州510080 [4]广州市肿瘤医院内科,广东广州510095 [5]福建省肿瘤医院内科,福建福州350014

出　　处：《癌症》2003年第12期1334-1338,共5页Chinese Journal of Cancer

摘　　要：背景和目的:羟基喜树碱(HCPT)属拓扑异构酶I(TOPOI)抑制剂,对多种实体肿瘤有一定抗瘤活性,拓僖是羟基喜树碱冻干粉针,其纯度和稳定性明显高于水针剂。本研究的目的是通过用药试验,探索该药临床应用最适剂量以及初步了解其疗效和毒副反应。方法:本多中心研究采用单药拓僖6～8mg/(m2·d),连用5～10天,共治疗各种晚期实体肿瘤60例,其中男性42例,女性18例,年龄17～73岁,中位年龄53岁。初治18例(含6例放疗后),复治42例;肺癌22例,鼻咽癌12例,原发性肝癌9例,胰腺癌2例,结直肠癌9例,其它6例。结果:可评价疗效51例,全组总的有效率为15.7%;6mg/m2组有效率为16%,8mg/m2组有效率为15.4%。按病种计算其有效率肺癌为13.7%(3/22),结直肠癌为33.3%(3/9)以及鼻咽癌为16.6%(2/12);本组60例患者中,总有效率(ITT)为13.3%(8/60),其中初治患者PR3例(16.7%),复治患者PR5例(11.9%)。拓僖的适用剂量为6～8mg/m24小时静脉滴注,连用5～10天,每3周重复;剂量限制性毒性是骨髓抑制,其次为恶性呕吐、腹泻和皮疹,其中Ⅲ+Ⅳ度发生率分别为:WBC下降32%,皮疹8%和血小板8%,恶性呕吐6%,腹泻4%;未发现心脏、肺和肾的毒性反应。结论:拓僖单药(HCPT冻干粉针剂)对复治结直肠癌、非小细胞肺癌和鼻咽癌有较好的疗效,值得在联合化疗中对多种实体肿瘤?BACKGROUND &OBJECTIVE:10-Hydroxycamptothecin (HCPT) is the inh ib itor of topoisomerase I with anti-cancer effectiveness on several solid tumors. TUOXI (lyophilized HCPT) has higher purity and stability in comparison with sol ution for injection HCPT. The purpose of this study was to investigate the effic acy, toxicity, and proper dosage of TUOXI as single agent in treatment of advanc ed and recurrent solid tumors. METHODS: Sixty patients with the median age of 53 (range from 17 to 73 years) were enrolled into this multicenter phase Ⅱclinica l trial. Among them, 18 patients were chemonaive and 42 were recurrent from chem otherapy; 22 patients with NSCLC, 12 nasopharyngeal carcinoma, 9 primary liver c ancer, 9 colorectal carcinoma, 2 pancreatic carcinoma, and 6 miscellaneous malig nancies. HCPT was given at the dosage of 6-8 mg/m2·d for 5-10 consecutive day s based on the toxicity. RESULTS: Fifty-one patients were valuable for effectiv eness. The objective response rate for the whole group was 15.7%. The partial r emission (PR) rates were 16%for 6 mg/m2 group and 15.4%for 8 mg/m2 group, resp ectively. The PR rates were 13.7%(3/22) for NSCLC, 33.3%(3/9) for colorectal c arcinoma, and 16.6%(2/12) for advanced nasopharyngeal carcinoma, respectively. The PR rate for 60 intent-to-treat patients was 13.3%(8/60). Myelosuppression was the dose-limiting toxicity and other adverse reactions included nausea/vom iting, diarrhea, and skin rash. The incidence of grade Ⅲ+Ⅳadverse events were 32%, 8%, 8%, 6%, and 4%for leucopenia, skin rash, thrombocytopenia, nausea /vomiting, and diarrhea, respectively. No renal, pulmonary, and cardiac toxicity were found. CONCLUSION: TUOXI (HCPT lyophilized powder) had relatively broad-s pectrum anti-cancer efficacy and was effective on advanced or recurrent NCSLC, colorectal carcinoma, and NPC. And the recommended dosage is 6-8 mg/m2 as 4 hou rs infusion for 5-10 consecutive days every 3 weeks. Further clinical investiga tion on large number of solid tumors cases are warranted.

关 键 词：羟基喜树碱冻干粉针 拓僖 单药 治疗 晚期恶性肿瘤 临床研究 

分 类 号：R730.5[医药卫生—肿瘤]