Preliminary Study of Lyophilized 10-Hydroxycamptothecin in Advanced or Recurrent Malignancies
Huang Hui-Qiang1, Jiang Wen-Qi1, Hu Xiao-Hua2, Lin Xu-Bin1, Liu Kui-Feng3 , Li Yu-Hong1, Lin Zhong3, Shen Wei-Xi4, Chen Qiang5, He You-Jian1, Guan Zhong-Zhen1 1.Department of Medical Oncology, Cancer Center,Sun Yat-sen University, Guangzhou,Guangdong,510060, P.R.China 2.Department of Medical Oncology, Cancer Center,Guangxi Medical University, Nanning,Guangxi,530027, P.R.China 3.Department of Oncology, Guangzhou Rail General Hospital, Guangzhou,Guangdong,510080, P.R.China 4.Department of Medical Oncology, Cancer Center of Guangzhou, Guangzhou,Guangdong,510095, P.R.China 5.Department of Medical Oncology, Cancer Center of Fujian Province, Fuzhou,Fujian,350014, P.R.China
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.
【CateGory Index】： R730.5