OBJECTIVE: To investigate the response rate (RR), time to tumor progression (TTP), quality of life (QOL) and adverse reaction in the treatment of pretreated advanced non-small cell lung cancer (NSCLC) using escalated doses of rh-endostatin (YH-16), and to determine the optimal dose for clinical application. METHODS: In this phase II randomized, controlled, multicenter trial, the patients were randomly divided into two groups to receive daily 3 hours intravenous infusion of either 7.5 mg x m(-2) or 15 mg/m(2) YH-16 for 28 days. RESULTS: Totally, 68 patients were entered and 60 patients were evaluable. There were no differences in RR (3.0% in both groups, P > 0.05), median TTP (ITT: 60 days versus 71 days, P > 0.05), QOL and incidence rate of adverse reactions (48.6% versus 38.7%, P > 0.05). No significant unexpected adverse events were observed. CONCLUSION:Rh-endostatin may have anti-tumor activity with high clinical benefit rate and is well tolerated in pretreated advanced NSCLC patients. The dose of 7.5 mg x (m(2))(-1) x d(-1) is clinically recommended.
RCT Entities:
OBJECTIVE: To investigate the response rate (RR), time to tumor progression (TTP), quality of life (QOL) and adverse reaction in the treatment of pretreated advanced non-small cell lung cancer (NSCLC) using escalated doses of rh-endostatin (YH-16), and to determine the optimal dose for clinical application. METHODS: In this phase II randomized, controlled, multicenter trial, the patients were randomly divided into two groups to receive daily 3 hours intravenous infusion of either 7.5 mg x m(-2) or 15 mg/m(2) YH-16 for 28 days. RESULTS: Totally, 68 patients were entered and 60 patients were evaluable. There were no differences in RR (3.0% in both groups, P > 0.05), median TTP (ITT: 60 days versus 71 days, P > 0.05), QOL and incidence rate of adverse reactions (48.6% versus 38.7%, P > 0.05). No significant unexpected adverse events were observed. CONCLUSION: Rh-endostatin may have anti-tumor activity with high clinical benefit rate and is well tolerated in pretreated advanced NSCLCpatients. The dose of 7.5 mg x (m(2))(-1) x d(-1) is clinically recommended.
Authors: Chun-Te Chen; Hirohito Yamaguchi; Hong-Jen Lee; Yi Du; Heng-Huan Lee; Weiya Xia; Wen-Hsuan Yu; Jennifer L Hsu; Chia-Jui Yen; Hui-Lung Sun; Yan Wang; Edward T H Yeh; Gabriel N Hortobagyi; Mien-Chie Hung Journal: Mol Cancer Ther Date: 2011-05-24 Impact factor: 6.261
Authors: Chun Huang; Xuan Wang; Jing Wang; Li Lin; Zhujun Liu; Wenjing Xu; Liuchun Wang; Jianyu Xiao; Kai Li Journal: Thorac Cancer Date: 2014-08-25 Impact factor: 3.500
Authors: Ma Honglian; Hui Zhouguang; Peng Fang; Zhao Lujun; Li Dongming; Xu Yujin; Bao Yong; Xu Liming; Zhai Yirui; Hu Xiao; Wang Jin; Kong Yue; Wang Lvhua; Chen Ming Journal: Thorac Cancer Date: 2020-02-18 Impact factor: 3.500