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  • Title: [Randomized phase II trial on escalated doses of Rh-endostatin (YH-16) for advanced non-small cell lung cancer].
    Author: Yang L, Wang JW, Sun Y, Zhu YZ, Liu XQ, Li WL, Di LJ, Li PW, Wang YL, Song SP, Yao C, You LF.
    Journal: Zhonghua Zhong Liu Za Zhi; 2006 Feb; 28(2):138-41. PubMed ID: 16750022.
    Abstract:
    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.
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