Phase II study of oxaliplatin in patients with unresectable, metastatic, or recurrent hepatocellular cancer a California cancer consortium trial

Y. Yen, Dean W. Lim, Vincent Chung, Robert J. Morgan, Lucille A. Leong, Stephen I. Shibata, Stephen D. Wagman, Howard Marx, Peiguo G. Chu, Jeffrey A. Longmate, Heinz Josef Lenz, Ramesh K. Ramanathan, Chandra P. Belani, David R. Gandara

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36 引文 斯高帕斯(Scopus)

摘要

Purpose: Prolonged survival for patients with unresectable hepatocellular carcinoma (HCC) is consistently reported at lower than 6 months. Oxaliplatin has recently demonstrated activity in HCC. The objective of this study was to determine the response rate, survival, time to progression, and toxicity in patients with poor prognosis HCC when treated with oxaliplatin. Experimental Design: Patients were required to have measurable recurrent, metastatic or unresectable HCC, and to have previously been exposed to no more than 2 prior chemotherapy regimens. Karnofsky performance of 70% or above and adequate organ and hematologic function were required. All patients received treatment with oxaliplatin 100 mg/m2 on day 1 and 15 as a 2-hour intravenous infusion and were pretreated with antiemetics. Treatment was repeated every 28 days. Results: Thirty-six patients were enrolled and evaluated, although 6 expired before the first planned evaluation. Karnofsky performance status was 70/80/90/100% in 5/9/9/13 patients, respectively. The median time to progression was 2 months; median survival was 6 months. The 6-month overall survival was 55% (95% confidence interval 41%-74%), and the 6 month event-free survival was 11% (95% confidence interval 4%-28%). Conclusion: Single agent, oxaliplatin, has produced one partial response of good duration in 36 patients, but failed to meet the a priori criterion for promise in this trial. Sixteen patients were observed to have stable disease with a well tolerated toxicity profile. The combination of oxaliplatin and other agents should be considered to treat HCC in those patients with good functional status.

原文英語
頁(從 - 到)317-322
頁數6
期刊American Journal of Clinical Oncology: Cancer Clinical Trials
31
發行號4
DOIs
出版狀態已發佈 - 8月 1 2008
對外發佈

ASJC Scopus subject areas

  • 腫瘤科
  • 癌症研究

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