Phase II Study of Oxaliplatin in Patients With Unresectable, Metastatic, or Recurrent Hepatocellular Cancer
Autor: | Y, Yen, Dean W, Lim, Vincent, Chung, Robert J, Morgan, Lucille A, Leong, Stephen I, Shibata, Lawrence D, Wagman, 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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Rok vydání: | 2008 |
Předmět: |
Adult
Male Oncology Cancer Research medicine.medical_specialty Carcinoma Hepatocellular Organoplatinum Compounds Phases of clinical research Antineoplastic Agents Cholangiocarcinoma Capecitabine Carcinoma Non-Small-Cell Lung Internal medicine medicine Humans neoplasms Aged Aged 80 and over Salvage Therapy Response rate (survey) business.industry Liver Neoplasms Cancer Hepatitis C Middle Aged Prognosis medicine.disease digestive system diseases Oxaliplatin Survival Rate Treatment Outcome Hepatocellular carcinoma Toxicity Female Neoplasm Recurrence Local business medicine.drug |
Zdroj: | American Journal of Clinical Oncology. 31:317-322 |
ISSN: | 0277-3732 |
Popis: | 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.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/m on day 1 and 15 as a 2-hour intravenous infusion and were pretreated with antiemetics. Treatment was repeated every 28 days.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%).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. |
Databáze: | OpenAIRE |
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