期刊
ANNALS OF ONCOLOGY
卷 14, 期 4, 页码 580-585出版社
OXFORD UNIV PRESS
DOI: 10.1093/annonc/mdg170
关键词
gemcitabine; oxaliplatin; pancreatic cancer; phase II trial
类别
资金
- NCI NIH HHS [CA-35269, CA-35415, CA-60276, CA-25224, CA-35448, CA-35101, CA-35195, CA-37417, CA-52352, CA-37404, CA-63849, CA-35113, CA-35103] Funding Source: Medline
Background: This study was performed to determine the efficacy of gemcitabine and oxaliplatin in patients with advanced or metastatic pancreatic adenocarcinoma (ACA). Patients and methods: Pancreatic ACA patients with previously untreated advanced or metastatic disease were enrolled in a phase 11 study of gemcitabine and oxaliplatin. Oxaliplatin was given i.v. on day I and gemcitabine i.v. on days I and 8 of a 3-week cycle. The primary end point of the trial was 6-month survival. Secondary end points included response rate, overall survival, median time to progression and toxicity. Results: A total of 47 patients were enrolled, 46 of whom were evaluable. Of those patients assessed for the primary end point 50% lived for greater than or equal to6 months. The median time to progression was 4.53 months. Five confirmed responses were seen with a median duration of response of 2.7 months. Overall, the treatment was well tolerated. However, one patient died as a result of treatment-related hemolytic uremic syndrome. Conclusions: Gemcitabine and oxaliplatin, at doses of 1000 mg/m(2) and 100 mg/m(2), respectively, showed moderate, activity in patients with pancreatic ACA. Based on the results of this study further evaluation of this combination is warranted.
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