Author(s): Carlson H, Lenzi R, Raber MN, Varadhachary GR
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Abstract BACKGROUND: Preclinical and clinical data suggest synergy for gemcitabine and oxaliplatin. These agents were tested in several known cancers that also comprise the common carcinoma of unknown primary (CUP) subtypes; namely, lung and pancreaticobiliary profiles. METHODS: The study enrolled 29 patients of whom 28 patients were eligible for treatment. Gemcitabine was given at 1,000 mg/m(2) as a fixed dose rate infusion and oxaliplatin was infused at 100 mg/m(2) every 2 weeks with restaging performed after 3 cycles at 6 weeks. RESULTS: The study reported one complete response (CR) (4\%), 6 patients with a partial response (PR) (25\%), and 13 with stable disease (SD) (54\%); and 4 patients had progressive disease (PD) (17\%) on restaging. Median overall survival (OS) and progression-free survival were 12.8 months (95\% confidence interval [CI] 8.5-18.5) and 3.1 months (95\% CI 1.7-6), respectively. The 1-year OS was 54\%. The most common grade 3 toxicities were nausea (22\%), vomiting (15\%), and fatigue (11\%). There were no grade 4 toxicities. This study was closed early as we moved from an empiric therapy platform to a more individualized approach. CONCLUSIONS: Gemcitabine and oxaliplatin is a well-tolerated regimen in CUP with similar outcomes to previously documented CUP studies. In selected good performance status patients this combination may serve as a first-line doublet chemotherapy option for CUP patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT00353145.
This article was published in Int J Clin Oncol
and referenced in JBR Journal of Clinical Diagnosis and Research