Pharma Medical News about advanced biliary carcinoma;biweekly oxaliplatin;high-dose 5-FU and leucorvin

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A phase II trial of biweekly oxaliplatin with simplified schedule of 48-h infusion of high-dose 5-fluorouracil and leucorvin for advanced biliary tract carcinoma
Cancer Chemotherapy and Pharmacology, 05/28/09

Chen JS et al. - In a trial to investigate the efficacy and toxicity of biweekly oxaliplatin (OXA) with 48-hr infusion of 5-FU/LV in advanced biliary tract carcinoma (BTC), it was reported that biweekly OXA and 48-hr infusion of 5-FU/LV in pts with advanced BTC were tolerable and showed efficacy equivalent to other combination regimens.

Methods

All pts had histologic confirmation of BTC, at least 1 measurable site of disease, and had received no prior chemotherapy.
Pts were older than 20 yrs with ECOG performance scores (PS) of 0–2.
Treatment involved 2-hr infusion of oxaliplatin (85 mg/m2) diluted in D5W 500 ml followed by 48-hr infusion of 5-FU (3000 mg/m2) and LV (100 mg/m2) biweekly.
Response evaluation was based on RECIST criteria and was carried out every 2 courses of treatment; toxicity evaluation was based on NCI common toxicity criteria version 3.0.

Results

34 chemotherapy-naive pts with advanced BTC were enrolled and 32 intention-to-treat pts were evaluated.
Partial response was 18.8%, stable disease was 31.3%, resulting in a disease control rate of 50.0%.
Median time to progression and survival was 3.7 and 7 mos, respectively.
Most common grade 3/4 toxicities were neutropenia 15.6% (5/32), stomatitis 9.4% (3/32), thrombocytopenia 6.3% (2/32), diarrhea 6.3% (2/32), and neuropathy 3.1% (1/32).
No treatment-related deaths occurred.

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