Oxaliplatin Plus 5-Fluorouracil and Folinic Acid (OFF) in Gemcitabine-Pretreated Advanced Pancreatic Cancer: A Phase II Study

Department of Clinical Oncology and Nuclear Medicine, Faculty of Medicine, Mansoura University, Mansoura, Egypt, .
Journal of Gastrointestinal Cancer (Impact Factor: 0.38). 04/2013; 44(3). DOI: 10.1007/s12029-013-9495-5
Source: PubMed


Despite median survival of less than 6 months, there is a significant proportion of advanced pancreatic cancer patients who progress on gemcitabine that remains fit, and these patients are candidates for second-line treatment.
The objective of this study is to evaluate the efficacy and safety of oxaliplatin plus 5-fluorouracil and folinic acid in patients with gemcitabine-pretreated advanced pancreatic cancer.
Patients and Methods
Thirty patients with advanced pancreatic cancer who were pretreated with gemcitabine received oxaliplatin (85 mg/m2) on days 1 and 15 followed by leucovorin (20 mg/m2) and 5-fluorouracil (500 mg/m2) on days 1, 8, and 15. The cycle was repeated every 3 weeks.
The majority of patients (80 %) had locally advanced disease. Median age was 63 years, and 60 % were males. The liver was the most common site of metastasis. Partial response was observed in 2 patients (6.7 %) and stable disease in 6 patients (20 %), while 12 patients progressed (40 %). Improved performance status was reported in 10 patients (33.3 %). The median duration of response was 13 weeks, and median overall survival was 22 weeks. There was no grade 4 toxicity apart from grade 4 neutropenia in 6.6 % of patients. Neutropenia (46.5 %) and neuropathy (43.2 %) were the most common toxicities, while hand–foot syndrome was the least frequent one (20 %). There were no treatment-related deaths. The 6-month survival rate was 30 %.
This regimen is feasible and active with an acceptable toxicity; however, further investigation in phase III trial is needed.

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    • "Single agent docetaxel achieves response rates of up to 15 % as first line therapy of advanced PDAC[12,13], and has moderate activity as second line treatment of PDAC in retrospective analyses[14,15]. Oxaliplatin-based combination regimen show similar response rates as docetaxel161718. Several phase I/II studies confirmed the efficacy and safety of the combination of docetaxel plus oxaliplatin for different tumor entities192021. "
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