Gemcitabine and oxaliplatin combination as first-line treatment for advanced pancreatic cancer: a multicenter phase II study

Abstract

Gemcitabine is the only drug approved for single-agent therapy in advanced pancreatic carcinoma (APC). Gemcitabine-based combination chemotherapy has not yet shown promising results. This multicenter phase II study enrolled previously untreated patients with locally advanced and/or metastatic pancreatic adenocarcinoma. Patients received 1,000 mg/m(2) gemcitabine, 100-min infusion, day 1 and 100 mg/m(2) oxaliplatin, 2-h infusion, day 2; q2w. The primary end point was response rate (RR). Thirteen study centers enrolled 48 eligible patients of which 44 were evaluable. The RR, median overall survival, and median time to progression were 18.2%, 9.4 and 5.6 months, respectively. Sixteen patients (36.4%) experienced clinical benefit. The global quality of life scores improved by 11.71. Grade 3/4 peripheral sensory neuropathy was noted (2.1%), while the most common hematologic toxicity was anemia (grade 3/4, 6.3%). Gemcitabine and oxaliplatin combination chemotherapy showed a promising activity in APC patients and was well tolerated.