OBJECTIVES: This phase 2 study evaluated clinical efficacy, toxicity, and pharmacokinetics of combination gemcitabine (GEM) and oxaliplatin (OXA) in patients with advanced pancreatic adenocarcinoma. METHODS: Of 30 eligible patients, 20 had metastatic disease and 10 had nonmetastatic unresectable locally advanced disease. Gemcitabine 1000 mg/m2 as a 10 mg/m2/min intravenous infusion on day 1 and oxaliplatin 100 mg/m2 as a 2-hour intravenous infusion on day 2 were administered every 2 weeks. Pharmacokinetics were evaluated in 11 patients by administering the 2 drugs in opposing sequences GEM-OXA (GEM day 1, OXA day 2) and OXA-GEM (OXA day 1, GEM day 2). RESULTS: Of 30 patients evaluated, 9 had a partial response, 11 had disease stabilization, and 10 had disease progression. Median progression-free survival and overall survival were 5.5 and 9.5 months, respectively. The 1-year survival was 37% for all patients. This study revealed no significant pharmacokinetic interaction between the 2 drugs in the GEM-OXA or in the OXA-GEM sequence. CONCLUSIONS: The combination of GEM and OXA was well tolerated and showed a promising activity in patients with advanced pancreatic adenocarcinoma; no sequence-dependent pharmacokinetic interaction occurred when comparing the GEM-OXA versus the OXA-GEM sequence, with a 24-hour interval.
OBJECTIVES: This phase 2 study evaluated clinical efficacy, toxicity, and pharmacokinetics of combination gemcitabine (GEM) and oxaliplatin (OXA) in patients with advanced pancreatic adenocarcinoma. METHODS: Of 30 eligible patients, 20 had metastatic disease and 10 had nonmetastatic unresectable locally advanced disease. Gemcitabine 1000 mg/m2 as a 10 mg/m2/min intravenous infusion on day 1 and oxaliplatin 100 mg/m2 as a 2-hour intravenous infusion on day 2 were administered every 2 weeks. Pharmacokinetics were evaluated in 11 patients by administering the 2 drugs in opposing sequences GEM-OXA (GEM day 1, OXA day 2) and OXA-GEM (OXA day 1, GEM day 2). RESULTS: Of 30 patients evaluated, 9 had a partial response, 11 had disease stabilization, and 10 had disease progression. Median progression-free survival and overall survival were 5.5 and 9.5 months, respectively. The 1-year survival was 37% for all patients. This study revealed no significant pharmacokinetic interaction between the 2 drugs in the GEM-OXA or in the OXA-GEM sequence. CONCLUSIONS: The combination of GEM and OXA was well tolerated and showed a promising activity in patients with advanced pancreatic adenocarcinoma; no sequence-dependent pharmacokinetic interaction occurred when comparing the GEM-OXA versus the OXA-GEM sequence, with a 24-hour interval.
Authors: Anteneh A Tesfaye; Hongkun Wang; Marion L Hartley; Aiwu Ruth He; Louis Weiner; Nina Gabelia; Lana Kapanadze; Muhammad Shezad; Jonathan R Brody; John L Marshall; Michael J Pishvaian Journal: J Pancreat Cancer Date: 2019-05-02