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Second-line therapy in refractory pancreatic cancer. results of a phase II study

Item Type:Article
Title:Second-line therapy in refractory pancreatic cancer. results of a phase II study
Creators Name:Pelzer, U. and Stieler, J. and Roll, L. and Hilbig, A. and Doerken, B. and Riess, H. and Oettle, H.
Abstract:BACKGROUND: This phase II trial investigated the efficacy and safety of oxaliplatin (O), 5-fluorouracil (5-FU), and folinic acid (FA) (OFF) as second-line treatment for patients with metastatic pancreatic adenocarcinoma after failure of first-line gemcitabine treatment. PATIENTS AND METHODS: 37 patients with confirmed progressive disease on gemcitabine therapy were treated with OFF (O 85 mg/m(2) days 8, 22; FA 500 mg/m(2), followed by 5-FU 2,600 mg/m(2) days 1, 8, 15, 22) every 6 weeks. Patients were treated on an outpatient basis and remained on treatment until disease progression. RESULTS: All patients were assessable for toxicity and effectiveness. We observed moderate hematotoxicity, the most common non-hematologic toxicity was neurotoxicity. A total of 12 patients had grade 3 nonhematologic toxicities: nausea and vomiting (4 patients), reversible neurotoxicity (5 patients), and diarrhea (3 patients). No grade 4 toxicities were observed. Median time to progression was 12 (1-125) weeks. Survival in second line was 22 (4-326+) weeks. Overall disease control rate was 49% (complete remission = 3%; partial remission = 3%; stable disease > 12 weeks = 43%). CONCLUSIONS: This regimen is feasible and active with an acceptable toxicity profile; it can be safely administered in an outpatient setting. There is an urgent need for further investigation in phase III trials.
Keywords:Pancreatic Cancer, Salvage Therapy, Oxaliplatin, Infusional 5-FU
Page Range:99-102
Date:March 2009
Official Publication:https://doi.org/10.1159/000197769
PubMed:View item in PubMed

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