Medline ® Abstract for Reference 154
Second-line therapy in refractory pancreatic cancer. results of a phase II study.
Pelzer U, Stieler J, Roll L, Hilbig A, Dörken B, Riess H, Oettle H
Onkologie. 2009;32(3):99. Epub 2009 Feb 18.
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 diseasecontrol 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.
Universitatsmedizin Berlin, CharitéCentrum fur Tumormedizin, Medizinische Klinik m.S. Hamatologie/Onkologie, Berlin, Germany. email@example.com