Gemcitabine plus sorafenib in patients with advanced pancreatic cancer: a phase II trial of the University of Chicago Phase II Consortium |
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| Authors: | Hedy Lee Kindler Kristen Wroblewski James A Wallace Michael J Hall Gershon Locker Sreenivasa Nattam Edem Agamah Walter M Stadler Everett E Vokes |
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| Institution: | (1) Department of Medicine, Section of Hematology/Oncology, University of Chicago, 5841 South Maryland Avenue, MC 2115, Chicago, IL 60637, USA;(2) Department of Health Studies, University of Chicago, Chicago, IL, USA;(3) North Shore University Health System, Evanston, IL, USA;(4) Fort Wayne Medical Oncology, Ft. Wayne, IN, USA;(5) Central Illinois Hematology/Oncology, Springfield, IL, USA |
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| Abstract: | Background Sorafenib, an inhibitor of B-raf, VEGFR2, and PDGFR-β, has activity against pancreatic cancer in preclinical models. In a
phase I trial of gemcitabine plus sorafenib, 57% of pancreatic cancer patients achieved stable disease. Patients and methods We conducted a multi-center phase II trial of sorafenib plus gemcitabine in chemo-na?ve patients with histologically-confirmed,
advanced pancreatic cancer. Patients received sorafenib 400 mg twice daily and gemcitabine 1,000 mg/m2 on days 1, 8 and 15 of a 28 day cycle. Results Seventeen patients enrolled at 4 centers; 13 were evaluable for response. There were no objective responses; 18% had stable
disease. Median overall survival was 4.0 months (95% CI: 3.4, 5.9); median progression-free survival was 3.2 months (95% CI:
1.6, 3.6). Grade 3/4 toxicities included thrombosis in 18% of patients, dehydration or hand-foot syndrome in 12%, and hypertension
or gastrointestinal bleeding in 6%. Conclusion Gemcitabine plus sorafenib is inactive in advanced pancreatic cancer. |
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