Gemcitabine, oxaliplatin, and capecitabine (GEMOXEL) compared with gemcitabine alone in metastatic pancreatic cancer: a randomized phase II study
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Single-agent gemcitabine (GEM) has been considered for many years as the standard first-line treatment for advanced pancreatic cancer. However, recently, several studies reported encouraging activity and good tolerability for some combination regimens. Considering the apparently non-overlapping toxicity and the proved individual efficacy of GEM, oxaliplatin (l-OHP), and capecitabine (CAP), this randomized phase II study compared the activity and safety of the combination GEM, l-OHP, and CAP (GEMOXEL) versus GEM alone, in patients with metastatic pancreatic cancer.
Materials and methods
The treatment in GEMOXEL arm consisted of GEM 1,000 mg/m2 as a 30-min intravenous infusion on days 1, 8, 15, 22, l-OHP 100 mg/m2 i.v. on day 2, and CAP 1,500 mg/m2/day in two divided doses on days 1–14, every 21 days (one cycle). In both treatment groups, GEM was administered weekly for seven consecutive weeks followed by 1-week rest for the first 8 weeks, and thereafter, GEM was continued on days 1, 8, 15, every 28 days. Chemotherapy was administered until disease progression or unacceptable toxicity.
Sixty-seven patients were enrolled in the study. Thirty-four were randomly assigned to GEMOXEL and 33 to GEM. At 4 months, disease control rate was 79.4 % with GEMOXEL versus 45.4 % with GEM (p = 0.004). The median progression-free survival was 6.8 months (95 % CI 5.3–7.3 months) in GEMOXEL arm and 3.7 months (95 % CI 2.9–4.7 months) in GEM arm (p < 0.001). The median OS was 11.9 months (95 % CI 10.6–12.9 months) in GEMOXEL arm and 7.1 months (95 % CI 5.5–9.1 months) in GEM arm (p < 0.001). Hematologic and non-hematologic toxicity was more severe with combination chemotherapy, yet still tolerable. No grade 4 adverse events were observed with either regimen.
GEMOXEL regimen seemed to be safe and more efficient than the standard therapy with GEM alone in the treatment of metastatic pancreatic cancer.
KeywordsCapecitabine Cisplatin Gemcitabine Irinotecan Oxaliplatin Pancreatic cancer
The authors wish to thank all the members of the local Oncology Group on Gastrointestinal Tumors and the following oncologists and surgeons who substantially contributed to recruit eligible patients and made this study possible: Dr. Franco Papi, Dr Vinno Savelli, General Surgery, University of Siena; Dr. Carmine Andrea Calvanese, Medical Oncology, Salerno; Dr. G. Giusti, USL 10, Pisa, Italy; Dr. G. Vegni, Volterra Hospital; Dr.ssa T. Cerri Vestri, USL Arezzo.
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