A prospective randomized trial of gemcitabine alone or gemcitabine + cisplatin in the treatment of metastatic pancreatic cancer

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Abstract
4144 Background: To determine the efficacy and toxicity of gemcitabine alone (GEM) versus GEM + cisplatin (G + C) in the treatment of metastatic pancreatic cancer. Methods: From Jan-98 to Jun-02, 46 patients with metastatic pancreatic cancer were studied. Twenty-five patients were randomized to receive GEM (1000 mg/m2/week × 3 every 4 weeks), and 21 patients to G + C (GEM 1000 mg/m2/week and cisplatin 25 mg/m2/week × 3 every 4 weeks). The primary endpoint was patients' survival. Results: The planned accrual was 24 patients per arm. The reported accrual was 25 patients in GEM group and 21 in G + C group. The median duration of follow-up was 5.3 months. Sex, age, pre-treatment serum biochemistries, tumor size and location, and performance status were similar between both groups. Gemcitabine dose intensity was similar between GEM and G + C (684 ± 32 vs 617 ± 31 mg/m2/wk). Cisplatin dose intensity was 15.1 ± 0.9 mg/m2/wk × 9.9 ± 1.8 weeks. Median survival and median time to progression (TTP) were 4.6 months and 2.8 months for GEM and 5.6 months and 2.8 months for G + C patients (p= 0.75 and p= 0.9). Clinical benefit (including pain control, performance status, and body weight gain) was 36% for GEM and 29 % for G + C (p> 0.05). Quality-adjusted-life-months survival were 5.6 ± 0.3 months for GEM and 3.8 ± 0.2 months for G + C patients (p< 0.001). Response rates were 12% (3 PR) for GEM and 10% (2 PR) for G + C patients (p> 0.05). Grade 3–4 neutropenia (8% vs 19%), anemia (8% vs 10%) or hospitalization days per month of survival (6.8 ± 2.2 vs 6.2 ± 1.6 days) was not significantly different between GEM and G + C patients, but G + C had higher rate of thrombocytopenia than GEM patients (24% vs 4%, p = 0.012). Conclusions: GEM and G + C had comparable and modest response rates for metastatic pancreatic cancer, but GEM produced lesser toxicities than G + C. No significant financial relationships to disclose.

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