Phase II study of biweekly gemcitabine followed by oxaliplatin and simplified 48-h infusion of 5-fluorouracil/leucovorin (GOFL) in advanced pancreatic cancer |
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Authors: | Hui-Ju Ch’ang Chin-Lun Huang Hsiu-Po Wang Her-Shyong Shiah Ming-Chu Chang Chang-Ming Jan Jen-Shi Chen Yu-Wen Tien Tsann-Long Hwang Jaw-Town Lin Ann-Lii Cheng Jacqueline Whang-Peng Li-Tzong Chen |
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Institution: | Hui-Ju Ch’ang, Chin-Lun Huang, Hsiu-Po Wang, Her-Shyong Shiah, Ming-Chu Chang, Chang-Ming Jan, Jen-Shi Chen, Yu-Wen Tien, Tsann-Long Hwang, Jaw-Town Lin, Ann-Lii Cheng, Jacqueline Whang-Peng and Li-Tzong Chen |
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Abstract: | Purpose To evaluate the efficacy and safety profile of a triplet regimen consisting of gemcitabine, oxaliplatin, and infusional fluorouracil and leucovorin (LV) in advanced pancreatic carcinoma (APC). Patients and methods Chemotherapy-naïve patients with histo-/cytologically proven unresectable APC, and bi-dimensionally measurable diseases were eligible. Treatment consisted of fixed-dose rate (10 mg/m2/min) infusion of 800 mg/m2 gemcitabine followed by 2-h infusion of 85 mg/m2 oxaliplatin and then 48-h infusion of fluorouracil and LV (3,000 and 300 mg/m2, respectively) every 2 weeks (the GOFL regimen). The primary end-point was objective response rate. Results Forty-five patients were enrolled and received a median of seven 95% confidence interval (CI) 6.4–8.8] cycles of treatment. On intent-to-treat analysis, the overall response and disease-control rates were 33.3% (95% CI 21.4–48.0%) and 68.9% (95% CI 54.8–83.0%), respectively. Clinical benefit response was observed in 46.2% of initially symptomatic patients. The median time-to-tumor progression and overall survival were 5.1 (95% CI 4.0–6.3) months and 8.7 (95% CI, 6.1–11.3) months, respectively. Major grade 3–4 toxicities were neutropenia (28.9%, with 4.4% complicated with fever), peripheral sensory neuropathy (15.6%), nausea/vomiting (13.3%), and diarrhea (6.7%). Conclusions The triplet regimen is feasible and exhibits promising activity against APC, deserving further exploration. |
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Keywords: | Gemcitabine Oxaliplatin Fluorouracil Pancreatic cancer Phase II |
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