Objective: The purpose of the retrospective analysis is to elucidate the treatment efficacy and toxicity as well as to identify prognostic factors in Japanese patients with advanced pancreatic cancer treated with gemcitabine.
Methods: Two hundred and sixty-four patients with pathologically confirmed locally advanced or metastatic pancreatic cancer, who had received gemcitabine monotherapy as first-line chemotherapy for pancreatic cancer, were analyzed. A dose of 1000 mg/m(2) gemcitabine was administered intravenously for 30 min on Days 1, 8 and 15 of a 28-day cycle.
Results: One patient achieved a complete response (0.3%) and 27 patients showed a partial response (10.2%), with an overall response rate of 10.6% (95% confidence interval: 6.9-14.3%). The main grade 3/4 toxicities were neutropenia in 94 patients (35.6%) and leukocytopenia in 52 patients (19.7%). The median survival time, 1-year survival proportion and median progression-free survival time were 6.8 months, 21.6% and 3.7 months, respectively. A multivariate analysis using the Cox proportional hazards model demonstrated that a Karnofsky performance status > or = 90 (P = 0.01), Stage III (P = 0.01), serum carbohydrate antigen 19-9 level <10,000 U/ml (P = 0.02), serum hemoglobin level > or = 10 g/dl (P = 0.01) and serum C-reactive protein level <5.0 mg/dl (P < 0.01) were the independent favorable prognostic factors.
Conclusions: The treatment efficacy, toxicity and prognostic factors of single-agent gemcitabine in Japanese patients with advanced pancreatic cancer are comparable to those that have been reported in Western patients. These results may be useful as reference data in determining treatments strategies and planning for further clinical trials in Japanese patients with advanced pancreatic cancer.