Background/Aims: The efficacy of gemcitabine (GEM) on unresectable pancreatic cancer has been reported. However, in elderly patients, severe toxicities are frequently observed. In this study we aimed to assess the efficacy of low-dose GEM on unresectable pancreatic cancer in elderly patients. Methods: We reviewed 68 elderly patients (6 65 years) with unresectable pancreatic cancer. Thirty-six patients were treated with low-dose GEM (600-800 mg/m(2); GEM group), and the other 32 received best supportive care (BSC group). Results: Median survival was 7.6 and 2.3 months in the GEM and BSC groups, respectively. In the GEM group, the median survival period was longer in 24 patients showing partial response or stable disease than in 12 patients showing progressive disease (11.4 vs. 5.3 months). Furthermore, the patients showing progressive disease had better 6-month survival than patients in the BSC group. Thirteen patients (36%) developed severe toxicities (grade 3 or 4). Low-dose GEM, stage of disease and performance status were associated with the prognosis. Conclusions: Low-dose GEM may improve the prognosis of elderly patients with un-resectable pancreatic cancer. Furthermore, frequencies of severe toxicity seem lower in patients treated with low-dose GEM compared with previous reports. Copyright (C) 2011 S. Karger AG, Basel