EFFICACY AND FEASIBILITY OF A FIXED-DOSE RATE INFUSION OF LOW-DOSE GEMCITABINE IN PANCREATIC CANCER

Gemcitabine (GEM) has been reported to be an active agent in pancreatic cancer. Single-agent gemcitabine is currently the chemotherapy standard, although response rate being modest. Therefore, studies over the past few years have focused on gemcitabine-based combination chemotherapy and recent applications have included the use of a fixed-dose rate regimen. The purpose of this study is to evaluate the feasibility and efficacy of a new regimen, a fix-dose rate infusion of low-dose GEM (FRI regimen), as compared with a standard infusion (SI regimen) in patients with pancreatic cancer. 27 patients were enrolled (12 patients were resectable and 15 patients were unresectable). This FRI regimen consisted of gemcitabine 300 mg/m2 i.v. 30 minutes once weekly (10 mg/m2/min). Among unresectable patients, partial response was observed each in one patient, while stable disease was seen in four and five patients (FRI versus SI), respectively. A CBR was achieved in three versus two patients. As side effects, grade 3 toxicities were not observed in patients treated with the FRI regimen. The median survival time was 10 months versus 8 months, and this survival difference is not statistical significant. In the adjuvant setting with GEM, 5 of 7 patients treated with the SI regimen discontinued the treatment within 3 cycles because of severe grade 3 or 4 toxicities in spite of dose reduction, while all patients with FRI regimen achieved the entire treatment. The median survival time and disease-free survival time were no significant difference between two groups. In conclusion, the FRI regimen is well tolerated and offers good palliation, as well as the SI regimen, in patients with locally advanced pancreatic cancer. Furthermore, in the adjuvant setting, the FRI regimen resulted in better clinical benefit on quality of life and fewer side effects than the SI regimen.