Compassionate use of Gemzar in advanced pancreatic cancer: a Belgian experience.
Gemzar is a nucleoside analog that has been shown to be superior to 5-fluorouracil for the treatment of advanced pancreatic cancer in terms of both clinical benefit and survival. This open label program enrolled 214 patients. Patients eligible for this program had advanced or metastatic pancreatic cancer, received up to one previous chemotherapy, a baseline Karnofsky performance status (KPS) of at least 50, measurable or evaluable disease, adequate organ function defined as: absolute leucocyte count > 3 x 10(9)/L, platelet count > 100 x 10(9)/L, hemoglobin > 9 gr/dL, total bilirubin < 2 x upper limit of normal (ULN), creatinine < 2 x ULN, ALT and AST levels < 5 x ULN and were at least 18 years. A 1000 mg/m2 of Gemzar was administered weekly up to 7 weeks followed by a week of rest, then once weekly for 3 weeks out of every 4 weeks. The median age at inclusion was 64 years, 52% of the patients were male, 27% were 70 year or older, 66% had stage IV disease, 66% had a KPS of 80 or higher and 34% had received no prior chemotherapy. The overall response rate is 7%. A time-to-first-serious-event analysis was performed since only a limited number of dates of death were available. The first serious event (FSE) was considered as the earliest of the following: increase by at least 2 of the pain score, deterioration of KPS of at least 20, documentation of progressive disease or death. The median time to FSE was 4 months, the free FSE rate at 1 year was 14%. We conclude that the results observed in this program confirm the established efficacy of Gemzar in pancreatic cancer.