Gemcitabine monotherapy in patients with locally advanced or metastatic pancreatic cancer: a prospective observational study.

Pancreatic cancer has one of the worst prognosis of any malignant disease. Systemic therapy is often administered because the disease is usually detected at advanced stages. Gemcitabine (Gemzar trade mark, Eli Lilly & Co.) has proven activity in the treatment of pancreatic cancer. Gemcitabine 1000 mg/m(2) was given on days 1, 8 and 15, every 4 weeks. A total of 100 chemonaive patients with locally advanced or metastatic pancreatic cancer were enrolled; 32 and 68% had stage III and IV disease, respectively. The average number of administered cycles was 3.5 (range: 1 - 12). The overall response rate was 13%, with 13 partial responders. The median time to progression was 13.5 weeks (range: 3 - 56; 95% CI = 12 - 14). The median survival was 32 weeks (range: 4 - 104; 95% CI = 27 - 36). Clinical benefit response was acheived for 26 patients (26%). Grade 3/4 haematological toxicities occurred infrequently (anaemia: 5%; neutropenia: 8% and thrombocytopenia: 3% of patients). Grade 3/4 non-haematological toxicities were not observed. There were no treatment-related deaths. Gemcitabine treatment of patients with locally advanced or metastatic pancreatic cancer is effective and well-tolerated.