Gemcitabine and cisplatin in the treatment of advanced or metastatic pancreatic cancer

Background This phase II study was initiated to determine the efficacy and safety of gemcitabine plus cisplatin in patients with pancreatic cancer. Patients and methods Gemcitabine 1000 mg/m2 was given on days 1, 8, and 15 of a 28-day schedule, and cisplatin 50 mg/m2 on days 1 and 15 to chemonaive patients with locally advanced or metastatic pancreatic cancer. Results Of the 41 patients enrolled (median age 57, and 61% male), median Karnofsky performance status was 80%. Patients received a median of 4.2 cycles (range 1–11). In 35 evaluable patients, one complete response (CR) and three partial responses (PR) were observed, for an overall response rate of 11% (95% confidence interval (95% CI): 3.2%–26.7%). Stable disease (SD) >3 months occurred in 20 (57%) patients; 6 survived ≥ 1 year. Median time to progressive disease was 4.3 months (95% CI: 3.0–5.7 months). For all patients, median survival was 8.2 months (95% CI: 6.1–10.6 months) with a one-year survival rate of 27%. Therapy was well tolerated. Grade 3–4 neutropenia (no grade 3–4 infection), thrombocytopenia (no bleeding), nausea/vomiting, and alopecia were reported in 29%, 13%, and 2.6% of patients, respectively. Conclusions The combination of gemcitabine and cisplatin is a moderately active treatment for patients with locally advanced and metastatic pancreatic cancer without compromising tolerability.