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	New Treatment Combination Containing Irinotecan Shows Promising Survival Rate For Patients With Advanced Pancreatic Cancer -Treatment well tolerated, improved tumor response rates TAMPA, Florida, March 6, 2002 The combination of irinotecan (also known as CPT-11, CAMPTOSAR®) and gemcitabine shows promise in treating pancreatic cancer, a disease with a very high mortality rate compared to other forms of cancer. This combination treatment demonstrated a one-year survival rate of 27 percent, which is greater than that reported with gemcitabine alone in previous studies of patients with advanced pancreatic cancer (15 percent and 18 percent one-year survival rates, respectively). This new study finding has been published in the March 2002 issue of the Journal of Clinical Oncology. "The findings suggest that the addition of irinotecan to gemcitabine may enhance the clinical benefit of gemcitabine as well as increase survival in a disease in which eight out of ten patients die within a year of being diagnosed," said Caio Max S. Rocha Lima, MD, Assistant Professor of Medicine, University of South Florida, H. Lee Moffitt Cancer Center & Research Institute. "Irinotecan, the standard of care for the treatment of advanced colorectal cancer, is showing promise in this difficult tumor type and is offering hope to patients with this devastating disease." The Phase II study, consisting of 45 patients, evaluated the efficacy and safety of irinotecan combined with gemcitabine in patients with previously untreated unresectable or metastatic pancreatic cancer. Median survival in patients treated with combination therapy was 5.7 months [range, 0.4-19.4+ months]. Patients treated with both drugs also experienced a favorable tumor response rate (decreased tumor size by greater than or equal to 50 percent) than with conventional rates from single agent therapy. In addition, the combination regimen was well tolerated, with minimal severe toxicity. Pancreatic cancer is the fourth leading cause of cancer deaths in the United States. It is estimated that 30,000 new cases of pancreatic cancer will be diagnosed this year, resulting in an almost equal number of deaths. The nonspecific nature of symptoms often results in delayed detection where most patients are often diagnosed with advanced disease. Consequently, survival time after diagnosis is approximately 6 to 10 months for patients with locally advanced pancreatic cancer and 3 to 6 months for those with metastatic disease. Irinotecan is a chemotherapeutic agent used in the treatment of advanced colorectal cancer. The bolus chemotherapy regimen containing irinotecan (irinotecan+bolus 5-FU/LV, also known as the Saltz regimen), is recognized as the standard of care in treating advanced colorectal cancer. Two previous phase II studies have shown that irinotecan alone also demonstrated antitumor activity in pancreatic cancer. Gemcitabine is a chemotherapeutic agent with demonstrated activity in pancreatic cancer and is considered the standard of care for this disease. Studies have shown it demonstrates positive clinical and tumor response rates and improves median and 1-year survival. Participants of the multi-center, open-label, single-arm study received repeated 21-day cycles of gemcitabine 1000 mg/m2 for 30 minutes followed by irinotecan 100 mg/m2 for 90 minutes, both administered intravenously on days 1 and 8. The study's endpoints included objective tumor response rate, time to tumor progression (TTP, the time from baseline to first documented tumor progression or death), and survival. "The study findings are significant because patients with pancreatic cancer often are severely debilitated," said Dr. Rocha Lima. "We are encouraged by these data that show that the combination was safe, and demonstrated notable one-year survival. Based on these results, we have initiated a Phase III study which is now fully accrued and which will allow further evaluation of this combination therapy." Located on the campus of the University of South Florida, Moffitt Cancer Center is a world-renowned cancer treatment and research facility. Moffitt is the only National Cancer Institute designated Comprehensive Cancer Center in Florida. Its mission is to contribute to the prevention and cure of cancer.   Press Release SOURCE: H. Lee Moffitt Cancer Center & Research Institute
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