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Pancreas Cancer News and Archives | |
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Combination Therapy With Gemzar and Alimta Shows Activity In Treatment of Advanced Pancreatic Cancer INDIANAPOLIS, Indiana, May 18, 2002
In a Phase II study unveiled today at the annual meeting of the American Society of Clinical Oncology (ASCO), the Gemzar-Alimta combination had a one year survival rate of 32%, which has prompted a Phase III study comparing Gemzar-Alimta to Gemzar alone. Gemzar is the first and only drug to date to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with pancreatic cancer. Alimta, a multitargeted antifolate, is an investigational anti-cancer agent. Both products are registered trademarks of Eli Lilly and Company, which sponsored the study presented at ASCO. "The results of this Phase II study are potentially exciting," said Hedy Lee Kindler, MD, the study's principal investigator and Assistant Professor of Medicine, University of Chicago. "However, this was a non-randomized study, meaning all patients received the combination of Gemzar and Alimta. The proof of effectiveness will come in a Phase III study. It's only through large, well-designed randomized studies in which one treatment option is directly compared to another that we get treatment-changing answers." The study involved 42 patients in the U.S. with previously untreated advanced pancreatic cancer. All patients in this multi-center, single-arm study received repeated 21-day cycles of Gemzar 1250 mg/m2 on days 1 and 8, and Alimta 500 mg/m2 for 10 minutes on day 8. Both agents were administered intravenously for a total of 213 treatment cycles. The study's primary endpoint was objective response rate, medical parlance for significant tumor shrinkage. Secondary endpoints included clinical benefit response (which measures the amount of pain medication taken, level of pain experienced and the ability to perform usual activities); time to event efficacy (including survival and time to disease progression), and toxicity. The results were as follows: Objective Response Rate: 12% In this study, the combination of Gemzar and Alimta was associated with an acceptable toxicity profile. The most serious and common side effects were hematologic, or blood related, and included neutropenia (a decrease in infection-fighting white blood cells), thrombocytopenia (a decrease in the number of platelets), and anemia (a decrease in the number of oxygen-carrying red blood cells). Cases of Grade 3 and 4 febrile neutropenia were 7% and 5% respectively. Febrile neutropenia is neutropenia associated with fever and often requires hospitalization. "It has been my experience that most patients with pancreatic cancer really want to accomplish one main thing -- to live as long as they possibly can, but to do so with the best quality of life that can be achieved under the circumstances," said Dr. Kindler. "Based on these study findings, it appears that the combination of Alimta and Gemzar enables patients to meet both objectives." For the Phase III study, 520 patients will be enrolled from countries around the world, including the United States. This study should determine whether the addition of Alimta to Gemzar improves survival, response and quality of life in pancreatic cancer. For more information on this Lilly-sponsored study, call 1-877-CT Lilly (1-877-285-4559). "Pancreatic cancer is a terrible disease and Gemzar is the cornerstone treatment for it," said Alan Hatfield, MD, medical director of Lilly Oncology's U.S. affiliate. "However, we will not rest until the last patient has been helped. That is why we continue to do research in pancreatic cancer and why we are evaluating Gemzar-Alimta combination." Lilly, a leading innovation-driven corporation is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at www.Lilly.com. Alimta® (pemetrexed, Lilly) Gemzar® (gemcitabine hydrochloride, Lilly) -------------------------------------------------------------------------------- Press Release |
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