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First Therapy to Improve Treatment in Ten Years
Toronto (May 13, 2005) - An international clinical trial led by researchers at Princess Margaret Hospital and the National Cancer Institute of Canada Clinical Trials Group has shown that adding erlotinib to the standard chemotherapy treatment increases one-year survival for patients with advanced pancreatic cancer. The standard chemotherapy treatment of gemcitabine offers patients a 17% chance of surviving the disease for one year. The addition of Tarceva (erlotinib) offers patients a 24% chance of surviving the disease for one year. The results were presented at the plenary session of the Annual Meeting of the American Society of Clinical Oncologists in Orlando, Florida on May 15, 2005.
With 569 patients from North America, Australia, Asia, Europe, Australia, and Israel, this is the first randomized trial in ten years to demonstrate any improvement over the standard treatment.
"This is a terrible disease that is difficult to treat and this study shows that we've been able to increase survival for some patients," said Dr. Malcolm Moore, the study's lead investigator, a medical oncologist and director of the New Drug Development Program at Princess Margaret Hospital, as well as Professor of Medicine and Pharmacology at University of Toronto. "Often, by the time patients are diagnosed with pancreatic cancer, the disease is very advanced and surgery usually isn't a helpful option."
Patients take the new treatment in the form of a pill once daily. The new treatment specifically targets the cancer, resulting in minor side effects such as rash, diarrhea, and sore mouth. Interestingly, the investigators found that patients who reacted with a rash also responded better to the treatment.
Also known commercially as Tarceva, erlotinib slows down tumour growth by interfering with a specific cellular pathway that promotes cell division. The drug interferes with the epidermal growth factor receptors (EGFR), which receive an ongoing signal for the cells to divide thus driving the cancer's growth. Erlotinib specifically targets EGFR to prevent the tumour from growing.
"Our study shows that this approach of targeted therapy works and it gives us hope that it will be effective in treating other cancers which also express EGFR," said Dr. Moore. "We anticipate that erlotinib and gemcitabine will become the new standard of treatment for advanced pancreatic cancer."
According to the American Cancer Society, an estimated 32,180 Americans will be diagnosed with pancreatic cancer in 2005, and an estimated 31,800 Americans will die of the disease. The Canadian Cancer Society estimates that 3,400 Canadians will develop pancreatic cancer, and 3,300 Canadians will die of pancreatic cancer in 2005.
The pancreas is a small organ near the stomach that plays a role in producing enzymes to digest food and in producing insulin to regulate blood sugar levels. Symptoms of pancreatic cancer include abdominal pain, jaundice, weight loss, nausea, constipation, and diarrhea.
In the United States, a company has filed an application with the U.S. Food and Drug Administration for erlotinib to be approved for use with pancreatic cancer. The drug is not yet available in Canada. The clinical trial was coordinated by the National Cancer Institute of Canada Clinical Trials Group with funding from the Canadian Cancer Society. This research was also supported by OSI Pharmaceuticals. In Canada, the drug is licenced by Roche.
Princess Margaret Hospital and its research arm, Ontario Cancer Institute, have achieved an international reputation as global leaders in the fight against cancer. Princess Margaret Hospital is a member of the University Health Network, which also includes Toronto General Hospital and Toronto Western Hospital. All three are teaching hospitals affiliated with the University of Toronto.
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