Tuesday, May 31, 2011
New findings published in the Journal of Clinical Oncology show that adding Tarceva (erlotinib) to gemcitabine chemotherapy improves survival by 22 percent in patients with advanced pancreatic cancer. (Reference: Moore MJ, Goldstein D, Hamm J, et al.: Erlotinib plus gemcitabine Compared with gemcitabine alone in Patients with advanced pancreatic cancer: A phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol doi: 10.1200/JCO.2006.07.9525.)
This increase in survival is impressive as pancreatic cancer is a particularly fatal form of cancer, responsible for over 80,000 deaths across Europe each year. Despite significant advances in the treatment of many other tumors, treatment options for pancreatic patients are extremely limited, and so far no therapy had demonstrated an improvement in survival over the last decade.
"This study is important because it demonstrates the benefit of a new approach for the treatment of this deadly disease," said Dr. Malcolm Moore, president of research and head of Hematology and Medical Oncology at Princess Margaret Hospital, University of Toronto. "This is the first study in ten years to demonstrate improved survival in pancreatic cancer, and as a physician I am delighted to have other treatment options for my patients."
The data in this study, conducted by the National Cancer Institute of Canada (National Cancer Institute of Canada - NCIC, according to its acronym in English) formed the basis for the recent approval of Tarceva in Europe for the treatment of patients with metastatic pancreatic cancer (in combination with chemotherapy), announced in January this year. The results showed a statistically significant increase in overall survival of patients with advanced pancreatic cancer receiving Tarceva plus gemcitabine, compared with patients who received gemcitabine alone, with an overall improvement of 22 percent in survival (p = 0.038) . A higher percentage of patients were alive at 12 months in the group treated with Tarceva plus gemcitabine, compared with those treated with chemotherapy alone (23% vs. 17%, p = 0.023). Progression-free survival also improved significantly for patients treated with Tarceva (p = 0.004).
Pancreatic cancer ranks sixth among the most frequent in Europe. In 2002 he was diagnosed more than 78,000 new cases of pancreatic cancer with a death rate of approximately 82,000 people per year. Pancreatic cancer is difficult to treat because it is often resistant to chemotherapy and radiotherapy, and tends to spread quickly to other parts of the body, leading to high mortality and short life expectancy. Most people who are diagnosed with pancreatic cancer have less than a year. This is the second type of cancer in which Tarceva has demonstrated a clear survival advantage, this makes Tarceva the first and only EGFR-targeted therapy (x) which has demonstrated a significant survival benefit in patients with pancreatic cancer, be added to gemcitabine, and in patients with lung cancer non-small cell (NSCLC, according to its acronym in English).
The international multicenter study, randomized, double-blind, placebo-controlled, phase III, was conducted by the Clinical Trials Group National Cancer Institute of Canada (National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) in Queen's University in cooperation with AGITG and researchers in 15 countries, and co-sponsored by OSI Pharmaceuticals. The study evaluated the drug Tarceva in doses of 100 mg or 150 mg per day in patients with metastatic pancreatic cancer or locally advanced. Patients received gemcitabine with Tarceva or gemcitabine plus placebo. A total of 569 randomized patients for the study, 285 patients received Tarceva plus gemcitabine and 284 patients placebo plus gemcitabine. The treatment was generally well tolerated in both arms. Most of the events effects associated with Tarceva plus gemcitabine in this study were mild to moderate and were consistent with those observed in previous clinical trials, including rash and diarrhea.
Tarceva is approved by the FDA since November 2005 for the treatment of metastatic pancreatic cancer, inoperable locally advanced or in combination with gemcitabine chemotherapy, and has been approved for the treatment of metastatic pancreatic cancer in the European Union since January 2007.
Tarceva has won European Union approval in September 2005 and in the United States since November 2004 for the treatment of cancer patients with non-small cell lung metastatic or locally advanced, after the failure of at least one previous chemotherapy treatment . Are also conducting trials of Tarceva in early for other solid tumors as part of ongoing research.
About the Study
The study evaluated the drug Tarceva in doses of 100 mg or 150 mg per day in patients with metastatic pancreatic cancer or locally advanced, and patients were randomized to receive gemcitabine plus Tarceva or gemcitabine plus placebo. Gemcitabine was administered at doses of 1,000 mg / m intravenously once a week. Tarceva plus placebo was administered orally at doses of 100 or 150 mg / day until disease progression or unmanageable toxicity. Approximately 75 percent of patients in the study had metastatic cancer and 25 percent had locally advanced disease. The study involved centers in the United States, Asia, Canada, Europe, Australia and South America. The study was conducted by the Clinical Trials Group National Cancer Institute of Canada based in the Queen's University in Ontario, in collaboration with OSI Pharmaceuticals.
About Tarceva
Tarceva (erlotinib) is a small molecule that targets the receptor pathway of human epidermal growth factor receptor (HER1). HER1, also known as EGFR, is a key component of this signaling pathway, which plays a role in the formation and growth of numerous cancers. Tarceva blocks tumor cell growth by inhibiting the tyrosine kinase activity of the HER1 signaling pathway inside the cell. Taken in the form of oral administration once daily, Tarceva is the only EGFR inhibitor to have demonstrated a survival benefit in lung cancer and pancreatic cancer. Currently the majority of patients with pancreatic and lung cancer are treated wholly with chemotherapy which can be very debilitating due to its toxic nature. Tarceva works differently to chemotherapy, specifically targeting tumor cells, and avoids the typical side effects of chemotherapy.
Tarceva is approved in the United States and the European Union for patients with lung cancer non-small cell (NSCLC) metastatic or locally advanced, after the failure of at least one prior chemotherapy. It is also approved in the U.S. as first-line treatment for patients with metastatic pancreatic cancer, inoperable locally advanced or in combination with gemcitabine chemotherapy, and in the EU for the treatment of metastatic pancreatic cancer.
Tarceva is currently being evaluated in a comprehensive clinical development program for a global alliance among OSI Pharmaceuticals, Genentech and Roche, which focuses on the early stages of NSCLC. Additionally, Tarceva is being studied in combination with Avastin in NSCLC and in a wide variety of other types of solid tumors.
Tarceva extends life of Patients with pancreatic cancer
Switzerland's Roche and Its U.S. partner OSI Pharmaceuticals say That New results published in the Journal of Clinical Oncology reveal That Tarceva to gemcitabine chemotherapy Adding Significantly Improves Survival in Patients with advanced pancreatic cancer.
Data from this study, Conducted by the National Cancer Institute of Canada, formed the basis of the Recent European Approval of Tarceva (erlotinib) for the Treatment of Patients with metastatic pancreatic cancer (in combination with chemotherapy) Announced in January. The results show to Statistically Significant Increase in Overall Survival in Patients with advanced pancreatic cancer Who Received Tarceva plus gemcitabine, Compared to Patients receiving gemcitabine alone overalls with an 22% improvement in survival.
A Higher Percentage of Patients Were Alive at 12 months in the group Treated with Tarceva plus gemcitabine, Compared to Those Treated with chemotherapy alone (23% v 17%), while progression-free survival WAS Also Significantly Improved for Patients Treated with the Roche / OSI drug.
The Swiss drugs major Said That this is Impressive Increase survival as pancreatic cancer is a fatal form of cancer Particularly responsible for over 80.000 Deaths Each year across Europe, and Despit Significant Advances in the Treatment of Many Other Tumours, "options for pancreatic Patients Are Extremely Until now limited and not Therapies Have Demonstrated an improvement in survival for the past decade. "
Approved también Tarceva to treat non-small cell lung cancer and is Currently Being Studied in combination with Avastin (bevacizumab) in That disease and in a wide Variety of Other Solid Tumour types.
No comments:
Post a Comment