Oct. 22, 2003 NEW YORK, October 22, 2003-- A new anti-cancer agent designed to block the signals responsible for telling cancer cells to grow has shown promising results for patients with advanced non-small cell lung cancer. The results of a double blind, randomized trial of the compound, gefinitib (Iressa), led by Dr. Mark Kris, chief of thoracic oncology at Memorial Sloan-Kettering Cancer Center, are published in the October 22 Journal of the American Medical Association. A subset of the data from this clinical trial formed the basis for approval of the drug by the Food and Drug Administration on May 5, 2003.
"This compound is the first new way to treat lung cancer in decades, and this is good news," said Dr. Kris, lead investigator of the multi-center trial. "It is what all people trying to fight cancer want; a pill that specifically attacks the cancer yet does little to adversely effect the person."
Gefinitib is a "designer" drug that targets and blocks an enzyme called tyrosine kinase, part of the epidermal growth factor receptor. Found on the cell surface, the epidermal growth factor receptor is over-expressed in many non-small cell lung cancers. When the epidermal growth factor response is activated, it signals tumor cells to proliferate and grow. When the signal is disrupted, the tumors regress and apoptosis or cell death occurs.
A double-blind, randomized phase II clinical trial of gefinitib was conducted at thirty academic and community oncology centers in the United States. Participating were 221 patients who had either stage IIIB or IV non-small cell lung cancer for which they had received at least two prior chemotherapy regimens. The drug, taken in pill form, was taken daily in doses of either 500 mg (administered as two 250 mg gefinitib tablets) or 250 mg (administered as one 250 mg gefinitib tablet and a matching placebo). Of the 221 patients enrolled, 216 received the randomized doses.
An improvement of their symptoms that included shortness of breath, cough, loss of appetite, tightness in the chest, and weight loss was seen in 43 percent of the patients receiving the 250 mg dose and 35 percent of patients receiving the 500 mg dose reported. This improvement was seen within three weeks for 73 percent of the patients who responded. Partial responses were observed radiographically in 12 per cent of the patients receiving the 250 mg dose and 9 percent of patients on the 500 mg dose. Symptoms improved in 96 percent of the patients with partial radiographic responses. The overall survival at one year was 25 percent. There was no significant difference between the 250 mg and 500 mg doses in rates of symptom improvement, radiographic tumor regression and projected 1-year survival.
For all patients, the drug was well tolerated with few toxic side effects. These consisted mainly of mild diarrhea and an acne-like skin rash and the effects were seen more frequently in patients receiving the 500 mg doses. All side effects were reversible when drug use was stopped. The Food and Drug Administration approved the 250 mg. dose of gefinitib for treatment of advanced non-small cell lung cancer.
"For patients with metastatic lung cancer who have no other options, lessening their symptoms without adding burdensome side effects is a very real benefit," said Dr. Kris. "It gives hope that with more research and improved targets, we will do even better."
This study was conducted by Memorial Sloan-Kettering; Cedars-Sinai Comprehensive Cancer Center; M.D. Anderson Cancer Center; Massachusetts General Cancer Center; UCLA Medical Center; University of Pittsburgh Cancer Institute; University of Wisconsin Hospital - Madison; University of Colorado Health Sciences Center; Hematology-Oncology Consultants, Inc. of Columbus, Ohio; Vanderbilt University; Loyola University Medical Center; and Northwestern University. The study was sponsored by AstraZeneca Pharmaceuticals, developer of the study drug.
Memorial Sloan-Kettering Cancer Center is the world's oldest and largest institution devoted to prevention, patient care, research and education in cancer. Our scientists and clinicians generate innovative approaches to better understand, diagnose and treat cancer. Our specialists are leaders in biomedical research and in translating the latest research to advance the standard of cancer care worldwide. For more information, go to http://www.mskcc.org.
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