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M. D. Anderson One of Top Enrollers on Iressa Study

M. D. Anderson One of Top Enrollers on Iressa Study
Center's Early Clinical Work Vital to Drug Development
M. D. Anderson News Release 05/19/02

The University of Texas M. D. Anderson Cancer Center was one of the top participants in the national trial of an oral drug that shows promise in the treatment of non-small cell lung cancer.

In a presentation today (Sunday, May 19) at the annual meeting of the American Society of Clinical Oncology, researchers found the drug, Iressa, to significantly stabilize tumors in patients who had previously failed two or more chemotherapy regimens. Principal investigator Dr. Mark Kris of Memorial Sloan-Kettering Cancer Center presented the data.

M. D. Anderson enrolled 19 of the 216 patients, nearly 10 percent of the patients on the study presented today. Thirty institutions participated in the U.S. trial.

The Phase II trial compared the tumor response, disease-related symptom response (improvement for one or more months) and safety of daily doses of 250 mg to 500 mg of Iressa.

According to the study, almost 12 percent of patients on 250 mg of Iressa and almost nine percent of patients on 500 mg of the drug showed 50 percent or greater shrinkage of their tumors. Thirty one percent of patients on the trial had their disease stabilize while taking 250 mg, while 27 percent had stable disease on 500 mg a day. Median survival for both groups was approximately six months.

All 216 patients on the trial had locally advanced or metastatic non-small cell lung cancer and had received two or more prior chemotherapy regimens containing platinum and docetaxel. 

According to the study, side effects from Iressa included diarrhea and skin rash but were considered were mild and treatable. About 40 percent of patients reported disease-related symptoms improved and approximately one-third had an improved quality of life using the drug.

Dr. Roy Herbst, chief of the Section of Thoracic Oncology in the Department of Thoracic/Head and Neck Medical Oncology at M. D. Anderson and one of the lead investigators on the trial, said Iressa appears to be most beneficial in either shrinking or stabilizing advanced disease, offering relief from symptoms and improving quality of life. 

According to Dr. Herbst, the results of the trial were particularly impressive because patients had failed one or multiple previous therapies.

Dr. Herbst suggested, however, that ultimately this agent will be used as a front-line therapy in an attempt to arrest metastasis, or spread of the disease to other organ sites. He said it is the spread of the disease to other parts of the lung, the brain, bone and/or liver that makes non-small cell lung cancer so deadly. 
 
Iressa works by selectively blocking signaling pathways that are vital to cell growth and survival.  Specifically, the drug blocks the tyrosine kinase enzyme of EGFR, a growth factor associated with several cellular activities including cell proliferation, angiogenesis and cell death, explained Dr. Herbst. Because EGFR is present or increased in 60 to 70 percent of advanced non-small cell lung cancer cases, the drug is particularly effective, he continued.

"Iressa is a major step in the treatment of lung cancer," said Dr. Herbst. "We hope this is the beginning of a paradigm shift in the treatment of lung cancer that is taking advantage of advances in newly-identified molecular targets and growth mechanisms. Not only does the drug appear to be effective, but it is also less toxic than chemotherapy and offers patients a better quality of life.  Patients are living better with their lung cancer."

M. D. Anderson has played a significant role in the development of Iressa, said Dr. Herbst. The study announced at ASCO was based on earlier clinical work led by him and others at M. D. Anderson.

In addition to having one of the largest enrollments of patients on the Phase II trial, M. D. Anderson has been a leader in opening patient access to the drug.

"M. D. Anderson has been instrumental in bringing Iressa to patients with non-small cell lung cancer," said Dr. Herbst. "M. D. Anderson has more patients on this drug than anyone we know of in the country. We look forward to continuing research with this drug to see if it ultimately will affect a patient's survival."

Non-small cell lung cancer is one of two major types of lung cancer, with non-small cell lung cancer the more common of the two. Non-small cell lung cancer and small cell lung cancer are differentiated by biology and grow and spread in different ways. According to the National Cancer Institute, in patients with non-small cell lung cancer results of standard treatment are poor in all but most localized cancers. Some 170,000 people die each year from this form of lung cancer.

Iressa is a trademark of the AstraZeneca group of companies.

05/19/02


© 2014 The University of Texas MD Anderson Cancer Center