American Cancer Society Responds to Iressa Study

American Cancer Society
Thursday, 29 April 2004

Study Has Significant Implications for Treatment, Future of Targeted Therapies

A study released early from the May 20, 2004 issue of the New England Journal of Medicine study suggests that a sub-group of patients diagnosed with non-small cell lung cancer are more responsive to treatment with gefitinib (trade name Iressa). Harmon Eyre, MD, the chief medical officer of the American Cancer Society offers the following response.

What it means for lung cancer:

"Lung cancer is the leading cause of cancer death in men and women in the United States. We know that many lung cancers have elevated EGFR expression, but only a few thus far have been shown to respond to Iressa. Now we know more about what will cause cancer cells to respond, so this is important. This study indicates potentially better outcomes for 10 to 15 percent of those diagnosed with non-small cell lung cancer, primarily non-smoking women, and while it may not have a huge impact in terms of sheer numbers, it is a major step forward. This will be very important for physicians considering giving Iressa to patients in the future. After resection, the patient's tissue can be stored so that the gene mutation profile can be assessed, and the potential for Iressa to be effective can be evaluated."

What it means for targeted therapies:

"This study has tremendous significance for the future of targeted therapies. It demonstrates that human genome sequencing can identify in cancers what genes are mutated or expressed inappropriately, and so enable consideration of very targeted therapies. We are just beginning to understand targeted therapies, and this study opens the door to better understanding of potential combination therapies. Since human cells have multiple pathways that control growth, blocking single pathways will probably not be effective in stopping solid tumor growth. So it's likely we'll have to use combination therapies in treating solid tumors. To that end, the identification of drugs like Iressa, which are effective as single agents, can improve our ability to treat using combination therapy."

Other thoughts:

"There is still a lot to understand. This was a very small trial, and we look forward to seeing the results repeated in additional, larger trials. In the past, FDA approvals have been based on tumor response or survival, which are somewhat late endpoints. Demonstration of inhibition of growth pathways using molecular monitors could move us away from these traditional endpoints, and could be a better indicator of efficacy."

For more information, or to contact American Cancer Society, see their website at: www.cancer.org

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