Gefitinib Helpful in Non-Small Cell Lung Cancer

Laurie Barclay, MD

October 21, 2003

Oct. 21, 2003 — Gefitinib (Iressa) improves symptoms and induces radiographic regression of non-small cell lung cancer, according to the results of a randomized controlled study published in the Oct. 22/29 issue of The Journal of the American Medical Association. Based on this double-blind, phase II clinical trial conducted at 30 U.S. academic and community oncology centers, the Food and Drug Administration approved gefinitib, 250 mg, for the treatment of advanced non-small cell lung cancer on May 5, 2003.

"This compound is the first new way to treat lung cancer in decades, and this is good news," lead author Mark G. Kris, MD, from the Memorial Sloan-Kettering Cancer Center in New York City, says in a news release. "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 blocks tyrosine kinase, part of the epidermal growth factor receptor, which is overexpressed in many non-small cell lung cancers. Disruption of activation of the epidermal growth factor response leads to tumor regression and apoptosis.

Of 221 patients with either stage IIIB or IV non-small cell lung cancer for which they had received at least two prior chemotherapy regimens, 216 received randomized 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).

Within three weeks, 43% (95% confidence interval [CI], 33%-53%) of the 250-mg group and 35% (95% CI, 26%-45%) of the 500-mg group reported improvement in symptoms including dyspnea, cough, loss of appetite, chest tightness, and weight loss. Symptoms improved in 96% of patients with partial radiographic responses, which occurred in 12% (95% CI, 6%-20%) of patients receiving the 250-mg dose and in 9% (95% CI, 4%-16%) of patients receiving the 500-mg dose.

Overall one-year survival was 25%. Rates of symptom improvement, radiographic tumor regression, and projected one-year survival were similar in both groups. Although the drug was generally well tolerated with few adverse effects, all of which were reversible, mild diarrhea and acneiform rash were more frequent in the 500-mg dose group.

"For patients with metastatic lung cancer who have no other options, lessening their symptoms without adding burdensome side effects is a very real benefit," Dr. Kris says. "It gives hope that with more research and improved targets, we will do even better."

AstraZeneca Pharmaceuticals sponsored this study, employs four of its authors, and has financial arrangements with Dr. Kris and other authors. One of the other authors also reports financial arrangements with other pharmaceutical companies.

JAMA. 2003;290:2149-2158

Reviewed by Gary D. Vogin, MD

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