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Title: Gefitinib Demonstrates Efficacy for Treatment of Bronchioloalveolar Lung Cancer: Presented at ASCO

"Gefitinib Demonstrates Efficacy for Treatment of Bronchioloalveolar Lung Cancer: Presented at ASCO"

By M. M. Pennell NEW ORLEANS, LA -- June 7, 2004 -- Gefitinib (Iressa) is an effective single-agent treatment for bronchioloalveolar lung cancer (BAC) in both treatment naïve and previously treated patients, according to results presented here June 7th at the American Society of Clinical Oncology 40th Annual Meeting. The agent works best in women, patients with no smoking history, and patients who develop an acne-like rash early in treatment, said lead investigator Howard J. West, MD, Medical Oncologist, Swedish Cancer Institute, Seattle, Washington. The median survival in women was 19 months versus 8 months in men and the response rate in women was 20%, while in men the response rate was 13%. "Survival among never smokers was especially good -- this group has not yet met median survival, while median survival among smokers was 10 months," he said. Rash was a particular strong marker for outcome -- the response rate was 21% among patients with rash and none of the patients with no rash responded, he said. Median survival was 13 months for patients with rash and 5 months for patients with no rash. This response is similar to that reported for other drugs that target the epidermal growth factor receptor (EGFR) pathway, he said. Dr. West, who discussed the study at a press conference here June 5th, said the Southwest Oncology Group (SWOG) initiated the study in response to anecdotal reports "about the efficacy of gefitinib in these patients." He noted that BAC "is an unusual cancer but [its incidence] has been rising steadily in recent years, especially among younger women, and there is no standard therapy and minimal response to any therapy." The researchers treated 102 treatment naïve patients and 36 who were previously treated. Median age of patients was 68 years. Patients received 500 mg of gefitinib until evidence of progression or drug toxicity. Dr. West said the 500 mg dose was selected because the trial was initiated in 2001 "before it was known that 250 mg was the maximum effective dose." Among the 69 treatment naïve patients with measurable disease, the response rate was 19%, and 6% had a complete response. Among the 22 previously treated patients with measurable disease the response rate was 9%. The median survival in previously untreated patients was 12 months and in previously treated patients median survival was 13 months, he said. The study was funded by AstraZeneca. [Presentation title: Gefitinib (ZD1839) Therapy for Advanced Bronchioloalveolar Lung Cancer (BAC): Southwest Oncology Group (SWOG) Study S0126. Abstract 7014]

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