"This is 'real world' data showing 1-year survival of about 30%, which is comparable to that of single agent chemotherapy in the recurrent setting," said Mikael von Euler, MD, PhD, AstraZeneca, Alderley Park, Macclesfield, United Kingdom.

Previously, all data on survival rates for patients treated with gefitinib (Iressa TM, zd1839) was based on clinical trials with typically about 200 patients, said Dr. Euler, who presented the results here September 6^th.

The compassionate use program, the largest ever in the United States, followed 9,501 patients for a minimum of 1 year and treated 21,064 patients with at least 1 dose. Patients were in stage III or IV of the disease and had failed or were intolerant to chemotherapy.

Treatment in the non-randomised, open-label program was measured from therapy start to the patient's last re-supply for ongoing patients or to last dose for those who withdrew. Patients received 250 mg daily. Notably, 23.1% of patients were older than 75 years and 71.8% were in stage IV of the disease.

The 1-year survival rate for these advanced non-small cell lung cancer patients was 29.9%, with a narrow 95% confidence interval of 28.8 to 31.1%.

Third- or forth-line treatments for the disease typically have about a 5% 1-year survival rate whereas first- or second-line chemotherapy treatment yields a rate of about 35%, Dr. Euler said. Gefitinib thus represents a large improvement for patients who cannot tolerate chemotherapy or have a refractory condition, he said.

"One-year survival was the same as you would expect in patients who have not been treated [previously with chemotherapy]," Dr. Euler said.

Side effects were mild compared to those generally seen with chemotherapy, according to Dr. Euler. Drug related serious adverse events occurred in 2.3% of patients, 0.3% had a drug-related death, and 1.1% discontinued therapy. The incidence of interstitial lung disease from all causes was 0.3%; one third of cases were fatal.

Gefitinib is an orally active compound that appears to prevent lung cancer cells from growing and multiplying. It is an epidermal growth factor receptor tyrosine kinase inhibitor used for patients with stage III or IV non-small cell lung cancer.


[Presentation title: "Compassionate-Use Gefitinib in Non–Small Cell Lung Cancer (NSCLC): Results From a US Expanded Access Program (EAP)." Abstract 1524]

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