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Survival Rate of Patients Receiving Gefitinib Through Compassionate Use Program Reported To Be 29 Percent

NEW ORLEANS, June 6 /PRNewswire-FirstCall/ -- Final data from more than 21,000 non-small-cell lung cancer (NSCLC) patients who received the oral cancer drug IRESSA® (gefitinib) through AstraZeneca's pre-approval expanded access program (EAP) in the United States were presented today at the American Society of Clinical Oncology (ASCO) meeting. The one-year survival rate in patients treated with IRESSA on a compassionate basis was reported as 29.9%. This data set represents the largest reporting to date of clinical use of an agent in the epidermal growth factor receptor (EGFR) class.

The IRESSA EAP was initiated to allow access to the drug while it was pending U.S. Food and Drug Administration (FDA) approval. The program ran from August 2000 to July 2003 in the United States and enrolled 23,383 advanced (stage III/IV) non-small-cell lung cancer patients who had exhausted all approved treatment options or were unable to tolerate chemotherapy.

"Because the EAP enabled the use of IRESSA outside of a formal clinical trial setting, it provides a unique look at patient impact in a true clinical setting," said Judith Ochs M.D., Senior Medical Director, AstraZeneca LP, lead author of the study.

The data presented followed 21,064 patients who received greater than or equal to 1 dose of IRESSA. Patient demographics included 9,979 women and 11,040 men. Median age was 67 years and 72.7% of patients had stage IV disease. Median survival was 5.3 months (95% CI, 5.1 - 5.5 mo) and 1-year survival was 29.9% (95% CI, 28.8 - 31.1). Duration of therapy and survival were measured from the start of initial therapy to the last resupply date for ongoing patients or the date of last dose for withdrawn patients. For surviving patients who withdrew, periodic follow-up data were not collected, and patients were censored for survival at withdrawal until death was reported.

In the EAP 2.3% of patients reported a serious treatment-related adverse (AE) event; 1.1% discontinued therapy due to a serious drug-related AE, and 0.3% had an investigator-assessed, drug-related death.

About IRESSA

IRESSA is approved in the United States for use as monotherapy for the treatment of patients with locally advanced or metastatic NSCLC after failure of both platinum-based and docetaxel chemotherapies. The effectiveness of IRESSA is based on objective response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival. Results from two large (N = 2,130), controlled, randomized trials in first-line treatment of NSCLC (INTACT 1 & 2) showed no benefit from adding IRESSA to a doublet, platinum-based chemotherapy. Therefore, IRESSA is not indicated for use in this setting.

The mechanism of the clinical antitumor action of IRESSA is not fully characterized. IRESSA inhibits the intracellular phosphorylation of several tyrosine kinases associated with transmembrane cell surface receptors, including the tyrosine kinases associated with the epidermal growth factor receptor (EGFR-TK). No clinical studies have been performed that demonstrate a correlation between EGFR expression and response to IRESSA.

The most frequent drug-related adverse events associated with IRESSA were diarrhea (48%) sometimes associated with dehydration, rash (43%), acne (25%), dry skin (13%), nausea (13%), and vomiting (12%). These events generally occurred within the first month of therapy and usually were mild to moderate. Two percent of patients stopped taking IRESSA due to an adverse drug reaction. Infrequent cases (about 1%) of interstitial lung disease (ILD-described as interstitial pneumonia, pneumonitis, and alveolitis) have been observed in patients receiving IRESSA. Approximately 1/3 of the ILD cases were fatal. When ILD occurred, it was often accompanied by acute onset of breathing difficulty with cough or low grade fever requiring hospitalization. The reported incidences of ILD in the 23,000 patient US expanded access program was about 0.3%. In Japanese postmarketing experience the reported rate of ILD was about 2%. In the phase III controlled studies in combination with chemotherapy, there were similar rates of ILD (about 1%) reported in both the placebo and IRESSA arms of the study. IRESSA may cause fetal harm if administered to a pregnant woman. Asymptomatic increases in liver enzymes and eye irritation have also been observed in patients receiving IRESSA. Increases in bleeding events have been observed in cancer patients taking warfarin and IRESSA.

Physicians and patients can obtain additional information about IRESSA by calling the AstraZeneca Cancer Support Network at 1-866-99-AZCSN (1-866-992-9276).

Source: AstraZeneca

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