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Final Results For IRESSA(R) (gefitinib) Tablets Reported From
Compassionate Use Program in Non-Small-Cell Lung Cancer Patients
Data presented at the American Society of Clinical Oncology (ASCO) 40th Annual
Meeting
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(R) (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.
(Photo: http://www.newscom.com/cgi-bin/prnh/20030505/PHM039 )
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date of last dose for withdrawn patients.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).
AstraZeneca is a major international healthcare business engaged in the
research, development, manufacture and marketing of prescription
pharmaceuticals and the supply of healthcare services. It is one of the world's
leading pharmaceutical companies with healthcare sales of over $18.8 billion
and leading positions in sales of gastrointestinal, oncology, cardiovascular,
neuroscience and respiratory products. In the United States, AstraZeneca is an
$8.7 billion healthcare business with more than 11,000 employees. AstraZeneca
is listed in the Dow Jones Sustainability Index (Global and European) as well
as the FTSE4Good Index.
For more information about AstraZeneca, please visit:
http://www.astrazeneca-us.com/
Abstract numbers: 7060
IRESSA is a registered trademark of the AstraZeneca group of companies.
http://www.newscom.com/cgi-bin/prnh/20030505/PHM039
http://photoarchive.ap.org/
DATASOURCE: AstraZeneca
CONTACT: Mary Lynn Carver of AstraZeneca, +1-302-886-7859,
Web site: http://www.astrazeneca-us.com/
Company News On-Call: http://www.prnewswire.com/comp/985887.html