New IRESSA(R) (Gefitinib) Data Presented in Bronchioalveolar Lung Cancer

New IRESSA(R) (Gefitinib) Data Presented in Bronchioalveolar Lung
Cancer
Data from the largest study ever conducted of patients with bronchioalveolar
cancer reported 


NEW ORLEANS, June 5  /PRNewswire-FirstCall/ -- Data from the largest study ever
conducted of patients with bronchioalveolar cancer (BAC) was presented today at
the American Society of Clinical Oncology (ASCO) 40th Annual Meeting. Patients
in this study received the oral medication IRESSA (gefitinib).  BAC is a type
of non-small-cell lung cancer (NSCLC) that has distinctive clinical, pathologic
and radiographic characteristics.

(Photo:  http://www.newscom.com/cgi-bin/prnh/20030505/PHM039 )

"These results represent an important step forward in our efforts to better
understand the complexities of this unique subset of non-small-cell lung
cancer," said Dr. Howard West, lead investigator for the trial.

The study was conducted by the Southwestern Oncology Group (SWOG) and enrolled
138 patients (102 chemo-naïve, 36 previously treated) who received 500 mg of
IRESSA once daily until disease progression or drug-related toxicity.  Among 69
chemo-naive patients with measurable disease, the response rate (RR) was 19%,
with 6% of patients experiencing a complete response (CR). In 22 previously
treated patients with measurable disease, RR was 9% (0% CR). One-year survival
was reported as approximately 50% in each group.  Adverse events in the BAC
trial included acneiform rash, diarrhea and pulmonary toxicity.

Lung cancer is the leading cause of cancer deaths in the United States,
estimated to account for more than 160,000 deaths in 2004.(1)  NSCLC is the
most common form of lung cancer, accounting for 80 percent of all lung cancer
cases.  BAC is increasing in incidence, especially in younger non-smoking
women.

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 recommended dose of IRESSA in advanced NSCLC patients who have received
platinum and docetaxel is 250 mg daily.  Higher doses did not produce increased
efficacy and resulted in increased toxicity.  The response rates in the IDEAL 2
study were 13.6% (95% CI: 6.4-24.3%) at the recommended dose of 250 mg and
10.6% (95% CI: 6.0 - 16.8%) for the 250 mg and 500 mg groups combined.  In a
retrospective analysis, the response rates appeared to be highly variable in
sub-groups of the treated population (gender, smoking history, and histology),
varying from 4.6% to 29.4%.

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.

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-.com/

(1) American Cancer Society "Cancer Facts & Figures 2004" - 2004; 13

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, AstraZeneca, [phone],





Web site:  http://www.astrazeneca-us.com/



Company News On-Call:  http://www.prnewswire.com/comp/985887.html

Copyright