MILAN--12 Oct--PRNewswire-AsiaNet/ InfoQuest
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Mature data from the IPASS study, presented today at the 2010 ESMO congress, showed that overall survival (OS) was similar, with no significant difference, between IRESSA (an EGFR tyrosine kinase inhibitor (TKI)) and carboplatin/paclitaxel (doublet chemotherapy) in the overall population (HR=0.90, 95% CI 0.79-1.02, p=0.11, median OS 18.8 vs. 17.4 months). Neither was there a significant difference between treatment arms for OS in the subgroups defined by EGFR mutation status: EGFR mutation-positive patients (HR=1.00, 95% CI 0.76-1.33, median OS 21.6 vs. 21.9 months); EGFR mutation-negative patients (HR=1.18, 95% CI 0.86-1.63, median OS 11.2 vs. 12.7 months); and patients whose EGFR mutation status was unknown (HR=0.82, 95% CI 0.70-0.96, median OS 18.9 vs. 17.2 months).[1]
(Photo: http://www.newscom.com/cgi-bin/prnh/20101011/412970-a )
(Photo: http://www.newscom.com/cgi-bin/prnh/20101011/412970-b )
The mature IPASS OS data confirm that patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC) had better outcomes, regardless of which treatment arm they were in, compared to patients with EGFR mutation-negative disease. Median survival times were around 22 months for EGFR mutation-positive patients, but only 11-12 months for EGFR mutation-negative patients.[1] The majority of EGFR mutation-positive patients in IPASS received an EGFR-TKI at some point as 64% of those randomised to carboplatin/paclitaxel later received an EGFR-TKI as subsequent therapy.
"I believe that progression-free survival is a better endpoint than overall survival for evaluation of treatment effect in the first-line setting," said IPASS investigator, Professor James Yang from National Taiwan University Hospital. "However, the IPASS data show that EGFR mutation-positive patients have better survival outcomes than EGFR mutation-negative patients, regardless of whether they were randomised to IRESSA or chemotherapy. Lung cancer patients should be tested to determine their EGFR mutation status, as EGFR mutation-positive patients benefit from treatment with IRESSA through longer progression-free survival, improved control of their symptoms and better quality of life, compared with doublet chemotherapy. It's important to consider very carefully when choosing a first-line treatment for advanced NSCLC, as many patients in clinical practice will not receive further active treatment."
Analysis of the primary endpoint of IPASS in 2008 demonstrated that IRESSA was superior to carboplatin/paclitaxel in terms of progression-free survival (PFS) in the overall population (HR 0.74, 95% CI 0.65-0.85, p