Presentations at the 2nd European Lung Cancer included QoL data from the IPASS study.
The study compared first-line use of IRESSA vs. standard doublet chemotherapy (carboplatin/paclitaxel) in clinically selected advanced NSCLC patients . IPASS demonstrated superior progression-free survival for IRESSA versus carboplatin/paclitaxel in the subgroup of patients with EGFR mutation-positive disease.
Post hoc analyses of QoL by EGFR mutation status showed that, in the EGFR mutation-positive subgroup, significantly more patients had improved QoL (as measured by Function Assessment of Cancer Therapy “Lung (FACT-L)) with IRESSA compared with doublet chemotherapy (70% of patients treated with IRESSA had improved QoL (FACT-L) vs. 45% for those who received chemotherapy ; p<0.001). In addition to greater QoL improvement rates, significantly more patients had improvements in lung cancer symptoms (as measured by the Lung Cancer Subscale (LCS) of FACT-L) with IRESSA compared with doublet chemotherapy (76% vs. 54%; p<0.001). For patients who experienced QoL or symptom improvement with IRESSA, this was generally rapid” median time to improvement was 8 days for both QoL and lung cancer symptoms.
These significant benefits in QoL and symptom improvement in EGFR mutation-positive patients support the efficacy benefits of IRESSA in terms of progression-free survival and objective response rate in these patients. In contrast, QoL and symptom improvement rates were significantly greater with doublet chemotherapy than with IRESSA in patients with EGFR mutation-negative advanced NSCLC, reflecting the superior efficacy of chemotherapy in these patients.
The presenter of the data, Dr Sumitra Thongprasert from Chiang Mai Hospital, Thailand, stated, “The patient’s quality of life is an important consideration for any physician when selecting a treatment. These data have shown that there is an option for advanced NSCLC patients with EGFR mutation-positive disease, which has significant benefits in quality of life compared with standard doublet chemotherapy.”
Alison Armour, Medical Science Director for AstraZeneca, today said, “These results highlight the importance of testing patients to determine their EGFR mutation status. We have seen the improvements in progression-free survival which can be achieved by using IRESSA as first-line therapy in EGFR mutation-positive advanced NSCLC patients. These efficacy benefits are supported by significant improvements in QoL and lung cancer symptoms, thus making IRESSA an important treatment option in first-line EGFR mutation-positive disease.”
IRESSA was approved in July 2009 in Europe for the treatment of patients with EGFR mutation-positive advanced NSCLC. Outside Europe, a programme of regulatory submissions to extend existing labels to include use of IRESSA in first-line EGFR mutation-positive advanced NSCLC is ongoing.