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| |  Gefitinib Promising for Treatment of Non-Small-Cell Lung Cancer: Presented at ESMO By Janet Fricker STOCKHOLM, Sweden -- September 15, 2008 -- The targeted therapy gefitinib should be considered first-line in nonsmoking, chemotherapy-naïve Asian patients with advanced non-small-cell lung cancer (NSCLC), according to the results of the phase 3 study presented here at the 33rd European Society for Medical Oncology Congress (ESMO). The First Line IRESSA Versus Carboplatin/Paclitaxel in Asia (IPASS) study -- heralded as proof of principle for targeted chemotherapy in lung cancer -- demonstrated progression-free survival advantages for gefitinib over the standard-of-care therapy (combination carboplatin/paclitaxel). "This study will change the treatment paradigm for patients treated first line for advanced NSCLC in Asia," predicted Tony Mok, MD, Chinese University of Hong Kong, Hong Kong, China, presenting a late-breaking abstract here on September 15 at the Presidential Symposium. Dr. Mok added that there were also important implications for western patients. "For the first time, we have a new treatment option for first-line therapy in addition to chemotherapy." Gefitinib, an epidermal growth factor receptor (EGFR) inhibitor, targets a mutation in the EGFR tyrosine kinase domain responsible for activating anti-apoptotic pathways. Altogether, said Dr. Mok, around 60% of NSCLC patients in Asia have mutations in EGFR, compared to only around 15% of NSCLC patients in the West. In the IPASS study, 1,217 patients with advanced NSCLC (Stage IIIB/IV) who had never received chemotherapy, and who had either never smoked or were former "light smokers," were randomised to receive gefitinib 250 mg/day (n = 609) or a combination of carboplatin and paclitaxel, 200 mg/m2 (n = 608). The study was conducted in 7 Asian countries. Over 22 months of follow-up, results demonstrated that 453 (74.4%) patients in the gefitinib group experienced disease progression, compared to 497 (81.7%) patients in the combination arm (HR 0.74; 95% CI, 0.65-0.85; P < .0001). In a subanalysis, results were reworked according to individual EGFR mutation status. For EGFR-positive patients, the progression-free survival was significantly better in the gefitinib-treated group compared to those receiving the carboplatin/paclitaxel combination (HR = 0.48, P < .0001). For EGFR-negative patients, however, the chemotherapy arm did better (HR = 2.85, P < .0001). Additional results demonstrate that quality-of-life scores, as documented by the patient, were significantly higher in the gefitinib group than in the carboplatin/paclitaxel combination group (P = .0148). "Since so many Asian patients with NSCLC have the mutation, I believe we'll be able to use clinical criteria to select those who will be suitable for gefitinib treatment. But for western patients, where mutations are rarer, mutation analysis will be needed," said Dr. Mok, adding that he hoped new technology would soon make mutation analyses quicker and more convenient for the patient. [Presentation title: Phase III, Randomised, Open-Label, First-Line Study of Gefitinib (G) vs Carboplatin/Paclitaxel (C/P) in Clinically Selected Patients (PTS) With Advanced Non-Small-Cell Lung Cancer (NSCLC) (IPASS). Abstract LBA2]
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