zurück	IPASS
allgemeines	IRESSA Pan-Asia Study
Fragestellung
Ergebnis
Patienten
Vorbehandlung
Random	Erlotinib	Placebo
Anzahl
PFS			p < 0,0001
	Mok TS, Wu YL, Thongprasert S, et al. (2009) Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 361:947–957 Biomarker Analyses and Final Overall Survival Results From a Phase III, Randomized, Open-Label, First-Line Study of Gefitinib Versus Carboplatin/Paclitaxel in Clinically Selected Patients With Advanced Non–Small-Cell Lung Cancer in Asia (IPASS) Masahiro Fukuoka, Yi-Long Wu, Sumitra Thongprasert, Patrapim Sunpaweravong, Swan-Swan Leong, Virote Sriuranpong, Tsu-Yi Chao, Kazuhiko Nakagawa, Da-Tong Chu, Nagahiro Saijo, Emma L. Duffield, Yuri Rukazenkov, Georgina Speake, Haiyi Jiang, Alison A. Armour, Ka-Fai To, James Chih-Hsin Yang, and Tony S.K. Mok J Clin Oncol 29:2866-2874. © 2011 In all, 1,217 patients were randomly assigned. Biomarkers analyzed were EGFR mutation (amplification mutation refractory system; 437 patients evaluable), EGFR gene copy number (fluorescent in situ hybridization; 406 patients evaluable), and EGFR protein expression (immunohistochemistry; 365 patients evaluable). OS analysis was performed at 78% maturity. A Cox proportional hazards model was used to assess biomarker status by randomly assigned treatment interactions for progression-free survival (PFS) and OS. Results OS (954 deaths) was similar for gefitinib and carboplatin/paclitaxel with no significant difference between treatments overall (hazard ratio [HR], 0.90; 95% CI, 0.79 to 1.02; P .109) or in EGFR mutation–positive (HR, 1.00; 95% CI, 0.76 to 1.33; P .990) or EGFR mutation–negative (HR, 1.18; 95% CI, 0.86 to 1.63; P .309; treatment by EGFR mutation interaction P .480) subgroups. A high proportion (64.3%) of EGFR mutation–positive patients randomly assigned to carboplatin/paclitaxel received subsequent EGFR tyrosine kinase inhibitors. PFS was significantly longer with gefitinib for patients whose tumors had both high EGFR gene copy number and EGFR mutation (HR, 0.48; 95% CI, 0.34 to 0.67) but significantly shorter when high EGFR gene copy number was not accompanied by EGFR mutation (HR, 3.85; 95% CI, 2.09 to 7.09). Patients were eligible for inclusion in the study if they were 18 years of age or older, had histologically or cytologically confirmed stage IIIB or IV non–small-cell lung cancer with histologic features of adenocarcinoma (including bronchoalveolar carcinoma), were nonsmokers (defined as patients who had smoked <100 cigarettes in their lifetime) or former light smokers (those who had stopped smoking at least 15 years previously and had a total of =10 pack-years of smoking), and had had no previous chemotherapy or biologic or immunologic therapy. From March 2006 through October 2007, a total of 1217 patients from 87 centers in Hong Kong, elsewhere in China, Indonesia, Japan, Malaysia, the Philippines, Singapore, Taiwan, and Thailand were randomly assigned to a study group (Fig. 1). The two groups were well balanced with respect to demographic and baseline characteristics (Table 1). The mean duration of treatment was 6.4 months (median, 5.6; range, 0.1 to 22.8) for gefitinib and 3.4 months (median, 4.1; range, 0.7 to 5.8) for carboplatin–paclitaxel. The median number of treatment cycles in the carboplatin–paclitaxel group was six. At the cutoff date for collection of data (April 14, 2008), a total of 24.5% of the patients in the gefitinib group were continuing to receive the study treatment; all patients in the carboplatin– paclitaxel group had discontinued the drugs. The median follow-up period for the analysis of progression-free survival was 5.6 months. The median progression-free survival was 5.7 months in the gefitinib group and 5.8 months in the carboplatin– paclitaxel group, approximately coinciding with crossing of the Kaplan–Meier curves. The 12-month rates of progression-free survival were 24.9% with gefitinib and 6.7% with carboplatin– paclitaxel; a total of 950 patients had progression of disease.

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