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Phase III, randomized, open-label, first-line study in Asia of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non-small-cell lung cancer: evaluation of patients recruited from mainland China

Authors


  • Presented in part in Mok et al. New England Journal of Medicine 2009; 361: 947–957, and at the American Society of Clinical Oncology Annual Meeting, May 29-June 2, 2009, Orlando. FL, USA.

  • Author disclosure information: Yi-Long Wu has received honoraria from AstraZeneca, Roche, Eli Lilly and Pfizer. Da-Tong Chu has received honoraria and consultancy fees from AstraZeneca. Li Zhang has received research funding from AstraZeneca. Tony Mok has received consultancy fees from AstraZeneca, Roche, Pfizer, Eli Lilly, Taiho, Merck-Serono and Eisai; honoraria from AstraZeneca, Roche, Pfizer, Eli Lilly, Taiho and Eisai and research funding from AstraZeneca. Haiyi Jiang and Emma Duffield are employees of AstraZeneca and hold stock in AstraZeneca. Masahiro Fukuoka has received honoraria from AstraZeneca, Chugai Pharma, Daiichi Sankyo, Ono Pharma, and Eisai. Baohui Han, Xuyi Liu, Caicun Zhou and Meilin Liao have no conflicts of interest to disclose.

Professor Yi-Long Wu MD, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, 106 Zhongshan Er Road, Guangzhou 510080, China. Email: syylwu@live.cn

Abstract

Aim:  In the IRESSA Pan-Asia Study (IPASS), 1217 patients in East Asia with pulmonary adenocarcinoma who were never-smokers or ex/light-smokers received first-line gefitinib (250 mg/day) or carboplatin/paclitaxel (area under the curve 5/6; 200 mg/m2). Efficacy analyses were pre-planned in patients in China.

Methods:  In China, 372 patients (30.6% of the overall group) were randomized. The primary end-point was progression-free survival (PFS). Secondary end-points were overall survival (OS), objective response rate (ORR), health-related quality of life (HRQoL), symptom improvement, safety and tolerability.

Results:  For patients in China, PFS did not significantly differ from the overall IPASS population (interaction test P= 0.427). PFS was numerically longer (hazard ratio [HR] 0.79; 95% CI 0.62–1.01; P= 0.065; median PFS 6.8 months for both treatments) and ORR significantly higher (ORR 44.6 vs 29.8%; odds ratio 1.88; 95% CI 1.22–2.89; P= 0.004) for gefitinib than carboplatin/paclitaxel. OS (mature data) was similar for both treatments (HR 0.92; 95% CI 0.73–1.17; P= 0.511; median OS gefitinib 18.1 months vs 18.3 months carboplatin/paclitaxel). HRQoL improvement rates favored gefitinib; symptom improvement rates were similar for both treatments. Gefitinib had a more favorable tolerability profile than carboplatin/paclitaxel. Efficacy by epidermal growth factor receptor biomarker status (exploratory analyses) was difficult to interpret due to low patient numbers with known biomarker status.

Conclusion:  For the Chinese subgroup of IPASS, gefitinib demonstrated improved PFS and ORR, similar OS, higher HRQoL, similar symptom improvement rates and a more favorable tolerability profile than carboplatin/paclitaxel, generally consistent with the overall IPASS population.

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