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

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 i...

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Published in:Asia-Pacific journal of clinical oncology 2012-09, Vol.8 (3), p.232-243
Main Authors: WU, Yi-Long, CHU, Da-Tong, HAN, Baohui, LIU, Xuyi, ZHANG, Li, ZHOU, Caicum, LIAO, Meilin, MOK, Tony, JIANG, Haiyi, DUFFIELD, Emma, FUKUOKA, Masahiro
Format: Article
Language:English
Subjects:
Adenocarcinoma - drug therapy
Adenocarcinoma - enzymology
Adenocarcinoma - genetics
Adenocarcinoma - pathology
Adenocarcinoma of Lung
Adult
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Biomarkers, Tumor - genetics
Carboplatin - administration & dosage
Carboplatin - adverse effects
China
Disease-Free Survival
epidermal growth factor receptor (EGFR)
ErbB Receptors - antagonists & inhibitors
ErbB Receptors - genetics
Female
Gefitinib
Humans
Lung Neoplasms - drug therapy
Lung Neoplasms - enzymology
Lung Neoplasms - genetics
Lung Neoplasms - pathology
Male
Middle Aged
Mutation
non-small-cell lung cancer
Paclitaxel - administration & dosage
Paclitaxel - adverse effects
Quality of Life
Quinazolines - adverse effects
Quinazolines - therapeutic use
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Summary: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.
ISSN:1743-7555
1743-7563
DOI:10.1111/j.1743-7563.2012.01518.x