Ahn, Myung-Ju; Yang, James Chih-Hsin; Liang, Jun; Kang, Jin-Hyoung; Xiu, Qingyu; Chen, Yuh-Min; Blair, Julie Michelle; Peng, Guangbin; Linn, Carlos; Orlando, Mauro
Lung cancer (Amsterdam, Netherlands)
2012Aug ; 77 ( 2 ) :346-52.
PMID : 22534669
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Ahn, Myung-Ju -
Yang, James Chih-Hsin -
Liang, Jun -
Kang, Jin-Hyoung -
Xiu, Qingyu -
Chen, Yuh-Min -
Blair, Julie Michelle -
Peng, Guangbin -
Linn, Carlos -
Orlando, Mauro -
ABSTRACT
INTRODUCTION: Treatment with epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors or chemotherapy have shown improved survival outcomes in East Asian, never-smoker patients with non-small cell lung cancer (NSCLC). However, treatment sequence has not been optimized in patients with unknown EGFR mutation status. This trial compared first-line chemotherapy with pemetrexed (P)-cisplatin (C), followed by either gefitinib (G) or P maintenance.
METHODS: East Asian, never-smoker, chemo-naive patients with stage IIIB/IV NSCLC, performance status =1 and unknown EGFR mutation status were randomized 1:1 to receive 4 cycles of pemetrexed [500 mg/m(2)]+cisplatin [75 mg/m(2)] q3 weeks, followed by maintenance with either gefitinib [250 mg/d] (PC/G) or pemetrexed [500 mg/m(2)] q3 weeks and =2 optional cycles of cisplatin (PC/P). The primary endpoint, progression-free survival (PFS), was calculated from randomization date.
RESULTS: Between Feb and Nov 2007, 70 patients from China, Korea, and Taiwan were randomized and treated, among whom 59 patients (84.3%) had non-squamous NSCLC. Forty-nine patients (70.0%) completed the full sequential treatment (n=25 G; n=24 P). Median PFS was numerically longer for patients on PC/G (9.95 months) than those on PC/P (6.83 months; hazard ratio [HR]=0.53, 95% confidence interval [CI]=0.27, 1.04). In contrast, median overall survival was numerically higher for patients on PC/P (HR=2.15, 95% CI=0.83, 5.60), though there was a high censoring rate. Response rate was similar in both arms. Treatment arms were similar for grade 3/4/5 toxicities.
CONCLUSIONS: East Asian never-smoker patients with advanced NSCLC and unknown EGFR mutation status had improved PFS following treatment with first-line PC and sequential G. Irrespective of subsequent maintenance treatment, induction PC was safe and efficacious, leading to prolonged OS in the Asian patient population. CI - Copyright (c) 2012 Elsevier Ireland Ltd. All rights reserved.
Non-small cell lung cancer; Never-smoker; Pemetrexed; Gefitinib; Unknown EGFR mutation status; Maintenance therapy
MESH
Adult, Aged, Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use, Asian Continental Ancestry Group, Carcinoma, Non-Small-Cell Lung/*drug therapy/mortality/*pathology, Cisplatin/administration & dosage, Female, Glutamates/administration & dosage, Guanine/administration & dosage/analogs & derivatives, Humans, Lung Neoplasms/*drug therapy/mortality/*pathology, Male, Middle Aged, Neoplasm Staging, Pemetrexed, Quinazolines/administration & dosage, Treatment Outcome
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