TY - JOUR
T1 - Randomized phase II trial of first-line treatment with pemetrexed-cisplatin, followed sequentially by gefitinib or pemetrexed, in East Asian, never-smoker patients with advanced non-small cell lung cancer
AU - Ahn, Myung Ju
AU - Yang, James Chih Hsin
AU - Liang, Jun
AU - Kang, Jin Hyoung
AU - Xiu, Qingyu
AU - Chen, Yuh Min
AU - Blair, Julie Michelle
AU - Peng, Guangbin
AU - Linn, Carlos
AU - Orlando, Mauro
PY - 2012/8
Y1 - 2012/8
N2 - 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-naïve patients with stage IIIB/IV NSCLC, performance status ≤1 and unknown EGFR mutation status were randomized 1:1 to receive 4 cycles of pemetrexed [500mg/m 2]+cisplatin [75mg/m 2] q3 weeks, followed by maintenance with either gefitinib [250mg/d] (PC/G) or pemetrexed [500mg/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.
AB - 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-naïve patients with stage IIIB/IV NSCLC, performance status ≤1 and unknown EGFR mutation status were randomized 1:1 to receive 4 cycles of pemetrexed [500mg/m 2]+cisplatin [75mg/m 2] q3 weeks, followed by maintenance with either gefitinib [250mg/d] (PC/G) or pemetrexed [500mg/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.
KW - Gefitinib
KW - Maintenance therapy
KW - Never-smoker
KW - Non-small cell lung cancer
KW - Pemetrexed
KW - Unknown EGFR mutation status
UR - https://www.scopus.com/pages/publications/84863783193
U2 - 10.1016/j.lungcan.2012.03.011
DO - 10.1016/j.lungcan.2012.03.011
M3 - Article
C2 - 22534669
AN - SCOPUS:84863783193
SN - 0169-5002
VL - 77
SP - 346
EP - 352
JO - Lung Cancer
JF - Lung Cancer
IS - 2
ER -
