TY - JOUR
T1 - Phase II randomized trial of erlotinib or vinorelbine in chemonaive, advanced, non-small cell lung cancer patients aged 70 years or older
AU - Chen, Yuh Min
AU - Tsai, Chun Ming
AU - Fan, Wen Chien
AU - Shih, Jen Fu
AU - Liu, Shih Hao
AU - Wu, Chieh Hung
AU - Chou, Teh Ying
AU - Lee, Yu Chin
AU - Perng, Reury Perng
AU - Whang-Peng, Jacqueline
PY - 2012/2
Y1 - 2012/2
N2 - Introduction: The primary objective of this study was to compare the response rates of elderly, chemonaive patients with advanced non-small cell lung cancer (NSCLC) treated with daily oral erlotinib versus oral vinorelbine. Methods: Chemonaive Taiwanese patients aged 70 years or older who had advanced NSCLC were randomized to receive either oral erlotinib 150 mg (E) daily or oral vinorelbine 60 mg/m 2 (V) on days 1 and 8 every 3 weeks. Results: From February 2007 to July 2008, 116 patients were enrolled and 113 were included in the intent-to-treat population: 57 patients in the E group and 56 patients in the V group. Objective response rates were 22.8% (13 of 57) in E and 8.9% (5 of 56) in V (p = 0.0388). Median progression-free survival (PFS) was 4.57 months in E and 2.53 months in V (p = 0.0287), with an 80.6% increase in median PFS for E compared with V. Median survival time was 11.67 months in E and 9.3 months in V (p = 0.6975). Toxicities were generally mild in both groups. Median PFS was longest for epidermal growth factor receptor gene (EGFR)-mutated patients in the E group, followed by EGFR-mutated patients in V, EGFR wild type in E, and EGFR wild type in V (p = 0.0034). Overall survival was longer for EGFR-mutated patients than for EGFR wild-type patients (p < 0.0001). Conclusions: Erlotinib is highly effective compared with oral vinorelbine in elderly, chemonaive, Taiwanese patients with NSCLC. EGFR-mutated patients had better survival than those with EGFR wild-type disease, regardless of the treatment received.
AB - Introduction: The primary objective of this study was to compare the response rates of elderly, chemonaive patients with advanced non-small cell lung cancer (NSCLC) treated with daily oral erlotinib versus oral vinorelbine. Methods: Chemonaive Taiwanese patients aged 70 years or older who had advanced NSCLC were randomized to receive either oral erlotinib 150 mg (E) daily or oral vinorelbine 60 mg/m 2 (V) on days 1 and 8 every 3 weeks. Results: From February 2007 to July 2008, 116 patients were enrolled and 113 were included in the intent-to-treat population: 57 patients in the E group and 56 patients in the V group. Objective response rates were 22.8% (13 of 57) in E and 8.9% (5 of 56) in V (p = 0.0388). Median progression-free survival (PFS) was 4.57 months in E and 2.53 months in V (p = 0.0287), with an 80.6% increase in median PFS for E compared with V. Median survival time was 11.67 months in E and 9.3 months in V (p = 0.6975). Toxicities were generally mild in both groups. Median PFS was longest for epidermal growth factor receptor gene (EGFR)-mutated patients in the E group, followed by EGFR-mutated patients in V, EGFR wild type in E, and EGFR wild type in V (p = 0.0034). Overall survival was longer for EGFR-mutated patients than for EGFR wild-type patients (p < 0.0001). Conclusions: Erlotinib is highly effective compared with oral vinorelbine in elderly, chemonaive, Taiwanese patients with NSCLC. EGFR-mutated patients had better survival than those with EGFR wild-type disease, regardless of the treatment received.
KW - Chemotherapy
KW - Epidermal growth factor receptor
KW - Nonsmall-cell lung cancer
KW - Targeted therapy
KW - Tyrosine-kinase inhibitor
UR - http://www.scopus.com/inward/record.url?scp=84858339030&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84858339030&partnerID=8YFLogxK
U2 - 10.1097/JTO.0b013e31823a39e8
DO - 10.1097/JTO.0b013e31823a39e8
M3 - Article
C2 - 22157367
AN - SCOPUS:84858339030
SN - 1556-0864
VL - 7
SP - 412
EP - 418
JO - Journal of Thoracic Oncology
JF - Journal of Thoracic Oncology
IS - 2
ER -