TY - JOUR
T1 - Quality of life with gefitinib in patients with EGFR-mutated non-small cell lung cancer
T2 - Quality of life analysis of north east Japan study group 002 trial
AU - Oizumi, Satoshi
AU - Kobayashi, Kunihiko
AU - Inoue, Akira
AU - Maemondo, Makoto
AU - Sugawara, Shunichi
AU - Yoshizawa, Hirohisa
AU - Isobe, Hiroshi
AU - Harada, Masao
AU - Kinoshita, Ichiro
AU - Okinaga, Shoji
AU - Kato, Terufumi
AU - Harada, Toshiyuki
AU - Gemma, Akihiko
AU - Saijo, Yasuo
AU - Yokomizo, Yuki
AU - Morita, Satoshi
AU - Hagiwara, Koichi
AU - Nukiwa, Toshihiro
PY - 2012
Y1 - 2012
N2 - Background. For non-small cell lung cancer (NSCLC) Patients with epidermal growth factor receptor (EGFR) mutations, first-line gefitinib produced a longer progressionfree survival interval than first-line carboplatin plus paclitaxel but did not show any survival advantage in the North East Japan 002 study. This report describes the quality of life (QoL) analysis of that study. Methods. Chemotherapy-naïve patients with sensitive EGFR-mutated, advanced NSCLC were randomized to receive gefitinib or chemotherapy (carboplatin and paclitaxel). Patient QoL was assessed weekly using the Care Notebook, and the primary endpoint of the QoL analysis was time to deterioration from baseline on each of the physical, mental, and life well-being QoL scales. Kaplan- Meier probability curves and log-rank tests were employed to clarify differences. Results. QoL data from 148 patients (72 in the gefitinib arm and 76 in the carboplatin plus paclitaxel arm) were analyzed. Time to defined deterioration in physical and life well-being significantly favored gefitinib over chemotherapy (hazard ratio [HR] of time to deterioration, 0.34; 95% confidence interval [CI], 0.23- 0.50; p <.0001 and HR, 0.43; 95% CI, 0.28 - 0.65; p <.0001, respectively). Conclusion. QoL was maintained much longer in patients treated with gefitinib than in patients treated with standard chemotherapy, indicating that gefitinib should be considered as the standard first-line therapy for advanced EGFR-mutated NSCLC in spite of no survival advantage.
AB - Background. For non-small cell lung cancer (NSCLC) Patients with epidermal growth factor receptor (EGFR) mutations, first-line gefitinib produced a longer progressionfree survival interval than first-line carboplatin plus paclitaxel but did not show any survival advantage in the North East Japan 002 study. This report describes the quality of life (QoL) analysis of that study. Methods. Chemotherapy-naïve patients with sensitive EGFR-mutated, advanced NSCLC were randomized to receive gefitinib or chemotherapy (carboplatin and paclitaxel). Patient QoL was assessed weekly using the Care Notebook, and the primary endpoint of the QoL analysis was time to deterioration from baseline on each of the physical, mental, and life well-being QoL scales. Kaplan- Meier probability curves and log-rank tests were employed to clarify differences. Results. QoL data from 148 patients (72 in the gefitinib arm and 76 in the carboplatin plus paclitaxel arm) were analyzed. Time to defined deterioration in physical and life well-being significantly favored gefitinib over chemotherapy (hazard ratio [HR] of time to deterioration, 0.34; 95% confidence interval [CI], 0.23- 0.50; p <.0001 and HR, 0.43; 95% CI, 0.28 - 0.65; p <.0001, respectively). Conclusion. QoL was maintained much longer in patients treated with gefitinib than in patients treated with standard chemotherapy, indicating that gefitinib should be considered as the standard first-line therapy for advanced EGFR-mutated NSCLC in spite of no survival advantage.
KW - EGFR
KW - Epidermal growth factor receptor
KW - Gefitinib
KW - Lung carcinoma
KW - QoL
KW - Quality of life
KW - TKI
KW - Tyrosine kinase inhibitor
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U2 - 10.1634/theoncologist.2011-0426
DO - 10.1634/theoncologist.2011-0426
M3 - Article
C2 - 22581822
AN - SCOPUS:84862880250
VL - 17
SP - 863
EP - 870
JO - Oncologist
JF - Oncologist
SN - 1083-7159
IS - 6
ER -