Open AccessQuality of Life with Gefitinib in Patients with EGFR ‐Mutated Non‐Small Cell Lung Cancer: Quality of Life Analysis of North East Japan Study Group 002 Trial
Author(s) -
Oizumi Satoshi,
Kobayashi Kunihiko,
Inoue Akira,
Maemondo Makoto,
Sugawara Shunichi,
Yoshizawa Hirohisa,
Isobe Hiroshi,
Harada Masao,
Kinoshita Ichiro,
Okinaga Shoji,
Kato Terufumi,
Harada Toshiyuki,
Gemma Akihiko,
Saijo Yasuo,
Yokomizo Yuki,
Morita Satoshi,
Hagiwara Koichi,
Nukiwa Toshihiro
Publication year - 2012
Publication title -
the oncologist
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.176
H-Index - 164
eISSN - 1549-490X
pISSN - 1083-7159
DOI - 10.1634/theoncologist.2011-0426
Subject(s) - gefitinib , medicine , carboplatin , lung cancer , hazard ratio , oncology , chemotherapy , quality of life (healthcare) , clinical endpoint , paclitaxel , confidence interval , epidermal growth factor receptor , performance status , randomized controlled trial , cancer , cisplatin , nursing
Background. For non‐small cell lung cancer (NSCLC) patients with epidermal growth factor receptor ( EGFR ) mutations, first‐line gefitinib produced a longer progression‐free 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.