Quality 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:

Oizumi Satoshi1,Kobayashi Kunihiko2,Inoue Akira3,Maemondo Makoto4,Sugawara Shunichi5,Yoshizawa Hirohisa6,Isobe Hiroshi7,Harada Masao8,Kinoshita Ichiro9,Okinaga Shoji10,Kato Terufumi11,Harada Toshiyuki12,Gemma Akihiko13,Saijo Yasuo14,Yokomizo Yuki2,Morita Satoshi15,Hagiwara Koichi16,Nukiwa Toshihiro17

Affiliation:

1. a Hokkaido University School of Medicine, Sapporo, Japan;

2. b Saitama International Medical Center, Saitama, Japan;

3. c Tohoku University Hospital, Sendai, Japan;

4. d Miyagi Cancer Center, Miyagi, Japan;

5. e Sendai Kousei Hospital, Sendai, Japan;

6. f Niigata University Medical and Dental Hospital, Niigata, Japan;

7. g Kokka-komuin Kyosai-Kumiai Rengokai Sapporo Medical Center, Sapporo, Japan;

8. h National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan;

9. i Hokkaido University Graduate School of Medicine, Sapporo, Japan;

10. j Kesennuma City Hospital, Kesennuma, Japan;

11. k Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan;

12. l Hokkaido Social Insurance Hospital, Hokkaido, Japan;

13. m Nippon Medical School, Sendagi, Japan;

14. n Graduate School of Medicine, Hirosaki University, Hirosaki, Japan;

15. o Yokohama City University Medical Center, Yokohama, Japan;

16. p Saitama Medical University, Saitama, Japan;

17. q Tohoku University Graduate School of Medicine, Sendai, Japan

Abstract

Abstract 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.

Funder

Japan Society for Promotion of Science

Japanese Foundation for the Multidisciplinary Treatment of Cancer

Tokyo Cooperative Oncology Group

Publisher

Oxford University Press (OUP)

Subject

Cancer Research,Oncology

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