Annals of Oncology Advance Access published online on March 12, 2009
Annals of Oncology, doi:10.1093/annonc/mdp031
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Quality of life and disease-related symptoms in previously treated Japanese patients with non-small-cell lung cancer: results of a randomized phase III study (V-15-32) of gefitinib versus docetaxel
1 Division of Internal Medicine and Thoracic Oncology, National Cancer Center Hospital, Tokyo
2 Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka
3 Department of Thoracic Oncology, National Cancer Center Hospital East, Chiba
4 Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka
5 Department of Thoracic Surgery and Oncology, Tokyo Medical University Hospital, Tokyo
6 Department of Medical Oncology, Kinki University School of Medicine, Osaka
7 Department of Internal Medicine, Respiratory Division, NHO Shikoku Cancer Center, Ehime
8 Department of Thoracic Oncology, Hyogo Cancer Center, Hyogo
9 Department of Pulmonary Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka
10 Department of Internal Medicine and Medical Oncology, Teikyo University School of Medicine, Kanagawa
11 Department of Clinical Oncology, Osaka City General Hospital, Osaka
12 Clinical Division, Research and Development, AstraZeneca KK, Osaka, Japan
* Correspondence to: Dr I. Sekine, Division of Internal Medicine and Thoracic Oncology, National Cancer Center Hospital, Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045, Japan. Tel: +81-3-3542-2511; Fax: +81-3-3542-3815; E-mail: isekine{at}ncc.go.jp
Background: This report describes quality of life (QoL) findings of a randomized study comparing gefitinib with docetaxel in patients with advanced/metastatic pretreated non-small-cell lung cancer.
Patients and methods: This open-label, phase III study randomized 490 Japanese patients to gefitinib (250 mg/day) or docetaxel (60 mg/m2/3 weeks), with survival as the primary outcome. Preplanned QoL analyses included Functional Assessment of Cancer Therapy-Lung (FACT-L), Trial Outcome Index (TOI) and Lung Cancer Subscale (LCS) improvement rates, and mean change from baseline.
Results: Gefitinib showed statistically significant benefits over docetaxel in QoL improvement rates (FACT-L 23% versus 14%, P = 0.023; TOI 21% versus 9%, P = 0.002) and mean change from baseline score [mean treatment difference: FACT-L 3.72 points, 95% confidence interval (CI) 0.55–6.89, P = 0.022; TOI 4.31 points, 95% CI 2.13–6.49, P < 0.001], although differences did not meet the clinically relevant six-point change. There were no significant differences between treatments in LCS improvement rates (23% versus 20%, P = 0.562) or mean change from baseline score (0.63 points, 95% CI –0.07 to 1.34, P = 0.077).
Conclusions: Gefitinib improved aspects of QoL over docetaxel, with superior objective response rate and a more favorable tolerability profile and no statistically significant difference in overall survival (although noninferiority was not statistically proven).
docetaxel, gefitinib, non-small-cell lung cancer, quality of life
Received for publication November 11, 2008. Revision received January 14, 2009. Accepted for publication January 26, 2009.
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