title: 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.
abstract: 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.
  
  
  METHODS
  This open-label, phase III study randomized 490 Japanese patients to gefitinib (250 mg/day) or docetaxel (60 mg/m(2)/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).
authors.affiliation: Division of Internal Medicine and Thoracic Oncology, National Cancer Center Hospital, Tokyo. Electronic address: isekine@ncc.go.jp.
authors.forename: I
authors.initials: I
authors.lastname: Sekine
authors.affiliation: Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka.
authors.forename: Y
authors.initials: Y
authors.lastname: Ichinose
authors.affiliation: Department of Thoracic Oncology, National Cancer Center Hospital East, Chiba.
authors.forename: Y
authors.initials: Y
authors.lastname: Nishiwaki
authors.affiliation: Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka.
authors.forename: N
authors.initials: N
authors.lastname: Yamamoto
authors.affiliation: Department of Thoracic Surgery and Oncology, Tokyo Medical University Hospital, Tokyo.
authors.forename: M
authors.initials: M
authors.lastname: Tsuboi
authors.affiliation: Department of Medical Oncology, Kinki University School of Medicine, Osaka.
authors.forename: K
authors.initials: K
authors.lastname: Nakagawa
authors.affiliation: Department of Internal Medicine, Respiratory Division, NHO Shikoku Cancer Center, Ehime.
authors.forename: T
authors.initials: T
authors.lastname: Shinkai
authors.affiliation: Department of Thoracic Oncology, Hyogo Cancer Center, Hyogo.
authors.forename: S
authors.initials: S
authors.lastname: Negoro
authors.affiliation: Department of Pulmonary Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka.
authors.forename: F
authors.initials: F
authors.lastname: Imamura
authors.affiliation: Department of Internal Medicine and Medical Oncology, Teikyo University School of Medicine, Kanagawa.
authors.forename: K
authors.initials: K
authors.lastname: Eguchi
authors.affiliation: Department of Clinical Oncology, Osaka City General Hospital, Osaka.
authors.forename: K
authors.initials: K
authors.lastname: Takeda
authors.affiliation: Clinical Division, Research and Development, AstraZeneca KK, Osaka, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Itoh
authors.affiliation: Division of Internal Medicine and Thoracic Oncology, National Cancer Center Hospital, Tokyo.
authors.forename: T
authors.initials: T
authors.lastname: Tamura
authors.affiliation: Department of Thoracic Oncology, National Cancer Center Hospital East, Chiba.
authors.forename: N
authors.initials: N
authors.lastname: Saijo
authors.affiliation: Department of Medical Oncology, Kinki University School of Medicine, Osaka.
authors.forename: M
authors.initials: M
authors.lastname: Fukuoka
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D044466:Asian People; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D000077143:Docetaxel; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D011788:Quality of Life; D011799:Quinazolines / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D043823:Taxoids / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; D043823:Taxoids; D000077143:Docetaxel; D000077156:Gefitinib