I Sekine1, Y Ichinose2, Y Nishiwaki3, N Yamamoto4, M Tsuboi5, K Nakagawa6, T Shinkai7, S Negoro8, F Imamura9, K Eguchi10, K Takeda11, Y Itoh12, T Tamura13, N Saijo3, M Fukuoka6. 1. Division of Internal Medicine and Thoracic Oncology, National Cancer Center Hospital, Tokyo. Electronic address: isekine@ncc.go.jp. 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. 13. Division of Internal Medicine and Thoracic Oncology, National Cancer Center Hospital, Tokyo.
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. PATIENTS AND METHODS: This open-label, phase III study randomized 490 Japanese patients togefitinib (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).
RCT Entities:
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/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: Bruno Kovic; Xuejing Jin; Sean Alexander Kennedy; Mathieu Hylands; Michal Pedziwiatr; Akira Kuriyama; Huda Gomaa; Yung Lee; Morihiro Katsura; Masafumi Tada; Brian Y Hong; Sung Min Cho; Patrick Jiho Hong; Ashley M Yu; Yasmin Sivji; Augustin Toma; Li Xie; Ludwig Tsoi; Marcin Waligora; Manya Prasad; Neera Bhatnagar; Lehana Thabane; Michael Brundage; Gordon Guyatt; Feng Xie Journal: JAMA Intern Med Date: 2018-12-01 Impact factor: 21.873
Authors: Arijit Ganguli; Phillip Wiegand; Xin Gao; John A Carter; Marc F Botteman; Saurabh Ray Journal: Qual Life Res Date: 2012-07-18 Impact factor: 4.147
Authors: Gregory A Masters; Sarah Temin; Christopher G Azzoli; Giuseppe Giaccone; Sherman Baker; Julie R Brahmer; Peter M Ellis; Ajeet Gajra; Nancy Rackear; Joan H Schiller; Thomas J Smith; John R Strawn; David Trent; David H Johnson Journal: J Clin Oncol Date: 2015-08-31 Impact factor: 44.544