Jian Zeng1, Wei-Min Mao2, Qi-Xun Chen1, Tao-Bo Luo1, Yi-Long Wu3, Qing Zhou3, Xue-Ning Yang3, Hong-Hong Yan3, Wen-Zhao Zhong4, Qun Wang5, Song-Tao Xu5, Lin Wu6, Yi Shen7, Yong-Yu Liu8, Chun Chen9, Ying Cheng10, Lin Xu11, Jun Wang12, Ke Fei13, Xiao-Fei Li14, Jian Li15, Cheng Huang16, Zhi-Dong Liu17, Shun Xu18, Ke-Neng Chen19, Shi-Dong Xu20, Lun-Xu Liu21, Ping Yu22, Bu-Hai Wang23, Hai-Tao Ma24. 1. Department of Thoracic Surgery, Zhejiang Cancer Hospital, University of Chinese Academy of Sciences, Hangzhou, China. 2. Department of Thoracic Surgery, Zhejiang Cancer Hospital, University of Chinese Academy of Sciences, Hangzhou, China. Electronic address: maowm@zjcc.org.cn. 3. Department of Pulmonary Cancer, Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China. 4. Department of Pulmonary Surgery, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China. 5. Department of Thoracic Surgery, Fudan University Affiliated Zhongshan Hospital, Shanghai, China. 6. Department of Pulmonary Medicine, Hunan Cancer Hospital, Changsha, China. 7. Department of Thoracic Surgery, The Affiliated Hospital of Medical College Qingdao University, Qingdao, China. 8. Department of Thoracic Surgery, Liaoning Cancer Hospital, Shenyang, China. 9. Department of Thoracic Surgery, Fujian Medical University Union Hospital, Fuzhou, China. 10. Department of Oncology, Jilin Provincial Tumor Hospital, Changchun, China. 11. Department of Thoracic Surgery, Jiangsu Cancer Hospital, Nanjing, China. 12. Department of Thoracic Surgery, The People's Hospital of Peking University, Beijing, China. 13. Department of Thoracic Surgery, Shanghai Pulmonary Hospital, Tongji University, Shanghai, China. 14. Department of Thoracic Surgery, Tangdu Hospital, Xi'an, China. 15. Department of Thoracic Surgery, Peking University First Hospital, Beijing, China. 16. Department of Pulmonary Oncology, Fujian Cancer Hospital, Fuzhou, China. 17. Department of Thoracic Surgery, Beijing Chest Hospital, Beijing, China. 18. Department of Thoracic Surgery, The First Hospital of China Medical University, Shenyang, China. 19. Department of Thoracic Surgery, Beijing Cancer Hospital, Beijing, China. 20. Department of Thoracic Surgery, Harbin Medical University Cancer Hospital, Harbin, China. 21. Department of Thoracic Surgery, West China Hospital of Sichuan University, Chengdu, China. 22. Department of Thoracic Oncology, Sichuan Cancer Hospital, Chengdu, China. 23. Department of Oncology, The Northern Jiangsu People's Hospital, Yangzhou, China. 24. Department of Thoracic Surgery, The First Affiliated Hospital of Suzhou University, Suzhou, China.
Abstract
OBJECTIVES:Health-related quality of life (HRQoL) data complement conventional clinical endpoints when comparing adjuvant gefitinib with chemotherapy in patients with early-stage non-small-cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) mutations. This study aimed to assess changes in HRQoL with adjuvant gefitinib vs chemotherapy in this patient group. MATERIALS AND METHODS: In the phase III ADJUVANT trial, patients with completely resected, stage II-IIIA (N1-N2), EGFR-mutant NSCLC were randomized (1:1) to receive either gefitinib for 24 months or vinorelbine plus cisplatin (VP) every 3 weeks for four cycles. HRQoL was assessed as a secondary endpoint using the Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L), Lung Cancer Symptom Scale (LCSS) questionnaires, and Trial Outcome Index (TOI) composite score. HRQoL dynamics, improvements, and time to deterioration were compared between groups. RESULTS: At baseline, 104 of 106, and 80 of 87 patients receiving gefitinib and VP, respectively, completed two questionnaires (FACT-L and LCSS). Baseline scores were balanced between groups. Although HRQoL fluctuated and gradually improved in both groups, longitudinally higher scores were reported with gefitinib than VP (FACT-L, odds ratio 418.16, 95 % confidence interval [CI] 2.75-63509.05, p = 0.019; LCSS, 1.13, 1.04-1.22, p = 0.003; TOI, 88.39, 4.40-1775.05, p = 0.003). Time to deterioration in HRQoL was delayed with gefitinib compared with VP (FACT-L, median 69 vs 6 weeks, hazard ratio 0.62, 95 % CI 0.42-0.90, p = 0.013; LCSS, median 45 vs 6 weeks, 0.63, 0.43-0.93, p = 0.020; TOI, median 164 vs 9 weeks, 0.51, 0.33-0.77, p = 0.001). CONCLUSION:Adjuvant gefitinib is associated with improved HRQoL over VP, supporting its use in patients with stage II-IIIA (N1-N2), EGFR-mutant NSCLC.
RCT Entities:
OBJECTIVES: Health-related quality of life (HRQoL) data complement conventional clinical endpoints when comparing adjuvant gefitinib with chemotherapy in patients with early-stage non-small-cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) mutations. This study aimed to assess changes in HRQoL with adjuvant gefitinib vs chemotherapy in this patient group. MATERIALS AND METHODS: In the phase III ADJUVANT trial, patients with completely resected, stage II-IIIA (N1-N2), EGFR-mutant NSCLC were randomized (1:1) to receive either gefitinib for 24 months or vinorelbine plus cisplatin (VP) every 3 weeks for four cycles. HRQoL was assessed as a secondary endpoint using the Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L), Lung Cancer Symptom Scale (LCSS) questionnaires, and Trial Outcome Index (TOI) composite score. HRQoL dynamics, improvements, and time to deterioration were compared between groups. RESULTS: At baseline, 104 of 106, and 80 of 87 patients receiving gefitinib and VP, respectively, completed two questionnaires (FACT-L and LCSS). Baseline scores were balanced between groups. Although HRQoL fluctuated and gradually improved in both groups, longitudinally higher scores were reported with gefitinib than VP (FACT-L, odds ratio 418.16, 95 % confidence interval [CI] 2.75-63509.05, p = 0.019; LCSS, 1.13, 1.04-1.22, p = 0.003; TOI, 88.39, 4.40-1775.05, p = 0.003). Time to deterioration in HRQoL was delayed with gefitinib compared with VP (FACT-L, median 69 vs 6 weeks, hazard ratio 0.62, 95 % CI 0.42-0.90, p = 0.013; LCSS, median 45 vs 6 weeks, 0.63, 0.43-0.93, p = 0.020; TOI, median 164 vs 9 weeks, 0.51, 0.33-0.77, p = 0.001). CONCLUSION: Adjuvant gefitinib is associated with improved HRQoL over VP, supporting its use in patients with stage II-IIIA (N1-N2), EGFR-mutant NSCLC.