Quality of life with adjuvant gefitinib versus vinorelbine plus cisplatin in patients with completely resected stage II–IIIA (N1–N2) EGFR-mutant non-small-cell lung cancer: Results from the ADJUVANT (CTONG1104) study

医学 危险系数 内科学 肿瘤科 肺癌 置信区间 临床终点 长春瑞滨 优势比 吉非替尼 化疗 表皮生长因子受体 随机对照试验 癌症 顺铂
作者
Jing Zeng,Weimin Mao,Qixun Chen,Ting Luo,Yi-Long Wu,Qing Zhou,Xue-Ning Yang,Hong-Hong Yan,Wen-Zhao Zhong,Qun Wang,Songtao Xu,Lin Wu,Yi Shen,Yong-Yu Liu,Chun Chen,Ying Cheng,Lin Xu,Jun Wang,Ke Fei,Xiaofei Li,Jian Li,Cheng Huang,Zhidong Liu,Shun Xu,Ke-Neng Chen,Shidong Xu,Lunxu Liu,Ping Yu,Buhai Wang,Haitao Ma
出处
期刊:Lung Cancer [Elsevier]
卷期号:150: 164-171 被引量:4
标识
DOI:10.1016/j.lungcan.2020.09.027
摘要

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.
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