Yang James Chih-Hsin, Mok Tony S K, Lu Shun, Nakagawa Kazuhiko, Yamamoto Nobuyuki, Shi Yuan-Kai, Zhang Li, Soo Ross A, Morita Satoshi, Tamura Tomohide
Department of Oncology, National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Republic of China.
Department of Clinical Oncology, State Key Laboratory of Translational Oncology, Chinese University of Hong Kong, Shatin, Hong Kong Special Administrative Region, People's Republic of China.
JTO Clin Res Rep. 2021 Jan 7;2(3):100142. doi: 10.1016/j.jtocrr.2021.100142. eCollection 2021 Mar.
Despite recent advances in NSCLC treatment, specific data on the elderly population remain limited. In this post hoc subgroup analysis of the East Asia S-1 Trial in Lung Cancer (EAST-LC) trial, we compared S-1 and docetaxel (DTX) in patients aged 70 years old and above with pretreated advanced NSCLC.
Patients were randomly assigned (1:1) to receive S-1 (orally, twice daily on d 1-28 of a 6-wk cycle) or DTX (intravenously, on d 1 of a 3-wk cycle). The initial S-1 dose was 80, 100, or 120 mg/day on the basis of body surface area, and the DTX doses were 60 mg/m (Japan) or 75 mg/m (outside Japan). The primary end point was overall survival, and secondary end points included progression-free survival, response rate, quality of life (QOL) using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30, and safety.
Among 189 patients aged 70 years and above assessed as the full analysis set, baseline characteristics were generally similar between treatment arms. The median overall survival was 14.7 (S-1) versus 12.1 months (DTX); the hazard ratio was equal to 0.76, with a 95% confidence interval (CI) of 0.54-1.07. The median progression-free survival was similar in both arms (both 4.1 mo, hazard ratio = 0.84, 95% CI: 0.60-1.18); and the response rate was 12.9% (S-1) and 14.0% (DTX). The adjusted mean QOL score difference (S-1-DTX until wk 48) was 7.41 (95% CI: 0.37-14.46). Safety profiles were generally consistent with those of the overall EAST-LC population.
S-1 revealed comparable efficacy, safety, and QOL versus DTX in pretreated elderly patients with advanced NSCLC. Results were consistent with the overall EAST-LC data.
尽管非小细胞肺癌（NSCLC）治疗方面最近取得了进展，但关于老年人群的具体数据仍然有限。在这项肺癌东亚S-1试验（EAST-LC）的事后亚组分析中，我们比较了S-1和多西他赛（DTX）在70岁及以上经治晚期NSCLC患者中的疗效。
患者被随机分配（1:1）接受S-1（口服，每6周周期的第1 - 28天每日两次）或DTX（静脉注射，每3周周期的第1天）。S-1的初始剂量根据体表面积为80、100或120 mg/天，DTX剂量在日本为60 mg/m²，在日本以外地区为75 mg/m²。主要终点是总生存期，次要终点包括无进展生存期、缓解率、使用欧洲癌症研究与治疗组织生活质量问卷核心30（EORTC QLQ-C30）评估的生活质量（QOL）以及安全性。
在189例年龄70岁及以上被评估为全分析集的患者中，各治疗组的基线特征总体相似。S-1组的中位总生存期为14.7个月，DTX组为12.1个月；风险比为0.76，95%置信区间（CI）为0.54 - 1.07。两组的中位无进展生存期相似（均为4.1个月，风险比 = 0.84，95% CI：0.60 - 1.18）；缓解率分别为12.9%（S-1）和14.0%（DTX）。调整后的平均QOL评分差异（至第48周时S-1 - DTX）为7.41（95% CI：0.37 - 14.46）。安全性概况与整个EAST-LC人群的情况总体一致。
在经治的老年晚期NSCLC患者中，S-1在疗效、安全性和生活质量方面与DTX相当。结果与整个EAST-LC数据一致。
