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采用同期顺铂-口服长春瑞滨联合放疗治疗局部晚期非小细胞肺癌老年患者的综合老年评估管理效果:一项开放 II 期研究(GFPC 08-06)。

Impact of a comprehensive geriatric assessment to manage elderly patients with locally advanced non-small-cell lung cancers: An open phase II study using concurrent cisplatin-oral vinorelbine and radiotherapy (GFPC 08-06).

机构信息

Service de Pneumologie, GHEF site de Meaux, France.

Service de Radiothérepie, Institut Sainte-Catherine, Avignon, France.

出版信息

Lung Cancer. 2018 Jul;121:25-29. doi: 10.1016/j.lungcan.2018.04.017. Epub 2018 Apr 22.

DOI:10.1016/j.lungcan.2018.04.017
PMID:29858022
Abstract

INTRODUCTION

Few data have been published on the optimal management of elderly patients with locally advanced non-small-cell lung cancers (La-NSCLC). This prospective, multicenter, phase II study was undertaken to evaluate the ability of a comprehensive geriatric assessment (CGA) to select the elderly La-NSCLC patients who potentially may benefit from concurrent radio-chemotherapy.

METHODS

The main inclusion criteria were: La-NSCLC, >70 years old, at least one measurable target, ECOG performance status (PS) 0/1 and normal CGA. Weekly cisplatin (30 mg/m) and oral vinorelbine (30 mg/m) were combined with standard thoracic radiotherapy (66 Gy, 33 fractions) for 6.5 weeks. The primary evaluation criterion was <15% clinically relevant grade >2 toxicity. Secondary criteria were response rates, overall survival (OS) and progression-free survival (PFS).

RESULTS

Among the 49 patients screened, 40 were included: 87.5% men, median age: 75.1 (70-84) years, 67.5% with PS 0, 52.5% squamous cell carcinomas. The full concurrent regimen was administrated in 77.5% of the cases (chemotherapy: 85%, radiotherapy: 90%); 22.5% of the patients experienced toxicity grade >2 (with three treatment-imputed deaths), 15% when restricted to clinically relevant >2 grade toxicities. One (2.6%) patient achieved a complete response, 53.8% had partial responses and 35.9% stable disease. Median PFS was 15 (95%CI: 8,7-35,2) months, OS 21.8 (95%CI: 16-NR) months and 1-, 2- and 4-year survival rates were 77.5%, 45% and 34.8%.

CONCLUSION

CGA was able to select fit elderly patients with La-NSCLCs eligible for concurrent chemoradiotherapy with a satisfactory risk/benefit ratio.

摘要

简介

关于局部晚期非小细胞肺癌(La-NSCLC)老年患者的最佳治疗方法,相关数据较少。本前瞻性、多中心、二期研究旨在评估综合老年评估(CGA)选择可能从同期放化疗中获益的老年局部晚期非小细胞肺癌患者的能力。

方法

主要纳入标准为:La-NSCLC,年龄>70 岁,至少有一个可测量的靶标,ECOG 体能状态(PS)0/1 和正常 CGA。每周顺铂(30mg/m)和口服长春瑞滨(30mg/m)与标准胸部放疗(66Gy,33 次)联合使用 6.5 周。主要评价标准为<15%的临床相关>2 级毒性。次要标准为反应率、总生存期(OS)和无进展生存期(PFS)。

结果

在筛选的 49 名患者中,有 40 名患者入组:87.5%为男性,中位年龄 75.1(70-84)岁,67.5%PS 为 0,52.5%为鳞状细胞癌。77.5%的患者接受了完整的同期治疗方案(化疗:85%,放疗:90%);22.5%的患者出现>2 级毒性(其中 3 例因治疗而死亡),当限制在临床相关>2 级毒性时,这一比例为 15%。1 例(2.6%)患者完全缓解,53.8%部分缓解,35.9%疾病稳定。中位 PFS 为 15 个月(95%CI:8,7-35,2),OS 为 21.8 个月(95%CI:16-NR),1、2 和 4 年生存率分别为 77.5%、45%和 34.8%。

结论

CGA 能够选择适合进行同期放化疗的老年局部晚期非小细胞肺癌患者,风险/获益比令人满意。

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