Yano Tokujiro, Hamatake Motoharu, Tokunaga Shoji, Okamoto Tatsuro, Yamazaki Koji, Miura Takashi, Nagayasu Takeshi, Sato Masami, Fukuyama Seiichi, Sugio Kenji
Department of General Thoracic Surgery, National Hospital Organization Beppu Medical Center, 1473 Uchikamado, Beppu, 874-0011, Japan.
Department of Thoracic Surgery, Kitakyushu Municipal Medical Center, Kitakyushu, Japan.
Int J Clin Oncol. 2022 May;27(5):882-888. doi: 10.1007/s10147-022-02143-7. Epub 2022 Feb 25.
To examine the effects of postoperative adjuvant chemotherapy for elderly (≥ 75 years of age) patients with completely resected non-small cell lung cancer (NSCLC), we conducted a multi-institutional and prospective observational study.
Patients were recruited between January 2014 and December 2017, and assigned to two cohort groups based on the patients' choice either to receive postoperative adjuvant chemotherapy (Cohort B) or not (Cohort A). All the patients were observed for 2 years after enrollment. The primary endpoint was the postoperative change of Karnofsky Performance Status (KPS) at 2 years. The secondary endpoints were postoperative recurrence-free survival (RFS) and overall survival (OS) at 2 years, and the completion rate of the adjuvant chemotherapy.
Two hundred and seventy-two patients were enrolled (Cohort A, n = 225; Cohort B, n = 47). At any time point after surgery, no marked difference of KPS was observed between Cohort B and Cohort A. The RFS at 2 years was 70.8% (95% confidence interval [CI], 64.3-76.4) in Cohort A and 76.0% (95% CI 60.8-85.9) in Cohort B. The OS at 2 years was 85.9% (95% CI 80.4-89.9) in Cohort A and 89.1% (95% CI 75.8-95.3) in Cohort B. The completion rate of planned chemotherapy was 49.9% (95% CI 34.1-63.9%).
The elderly patients were not likely to choose to receive postoperative adjuvant chemotherapy; however, no significant adverse effect on postoperative KPS was identified.
Clinical Trial Registration ID: UMIN000020736.
为了研究术后辅助化疗对年龄≥75岁的完全切除的非小细胞肺癌（NSCLC）患者的影响，我们开展了一项多机构前瞻性观察性研究。
2014年1月至2017年12月招募患者，并根据患者选择分为两组队列，一组接受术后辅助化疗（队列B），另一组不接受（队列A）。所有患者入组后观察2年。主要终点是2年时卡氏功能状态（KPS）的术后变化。次要终点是2年时的术后无复发生存期（RFS）和总生存期（OS），以及辅助化疗的完成率。
共纳入272例患者（队列A，n = 225；队列B，n = 47）。术后任何时间点，队列B和队列A之间KPS均未观察到明显差异。队列A的2年RFS为70.8%（95%置信区间[CI]，64.3 - 76.4），队列B为76.0%（95% CI 60.8 - 85.9）。队列A的2年OS为85.9%（95% CI 80.4 - 89.9），队列B为89.1%（95% CI 75.8 - 95.3）。计划化疗的完成率为49.9%（95% CI 34.1 - 63.9%）。
老年患者不太可能选择接受术后辅助化疗；然而，未发现对术后KPS有显著不良影响。
临床试验注册编号：UMIN000020736。
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