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在非鼻咽癌高发地区,短期总生存(OS)可作为 5 年总生存(OS)的替代终点。

Short-term OS as a surrogate endpoint for 5-year OS in nasopharyngeal carcinoma in non-endemic area.

机构信息

Department of Radiation Oncology, Guangxi Medical University Cancer Hospital, Nanning, Guangxi, 530021, China.

Department of Oncology, Wuming Hospital of Guangxi Medical University, Nanning, Guangxi, 530199, China.

出版信息

World J Surg Oncol. 2024 Jul 11;22(1):180. doi: 10.1186/s12957-024-03460-z.

Abstract

PURPOSE

To address this evidence gap and validate short-term OS at less than 5 years as a reliable surrogate endpoint for 5-year OS.

METHODS

We analyzed data from the Surveillance, Epidemiology, and End Results (SEER) database, focusing on non-metastatic NPC patients diagnosed between 2010 and 2015. Patients were categorized into radiotherapy and chemoradiotherapy groups.

RESULTS

This retrospective study examined 2,047 non-metastatic NPC patients. Among them, 217 received radiotherapy, and 1,830 received chemoradiotherapy. Our analysis results indicated that the 4-year OS may serve as a reliable surrogate endpoint for patients with AJCC clinical stage I (80 vs. 78%, P = 0.250), regardless of the treatment received. Specifically, in the radiotherapy group, patients with stage I, T0-T1, and N0 NPC showed similar OS rates at 4 and 5 years (83 vs. 82%, P = 1.000; 78 vs. 76%, P = 0.250; 78 vs. 77%, P = 0.500, respectively). Similarly, patients with stage II-IV, T2-T4, and N1-3 NPC showed no significant difference in OS rates between 3 and 5 years (57 vs. 51%, P = 0.063; 52 vs. 46%, P = 0.250; 54 vs. 46%, P = 0.125, respectively) in the radiotherapy group. In the chemoradiotherapy group, only the 3-year OS rate did not significantly differ from that at 5 years in stage I patients (79vs. 72%, P = 0.063).

CONCLUSIONS

Our study suggests that short-term surrogate endpoints may be valuable for evaluating 5-year OS outcomes in NPC patients in non-endemic areas.

摘要

目的

为了解决这一证据空白,我们验证了 5 年以下的短期总生存期(OS)作为 5 年 OS 的可靠替代终点。

方法

我们分析了来自监测、流行病学和最终结果(SEER)数据库的数据,重点关注 2010 年至 2015 年间诊断的非转移性 NPC 患者。患者分为放疗和放化疗组。

结果

这项回顾性研究共纳入了 2047 名非转移性 NPC 患者。其中,217 例接受放疗,1830 例接受放化疗。我们的分析结果表明,4 年 OS 可作为 AJCC 临床分期 I 期患者(80%与 78%,P=0.250)的可靠替代终点,无论接受何种治疗。具体来说,在放疗组中,I 期 T0-T1 和 N0 NPC 患者的 4 年和 5 年 OS 率相似(83%与 82%,P=1.000;78%与 76%,P=0.250;78%与 77%,P=0.500)。同样,在放疗组中,II-IV 期 T2-T4 和 N1-3 NPC 患者的 3 年和 5 年 OS 率无显著差异(57%与 51%,P=0.063;52%与 46%,P=0.250;54%与 46%,P=0.125)。在放化疗组中,只有 I 期患者的 3 年 OS 率与 5 年 OS 率无显著差异(79%与 72%,P=0.063)。

结论

本研究表明,短期替代终点可能对评估非高发地区 NPC 患者的 5 年 OS 结局有价值。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ef3/11238357/1a25d13d4f90/12957_2024_3460_Fig1_HTML.jpg

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