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口服替加氟尿嘧啶与静脉化疗作为可切除的早期非小细胞肺癌患者的辅助治疗。

Oral uracil-tegafur compared with intravenous chemotherapy as adjuvant therapy for resected early-stage non-small cell lung cancer patients.

机构信息

Department of Medicine, National Taiwan University Cancer Center, Taipei, Taiwan.

Department of Internal Medicine, National Taiwan University Hospital, Hsinchu Branch, Hsinchu, Taiwan.

出版信息

Cancer Med. 2023 Sep;12(17):17993-18004. doi: 10.1002/cam4.6440. Epub 2023 Aug 9.

Abstract

BACKGROUND

Studies comparing the effectiveness of either adjuvant oral uracil-tegafur (UFT) or intravenous chemotherapy on early-stage (stage I and II) non-small cell lung cancer (NSCLC) patients treated with complete surgical treatment remain limited.

METHODS

From January 2011 to December 2017, patients with early-stage NSCLC (defined as tumor size >3 cm without mediastinal lymph node involvement or any distant metastasis) receiving either adjuvant oral UFT or intravenous chemotherapy after surgical resection were identified from the Taiwan Cancer Registry. Overall survival (OS) and relapse-free survival (RFS) were the primary and secondary outcomes, respectively. Propensity matching was used for controlling confounders.

RESULTS

A total of 840 patients receiving adjuvant therapy after surgery (including 595 oral UFT and 245 intravenous chemotherapy) were enrolled. Before matching, patients using oral UFT had significantly longer OS (HR: 0.69, 95% CI: 0.49-0.98, p = 0.0387) and RFS (HR: 0.79, 95% CI: 0.61-0.97, p = 0.0392) than those with intravenous chemotherapy. A matched cohort of 352 patients was created using 1:1 propensity score-matching. In the Cox regression analysis, the UFT and the matched chemotherapy groups had similar OS (HR: 0.80, 95% CI: 0.48-1.32, p = 0.3753) and RFS (HR: 0.98, 95% CI: 0.72-1.34, p = 0.9149). Among subgroup analysis, oral UFT use was associated with longer RFS among the subgroups of non-drinker (HR: 0.66, 95% CI: 0.34-0.99, p = 0.0478) and patients with stage IB disease (HR: 0.67, 95% CI: 0.42-0.97, p = 0.0341).

CONCLUSIONS

This population-based study in the real-world setting of Taiwan demonstrates comparable effectiveness between oral UFT and intravenous chemotherapy in terms of clinical outcomes for early-stage NSCLC patients after surgery.

摘要

背景

比较接受完全手术治疗的早期(I 期和 II 期)非小细胞肺癌(NSCLC)患者使用辅助口服替加氟尿嘧啶(UFT)或静脉化疗的有效性的研究仍然有限。

方法

从 2011 年 1 月至 2017 年 12 月,从台湾癌症登记处确定了接受手术切除后接受辅助口服 UFT 或静脉化疗的早期 NSCLC(定义为肿瘤大小>3cm 且无纵隔淋巴结受累或任何远处转移)患者。总生存期(OS)和无复发生存期(RFS)分别为主要和次要结局。采用倾向评分匹配来控制混杂因素。

结果

共纳入 840 例接受手术后辅助治疗的患者(包括 595 例口服 UFT 和 245 例静脉化疗)。在匹配之前,口服 UFT 组的 OS(HR:0.69,95%CI:0.49-0.98,p=0.0387)和 RFS(HR:0.79,95%CI:0.61-0.97,p=0.0392)明显长于静脉化疗组。使用 1:1 倾向评分匹配创建了一个匹配的 352 例患者队列。在 Cox 回归分析中,UFT 组和匹配化疗组的 OS(HR:0.80,95%CI:0.48-1.32,p=0.3753)和 RFS(HR:0.98,95%CI:0.72-1.34,p=0.9149)相似。在亚组分析中,在非饮酒者(HR:0.66,95%CI:0.34-0.99,p=0.0478)和 IB 期疾病患者(HR:0.67,95%CI:0.42-0.97,p=0.0341)亚组中,口服 UFT 与更长的 RFS 相关。

结论

这项基于人群的研究在台湾的真实环境中表明,口服 UFT 和静脉化疗在早期 NSCLC 患者手术后的临床结局方面具有相当的疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a904/10523960/e00b11cbc5bd/CAM4-12-17993-g001.jpg

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