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紫杉醇联合卡铂辅助化疗与替吉奥口服治疗非小细胞肺癌的临床结局:SLCG0401 试验的亚组分析。

Impact of pathological stage and histological subtype on clinical outcome of adjuvant chemotherapy of paclitaxel plus carboplatin versus oral uracil-tegafur for non-small cell lung cancer: subanalysis of SLCG0401 trial.

机构信息

Department of General Thoracic Surgery and Breast and Endocrinological Surgery, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.

Department of Thoracic Surgery, Kurashiki Central Hospital, Kurashiki, Japan.

出版信息

Int J Clin Oncol. 2019 Nov;24(11):1367-1376. doi: 10.1007/s10147-019-01508-9. Epub 2019 Jul 16.

Abstract

BACKGROUND

Pathological stage (pStage) and histological subtype are strong determinants of the treatment strategy for non-small cell lung cancer (NSCLC). Setouchi Lung Cancer study Group (SLCG) recently reported the results of a multicenter trial (SLCG0401) indicating that paclitaxel plus carboplatin (CBDCA/PTX) as adjuvant chemotherapy does not yield better survival than uracil-tegafur (UFT) in NSCLC patients with pStage IB-IIIA disease, while stratified analyses considering the pStage and histological subtype have not been performed.

METHODS

We reanalyzed the overall survival (OS) and relapse-free survival (RFS) in 402 patients who had been randomly assigned to receive CBDCA/PTX or UFT by multivariate analysis with adjustments for the pStage and histological subtype.

RESULTS

There were no significant differences in the OS or RFS between the two treatment settings either in the entire cohort (n = 402) and in some of subsets: pStage IB (n = 228), pStage II (n = 117), adenocarcinoma (AD, n = 265), and squamous cell carcinoma (SQ, n = 101). In pStage IIIA patients (n = 57), CBDCA/PTX yielded superior RFS to UFT [hazard ratio (HR) 0.44; P = 0.016]. Among the patients with non-AD and non-SQ histology (n = 36), UFT yielded both superior OS and RFS to CBDCA/PTX (HRs 0.16 and 0.23; P = 0.046 and 0.011, respectively).

CONCLUSIONS

There are subsets of patients in which one or the other between UFT and CBDCA/PTX is significantly more effective. Selection of adjuvant therapy for NSCLC patients needs to be made taking into consideration the pStage and histological subtype.

摘要

背景

病理分期(pStage)和组织学亚型是非小细胞肺癌(NSCLC)治疗策略的重要决定因素。Setouchi Lung Cancer study Group(SLCG)最近报告了一项多中心试验(SLCG0401)的结果,该试验表明紫杉醇加卡铂(CBDCA/PTX)作为辅助化疗并不能改善 pStage IB-IIIA 期 NSCLC 患者的生存,而分层分析考虑到 pStage 和组织学亚型尚未进行。

方法

我们通过多变量分析重新分析了 402 例随机分配接受 CBDCA/PTX 或 UFT 治疗的患者的总生存期(OS)和无复发生存期(RFS),并对 pStage 和组织学亚型进行了调整。

结果

在整个队列(n=402)和某些亚组中,两种治疗方案在 OS 和 RFS 方面均无显著差异:pStage IB(n=228)、pStage II(n=117)、腺癌(AD,n=265)和鳞状细胞癌(SQ,n=101)。在 pStage IIIA 患者(n=57)中,CBDCA/PTX 的 RFS 优于 UFT [风险比(HR)0.44;P=0.016]。在非 AD 和非 SQ 组织学患者(n=36)中,UFT 的 OS 和 RFS 均优于 CBDCA/PTX(HR 分别为 0.16 和 0.23;P=0.046 和 0.011)。

结论

在 UFT 和 CBDCA/PTX 之间,存在一些亚组患者的治疗效果显著更优。选择 NSCLC 患者的辅助治疗方案需要考虑 pStage 和组织学亚型。

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