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晚期食管鳞状细胞癌二线治疗的获益:一项三中心倾向评分分析。

Benefit of second-line therapy for advanced esophageal squamous cell carcinoma: a tri-center propensity score analysis.

作者信息

Müller Moritz, Posch Florian, Kiem Dominik, Barth Dominik, Horvath Lena, Stotz Michael, Schaberl-Moser Renate, Pichler Martin, Greil Richard, Jost Philipp J, Seeber Andreas, Amann Arno, Schlick Konstantin, Gerger Armin, Riedl Jakob M

机构信息

Division of Oncology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.

IIIrd Medical Department of Hematology, Medical Oncology, Hemostaseology, Rheumatology and Infectious Disease, Salzburg Cancer Research Institute, Paracelsus Medical University, Salzburg, Austria.

出版信息

Ther Adv Med Oncol. 2021 Sep 30;13:17588359211039930. doi: 10.1177/17588359211039930. eCollection 2021.

Abstract

BACKGROUND

The level of evidence for palliative second-line therapy in advanced esophageal squamous cell carcinoma (aESCC) is limited. This is the first study that reports efficacy data comparing second-line therapy + active symptom control (ASC) ASC alone in aESCC.

METHODS

We conducted a tri-center retrospective cohort study ( = 166) including patients with aESCC who had experienced disease progression on palliative first-line therapy. A propensity score model using inverse probability of treatment weighting (IPTW) was implemented for comparative efficacy analysis of overall survival (OS) in patients with second-line + ASC ( = 92, 55%) ASC alone ( = 74, 45%).

RESULTS

The most frequent second-line regimens used were docetaxel (36%) and paclitaxel (18%). In unadjusted primary endpoint analysis, second-line + ASC was associated with significantly longer OS compared with ASC alone [hazard ratio (HR) = 0.49, 95% confidence interval (CI): 0.35-0.69,  < 0.0001]. However, patients in the second-line + ASC group were characterized by more favorable baseline features including a better Eastern Cooperative Oncology Group (ECOG) performance status, a longer first-line treatment duration and lower C-reactive protein levels. After rigorous adjusting for baseline confounders by re-weighting the data with the IPTW the favorable association between second-line and longer OS weakened but prevailed. The median OS was 6.1 months in the second-line + ASC group and 3.2 months in the ASC group, respectively (IPTW-adjusted HR = 0.40, 95% CI: 0.24-0.69,  = 0.001). Importantly, the benefit of second-line was consistent across several clinical subgroups, including patients with ECOG performance status ⩾1 and age ⩾65 years. The most common grade 3 or 4 adverse events associated with palliative second-line therapy were hematological toxicities.

CONCLUSION

This real-world study supports the concept that systemic second-line therapy prolongs survival in patients with aESCC.

摘要

背景

晚期食管鳞状细胞癌(aESCC)姑息性二线治疗的证据水平有限。这是第一项报告比较二线治疗联合积极症状控制(ASC)与单纯ASC在aESCC中疗效数据的研究。

方法

我们进行了一项三中心回顾性队列研究(n = 166),纳入了在姑息性一线治疗后疾病进展的aESCC患者。采用倾向评分模型,使用治疗权重的逆概率(IPTW)对二线治疗联合ASC组(n = 92,55%)和单纯ASC组(n = 74,45%)患者的总生存期(OS)进行比较疗效分析。

结果

最常用的二线治疗方案是多西他赛(36%)和紫杉醇(18%)。在未经调整的主要终点分析中,二线治疗联合ASC与单纯ASC相比,OS显著延长[风险比(HR)= 0.49,95%置信区间(CI):0.35 - 0.69,P < 0.0001]。然而,二线治疗联合ASC组的患者具有更有利的基线特征,包括更好的东部肿瘤协作组(ECOG)体能状态、更长的一线治疗持续时间和更低的C反应蛋白水平。通过使用IPTW对数据进行重新加权以严格调整基线混杂因素后,二线治疗与更长OS之间的有利关联减弱但仍然显著。二线治疗联合ASC组和ASC组的中位OS分别为6.1个月和3.2个月(IPTW调整后的HR = 0.40,95% CI:0.24 - 0.69,P = 0.001)。重要的是,二线治疗的益处在几个临床亚组中是一致的,包括ECOG体能状态⩾1和年龄⩾65岁的患者。与姑息性二线治疗相关的最常见3级或4级不良事件是血液学毒性。

结论

这项真实世界研究支持全身二线治疗可延长aESCC患者生存期这一概念。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/75f9/8488508/87af707e5aaa/10.1177_17588359211039930-fig1.jpg

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