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真实世界中小细胞肺癌(SCLC)治疗的疗效和耐受性:系统文献回顾(SLR)。

Real-world effectiveness and tolerability of small-cell lung cancer (SCLC) treatments: A systematic literature review (SLR).

机构信息

Adelphi Values, Bollington, Cheshire, United Kingdom.

Bristol-Myers Squibb, Princeton, NJ, United States of America.

出版信息

PLoS One. 2019 Jul 18;14(7):e0219622. doi: 10.1371/journal.pone.0219622. eCollection 2019.

Abstract

OBJECTIVES

SCLC makes up approximately 15% of all lung carcinomas and is characterized by relatively aggressive spread and poorer prognosis compared to other lung cancers. Treatment options are limited, and their efficacy in randomized trials is poor, whilst outcomes in clinical practice remain unclear. The aim of this study was to assess the real-world effectiveness and tolerability of SCLC treatments.

METHODS

An SLR was conducted across nine databases accessed through OVID, capturing observational, non-randomized studies published between 01/2006-11/2018. In total, 554 abstracts were retrieved and systematically screened for eligibility. The eligible publications included effectiveness and tolerability data from adult SCLC patients (at any line of therapy). Additional grey literature searches were conducted.

RESULTS

Forty-three publications were included in this review-data from first-line therapies were captured most often (n = 32), while data from second (n = 14) and third line (n = 7) and beyond (n = 7) were less frequent. The publications reported primarily on chemotherapy/radiotherapy. The majority of publications lacked robustness and only 14/43 conducted statistical analyses or controlled for bias. Median OS for the largest SCLC populations were 9.6 months at first line (n = 23,535) and 4.9 months at second line (n = 254) for treatment with chemotherapy, and 4.7 months at third line (n = 120) for predominantly platinum-based chemotherapy or cyclophosphamide/adriamycin/vincristine. Hematologic toxicities (such as neutropenia, thrombocytopenia and anemia) were the most frequently reported TRAEs (n = 9).

CONCLUSIONS

Real-world treatment effectiveness and tolerability data were fragmented and inconsistently reported, and available publications were primarily of poor quality and lacked statistical analyses. This SLR showed limited treatment options and poor OS in SCLC, with no treatment option being clearly superior. TRAEs additionally increased the burden of this already challenging disease. Recent data suggest real-world outcomes are even poorer that those reported in clinical trials, and that novel therapies are needed to offer new treatment options for patients.

摘要

目的

小细胞肺癌约占所有肺癌的 15%,与其他肺癌相比,其具有侵袭性较强和预后较差的特点。治疗方案有限,且在随机试验中的疗效较差,而临床实践中的结果仍不清楚。本研究旨在评估小细胞肺癌治疗的真实世界疗效和耐受性。

方法

通过 OVID 访问的九个数据库进行 SLR,收集 2006 年 1 月至 2018 年 11 月期间发表的观察性、非随机研究。共检索到 554 篇摘要,并对其进行了系统筛选以确定其是否符合纳入标准。纳入的出版物包括成人小细胞肺癌患者(在任何治疗线)的有效性和耐受性数据。此外,还进行了额外的灰色文献检索。

结果

本综述共纳入 43 篇出版物-一线治疗的数据最为常见(n = 32),而二线(n = 14)、三线(n = 7)和三线以上(n = 7)的数据则较少。出版物主要报告了化疗/放疗。大多数出版物缺乏稳健性,仅有 14/43 篇进行了统计分析或控制了偏倚。最大的小细胞肺癌人群中,一线治疗的中位 OS 为 9.6 个月(n = 23535),二线治疗为化疗的 4.9 个月(n = 254),三线治疗为以铂类为基础的化疗或环磷酰胺/阿霉素/长春新碱的 4.7 个月(n = 120)。血液学毒性(如中性粒细胞减少症、血小板减少症和贫血)是最常报告的 TRAE(n = 9)。

结论

真实世界的治疗效果和耐受性数据分散且不一致,且现有的出版物主要质量较差,缺乏统计分析。本 SLR 表明小细胞肺癌的治疗选择有限且 OS 较差,没有一种治疗方法明显优于其他方法。TRAEs 还增加了这种已经具有挑战性的疾病的负担。最近的数据表明,真实世界的结果比临床试验报告的更差,需要新的治疗方法为患者提供新的治疗选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/85c2/6638917/d6915364389c/pone.0219622.g001.jpg

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