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用于小细胞肺癌的铂类与非铂类化疗方案

Platinum versus non-platinum chemotherapy regimens for small cell lung cancer.

作者信息

Amarasena Isuru U, Chatterjee Saion, Walters Julia A E, Wood-Baker Richard, Fong Kwun M

机构信息

School of Medicine, University of Tasmania, 43 Collins Street, Hobart, Tasmania, Australia, 7005.

出版信息

Cochrane Database Syst Rev. 2015 Aug 2;2015(8):CD006849. doi: 10.1002/14651858.CD006849.pub3.

Abstract

BACKGROUND

Small cell lung cancer (SCLC) is a very fast growing form of cancer and is characterised by early metastasis. As a result, chemotherapy is the mainstay of treatment. A number of different platinum-based chemotherapy regimens and non-platinum-based chemotherapy regimens have been used for the treatment of SCLC, with varying results. This review was conducted to analyse the data from these studies in order to compare their effectiveness.

OBJECTIVES

To determine the effectiveness of platinum chemotherapy regimens compared with non-platinum chemotherapy regimens in the treatment of SCLC with respect to survival, tumour response, toxicity and quality of life.

SEARCH METHODS

We searched the biomedical literature databases CENTRAL (TheCochrane Library 2014, Issue 7), MEDLINE, EMBASE and CINAHL from 1966 to August 2014. In addition, we handsearched reference lists from relevant resources.

SELECTION CRITERIA

All randomised controlled trials involving patients with pathologically confirmed SCLC (including both limited-stage disease and extensive-stage disease) and the use of a platinum-based chemotherapy regimen in at least one treatment arm and a non-platinum-based chemotherapy regimen in a separate arm.

DATA COLLECTION AND ANALYSIS

We used standard methodological procedures expected by the Cochrane Collaboration. Two authors independently assessed search results. We assessed included studies for methodological quality and recorded the following outcome data: survival, tumour response, toxicity and quality of life. We combined the results of the survival, tumour response and toxicity data in a meta-analysis. Quality-of-life data were analysed individually.

MAIN RESULTS

A total of 32 studies involving 6075 patients with SCLC were included in this systematic review. The majority of studies were multi-centre randomised controlled trials conducted throughout Europe, North America and Asia with the earliest study publishing data in 1981 and the latest in 2014. The duration of studies ranged from 12 to 72 months with a median of 32 months. The median age of patients in the vast majority of studies was between 60 and 65 years of age. Eighteen studies presented data on extensive-stage disease. Nine studies presented data on limited-stage disease. Eleven studies did not present data based on the disease stage. These data were analysed separately in subgroup analyses. Sixteen (50%) studies were of good quality with a low risk of bias and the data from these studies were analysed separately in a heterogeneity analysis.There was no statistically significant difference between treatment groups in terms of survival at 6 months, 12 months and 24 months. There was also no statistically significant difference in terms of overall tumour response. However, platinum-based treatment regimens did have a significantly higher rate of complete response. Platinum-based chemotherapy regimens had significantly higher rates of nausea and vomiting and thrombocytopenia toxicity. Four trials presented quality-of-life data, but, due to the different systems used to measure quality of life this data could not be combined in a meta-analysis.

AUTHORS' CONCLUSIONS: Platinum-based chemotherapy regimens did not offer a statistically significant benefit in survival or overall tumour response compared with non-platinum-based regimens. However, platinum-based chemotherapy regimens did increase complete response rates, at the cost of higher adverse events including nausea and vomiting, anaemia and thrombocytopenia toxicity. These data suggest non-platinum chemotherapy regimens have a more advantageous risk-benefit profile. This systematic review highlights the lack of quality-of-life data in trials involving chemotherapy treatment for SCLC. With poor long-term survival associated with both treatment groups, the issue of the quality of the survival period takes on even more significance. It would be beneficial for future trials in this area to include a quality-of-life assessment.

摘要

背景

小细胞肺癌(SCLC)是一种生长迅速的癌症,其特点是早期转移。因此,化疗是主要的治疗方法。多种不同的铂类化疗方案和非铂类化疗方案已被用于治疗SCLC,疗效各异。本综述旨在分析这些研究的数据,以比较它们的有效性。

目的

确定铂类化疗方案与非铂类化疗方案在治疗SCLC时在生存、肿瘤反应、毒性和生活质量方面的有效性。

检索方法

我们检索了生物医学文献数据库CENTRAL(《Cochrane图书馆》2014年第7期)、MEDLINE、EMBASE和CINAHL,检索时间范围为1966年至2014年8月。此外,我们还手工检索了相关资源的参考文献列表。

选择标准

所有随机对照试验,涉及病理确诊的SCLC患者(包括局限期疾病和广泛期疾病),且至少一个治疗组使用铂类化疗方案,另一个单独的组使用非铂类化疗方案。

数据收集与分析

我们采用了Cochrane协作网期望的标准方法程序。两位作者独立评估检索结果。我们评估纳入研究的方法学质量,并记录以下结局数据:生存、肿瘤反应、毒性和生活质量。我们对生存、肿瘤反应和毒性数据的结果进行了荟萃分析。生活质量数据进行单独分析。

主要结果

本系统综述共纳入32项涉及6075例SCLC患者的研究。大多数研究是在欧洲、北美和亚洲进行的多中心随机对照试验,最早的研究于1981年发表数据,最晚的于2014年发表。研究持续时间为12至72个月,中位数为32个月。绝大多数研究中患者的中位年龄在60至65岁之间。18项研究提供了广泛期疾病的数据。9项研究提供了局限期疾病的数据。11项研究未提供基于疾病分期的数据。这些数据在亚组分析中分别进行了分析。16项(50%)研究质量良好,偏倚风险低,这些研究的数据在异质性分析中分别进行了分析。治疗组在6个月、12个月和24个月时的生存率无统计学显著差异。总体肿瘤反应方面也无统计学显著差异。然而,铂类治疗方案的完全缓解率显著更高。铂类化疗方案的恶心、呕吐和血小板减少毒性发生率显著更高。四项试验提供了生活质量数据,但由于用于测量生活质量的系统不同,该数据无法进行荟萃分析。

作者结论

与非铂类方案相比,铂类化疗方案在生存或总体肿瘤反应方面未显示出统计学显著益处。然而,铂类化疗方案确实提高了完全缓解率,但代价是更高的不良事件发生率,包括恶心、呕吐、贫血和血小板减少毒性。这些数据表明非铂类化疗方案具有更有利的风险效益比。本系统综述强调了SCLC化疗治疗试验中生活质量数据的缺乏。由于两个治疗组的长期生存率都很低,生存期质量问题变得更加重要。未来该领域的试验纳入生活质量评估将是有益的。

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