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广泛期小细胞肺癌的化疗与最佳支持治疗对比

Chemotherapy versus best supportive care for extensive small cell lung cancer.

作者信息

Pelayo Alvarez Marta, Gallego Rubio Oscar, Bonfill Cosp Xavier, Agra Varela Yolanda

机构信息

Atención Primaria área 11, Conselleria Valenciana, Valencia, Spain.

出版信息

Cochrane Database Syst Rev. 2009 Oct 7(4):CD001990. doi: 10.1002/14651858.CD001990.pub2.

Abstract

BACKGROUND

Combination chemotherapy has been the mainstay of treatment for extensive stage small celI lung cancer (SCLC) over the last 30 years even though it only gives a short prolongation in median survival time. The main goal for these patients should be palliation with the aim of improving their quality of life.

OBJECTIVES

To evaluate the effectiveness of chemotherapy in extensive SCLC compared with best supportive care (BSC) or placebo treatment.

SEARCH STRATEGY

MEDLINE (1966 to July 2008), EMBASE (1974 to week 31, 2008), and the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 3, 2008). Experts in the field were contacted.

SELECTION CRITERIA

Randomised controlled trials in which any chemotherapy treatment was compared with placebo or BSC in patients with extensive SCLC, as first or second therapy at relapse.

DATA COLLECTION AND ANALYSIS

Two authors independently extracted data and assessed study quality. We resolved disagreements by discussion. Additional information was obtained from one study author.

MAIN RESULTS

Two studies were included for first-line chemotherapy. A total of 65 patients were randomised to receive either placebo or ifosfamide. Ifosfamide gave an extra mean survival of 78.5 days compared with placebo. Partial tumour response was greater with the active treatment. Toxicity was only seen in the chemotherapy group.Two studies were included for second-line chemotherapy at relapse. A total of 531 patients were randomised to receive either methotrexate-doxorubicin or symptomatic treatment, or to receive oral topotecan versus BSC. The methotrexate-doxorubicin treatment gave a median survival of 63 days longer than in the symptomatic treatment group, and 21 days longer for patients allocated to receive four or eight cycles of first-line chemotherapy, respectively.Treatment with topotecan gave a median survival of 84 days longer than in the BSC group (log-rank P = 0.01). The adjusted hazard ratio for overall survival was 0.61 (95% CI, 0.43 to 0.87). Partial or complete response in the methotrexate-doxorubicin group was 22.3%. Five patients (7%, 95% CI, 2.33 to 15.67) showed a partial response with topotecan. Toxicity was worst in the chemotherapy group. Quality of life was better in the topotecan group.

AUTHORS' CONCLUSIONS: Chemotherapeutic treatment prolongs survival in comparison with placebo in patients with advanced SCLC. Nevertheless, the impact of first-line chemotherapy on quality of life and in patients with poor prognosis is unknown. Well-designed, controlled trials are needed to further evaluate the risks and benefits of different chemotherapeutic schedules in patients with advanced SCLC.

摘要

背景

在过去30年里,联合化疗一直是广泛期小细胞肺癌(SCLC)的主要治疗方法,尽管它仅能使中位生存时间稍有延长。这些患者的主要治疗目标应是姑息治疗,以提高其生活质量。

目的

评估与最佳支持治疗(BSC)或安慰剂治疗相比,化疗对广泛期SCLC的疗效。

检索策略

检索MEDLINE(1966年至2008年7月)、EMBASE(1974年至2008年第31周)以及Cochrane对照试验中心注册库(CENTRAL,2008年第3期)。并联系了该领域的专家。

入选标准

随机对照试验,其中将任何化疗方案与安慰剂或BSC用于广泛期SCLC患者,作为复发时的一线或二线治疗进行比较。

数据收集与分析

两位作者独立提取数据并评估研究质量。我们通过讨论解决分歧。从一位研究作者处获取了额外信息。

主要结果

两项研究纳入一线化疗。共65例患者被随机分配接受安慰剂或异环磷酰胺。与安慰剂相比,异环磷酰胺使平均生存时间延长了78.5天。积极治疗组的部分肿瘤缓解情况更好。仅化疗组出现了毒性反应。两项研究纳入复发时的二线化疗。共531例患者被随机分配接受甲氨蝶呤-阿霉素或对症治疗,或接受口服拓扑替康与BSC治疗。甲氨蝶呤-阿霉素治疗组的中位生存时间比对症治疗组长63天,对于分别接受四个或八个周期一线化疗的患者,中位生存时间分别长21天。拓扑替康治疗组的中位生存时间比BSC组长84天(对数秩检验P = 0.01)。总体生存的调整风险比为0.61(95%CI,0.43至0.87)。甲氨蝶呤-阿霉素组的部分或完全缓解率为22.3%。5例患者(7%,95%CI,2.33至15.67)接受拓扑替康治疗后出现部分缓解。化疗组的毒性反应最严重。拓扑替康组的生活质量更好。

作者结论

与安慰剂相比,化疗可延长晚期SCLC患者的生存时间。然而,一线化疗对生活质量以及预后不良患者的影响尚不清楚。需要设计良好的对照试验来进一步评估不同化疗方案在晚期SCLC患者中的风险和益处。

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