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成人局限性可切除软组织肉瘤的辅助化疗。肉瘤荟萃分析协作组(SMAC)。

Adjuvant chemotherapy for localised resectable soft tissue sarcoma in adults. Sarcoma Meta-analysis Collaboration (SMAC).

机构信息

London, UK

出版信息

Cochrane Database Syst Rev. 2000;2000(2):CD001419. doi: 10.1002/14651858.CD001419.

Abstract

BACKGROUND

Individually, randomised trilas have not shown conclusively whether adjuvant chemotherapy benefits adult patients with localised resectable soft-tissue sarcoma.

OBJECTIVES

Adjuvant chemotherapy aims to lessen the recurrence of cancer after surgery with or without radiotherapy. The objective of this review was to assess the effects of adjuvant chemotherapy in adults with resectable soft tissue sarcoma after such local treatment.

SEARCH STRATEGY

We searched the Cochrane Controlled Trials Register, UKCCCR Register of Cancer Trials, Physicians Data Query, EMBASE, MEDLINE and CancerLit.

SELECTION CRITERIA

Randomised trials of adjuvant chemotherapy after local treatment in adults with localised resectable soft tissue sarcoma were included. Only trials in which accrual was completed by December 1992 were included.

DATA COLLECTION AND ANALYSIS

Individual patient data were obtained. Accuracy of data and quality of randomisation and follow-up of trials was assessed.

MAIN RESULTS

Fourteen trials of doxorubicin-based adjuvant chemotherapy involving 1568 patients were included. Median follow-up was 9.4 years. For local recurrence-free interval the hazard ratio with chemotherapy was 0.73 (95% Confidence Interval 0.56-0.94). For distant recurrence-free interval it was 0. 70 (95% CI 0.57-0.85). For overall recurrence-free survival it was 0. 75 (95% CI 0.64-0.87). These correspond to significant absolute benefits of 6-10% at 10 years. For overall survival the hazard ratio of 0.89 (95% CI 0.76-1.03) was not significant but potentially represents an absolute benefit of 4% (95% CI -1 to 9) at 10 years. There was no consistent evidence of a difference in effect according to age, sex, stage, site, grade, histology, extent of resection, tumour size or exposure to radiotherapy. However, the strongest evidence of a beneficial effect on survival was shown in patients with sarcoma of the extremities.

REVIEWER'S CONCLUSIONS: Doxorubicin-based adjuvant chemotherapy appears to significantly improve time to local and distant recurrence and overall recurrence-free survival in adults with localised resectable soft tissue sarcoma. There is some evidence of a trend towards improved overall survival.

摘要

背景

个别随机试验尚未明确显示辅助化疗对局部可切除的软组织肉瘤成年患者是否有益。

目的

辅助化疗旨在降低手术联合或不联合放疗后癌症复发的风险。本综述的目的是评估辅助化疗对局部治疗后可切除软组织肉瘤成年患者的效果。

检索策略

我们检索了Cochrane对照试验注册库、英国癌症协作中心癌症试验注册库、医师数据查询库、EMBASE、MEDLINE和CancerLit。

入选标准

纳入局部可切除软组织肉瘤成年患者局部治疗后辅助化疗的随机试验。仅纳入1992年12月前完成病例积累的试验。

数据收集与分析

获取个体患者数据。评估数据准确性以及试验随机化和随访质量。

主要结果

纳入了14项基于阿霉素的辅助化疗试验,涉及1568例患者。中位随访时间为9.4年。对于局部无复发生存期,化疗的风险比为0.73(95%置信区间0.56 - 0.94)。对于远处无复发生存期,风险比为0.70(95%置信区间0.57 - 0.85)。对于总无复发生存期,风险比为0.75(95%置信区间0.64 - 0.87)。这些对应于10年时6% - 10%的显著绝对获益。对于总生存期,风险比为0.89(95%置信区间0.76 - 1.03)不显著,但可能代表10年时4%(95%置信区间 - 1至9)的绝对获益。没有一致的证据表明根据年龄、性别、分期、部位、分级、组织学、切除范围、肿瘤大小或放疗暴露情况,效果存在差异。然而,对生存期有益的最有力证据见于四肢肉瘤患者。

综述作者结论

基于阿霉素的辅助化疗似乎能显著改善局部可切除软组织肉瘤成年患者的局部和远处复发时间以及总无复发生存期。有一些证据表明总生存期有改善趋势。

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