Ghersi D, Wilcken N, Simes J, Donoghue E
NHMRC Clinical Trials Centre, The University of Sydney, Locked Bag 77, Camperdown, NSW, Australia.
Cochrane Database Syst Rev. 2003(3):CD003366. doi: 10.1002/14651858.CD003366.
It is generally accepted that taxanes are among the most active chemotherapy agents in the management of metastatic breast cancer.
To identify and review the randomised evidence comparing taxane containing chemotherapy regimens with regimens not containing a taxane in the management of women with metastatic breast cancer.
The specialised register maintained by the Editorial Base of the Cochrane Breast Cancer Group was searched on 2nd May 2003 using the codes for "advanced breast cancer", "chemotherapy". Details of the search strategy applied by the Group to create the register, and the procedure used to code references, are described in the Group's module on the Cochrane Library.
Randomised trials comparing taxane-containing chemotherapy regimens with regimens not containing taxanes in women with metastatic breast cancer.
Data were collected from published trials. Studies were assessed for eligiblity and quality, and data were extracted, by two independent reviewers. Hazard ratios were derived for time-to-event outcomes where possible, and a fixed effect model was used for meta-analysis. Response rates were analysed as dichotomous variables. Toxicity and quality of life data were extracted where present.
Twenty eligible trials were identified of which 17 had published at least some results, and 12 had published time-to-event data. The quality of randomisation was generally not described. An estimated 2659 deaths in 3643 randomised women demonstrate a statistically significant difference in favour of taxane-containing regimens with a HR for overall survival of 0.90 (95% CI=0.84-0.97, p=0.009) and no significant heterogeneity. If the analysis is restricted to trials of firstline chemotherapy the HR changes to 0.92 and is no longer statistically significant (95% CI 0.84-1.02, p=0.12). There was also a significant difference in favour of taxanes in relation to time to progression (overall HR 0.87, 95%CI 0.81-0.93, p<0.0001) and overall response (overall OR 1.29, 95%CI 1.13-1.47, p<0.0001) however there was strong statistical evidence of heterogeneity (P<0.00001), probably reflecting the varying efficacy of the comparator regimens used in the trials.
REVIEWER'S CONCLUSIONS: When all trials are considered, taxane-containing regimens appear to improve overall survival, time to progression and overall response in women with metastatic breast cancer. The degree of heterogeneity encountered indicates that taxane-containing regimens are more effective than some, but not all non-taxane-containing regimens.
一般认为紫杉烷类是转移性乳腺癌治疗中最有效的化疗药物之一。
识别并综述在转移性乳腺癌女性患者治疗中,含紫杉烷化疗方案与不含紫杉烷方案对比的随机对照证据。
2003年5月2日检索了Cochrane乳腺癌协作组编辑基地维护的专业注册库,使用了“晚期乳腺癌”“化疗”的检索词。该协作组用于创建注册库的检索策略细节以及参考文献编码程序,在Cochrane图书馆的协作组模块中有描述。
转移性乳腺癌女性患者中,含紫杉烷化疗方案与不含紫杉烷方案对比的随机对照试验。
从已发表的试验中收集数据。由两名独立评审员评估研究的纳入资格和质量,并提取数据。尽可能从事件发生时间结局中得出风险比,采用固定效应模型进行荟萃分析。将缓解率作为二分变量进行分析。如有毒性和生活质量数据也一并提取。
共识别出20项符合纳入标准的试验,其中17项至少发表了部分结果,12项发表了事件发生时间数据。随机分组的质量一般未作描述。3643例随机分组女性患者中估计有2659例死亡,结果显示含紫杉烷方案具有统计学显著差异,总生存风险比为0.90(95%CI=0.84 - 0.97,p = 0.009),且无显著异质性。若将分析局限于一线化疗试验,风险比变为0.92,不再具有统计学显著性(95%CI 0.84 - 1.02,p = 0.12)。在疾病进展时间方面(总风险比0.87,95%CI 0.81 - 0.93,p < 0.0001)和总缓解率方面(总比值比1.29,95%CI 1.13 - 1.47,p < 0.0001),支持紫杉烷类药物的差异也很显著,然而有强有力的统计学证据表明存在异质性(P < 0.00001),这可能反映了试验中所用对照方案疗效各异。
综合所有试验来看,含紫杉烷方案似乎可改善转移性乳腺癌女性患者的总生存、疾病进展时间和总缓解率。所遇到的异质性程度表明,含紫杉烷方案比部分但并非所有不含紫杉烷方案更有效。