Dent Susan, Messersmith Hans, Trudeau Maureen
The Ottawa Hospital Regional Cancer Centre, Ottawa, Canada.
Breast Cancer Res Treat. 2008 Apr;108(3):319-31. doi: 10.1007/s10549-007-9610-z. Epub 2007 May 26.
A systematic review of the evidence for gemcitabine chemotherapy, alone or in combination, in women with metastatic/advanced breast cancer was undertaken in order to determine gemcitabine's role in the first-line and/or second-line or greater setting.
MEDLINE, EMBASE, the American Society of Clinical Oncologists, San Antonio Breast Cancer Symposium proceedings, and the Cochrane Library were searched through September 2006 for randomized controlled trials and non-randomized phase two trials.
Eighty-three trials were identified, including four randomized phase III trials. All of the phase III trials included first-line patients. Two of the phase III trails demonstrated clinical benefit with gemcitabine-based chemotherapy in terms of superior efficacy or less toxicity while two phase III trials found no clinical benefit based on less efficacy or increased toxicity. Although 78 phase II trials of gemcitabine alone or in combination with other chemotherapy agents were identified, few combinations showed results compelling enough to warrant randomized trials.
Available data do not support the acceptance of gemcitabine as a standard therapeutic option in women with metastatic breast cancer in the third-line or greater setting, nor should it be considered as first-line therapy in anthracycline naïve women. Gemcitabine appears to be most effective when administered with a taxane (docetaxel/paclitaxel) in the first- or second-line setting, with gemcitabine/taxane combinations representing a viable alternative to currently accepted taxane combinations such as capecitabine/docetaxel. There is no evidence at this time to support the use of gemcitabine triplets, given the equal efficacy to anthracycline triplets and the added toxicity.
对吉西他滨单药或联合化疗用于转移性/晚期乳腺癌女性患者的证据进行系统评价，以确定吉西他滨在一线和/或二线及以上治疗中的作用。
检索截至2006年9月的MEDLINE、EMBASE、美国临床肿瘤学会、圣安东尼奥乳腺癌研讨会论文集以及Cochrane图书馆，查找随机对照试验和非随机二期试验。
共识别出83项试验，包括4项随机III期试验。所有III期试验均纳入一线患者。两项III期试验显示基于吉西他滨的化疗在疗效更佳或毒性更低方面具有临床获益，而两项III期试验基于疗效较差或毒性增加未发现临床获益。尽管识别出78项吉西他滨单药或与其他化疗药物联合的II期试验，但很少有联合方案显示出足以支持进行随机试验的结果。
现有数据不支持将吉西他滨作为三线及以上转移性乳腺癌女性患者的标准治疗选择，在未使用过蒽环类药物的女性中也不应将其视为一线治疗。在一线或二线治疗中，吉西他滨与紫杉烷（多西他赛/紫杉醇）联合使用时似乎最有效，吉西他滨/紫杉烷联合方案是目前公认的紫杉烷联合方案（如卡培他滨/多西他赛）的可行替代方案。鉴于与蒽环类三联方案疗效相当且毒性增加，目前没有证据支持使用吉西他滨三联方案。
