Mannocci Alice, De Feo Emma, de Waure Chiara, Specchia Maria Lucia, Gualano Maria Rosaria, Barone Carlo, Ricciardi Walter, La Torre Giuseppe
HTA Public Health Unit, Institute of Hygiene, Catholic University of the Sacred Heart, Rome, Italy.
Tumori. 2010 May-Jun;96(3):385-91. doi: 10.1177/030089161009600302.
Trastuzumab, a humanized monoclonal antibody directed against the extracellular domain of ErbB, has determined clinical benefit for women affected by metastatic or early stage HER2-positive breast cancer and never previously treated with trastuzumab. Trastuzumab is generally used as first-line treatment of HER2+ metastatic breast cancer and is currently administered beyond progression even without clear evidence supporting such clinical practice. In fact, HER2-positive metastatic breast cancer has a high risk of progressing after first-line therapy, and second-line treatments vary. The aim of the study was to investigate by a systematic review the efficacy of trastuzumab-based treatments beyond progression in HER2-positive metastatic breast cancer.
We performed a systematic review using Medline, Embase and Cochrane Library data bases and publications in principal meetings or congresses of oncology in Europe and America until September 2008. The main selection criterium was the reporting of time to progression, calculated from the start of each trastuzumab-based therapy to the date of progressive disease or death.
Twelve studies were selected that included a total of 516 patients. The weighted mean time to progression was 23.66 weeks (standard deviation, 4.37) and the median was 26 weeks (range, 13-39). Interestingly, combined trastuzumab plus vinorelbine treatment showed a lower mean and median time to progression (20.59 and 19.57 weeks, respectively), whereas trastuzumab plus capecitabine yielded a mean time to progression of 30.33 weeks.
The added value of the present study has been to provide a quantitative summary measure of time to progression which can be used for comparisons between current and future available regimens.
曲妥珠单抗是一种针对表皮生长因子受体2（ErbB）细胞外区域的人源化单克隆抗体，已确定对转移性或早期HER2阳性乳腺癌且此前未接受过曲妥珠单抗治疗的女性具有临床益处。曲妥珠单抗通常用作HER2 +转移性乳腺癌的一线治疗，目前即使在没有明确证据支持这种临床实践的情况下，在疾病进展后仍继续使用。事实上，HER2阳性转移性乳腺癌在一线治疗后进展风险很高，二线治疗方法各不相同。本研究的目的是通过系统评价来调查曲妥珠单抗为基础的治疗在HER2阳性转移性乳腺癌疾病进展后的疗效。
我们使用Medline、Embase和Cochrane图书馆数据库以及截至2008年9月在欧美肿瘤学主要会议或大会上发表的文献进行了系统评价。主要选择标准是报告疾病进展时间，从每种以曲妥珠单抗为基础的治疗开始到疾病进展或死亡日期进行计算。
选择了12项研究，共纳入516例患者。加权平均疾病进展时间为23.66周（标准差，4.37），中位数为26周（范围，13 - 39周）。有趣的是，曲妥珠单抗联合长春瑞滨治疗的平均和中位数疾病进展时间较低（分别为20.59周和19.57周），而曲妥珠单抗联合卡培他滨的疾病进展平均时间为30.33周。
本研究的附加价值在于提供了疾病进展时间的定量汇总指标，可用于当前和未来可用治疗方案之间的比较。
