Weekly epirubicin plus docetaxel as first-line treatment in metastatic breast cancer.
Weekly epirubicin plus docetaxel as first-line treatment in metastatic breast cancer.
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DOI：
10.1038/sj.bjc.6603982
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发表时间：
2007-10-22
影响因子：
8.8
通讯作者：
Meliffi L
中科院分区：
文献类型：
--
作者：
Gamucci T;D'Ottavio AM;Magnolfi E;Barduagni M;Vaccaro A;Sperduti I;Moscetti L;Belli F;Meliffi L
这项研究旨在评估表柔比星联合多西他赛治疗转移性乳腺癌(MBC)一线治疗的有效性和耐受性。43名此前没有接受过转移性疾病化疗的单核细胞白血病患者每周接受表阿霉素25 mg m−2和多西紫杉醇25 mg m−2治疗，最多5个周期(表阿霉素累计剂量⩽900 mg m−2)。剂量减少是不允许的。客观反应和毒性评估是主要的研究终点，进展时间和总生存期是次要终点。对患者进行了中位时间21(4-38)个月的随访。按治疗意向进行分析，33例患者完成了5个周期的治疗，43例患者的表阿霉素中位剂量为23 mg m−2。25例(58%)患者部分缓解，1例(2%)完全缓解。另有12名患者(28%)病情稳定。中位进展时间为11个月(95%可信区间(CI)7-14)，26例对治疗有反应的患者平均进展时间为13个月(95%可信区间(CI)12-14)。应答者的中位总生存期为25个月，无应答者为14个月。16%的患者出现3/4度中性粒细胞减少，6%的周期出现。1例患者出现心脏毒性(左心室射血分数减少20%)。表柔比星联合多西紫杉醇在MBC中非常有效，毒性可控。这样的每周计划可能会为MBC提供一个有价值的治疗选择。
This study was designed to evaluate the efficacy and tolerability of a weekly schedule of epirubicin in combination with docetaxel in the first-line treatment of patients with metastatic breast cancer (MBC). A total of 43 women with MBC not previously treated with chemotherapy for metastatic disease received weekly epirubicin 25 mg m−2 and docetaxel 25 mg m−2 for a maximum of five cycles (total cumulative epirubicin dose of ⩽900 mg m−2). Dose reduction was not permitted. Objective response and evaluation of toxicity profile were the primary study end points; time to progression and overall survival were secondary end points. Patients were followed for a median of 21 (4–38) months. Analysis was by intent to treat; 33 patients completed five cycles of therapy, and the median dose of epirubicin administered to the 43 patients was 23 mg m−2. Twenty-five patients (58%) achieved a partial response and one (2%) achieved a complete response. An additional 12 patients (28%) had stable disease. The median time to progression was 11 months (95% confidence intervals (CI) 7–14) overall, and 13 months (95% CI 12–14) in the 26 patients who responded to treatment. Median overall survival was 25 months for responders and 14 months for nonresponders. Grade 3/4 neutropenia occurred in 16% of patients and in 6% of cycles. One patient developed cardiac toxicity (20% reduction in left ventricular ejection fraction). The combination of epirubicin plus docetaxel is highly active in MBC, with a manageable toxicity profile. Such a weekly schedule might provide a valuable treatment option for MBC.
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影响因子：
45.3
作者：
O'Shaughnessy, J;Miles, D;Leonard, R
通讯作者：
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作者：
Pagani, O;Sessa, C;Goldhirsch, A
通讯作者：
Goldhirsch, A