Weekly paclitaxel in the adjuvant treatment of breast cancer
Weekly paclitaxel in the adjuvant treatment of breast cancer
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DOI：
10.1056/nejmoa0707056
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发表时间：
2008-04-17
影响因子：
158.5
通讯作者：
Davidson, Nancy E.
中科院分区：
文献类型：
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作者：
Sparano, Joseph A.;Wang, Molin;Davidson, Nancy E.
背景：我们比较了两种不同的紫杉烷，多西紫杉醇和紫杉醇，每周或每3周给予一次辅助治疗乳腺癌的疗效。方法：我们招募了4950名腋窝淋巴结阳性或高危、淋巴结阴性乳腺癌患者。随机分组后，所有患者先接受阿霉素和环磷酰胺静脉注射，间隔3周，然后分别给予紫杉醇或多西紫杉醇静脉注射，间隔3周，共4个周期，或间隔1周，共12个周期。结果：与接受标准治疗(每3周一次紫杉醇)的患者相比，每周接受紫杉醇治疗的患者无病生存的优势比为1.2 7(P=0.006)，每3周接受一次多西紫杉醇治疗的患者无病生存的优势比为1.2 3(P=0.0 2)，每周接受多西紫杉醇治疗的患者无病生存的优势比为1.09(P=0.2 9)。与标准治疗相比，每周一次的紫杉醇治疗也与存活率的提高有关(优势比，1.32；P=0.01)。一项对肿瘤不表达人类表皮生长因子受体2型蛋白的患者亚组的探索性分析发现，无论激素受体表达如何，每周接受紫杉醇治疗在无病和总存活率方面都有类似的改善。每周服用紫杉醇的2级、3级或4级神经病变的发生率高于每3周服用紫杉醇的患者(27%比20%)。结论：在乳腺癌患者接受阿霉素和环磷酰胺的标准辅助化疗后，每周服用紫杉醇可以提高患者的无病生存率和总体生存率。(ClinicalTrials.gov编号，NCT00004125)。
Background: We compared the efficacy of two different taxanes, docetaxel and paclitaxel, given either weekly or every 3 weeks, in the adjuvant treatment of breast cancer.Methods: We enrolled 4950 women with axillary lymph node-positive or high-risk, lymph node-negative breast cancer. After randomization, all patients first received 4 cycles of intravenous doxorubicin and cyclophosphamide at 3-week intervals and were then assigned to intravenous paclitaxel or docetaxel given at 3-week intervals for 4 cycles or at 1-week intervals for 12 cycles. The primary end point was disease-free survival.Results: As compared with patients receiving standard therapy (paclitaxel every 3 weeks), the odds ratio for disease-free survival was 1.27 among those receiving weekly paclitaxel (P=0.006), 1.23 among those receiving docetaxel every 3 weeks (P=0.02), and 1.09 among those receiving weekly docetaxel (P=0.29) (with an odds ratio >1 favoring the groups receiving experimental therapy). As compared with standard therapy, weekly paclitaxel was also associated with improved survival (odds ratio, 1.32; P=0.01). An exploratory analysis of a subgroup of patients whose tumors expressed no human epidermal growth factor receptor type 2 protein found similar improvements in disease-free and overall survival with weekly paclitaxel treatment, regardless of hormone-receptor expression. Grade 2, 3, or 4 neuropathy was more frequent with weekly paclitaxel than with paclitaxel every 3 weeks (27% vs. 20%).Conclusions: Weekly paclitaxel after standard adjuvant chemotherapy with doxorubicin and cyclophosphamide improves disease-free and overall survival in women with breast cancer. (ClinicalTrials.gov number, NCT00004125.).