2014年美国临床肿瘤学会年会将于当地时间5月30日-6月3日在芝加哥召开，根据大会的会议日程，我国肿瘤专家徐兵河教授在6月2日上午有一项研究在“General Poster Session”中展出，下面和大家提前分享这项精彩研究。医脉通小编们今年也将继续奔赴ASCO年会现场，及时将各项最新研究进展整理、发布，欢迎大家保持关注！

该研究旨在确定可以手术治疗的、腋窝淋巴结阳性的乳腺癌患者应用6疗程的表柔比星+紫杉醇方案（ET方案）与4疗程的表柔比星+环磷酰胺，随后加用4疗程的紫杉醇方案（EC-T方案）进行辅助化疗的疗效是否相似，前者是否治疗时间更短，毒性作用更小。

研究方法

可以手术治疗的、淋巴结阳性的乳腺癌患者被纳入了研究，并被随机分配到应用ET方案组（表柔比星75 mg/m² +紫杉醇175 mg/m² X 6 ，3周一疗程）或EC-T方案组（表柔比星90 mg/m² +环磷酰胺600 mg/m² X 4 ，3周一疗程，4疗程后改用紫杉醇175 mg/m² X4天，2周一疗程）。主要评价指标是无病生存期。试验设计的两种方案风险比的95%置信区间的上限为1.30。发现这种差异(a=0.05, β=80%)需要的样本量大小为905。假设失访率为10%，那么就需要996位患者。计划在50%的患者入组后进行首次无病生存期的分析。

研究结果

2009年8月至2013年10月，共有496位患者纳入了研究，445位患者完成了治疗方案，其中214位患者被分配到EC-T组，231位患者被分配到ET组。我们对两组患者的特点进行了比较。两组中患者的年龄的中位数为49岁。EC-T组和ET组的患者ER/PR阳性率分别为87.4% 和92.2%。随访时间的中位数为35.5个月，共观察到28例不良事件（每组14例）。EC-T组患者4年无病生存率为91.3%，ET组患者4年无病生存率为91.4%(时序检验 p= 0.719,HR = 0.873, 95%CI = 0.416-1.832)。两种方案的耐受性都很好。EC-T组92.1%的患者、ET组88.7%的患者完成全部疗程的治疗。EC-T组中24.8%的患者、ET组中35.5%的患者要求减量。最常见的3/4级毒性反应是中性粒细胞减少、恶心和贫血，两组并无显著性差异。

结论

淋巴结阳性的早期乳腺癌患者应用6疗程的ET方案和8疗程的EC-T方案的毒性作用相似。两种化疗方案的疗效还需要等待纳入更多的患者和进一步随访研究的结果。临床试验信息：NCT01134523.

医脉通整理报道，转载请注明出处。

会议专题》》》2014年ASCO年会专题报道

阅读英文摘要

Comparison of six cycles of epirubicin and paclitaxel (ET) versus four cycles of epirubicin and cyclophosphamide, followed by four cycles of paclitaxel (EC-T) as adjuvant therapy for operable breast cancer in women with positive axillary nodes.（Abstract No:1042）

Authors: Peng Yuan, Jiayu Wang, Fei Ma, Binghe Xu, et al.

Session Type: General Poster Session

Background: To determine if 6 cycles of ET has similar efficacy to 4 cycles of EC followed by 4 cycles of T, but with shorter treatment time and reduced toxicity. 

Methods: Patients with operable breast cancer and positive lymph nodes were enrolled and randomized to receive ET (75/175 mg/m2 X 6 every 21 days) or EC (90/600 mg/m2 X 4 every 21 days) followed by T (175 mg/m2 X4 every 14 days). The primary end point was DFS. The trial was designed to detect the upper limits of the 95% confidence interval of the hazard ratio of ET versus an EC-T < 1.30. A sample size of 905 patients was required to detect the difference (a=0.05, β=80%). Assuming a drop-out rate of 10%, 996 patients were required. The first analysis of DFS was planned at the time when 50% of patients were enrolled. 

Results: Between August 2009 and October 2013, 496 patients were enrolled in the study and 445 patients completed the study treatment protocol, among which 214 patients were in the EC-T arm and 231 patients were in the ET arm. The patient characteristics were well-matched between the two arms. The median age was 49 years in both groups. Of the patients in the EC-T and ET arms, 87.4% and 92.2% were ER/PR-positive, respectively. After a median follow-up of 35.5 months, 28 events were observed (14 each in both arms). The 4-year DFS was 91.3% in the EC-T arm and 91.4% in the ET arm (log-rank p= 0.719,HR = 0.873, 95%CI = 0.416-1.832). Both regimens were well-tolerated. Of the patients in the EC-T and ET groups, 92.1% and 88.7%, respectively, completed all treatment cycles per protocol. Dose reductions were required in 24.8% and 35.5% of the patients in the EC-T and ET arms, respectively. The most frequent grade 3 / 4 toxicities were neutropenia, nausea, and anemia, with no significant difference between the two regimens. 

Conclusions: The toxicity from six cycles of ET were similar to eight cycles of EC-T in patients with node-positive early breast cancer. The efficacy of the two chemotherapy regimens should await the enrollment of additional patients and a longer follow-up. Clinical trial information: NCT01134523.

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