■ERRB2阳性乳腺癌患者的标准辅助治疗是化疗加曲妥珠单抗1年。缩短曲妥珠单抗给药时间可提高心脏安全性,但是需要更多关于它们对生存的影响的信息。
比较曲妥珠单抗与相同辅助化疗后9周与1年的生存结果。
■这是对开放标签的事后二次分析,多中心,非劣效性设计的随机临床试验包括年龄在18岁或以上的早期ERBB2阳性的女性,2008年1月3日至2014年12月16日在7个欧洲国家的65个中心纳入的腋窝淋巴结阴性或腋窝淋巴结阳性乳腺癌.当前的探索性分析是在获得最大可达到的随访数据后进行的,当时最后一名患者在2022年12月完成了最后一次预定的访视。
■化疗包括3个周期的多西他赛,间隔3周,然后是3个周期的氟尿嘧啶,表柔比星,和环磷酰胺间隔3周。曲妥珠单抗与多西他赛同时给药9周。在9周组中,化疗后不再使用曲妥珠单抗,而在一年组中,曲妥珠单抗在化疗结束1年后继续治疗.
■主要目标是无病生存期(DFS)。远程DFS和OS是次要目标。使用Kaplan-Meier方法和对数秩检验或单变量Cox比例风险回归比较两组之间的生存率。
■在分析的2174名女性中,中位年龄为56岁(IQR,48-64岁)。中位随访时间为8.1年(IQR,8.0-8.9年);发生了357例DFS事件和176例死亡。与曲妥珠单抗1年相比,曲妥珠单抗9周的DFS较短(风险比[HR],1.36;90%CI,1.14-1.62);10年DFS在1年组中为80.3%,在9周组中为78.6%。9周组和1年组的5年和10年OS率相当(95.0%对95.9%和89.1%对88.2%,分别;所有时间点的HR,1.20;90%CI,0.94-1.54)。在多变量分析中,与1年治疗相比,9周治疗与较短的DFS相关(复发或死亡的HR,1.36;95%CI,1.10-1.68;P=0.005),但操作系统(HR,1.22;95%CI,0.90-1.64;P=.20)。只有4名患者(0.2%)死于心脏原因。
■在这项随机临床试验的二次分析中,在接受化疗的ERRB2阳性乳腺癌患者中,1年与9周辅助曲妥珠单抗与改善的DFS相关,但两组间OS无显著差异。
■ClinicalTrials.gov标识符:NCT00593697。
UNASSIGNED: The standard adjuvant treatment for patients with ERRB2-positive breast cancer is chemotherapy plus 1 year of trastuzumab. Shorter durations of trastuzumab administration improve cardiac safety, but more information is needed about their effect on survival.
UNASSIGNED: To compare survival outcomes after 9-week vs 1-year administration of trastuzumab with the same adjuvant chemotherapy.
UNASSIGNED: This post hoc secondary analysis of an open-label, multicenter, noninferiority-design randomized clinical trial included women aged 18 years or older with early ERBB2-positive, axillary node-negative or axillary node-positive breast cancer who were enrolled from January 3, 2008, to December 16, 2014, at 65 centers in 7 European countries. The current exploratory analysis was conducted after achieving the maximum attainable follow-up data when the last patient enrolled had completed the last scheduled visit in December 2022.
UNASSIGNED: Chemotherapy consisted of 3 cycles of docetaxel administered at 3-week intervals followed by 3 cycles of fluorouracil,
epirubicin, and cyclophosphamide at 3-week intervals. Trastuzumab was administered in both groups for 9 weeks concomitantly with docetaxel. In the 9-week group, no further trastuzumab was administered after chemotherapy, whereas in the 1-year group, trastuzumab was continued after chemotherapy to complete 1 year of administration.
UNASSIGNED: The primary objective was disease-free survival (DFS). Distant DFS and OS were secondary objectives. Survival between groups was compared using the Kaplan-Meier method and log-rank test or univariable Cox proportional hazards regression.
UNASSIGNED: Among the 2174 women analyzed, median age was 56 years (IQR, 48-64 years). The median follow-up time was 8.1 years (IQR, 8.0-8.9 years); 357 DFS events and 176 deaths occurred. Trastuzumab for 9 weeks was associated with shorter DFS compared with trastuzumab for 1 year (hazard ratio [HR], 1.36; 90% CI, 1.14-1.62); 10-year DFS was 80.3% in the 1-year group vs 78.6% in the 9-week group. The 5-year and 10-year OS rates were comparable between the 9-week and 1-year groups (95.0% vs 95.9% and 89.1% vs 88.2%, respectively; HR for all time points, 1.20; 90% CI, 0.94-1.54). In multivariable analyses, 9-week treatment was associated with shorter DFS compared with 1-year treatment (HR for recurrence or death, 1.36; 95% CI, 1.10-1.68; P = .005), but there was no between-group difference in OS (HR, 1.22; 95% CI, 0.90-1.64; P = .20). Only 4 patients (0.2%) died of a cardiac cause.
UNASSIGNED: In this secondary analysis of a randomized clinical trial, 1-year vs 9-week adjuvant trastuzumab was associated with improved DFS among patients with ERRB2-positive breast cancer receiving chemotherapy, but there was no significant difference in OS between the groups.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT00593697.