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UCBG 2-04: Long-term results of the PACS 04 trial evaluating adjuvant epirubicin plus docetaxel in node-positive breast cancer and trastuzumab in the human epidermal growth factor receptor 2-positive subgroup.
UCBG 2-04: PACS 04 试验的长期结果,该试验评估了在淋巴结阳性乳腺癌中辅助表阿霉素加多西他赛和在人表皮生长因子受体 2 阳性亚组中使用曲妥珠单抗。
Adjuvant chemotherapy Adjuvant trastuzumab Breast cancer Taxanes
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摘要

PURPOSE:We conducted a double-randomised phase III trial to evaluate a concomitant taxane-anthracycline regimen in node-positive breast cancer and the efficacy of trastuzumab in the human epidermal growth factor receptor 2 (HER2)-positive subpopulation.
METHODS:A total of 3010 patients with node-positive breast cancer were randomly assigned to receive 6 cycles of 500 mg/m2 of fluorouracil, 100 mg/m2 of epirubicin and 500 mg/m2 of cyclophosphamide (FEC) or 75 mg/m2 of epirubicin and 75 mg/m2 of docetaxel (ED). Patients with HER2-positive tumours were secondary randomly assigned to either trastuzumab or observation. The primary end-point was disease-free survival (DFS) in the two chemotherapy arms.
RESULTS:After a 115-month median follow-up, DFS was not significantly better in the ED arm (DFS: 70%, 95% confidence interval [CI]: 67-72) than in the FEC arm (DFS: 68%, 95% CI: 65-70; hazard ratio [HR] = 0.88, 95% CI: 0.77-1.01; p = 0.064). The OS was not different between FEC (OS: 80%, 95% CI: 78-83) and ED (OS: 81%, 95% CI: 79-83); HR = 0.97, 95% CI: 0.81-1.16; p = 0.729). ED appeared more toxic. In the 528 HER2-positive subset, there was trend for a higher DFS, in the intention-to-treat population, in the trastuzumab arm (DFS: 68%, 95% CI: 61-74) than in the observation arm (DFS: 60%, 95% CI: 54-66; HR = 0.77, 95% CI: 0.57-1.03; p = 0.079). In the per-protocol population, DFS was significantly higher in the trastuzumab arm (DFS: 70%, 95% CI: 63-76) than in the observation arm (DFS: 59%, 95% CI: 53-65; HR = 0.69, 95% CI: 0.51-0.94; p = 0.0156). The OS was not different between these 2 arms.
CONCLUSION:This study did not show superiority of the concomitant anthracycline-taxane arm which was more toxic in high-risk node-positive breast cancer patients. Long-term results of the HER2-positive subpopulation are in line with those of the other adjuvant trastuzumab trials but quantitatively less pronounced mostly because of lack of power.

译文

用途: 我们进行了一项双随机 III 期试验,以评估在淋巴结阳性乳腺癌中同时使用紫杉烷-蒽环类药物的方案以及曲妥珠单抗在人表皮生长因子受体 2 (HER2) 中的疗效 -正亚群。
方法: 共有 3010 名淋巴结阳性乳腺癌患者被随机分配接受 6 个周期的 500 mg/m2 的氟尿嘧啶, 100 毫克/平方米的表阿霉素和 500 毫克/平方米的环磷酰胺 (FEC) 或 75 毫克/平方米的表阿霉素和 75 毫克/平方米的多西他赛 (ED)。HER2-positive 肿瘤患者被再次随机分配到曲妥珠单抗或观察。主要终点是两个化疗组的无病生存 (DFS)。
结果: 经过 115 个月的中位随访,ED 组的 DFS 并没有明显好转 (DFS: 70%,95% 置信区间 [CI]: 67-72) 比 FEC 组 (DFS: 68%,95% CI: 65-70; 风险比 [HR] = 0.88,95% CI: 0.77-1.01; p = 0.064)。FEC (OS: 80%,95% CI: 78-83) 和 ED (OS: 81%,95% CI: 79-83) 之间的 OS 没有区别; HR = 0.97, 95% CI: 0.81-1.16; p = 0.729)。艾德看起来更有毒。在 528 HER2-positive 的子集中,在意向治疗人群中,曲妥珠单抗组有更高的 DFS 趋势 (DFS: 68%,95% CI: 61-74) 比观察组 (DFS: 60%,95% CI: 54-66; HR = 0.77,95% CI: 0.57-1.03; p = 0.079)。在符合方案的人群中,曲妥珠单抗组的 DFS 显著高于观察组 (DFS: 70%,95% CI: 63-76) (DFS: 59%,95% CI: 53-65; HR = 0.69,95% CI: 0.51-0.94; p = 0.0156)。这两个手臂之间的操作系统没有什么不同。
结论: 这项研究没有显示出同时使用的蒽环类-紫杉烷组的优越性,因为它在高危淋巴结阳性乳腺癌患者中毒性更大。HER2-positive 亚群的长期结果与其他曲妥珠单抗佐剂试验的结果一致,但由于缺乏力量,数量上不太明显。

Epidermal Growth Factor Receptor

肿瘤 靶向治疗 临床研究术语
概述  :  

表皮生长因子,简称为EGFR、ErbB-1或者Her1,是表皮生长因子受体(Her)家族成员之一。该家族成员包括EGFR(ErbB-1/Her1)、Her2(ErbB-2/NEU)、Her3(ErbB-3)以及Her4(ErbB-4)。EGFR信号通路在调控细胞生长、增殖、迁移以及分化等生理过程中发挥着重要作用,同时该分子在较多肿瘤中发生过表达或突变,与肿瘤的发生、发展关系紧密。 功能EGFR是由原癌基因c-ErbB-1编码的一种跨膜蛋白,其蛋白由三部分组成:1、细胞外结构域,也叫

Epidermal   /'ɛpə'dɝml/

       adj. [解剖][动] 表皮的;外皮的

       Epidermal buds grow down into the dermis at these sites.

               在这些部位,表皮芽向下生长到真皮层。

 

Growth   英 /grəʊθ/   美 /ɡroθ/ 

       n. 增长;发展;生长;种植

       But during their growth period.

               但是在生长的期间。

 

Factor   英 /'fæktə/   美 /'fæktɚ/ 

       n. 因素;要素;[物] 因数;代理人

               vi. 做代理商

               vt. 把…作为因素计入;代理经营;把…分解成

       But this cannot be the only factor.

               但这不可能是唯一的因素。

 

Receptor   /rɪˈseptə(r)/ 

       n. 感受器,受体,接受体

       But none of these proteins turned out to be the receptor , he said.

               他说,可是这些蛋白中没有一个最后被证实是它的受体。

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