PCR：病理完全解释定义为乳腺原发灶和腋窝淋巴结手术标本病理检查无浸润性肿瘤细胞残余。
HER2:人类表皮生长因子受体2 , human epidermal growth factor receptor-2 原癌基因人类表皮生长因子受体基因，即c-erbB-2基因，定位于染色体17q12-21.32上，编码相对分子质量为185000的跨膜受体样蛋白，具有酪氨酸激酶活性。检测方法有免疫组化、FISH等。目前已有针对该基因过度表达的药物---赫赛汀(Herceptin) 通用名:曲妥珠单抗 商品名:赫赛汀（罗氏）
Findings from a meta-analysis indicated that pathologic complete response is a notable predictor of outcomes in HER2-positive breast cancer.
一项综合分析的结果表明，病理完全缓解是 HER2 阳性乳腺癌预后的显著预测因子。
Pathologic complete response rate (pCR) was further validated as a predictor of outcomes in patients with HER2-positive breast cancer, particularly those who are hormone receptor (HR)-positive, according to findings from a meta-analysis published in ESMO Open.
根据发表在 ESMO Open 上的综合分析结果，病理完全缓解率 (pCR) 被进一步验证为 HER2 阳性乳腺癌患者尤其是激素受体 (HR) 阳性患者预后的预测因子。
Compared with patients who had residual disease, investigators reported that those who experienced a pCR had an improved recurrence-free survival (RFS; HR, 0.45; 95% CI, 0.34-0.60) and overall survival (OS; HR, 0.32; 95% CI, 0.22-0.48) for all combined treatments included in the analysis. In the population of patients with HR-negative disease, achievement of pCR was associated with a reduction in risk of relapse (65%) or death (73%).The HR-positive population also had an improvement in RFS following pCR, although less than the HR-negative population.
与有残留疾病的患者相比，研究人员报告说，经历 pCR 的患者的无复发生存期（RFS；HR，0.45；95% CI，0.34-0.60）和总生存期（OS；HR，0.32；95%）都有所提高。在 HR 阴性疾病患者群体中，实现 pCR 与降低复发 (65%) 或死亡 (73%) 的风险降低相关。HR 阳性人群在 pCR 后的 RFS 也有所改善，尽管低于 HR 阴性人群。
“As expected, in the present meta-analysis, we confirmed pCR to be strongly associated with prognosis…. This finding strengthens the already solid evidence supporting the role of pCR as a prognostic biomarker for single patients with HER2-positive [breast cancer] receiving chemotherapy [plus] HER2-targeted agents in the neoadjuvant setting. Notably, although pCR was found to be positively associated with long-term outcome in both [HR]-positive and [HR]-negative patients, the strength of the association was greater in this latter subgroup,” the authors wrote.
“正如预期的那样，在目前的综合分析中，我们证实 pCR 与预后密切相关...... 这一发现加强了之前的说法，支持在新辅助治疗中接受化疗+her2靶向药物的her2阳性乳腺癌患者中，pCR作为预后生物标志物的作用。值得注意的是，虽然发现 pCR 与 [HR] 阳性和 [HR] 阴性患者的长期结果呈正相关，但在后一个亚组中，这种关联的强度更大，”作者写道。
The systemic review used data from phase 2 and 3 randomized studies assessing lapatinib (Tykerb) plus neoadjuvant trastuzumab (Herceptin) and chemotherapy in patients with HER2-positive early breast cancer. A database search turned up 1794 records, of which 54 were assessed and 4 were included in the quantitative synthesis.
该系统使用2期和3期随机研究的数据，用于评估拉帕替尼（Lapatinib ditosylate，Tykerb)联合新辅助曲妥珠单抗（赫赛汀，Trastuzumab，Herceptin）和化疗对her2阳性早期乳腺癌患者的疗效。数据库检索了1794条记录，其中54条被评估，4条被纳入定量合成。
A total of 1410 patients were assessed as part of the survival analysis. In the population, investigators reported that dual HER2 blockade plus trastuzumab and lapatinib was successful in producing significantly improved RFS (HR, 0.62; 95% CI, 0.46-0.85). Moreover, dual blockade and lapatinib plus trastuzumab in addition to neoadjuvant chemotherapy was effective in improving OS vs trastuzumab alone (HR, 0.65; 95% CI, 0.43-0.98).
作为生存分析的一部分，总共评估了 1410 名患者。在人群中，研究人员报告说，双重 HER2 阻断加曲妥珠单抗和拉帕替尼对 RFS（HR，0.62；95% CI，0.46-0.85）有显著改善。此外，与单独使用曲妥珠单抗相比，双重阻断和拉帕替尼加曲妥珠单抗联合新辅助化疗在改善 OS 方面是有一定的效果（HR，0.65；95% CI，0.43-0.98）。
“Besides the established role of lapatinib for HER2-positive advanced [breast cancer] management, the present meta-analysis demonstrated significant survival benefit of an escalated approach including neoadjuvant dual HER2 blockade with lapatinib and trastuzumab for HER2-positive, high-risk patients [with breast cancer]. Also, in view of the maturity of the follow-up of the studies included, our results get the basis for reconsidering the role of lapatinib in the early setting,” the investigators wrote.
研究人员写道，“除了已确立的拉帕替尼在HER2阳性晚期治疗中的作用外，目前的综合分析表明，还包括拉帕替尼和曲妥珠单抗的新辅助双重 HER2 阻断对 HER2 阳性高风险患者的升级方法具有显着的生存益处 。此外，鉴于后续研究的成熟度，我们的研究结果为重新考虑拉帕替尼在早期环境中的作用奠定了基础”。
Other findings from the study identified a positive association between pCR and RFS (HR, 0.35; 95% CI, 0.23-0.53), as well as pCR and OS (HR, 0.27; 95% CI, 0.15-0.47) in patients with HR-negative disease. A significant association was also observed in the HR-positive group between pCR and RFS (HR, 0.60; 95% CI, 0.37-0.97), as well as a borderline significant association with OS (HR, 0.52; 95% CI, 0.23-1.15).
该项研究的其他结果表明了HR 患者的 pCR 和 RFS（HR，0.35；95% CI，0.23-0.53）以及 pCR 和 OS（HR，0.27；95% CI，0.15-0.47）之间的呈正相关性。在 HR 阳性组中也观察到 pCR 和 RFS 之间的显着关联性（HR，0.60；95% CI，0.37-0.97），以及与 OS 的临界之间的显着关联（HR，0.52；95% CI，0.23- 1.15）。
参考文献：
Guarneri V, Griguolo G, Miglietta F, et al. Survival after neoadjuvant therapy with trastuzumab–lapatinib and chemotherapy in patients with HER2-positive early breast cancer: A meta-analysis of randomized trials. ESMO Open. 2022;7(2):100433. doi:10.1016/j.esmoop.2022.100433
相关内容：
HER2阳性乳腺癌
HER2阳性 乳腺癌和脑转移瘤的放射和全身治疗
HER2+阳性乳腺癌和脑转移瘤的治疗策略
HER2+ MBC：为患者化疗做准备
以上内容转自：
https://www.cancernetwork.com/view/pcr-further-validated-as-predictor-of-outcomes-in-her2-breast-cancer
