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在neo-real研究中,接受新辅助派姆单抗联合化疗治疗的雌激素受体低/人表皮生长因子受体2阴性乳腺癌患者的病理完全缓解率。

Pathologic complete response rates of patients with ER-low/HER2-negative breast cancer treated with neoadjuvant pembrolizumab plus chemotherapy in the neo-real study.

作者信息

Bonadio Renata Colombo, Tavares Monique Celeste, Balint Flávia Cavalcanti, de Sousa Isadora Martins, Comini Ana Carolina Marin, Madasi Fernanda, Bines Jose, Ferreira Rafael Dal Ponte, Rosa Daniela Dornelles, Santos Candice Lima, de Souza Zenaide Silva, Assad-Suzuki Daniele, de Araújo Júlio Antônio Pereira, Gagliato Débora de Melo, Dos Anjos Carlos Henrique, Zucchetti Bruna M, Ferrari Anezka, de Brito Mayana Lopes, Cangussu Renata, Monteiro Maria Marcela Fernandes, Hoff Paulo M, Testa Laura, Estevez-Diz Maria Del Pilar, Barroso-Sousa Romualdo

机构信息

Instituto D'Or de Pesquisa E Ensino (IDOR), São Paulo, Brazil.

Grupo Brasileiro de Estudos Em Câncer de Mama (GBECAM), São Paulo, Brazil.

出版信息

Breast Cancer Res Treat. 2025 May;211(1):131-137. doi: 10.1007/s10549-025-07628-3. Epub 2025 Feb 3.

Abstract

PURPOSE

Estrogen receptor-low (ER-low) breast cancer (BC) present clinicopathological features and disease behavior resembling triple-negative breast cancer, but have been frequently excluded from pivotal trials designed for the latter. Since neoadjuvant pembrolizumab plus chemotherapy (P + CT) is the new standard of care for stage II-III triple-negative breast cancer (TNBC), we aimed to access the effectiveness of this therapy for ER-low tumors.

METHODS

We evaluated patients with ER-low BC included in the Neo-Real/ GBECAM-0123 study, a real-world data study evaluating patients treated with neoadjuvant P + CT since July 2020 across ten cancer centers. The objective of this study was to evaluate the effectiveness of neoadjuvant P + CT through pathologic complete response (pCR).

RESULTS

Twenty patients were included in this analysis. Median age was 40 years (range 28-64). Most patients had grade 3 tumors (n = 18, 90%), with a median Ki67 index of 75% (range 30-95%), and 70% had stage II tumors. All the twenty patients were submitted to surgery, with a pCR observed in 12 cases (pCR rate of 60%). Receiving less than 6 cycles of pembrolizumab was associated with a trend towards worse pCR rates (20% vs 73.3%).

CONCLUSIONS

The clinicopathological features and the response to neoadjuvant P + CT observed in this ER-low BC cohort are similar to that observed in TNBC. Patients with stage II-III ER-low/HER2- BC should be treated with neoadjuvant P + CT following the treatment standards for TNBC, and proper adherence to the regimen is relevant to improve effectiveness.

摘要

目的

雌激素受体低表达(ER-low)乳腺癌(BC)呈现出与三阴性乳腺癌相似的临床病理特征和疾病行为,但在为后者设计的关键试验中常常被排除在外。由于新辅助派姆单抗联合化疗(P + CT)是II-III期三阴性乳腺癌(TNBC)的新护理标准,我们旨在评估该疗法对ER-low肿瘤的有效性。

方法

我们评估了纳入Neo-Real/GBECAM-0123研究的ER-low BC患者,这是一项评估自2020年7月起在十个癌症中心接受新辅助P + CT治疗患者的真实世界数据研究。本研究的目的是通过病理完全缓解(pCR)评估新辅助P + CT的有效性。

结果

本分析纳入了20例患者。中位年龄为40岁(范围28 - 64岁)。大多数患者为3级肿瘤(n = 18,90%),中位Ki67指数为75%(范围30 - 95%),70%为II期肿瘤。所有20例患者均接受了手术,其中12例观察到pCR(pCR率为60%)。接受少于6个周期派姆单抗治疗与pCR率较差的趋势相关(20%对73.3%)。

结论

在这个ER-low BC队列中观察到的临床病理特征和对新辅助P + CT的反应与TNBC中观察到的相似。II-III期ER-low/HER2- BC患者应按照TNBC的治疗标准接受新辅助P + CT治疗,并且适当坚持治疗方案对于提高有效性至关重要。

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