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三阴性乳腺癌的新辅助化疗:基于真实世界证据评估早期临床反应、病理完全缓解率及铂盐添加的获益情况

Neoadjuvant Chemotherapy of Triple-Negative Breast Cancer: Evaluation of Early Clinical Response, Pathological Complete Response Rates, and Addition of Platinum Salts Benefit Based on Real-World Evidence.

作者信息

Holanek Milos, Selingerova Iveta, Bilek Ondrej, Kazda Tomas, Fabian Pavel, Foretova Lenka, Zvarikova Maria, Obermannova Radka, Kolouskova Ivana, Coufal Oldrich, Petrakova Katarina, Svoboda Marek, Poprach Alexandr

机构信息

Department of Comprehensive Cancer Care, Masaryk Memorial Cancer Institute, 656 53 Brno, Czech Republic.

Department of Comprehensive Cancer Care, Faculty of Medicine, Masaryk University, 625 00 Brno, Czech Republic.

出版信息

Cancers (Basel). 2021 Mar 30;13(7):1586. doi: 10.3390/cancers13071586.

Abstract

Pathological complete response (pCR) achievement is undoubtedly the essential goal of neoadjuvant therapy for breast cancer, directly affecting survival endpoints. This retrospective study of 237 triple-negative breast cancer (TNBC) patients with a median follow-up of 36 months evaluated the role of adding platinum salts into standard neoadjuvant chemotherapy (NACT). After the initial four standard NACT cycles, early clinical response (ECR) was assessed and used to identify tumors and patients generally sensitive to NACT. mutation, smaller unifocal tumors, and Ki-67 ≥ 65% were independent predictors of ECR. The total pCR rate was 41%, the achievement of pCR was strongly associated with ECR (OR = 15.1, < 0.001). According to multivariable analysis, the significant benefit of platinum NACT was observed in early responders ≥45 years, Ki-67 ≥ 65% and persisted lymph node involvement regardless of status. Early responders with pCR had a longer time to death (HR = 0.28, < 0.001) and relapse (HR = 0.26, < 0.001). The pCR was achieved in only 7% of non-responders. However, platinum salts favored non-responders' survival outcomes without statistical significance. Toxicity was significantly often observed in patients with platinum NACT ( = 0.003) but not for grade 3/4 ( = 0.155). These results based on real-world evidence point to the usability of ECR in NACT management, especially focusing on the benefit of platinum salts.

摘要

病理完全缓解(pCR)的达成无疑是乳腺癌新辅助治疗的关键目标,直接影响生存终点。这项对237例三阴性乳腺癌(TNBC)患者的回顾性研究,中位随访时间为36个月,评估了在标准新辅助化疗(NACT)中添加铂盐的作用。在最初四个标准NACT周期后,评估早期临床反应(ECR),并用于识别对NACT普遍敏感的肿瘤和患者。基因突变、较小的单灶性肿瘤以及Ki-67≥65%是ECR的独立预测因素。总pCR率为41%,pCR的达成与ECR密切相关(OR = 15.1,<0.001)。根据多变量分析,在≥45岁的早期反应者、Ki-67≥65%且无论状态如何均存在持续淋巴结受累的患者中,观察到铂类NACT有显著益处。达到pCR的早期反应者有更长的死亡时间(HR = 0.28,<0.001)和复发时间(HR = 0.26,<0.001)。在无反应者中只有7%实现了pCR。然而,铂盐有利于无反应者的生存结局,但无统计学意义。铂类NACT患者中毒性反应明显更常出现( = 0.003),但3/4级毒性反应无差异( = 0.155)。这些基于真实世界证据的结果表明ECR在NACT管理中的可用性,尤其关注铂盐的益处。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ffa4/8036281/69c4a9a9d468/cancers-13-01586-g001.jpg

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