我们能否通过专门的乳腺癌护理来平衡创新机会受限的问题?REAL-NOTE 研究。
Can we counterbalance restricted access to innovation through specialized breast cancer care? The REAL-NOTE study.
机构信息
Breast Unit, Champalimaud Clinical Centre/Champalimaud Foundation, Lisbon, Portugal.
Breast Unit, Champalimaud Clinical Centre/Champalimaud Foundation, Lisbon, Portugal.
出版信息
Breast. 2024 Dec;78:103793. doi: 10.1016/j.breast.2024.103793. Epub 2024 Sep 3.
INTRODUCTION
The KEYNOTE-522 (KN-522) trial showed that the addition of pembrolizumab to standard chemotherapy improved pathological complete response (pCR) and event-free survival (EFS) for patients with early triple negative breast cancer (TNBC). We analyzed results of a real-world cohort of patients treated in a certified Breast Unit, before the introduction of pembrolizumab, to see if high quality care can match outcomes brought by the addition of an innovative anticancer therapy.
METHODS
Observational, retrospective, single-center cohort study, with real-world data from an ongoing institutional database with prespecified variables. Inclusion criteria matched the ones from KN-522: previously untreated stage II or III TNBC, diagnosed between 2012 and 2022, who received neoadjuvant chemotherapy. The primary endpoints were pCR at the time of definitive surgery and EFS; overall survival (OS) was a secondary endpoint.
RESULTS
Total of 168 patients were included, median age 55 years, 55 % received neoadjuvant chemotherapy with dose dense anthracyclines and taxanes and 25 % carboplatin + paclitaxel, sequenced with dose dense anthracyclines. Most had Stage II disease (82.7 %), 47 % node + disease. pCR was achieved in 52.7 % cases. At 36 months, EFS was 83.3 % (95 % CI 75.1-89.0) and OS 89 % (95 % CI, 81.6 to 93.5).
CONCLUSIONS
Notwithstanding the study limitations, outcomes of patients treated with chemotherapy without immunotherapy were numerically similar to the experimental arm of KN-522 trial. These data highlight that providing care by a specialized multidisciplinary team in a certified unit might be just as impactful as the incorporation of new technologies.
简介
KEYNOTE-522(KN-522)试验表明,帕博利珠单抗联合标准化疗可提高早期三阴性乳腺癌(TNBC)患者的病理完全缓解(pCR)和无事件生存(EFS)。我们分析了在引入帕博利珠单抗之前,在一个认证的乳腺科治疗的真实患者队列的结果,以了解高质量的护理是否能与创新抗癌治疗带来的结果相匹配。
方法
这是一项观察性、回顾性、单中心队列研究,使用正在进行的机构数据库中的真实世界数据,这些数据有预先指定的变量。纳入标准与 KN-522 试验相匹配:未经治疗的 II 期或 III 期 TNBC,诊断时间为 2012 年至 2022 年,接受新辅助化疗。主要终点为确定性手术时的 pCR 和 EFS;总生存(OS)是次要终点。
结果
共纳入 168 例患者,中位年龄为 55 岁,55%接受了含密集蒽环类和紫杉类药物的新辅助化疗,25%接受了卡铂+紫杉醇,序贯密集蒽环类药物。大多数患者为 II 期疾病(82.7%),47%有淋巴结阳性疾病。52.7%的患者达到了 pCR。36 个月时,EFS 为 83.3%(95%CI 75.1-89.0),OS 为 89%(95%CI,81.6-93.5)。
结论
尽管存在研究局限性,但未接受免疫治疗的化疗患者的结果在数值上与 KN-522 试验的实验组相似。这些数据强调,在认证的多学科团队中提供护理可能与采用新技术一样具有影响力。
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