新辅助卡瑞利珠单抗联合nab-紫杉醇和表柔比星治疗早期三阴性乳腺癌:一项单臂 II 期临床试验。

Neoadjuvant camrelizumab plus nab-paclitaxel and epirubicin in early triple-negative breast cancer: a single-arm phase II trial.

机构信息

Department of Breast Disease, Henan Breast Cancer Center, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, 450008, China.

Department of Pathology, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, 450008, China.

出版信息

Nat Commun. 2023 Oct 20;14(1):6654. doi: 10.1038/s41467-023-42479-w.

Abstract

Immunotherapy combined with chemotherapy has been demonstrated to be effective in early triple-negative breast cancer (TNBC). In this single-arm, phase II study with Simon's two-stage design, we investigated the efficacy and safety of neoadjuvant camrelizumab plus chemotherapy in patients with early TNBC (NCT04213898). Eligible female patients aged 18 years or older with histologically confirmed treatment-naïve early TNBC were treated with camrelizumab (200 mg, on day 1), nab-paclitaxel (125 mg/m, on days 1, 8, and 15), and epirubicin (75 mg/m, on day 1) every three weeks for six cycles. The primary end point was the pathological complete response; secondary endpoints included safety, objective response rate, and long-term survival outcomes of event-free survival, disease-free survival, and distant disease-free survival. A total of 39 patients were enrolled between January 2020 and October 2021. Twenty-five patients achieved a pathological complete response (64.1%, 95%CI: 47.2, 78.8). The objective response rate was 89.7% (95%CI: 74.8, 96.7), including 35 patients with partial responses. Treatment-related adverse events of grade 3 or 4 occurred in 30 (76.9%) patients. In conclusion, the trial meets the prespecified endpoints showing promising efficacy and manageable safety of neoadjuvant camrelizumab plus nab-paclitaxel and epirubicin chemotherapy in female patients with early TNBC. Long-term survival outcomes are still pending.

摘要

免疫疗法联合化疗已被证明对早期三阴性乳腺癌(TNBC)有效。在这项采用 Simon 两阶段设计的单臂、二期研究中,我们研究了新辅助卡瑞利珠单抗联合化疗在早期 TNBC 患者中的疗效和安全性(NCT04213898)。符合条件的女性患者年龄在 18 岁及以上,组织学确诊为未经治疗的早期 TNBC,接受卡瑞利珠单抗(200mg,第 1 天)、白蛋白紫杉醇(125mg/m 2,第 1、8 和 15 天)和表柔比星(75mg/m 2,第 1 天)治疗,每 3 周为一个周期,共 6 个周期。主要终点为病理完全缓解;次要终点包括安全性、客观缓解率以及无事件生存、无病生存和远处无病生存的长期生存结局。2020 年 1 月至 2021 年 10 月期间共入组 39 例患者。25 例患者达到病理完全缓解(64.1%,95%CI:47.2,78.8)。客观缓解率为 89.7%(95%CI:74.8,96.7),包括 35 例部分缓解。30 例(76.9%)患者发生 3 级或 4 级治疗相关不良事件。总之,该试验达到了预设的终点,显示新辅助卡瑞利珠单抗联合白蛋白紫杉醇和表柔比星化疗在早期 TNBC 女性患者中具有良好的疗效和可管理的安全性。长期生存结局仍有待观察。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5204/10589334/4e079137180a/41467_2023_42479_Fig1_HTML.jpg

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