Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Breast Tumor Center, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Yanjiang West Road 107#, Guangzhou, 510120, Guangdong, China.
State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Sun Yat-Sen University, Dongfeng Road 651#, Guangzhou, 510060, Guangdong, China.
BMC Cancer. 2023 Jan 7;23(1):29. doi: 10.1186/s12885-023-10515-z.
PURPOSE: Despite the poor prognosis of triple-negative breast cancer (TNBC), it has been demonstrated that neoadjuvant immunotherapy in combination with chemotherapy can improve the pathologic complete response (pCR) rate and/or long-term outcome of TNBC. However, there have been no real-world studies reporting on the effectiveness of neoadjuvant checkpoint inhibitors in early TNBC. METHODS: Between November 2019 and December 2021, 63 early TNBC patients treated with anti-PD-1 antibodies (pembrolizumab or camrelizumab) or anti-PD-L1 antibody (atezolizumab) in combination with chemotherapy at seven institutions were included. PCR1 defined as ypT0/Tis and ypN0 was the primary endpoint. Secondary endpoints included pCR2 defined as ypT0/Tis, overall response rate (ORR), disease-free survival (DFS), drug-related adverse events (AEs) and biomarkers. RESULTS: Among the patients in the current study, 34.9% of patients were able to achieve pCR1, and 47.6% of patients had achieved pCR2. The ORR was 82.5%. 33 patients with non-pCR2 tumors were found to have a median DFS of 20.7 months (95% CI 16.3 months-not reached). The DFS of patients with pCR2 and non-pCR2 after neoadjuvant therapy was significantly different (HR = 0.28, 95% CI 0.10-0.79; P = 0.038). The most common AEs were nausea (63.4%), fatigue (42.7%), leucopenia (30.0%) and elevated transaminase (11.7%). CONCLUSION: It is possible to achieve a meaningful pCR rate and DFS by combining neoadjuvant checkpoint blockade with chemotherapy in patients with high-risk TNBC. Compared to clinical trials, however, there was a slightly lower pCR rate in this multicentered real-world study.
目的:尽管三阴性乳腺癌(TNBC)预后较差,但新辅助免疫治疗联合化疗已被证实可提高 TNBC 的病理完全缓解(pCR)率和/或长期预后。然而,目前尚无真实世界研究报告新辅助检查点抑制剂在早期 TNBC 中的有效性。
方法:本研究纳入了 2019 年 11 月至 2021 年 12 月期间在七家机构接受抗 PD-1 抗体(pembrolizumab 或 camrelizumab)或抗 PD-L1 抗体(atezolizumab)联合化疗治疗的 63 例早期 TNBC 患者。PCR1 定义为ypT0/Tis 和 ypN0,为主要终点。次要终点包括 pCR2 定义为 ypT0/Tis、总缓解率(ORR)、无病生存(DFS)、药物相关不良事件(AEs)和生物标志物。
结果:在本研究的患者中,34.9%的患者达到 pCR1,47.6%的患者达到 pCR2。ORR 为 82.5%。33 例非 pCR2 肿瘤患者的中位 DFS 为 20.7 个月(95%CI 16.3 个月-未达到)。新辅助治疗后 pCR2 和非 pCR2 患者的 DFS 有显著差异(HR=0.28,95%CI 0.10-0.79;P=0.038)。最常见的 AEs 是恶心(63.4%)、乏力(42.7%)、白细胞减少(30.0%)和转氨酶升高(11.7%)。
结论:在高危 TNBC 患者中,新辅助检查点阻断联合化疗可实现有意义的 pCR 率和 DFS。然而,与临床试验相比,本多中心真实世界研究的 pCR 率略低。
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