Qian Xiaoyan, Tao Yunxia, Chen Haizhu, Li Xin, Wang Yaqin, Xu Xiaoming, Li Shuo, Chen Haoyu, Cang Shundong, Liu Yang
Department of Oncology, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University, Zhengzhou, Henan 450001, P.R. China.
Department of Oncology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu 221000, P.R. China.
Oncol Lett. 2024 Oct 25;29(1):29. doi: 10.3892/ol.2024.14775. eCollection 2025 Jan.
The present study aimed to assess the efficacy and safety of immune checkpoint inhibitor (ICI)-based therapy in patients with metastatic breast cancer (MBC). Therefore, eligible patients with histologically confirmed MBC, treated with ICI-based therapy, were enrolled. The primary endpoint was progression-free survival (PFS) and the secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety. A total of 90 patients with MBC, treated with ICI-based therapy, with different treatment lines, were included in the present study. The median age was 50 years (range, 27-76). The predominant tumor subtypes were triple negative (53.3%) and luminal (31.1%) breast cancer. The majority of patients (61.1%) were heavily pretreated (lines of treatment, ≥3). Approximately half of the patients (46.7%) had ≥3 metastatic sites. The overall ORR was 36.7% (33/90 patients), while a DCR of 78.9% (71/90 patients) was also recorded. With a median follow-up of 16.0 months, the median PFS and OS were 4.9 months [95% confidence interval (CI), 3.8-6.1] and 13.9 months (95% CI, 9.5-18.2), respectively. Patients treated with ICIs as first-line therapy exhibited notable improvement, with a median PFS of 11.0 months (95% CI, 6.0-16.0) and a median OS of 24.3 months (95% CI, 11.4-37.2). In addition, the pretreatment blood platelet-to-lymphocyte ratio was an independent risk factor for PFS [hazard ratio (HR)=2.406; 95% CI, 1.325-4.370; P=0.004] and OS (HR=2.376; 95% CI, 1.059-5.328; P=0.036). The most common adverse events were nausea (44.4%), neutropenia (42.0%) and alanine aminotransferase/aspartate aminotransferase elevation (22.2%). Furthermore, three (3.3%) patients developed grade 1/2 immuno-related toxicity and recovered after supportive care. Overall, the present study suggested that the ICI-based therapy exhibited encouraging clinical outcomes with manageable toxicity in patients with MBC in real-world settings, with the most favorable efficacy in first-line treatment.
本研究旨在评估基于免疫检查点抑制剂（ICI）的疗法对转移性乳腺癌（MBC）患者的疗效和安全性。因此，纳入了经组织学确诊为MBC且接受基于ICI疗法治疗的符合条件的患者。主要终点为无进展生存期（PFS），次要终点包括客观缓解率（ORR）、疾病控制率（DCR）、总生存期（OS）和安全性。本研究共纳入90例接受基于ICI疗法治疗且处于不同治疗线的MBC患者。中位年龄为50岁（范围27 - 76岁）。主要的肿瘤亚型为三阴性乳腺癌（53.3%）和管腔型乳腺癌（31.1%）。大多数患者（61.1%）接受过大量预处理（治疗线数≥3）。约一半患者（46.7%）有≥3个转移部位。总体ORR为36.7%（33/90例患者），同时记录的DCR为78.9%（71/90例患者）。中位随访16.0个月，中位PFS和OS分别为4.9个月[95%置信区间（CI），3.8 - 6.1]和13.9个月（95% CI，9.5 - 18.2）。接受ICI作为一线治疗的患者有显著改善，中位PFS为
