Department of Pharmacy, Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.
Department of Pharmacy, Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China; School of Pharmacy, University of South China, Hengyang, China.
Lung Cancer. 2024 Oct;196:107936. doi: 10.1016/j.lungcan.2024.107936. Epub 2024 Aug 28.
Pralsetinib, a selective RET targeted tyrosine kinase inhibitor (TKI), has been approved for treating locally advanced or metastatic RET fusion-positive NSCLC in adults who have previously received platinum-based chemotherapy in China.
In this retrospective analysis conducted at Hunan Cancer Hospital in China, we examined 36 patients with advanced NSCLC with RET fusion, who were treated with pralsetinib between January 2021 and December 2023. The study focused on assessing the efficacy (Progression-free survival (PFS) and overall survival (OS)) and safety profile of pralsetinib in these patients. Statistical analyses were conducted using SPSS version 20.0, with a significance level set at p < 0.05.
The results revealed that pralsetinib exhibited significant activity in this patient cohort. Kaplan-Meier survival analysis indicated a median PFS of 10.7 months and a median OS of 21.2 months. The overall response rate(ORR) and disease control rate (DCR) was 55.6 % and 72.2 %, respectively. Pralsetinib was generally well tolerated, with most adverse events being mild to moderate (grades 1-2). The most common serious adverse events (≥grade 3) observed were lymphopenia (13.9 %), hypertension (11.1 %), leukopenia (8.3 %), neutropenia (8.3 %), and creatine kinase elevation (8.3 %).
Pralsetinib demonstrated promising activity in patients with advanced NSCLC harboring RET fusion with a favorable safety profile.
普拉替尼是一种选择性 RET 靶向酪氨酸激酶抑制剂（TKI），已在中国获批用于治疗既往接受过铂类化疗的局部晚期或转移性 RET 融合阳性 NSCLC 成人患者。
本研究回顾性分析了 2021 年 1 月至 2023 年 12 月期间在湖南省肿瘤医院接受普拉替尼治疗的 36 例晚期 NSCLC 伴 RET 融合患者。研究重点评估了普拉替尼在这些患者中的疗效（无进展生存期（PFS）和总生存期（OS））和安全性。统计分析采用 SPSS 版本 20.0，显著性水平设为 p<0.05。
结果显示，普拉替尼在该患者队列中表现出显著的活性。Kaplan-Meier 生存分析表明，中位 PFS 为 10.7 个月，中位 OS 为 21.2 个月。总缓解率（ORR）和疾病控制率（DCR）分别为 55.6%和 72.2%。普拉替尼总体耐受性良好，大多数不良反应为轻度至中度（1-2 级）。最常见的严重不良事件（≥3 级）为淋巴细胞减少症（13.9%）、高血压（11.1%）、白细胞减少症（8.3%）、中性粒细胞减少症（8.3%）和肌酸激酶升高（8.3%）。
普拉替尼在 RET 融合阳性晚期 NSCLC 患者中表现出良好的疗效和安全性。
