■不可切除的肝细胞癌(uHCC)继续提出有效的治疗选择。本研究的目的是评估低剂量环磷酰胺联合乐伐替尼的疗效和安全性。pembrolizumab和经动脉化疗栓塞(TACE)治疗uHCC。
■从2022年2月到2023年11月,共有40名诊断为uHCC的患者参加了这一小剂量,单中心,单臂,前瞻性研究。他们接受了低剂量环磷酰胺与乐伐替尼的联合治疗,pembrolizumab,和TACE。研究终点包括无进展生存期(PFS),客观反应率(ORR),和安全评估。使用改良的实体瘤反应评估标准(mRECIST)评估肿瘤反应,通过Kaplan-Meier曲线分析总生存期(OS)和PFS进行生存分析.根据美国国家癌症研究所不良事件通用术语标准(5.0版)评估不良事件(AE)。
■总共34名患者被纳入研究。中位随访时间为11.2[95%置信区间(95%CI),5.3-14.6]个月,中位PFS(mPFS)为15.5(95%CI,5.4-NA)个月。在研究期间未达到中位OS(mOS)。ORR为55.9%,疾病控制率(DCR)为70.6%。27例(79.4%)患者报告了不良事件。最常报告的不良事件(发生率>10%)包括肝功能异常(52.9%),腹痛(44.1%),腹胀和便秘(29.4%),高血压(20.6%),白细胞减少症(17.6%),便秘(17.6%),腹水(14.7%),失眠(14.7%)。肝功能异常(14.7%)最常见的是3级或更高的AE。
■低剂量环磷酰胺与乐伐替尼的组合,pembrolizumab,TACE对uHCC是安全有效的,展示了管理uHCC的有前途的治疗策略。
UNASSIGNED: Unresectable hepatocellular carcinoma (uHCC) continues to pose effective treatment options. The objective of this
study was to assess the efficacy and safety of combining low-dose cyclophosphamide with lenvatinib, pembrolizumab and transarterial chemoembolization (TACE) for the treatment of uHCC.
UNASSIGNED: From February 2022 to November 2023, a total of 40 patients diagnosed with uHCC were enrolled in this small-dose, single-center, single-arm, prospective
study. They received a combined treatment of low-dose cyclophosphamide with lenvatinib, pembrolizumab, and TACE.
Study endpoints included progression-free survival (PFS), objective response rate (ORR), and safety assessment. Tumor response was assessed using the modified Response Evaluation Criteria in Solid Tumors (mRECIST), while survival analysis was conducted through Kaplan-Meier curve analysis for overall survival (OS) and PFS. Adverse events (AEs) were evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).
UNASSIGNED: A total of 34 patients were included in the
study. The median follow-up duration was 11.2 [95% confidence interval (95% CI), 5.3-14.6] months, and the median PFS (mPFS) was 15.5 (95% CI, 5.4-NA) months. Median OS (mOS) was not attained during the
study period. The ORR was 55.9%, and the disease control rate (DCR) was 70.6%. AEs were reported in 27 (79.4%) patients. The most frequently reported AEs (with an incidence rate >10%) included abnormal liver function (52.9%), abdominal pain (44.1%), abdominal distension and constipation (29.4%), hypertension (20.6%), leukopenia (17.6%), constipation (17.6%), ascites (14.7%), and insomnia (14.7%). Abnormal liver function (14.7%) had the most common grade 3 or higher AEs.
UNASSIGNED: A combination of low-dose cyclophosphamide with lenvatinib, pembrolizumab, and TACE is safe and effective for uHCC, showcasing a promising therapeutic strategy for managing uHCC.