小剂量环磷酰胺联合来伐替尼、pembrolizumab和TACE治疗不可切除肝细胞癌的有效性和安全性:一项单中心、前瞻性、单臂临床试验。

IF 7 2区 医学 Q1 ONCOLOGY Chinese Journal of Cancer Research Pub Date : 2024-04-30 DOI:10.21147/j.issn.1000-9604.2024.02.02
Yupeng Ren, Yuxuan Li, Mingbo Cao, Yongchang Tang, Feng Yuan, Gaoyuan Yang, Zhiwei He, Zheng Shi, Xiaorui Su, Zhicheng Yao, Meihai Deng
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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).</p><p><strong>Results: </strong>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. 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引用次数: 0

摘要

目的:无法切除的肝细胞癌(uHCC)仍然是有效的治疗方案。本研究旨在评估低剂量环磷酰胺联合来伐替尼、pembrolizumab和经动脉化疗栓塞(TACE)治疗uHCC的有效性和安全性:从2022年2月到2023年11月,共有40名确诊为uHCC的患者参与了这项小剂量、单中心、单臂、前瞻性研究。他们接受了小剂量环磷酰胺联合来伐替尼、pembrolizumab和TACE的综合治疗。研究终点包括无进展生存期(PFS)、客观反应率(ORR)和安全性评估。肿瘤反应采用改良的实体瘤反应评估标准(mRECIST)进行评估,总生存期(OS)和PFS的生存分析采用卡普兰-梅耶曲线分析法。不良事件(AEs)根据美国国立癌症研究所不良事件通用术语标准(5.0版)进行评估:研究共纳入了 34 名患者。中位随访时间为11.2个月[95%置信区间(95% CI),5.3-14.6],中位PFS(mPFS)为15.5个月(95% CI,5.4-NA)。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%)患者出现了不良反应。最常报告的不良反应(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(17.6%)、便秘(17.6%)、腹水(14.7%)和失眠(14.7%)。肝功能异常(14.7%)是最常见的3级或以上AEs:结论:小剂量环磷酰胺联合来伐替尼、pembrolizumab和TACE治疗uHCC安全有效,是治疗uHCC的一种有前途的治疗策略。
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Efficacy and safety of low-dose cyclophosphamide combined with lenvatinib, pembrolizumab and TACE for unresectable hepatocellular carcinoma: A single-center, prospective, single-arm clinical trial.

Objective: 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.

Methods: 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).

Results: 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.

Conclusions: 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.

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来源期刊
自引率
9.80%
发文量
1726
审稿时长
4.5 months
期刊介绍: Chinese Journal of Cancer Research (CJCR; Print ISSN: 1000-9604; Online ISSN:1993-0631) is published by AME Publishing Company in association with Chinese Anti-Cancer Association.It was launched in March 1995 as a quarterly publication and is now published bi-monthly since February 2013. CJCR is published bi-monthly in English, and is an international journal devoted to the life sciences and medical sciences. It publishes peer-reviewed original articles of basic investigations and clinical observations, reviews and brief communications providing a forum for the recent experimental and clinical advances in cancer research. This journal is indexed in Science Citation Index Expanded (SCIE), PubMed/PubMed Central (PMC), Scopus, SciSearch, Chemistry Abstracts (CA), the Excerpta Medica/EMBASE, Chinainfo, CNKI, CSCI, etc.
期刊最新文献
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