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服用索拉非尼或乐伐替尼的晚期肝细胞癌(HCC)患者的临床特征与预后:来自一个中低收入国家的真实世界经验

Clinical Profile and Outcome of Patients With Advanced Hepatocellular Carcinoma (HCC) Taking Sorafenib or Lenvatinib: Real-World Experience From a Low-Middle Resource Country.

作者信息

Sabir Kinza, Sajid Jawayria, Butt Nauman I, Waris Barak, Zahra Amal, Shoaib Muhammad

机构信息

Medical Oncology, Nawaz Sharif Social Security Teaching Hospital, Lahore, PAK.

Medical Oncology, Shalamar Hospital, Shalamar Medical and Dental College, Lahore, PAK.

出版信息

Cureus. 2025 May 7;17(5):e83681. doi: 10.7759/cureus.83681. eCollection 2025 May.

Abstract

Background and objective Hepatocellular carcinoma (HCC) incidence is high in Asian countries, and the age-standardized ratio in Pakistan is 7.6/100000 for males and 2.8/100000 for females, where patients often present with advanced-stage disease due to limited early detection. While the tyrosine kinase inhibitor sorafenib has been the standard first-line therapy, another tyrosine kinase inhibitor, lenvatinib, has recently gained attention as a potential alternative. However, local data comparing their effectiveness and safety is scarce. The aim of the study was to assess the clinical profile of patients with advanced HCC and treatment outcomes with sorafenib or lenvatinib in a tertiary care setting in Pakistan. Methods This retrospective, data-based study was conducted at the Department of Medical Oncology, Nawaz Sharif Social Security Teaching Hospital, Lahore, Pakistan. Medical records of 104 patients classified as having Barcelona clinic liver cancer (BCLC) stage C HCC were included. Patients with incomplete medical records, missing essential clinical data, those lost to follow-up, or who died before initiation of treatment were excluded from the analysis. Demographic information, including age, gender, hepatitis B and C status, and co-morbid conditions, was evaluated. For documentation of baseline parameters, Eastern Cooperative Oncology Group (ECOG) performance status, number of lesions on CT scan, evidence of invasive or metastatic disease, and liver function parameters categorized by Child-Pugh class (A to C) were assessed. Treatment records were examined to determine whether patients received Sorafenib or Lenvatinib, and the outcome and adverse effects were noted. Results of follow-up CT scan performed at six months were used as the primary outcome measure to assess disease status, categorized as complete resolution, partial resolution, or no response/progression. Data were entered and analyzed using SPSS version 23 (IBM Inc., Armonk, New York). Results The mean age of the patients was 64.9±8.3 years, with 74 (71.2%) males. All patients had advanced HCC at BCLC stage C. Chronic hepatitis C was reported in 92 (88.5%) patients, while chronic hepatitis B in 02 (1.9%). The most frequent co-morbid conditions were hypertension (26, 25.0%) and diabetes mellitus (18, 17.3%). The majority of the patients (40, 38.5%) had grade 2 ECOG performance status, with 68 (65.4%) having multifocal HCC and 62 (59.6%) vascular invasion. Metastases were seen in 38 (36.5%) patients, with nodal metastasis being the most frequent site (18, 17.3%). The mean Child-Pugh score was 6.5±1.3, with the majority of the patients (62, 59.6%) having Child-Pugh class A. With regards to treatment, 66 (63.5%) patients received sorafenib while 38 (36.5%) received lenvatinib. At the six-month follow-up, repeat CT scan demonstrated complete resolution of HCC in 04 (3.8%) patients and partial resolution in 58 (55.8%) patients, whereas 42 (40.4%) patients showed no response or progression. Hand-foot syndrome was the most frequent adverse effect seen in eight (7.7%) patients, followed by diarrhea in four (3.8%) patients, and mucositis in two (1.9%) patients. Conclusion In this study, sorafenib and lenvatinib were both found to be effective treatment options for patients with advanced HCC at BCLC stage C, with partial resolution observed in the majority of patients.

摘要

背景与目的

亚洲国家肝细胞癌(HCC)发病率较高,巴基斯坦的年龄标准化发病率男性为7.6/100000,女性为2.8/100000,由于早期检测有限,患者常表现为晚期疾病。虽然酪氨酸激酶抑制剂索拉非尼一直是标准的一线治疗药物,但另一种酪氨酸激酶抑制剂仑伐替尼最近作为一种潜在的替代药物受到关注。然而,比较它们有效性和安全性的本地数据很少。本研究的目的是评估巴基斯坦一家三级医疗中心晚期HCC患者的临床特征以及使用索拉非尼或仑伐替尼的治疗结果。方法:这项基于数据的回顾性研究在巴基斯坦拉合尔纳瓦兹·谢里夫社会保障教学医院医学肿瘤学系进行。纳入104例被归类为巴塞罗那临床肝癌(BCLC)C期HCC的患者的病历。分析时排除病历不完整、缺少基本临床数据、失访或在治疗开始前死亡的患者。评估人口统计学信息,包括年龄、性别、乙肝和丙肝状况以及合并症。为记录基线参数,评估东部肿瘤协作组(ECOG)体能状态、CT扫描上的病灶数量、侵袭性或转移性疾病的证据以及根据Child-Pugh分级(A至C)分类的肝功能参数。检查治疗记录以确定患者是否接受索拉非尼或仑伐替尼,并记录结果和不良反应。将六个月时进行的随访CT扫描结果用作评估疾病状态的主要结局指标,分为完全缓解、部分缓解或无反应/进展。使用SPSS 23版(IBM公司,纽约州阿蒙克)输入和分析数据。结果:患者的平均年龄为64.9±8.3岁,男性74例(71.2%)。所有患者均为BCLC C期晚期HCC。92例(88.5%)患者报告有慢性丙型肝炎,而2例(1.9%)有慢性乙型肝炎。最常见的合并症是高血压(26例,25.0%)和糖尿病(18例,17.3%)。大多数患者(40例,38.5%)的ECOG体能状态为2级,68例(65.4%)有多灶性HCC,62例(59.6%)有血管侵犯。38例(36.5%)患者有转移,其中淋巴结转移是最常见的部位(18例,17.3%)。Child-Pugh评分的平均值为6.5±1.3,大多数患者(62例,59.6%)为Child-Pugh A级。关于治疗,66例(63.5%)患者接受索拉非尼,38例(36.5%)患者接受仑伐替尼。在六个月的随访中,重复CT扫描显示4例(3.8%)患者的HCC完全缓解,58例(55.8%)患者部分缓解,而42例(40.4%)患者无反应或病情进展。手足综合征是8例(7.7%)患者中最常见的不良反应,其次是腹泻4例(3.8%)患者,黏膜炎2例(1.9%)患者。结论:在本研究中,索拉非尼和仑伐替尼均被发现是BCLC C期晚期HCC患者的有效治疗选择,大多数患者观察到部分缓解。

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Global Epidemiology and Genetics of Hepatocellular Carcinoma.全球肝细胞癌的流行病学和遗传学
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World J Gastroenterol. 2020 Oct 14;26(38):5759-5783. doi: 10.3748/wjg.v26.i38.5759.

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