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索拉非尼治疗埃及肝细胞癌患者的疗效:一项回顾性队列研究。

Outcomes of treatment with sorafenib in Egyptian patients with hepatocellular carcinoma: a retrospective cohort study.

机构信息

a Medical Oncology Department , Maadi Armed Forces Medical Compound, Oncology and Hematology Hospital , Cairo , Egypt.

b Clinical Oncology Department, Faculty of Medicine , Ain Shams University , Cairo , Egypt.

出版信息

Expert Rev Gastroenterol Hepatol. 2018 Jan;12(1):99-107. doi: 10.1080/17474124.2018.1403898. Epub 2017 Nov 20.

Abstract

BACKGROUND

Sorafenib is the standard of care, first line treatment for advanced HCC. This study aims to evaluate real-life efficacy and safety of sorafenib in Egyptian patients with Hepatocellular carcinoma (HCC).

METHODS

This retrospective cohort study was conducted in the medical oncology department at Maadi Armed Forces Medical Compound. Patients with advanced HCC who received sorafenib between January and December 2015 were included (130 patients).

RESULTS

The median overall survival of patients with HCC treated with sorafenib was 5 months (CI: 4.166-5.834), and progression free survival was 4 months (CI: 3.479-4.521). Disease control rate was 45.44% with 2 patients experiencing complete remission (1.2%). The adverse events rate was 76.1% for toxicities of all grades; with hand and foot syndrome being the most common (32.3% of any grade) and liver dysfunction the most common grade III toxicity (13.8%). Treatment was stopped for radiological progression based on modified RECIST criteria in 47 patients (36.3%), 18 patients stopped the treatment for intolerable toxicity. At the end of treatment upon radiological progression, 51 patients (39.2%) were still classified as Child A class of cirrhosis.

CONCLUSION

Sorafenib use should be limited to patients with Child A, PS 0-1, and low disease burden.

摘要

背景

索拉非尼是晚期 HCC 的标准治疗方法,一线治疗药物。本研究旨在评估索拉非尼在埃及肝细胞癌(HCC)患者中的真实疗效和安全性。

方法

这是一项在 Maadi 武装部队医疗综合体医学肿瘤科进行的回顾性队列研究。纳入 2015 年 1 月至 12 月期间接受索拉非尼治疗的晚期 HCC 患者(130 例)。

结果

接受索拉非尼治疗的 HCC 患者的中位总生存期为 5 个月(CI:4.166-5.834),无进展生存期为 4 个月(CI:3.479-4.521)。疾病控制率为 45.44%,2 例患者完全缓解(1.2%)。所有级别毒性的不良反应发生率为 76.1%;手足综合征最常见(任何级别 32.3%),肝功能障碍最常见的 3 级毒性(13.8%)。根据改良 RECIST 标准,47 例(36.3%)因影像学进展而停止治疗,18 例因无法耐受毒性而停止治疗。在影像学进展结束时的治疗结束时,51 例(39.2%)患者仍被归类为肝硬化 Child A 级。

结论

索拉非尼的使用应限于 Child A、PS 0-1 和低疾病负担的患者。

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