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术前化疗联合肝切除术治疗可切除的 UICC7 期 IIIA、IIIB 期肝细胞癌:一项 II 期临床试验。

Preoperative Chemotherapy Followed by Hepatectomy for Potentially Resectable UICC7 Stage IIIA, IIIB Hepatocellular Carcinoma; A Phase II Clinical Trial.

机构信息

Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Kurume University School of Medicine.

Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine.

出版信息

Kurume Med J. 2023 Sep 25;68(3.4):239-245. doi: 10.2739/kurumemedj.MS6834010. Epub 2023 Jul 28.

Abstract

BACKGROUND

The Japanese guideline for therapeutic strategy in HCC does not recognize any benefit of preoperative chemotherapy for potentially resectable hepatocellular carcinoma (HCC), and only upfront resec tion is recommended even for an advanced HCC. Data on preoperative chemotherapy for advanced HCC is still limited. Poor prognostic factors of HCC after resection are tumor more than 5 cm in diameter, multiple lesions, and gross tumor thrombosis, which constitute UICC7 Stage IIIA and IIIB HCC. There are no prospective studies about preoperative chemotherapy in these patients.

AIM

To evaluate the benefit of preoperative chemotherapy for UICC7 Stage IIIA and IIIB potentially resectable HCC.

DISCUSSION

Our recent study demonstrated that the 5-year overall survival rate (OS) of patients diagnosed as UICC7 Stage IIIA and IIIB who had received upfront resection was only 16.5%. In contrast, the 5-year OS of UICC7 Stage IIIA and IIIB initially unresectable patients who had achieved conversion from unresectable to resect able status under successful hepatic infusion chemotherapy prior to resection was as high as 61.3%. Additionally, recent studies reported transarterial chemoembolization achieved outcomes comparable with those of resection. Therefore, we believe that patients with UICC7 Stage IIIA and IIIB should be considered borderline resectable. To evaluate this hypothesis we registered the present phase II clinical trial to assess the benefit of preoperative chemo therapy followed by hepatectomy in potentially resectable UICC7 Stage IIIA and IIIB HCC patients.

摘要

背景

日本 HCC 治疗策略指南不承认术前化疗对潜在可切除肝细胞癌(HCC)有任何益处,仅推荐直接进行切除术,即使是晚期 HCC 也是如此。关于晚期 HCC 术前化疗的数据仍然有限。 HCC 切除后不良预后因素包括肿瘤直径大于 5cm、多个病灶和大体肿瘤血栓形成,这些构成 UICC7 分期 IIIA 和 IIIB HCC。对于这些患者,没有关于术前化疗的前瞻性研究。

目的

评估术前化疗对潜在可切除的 UICC7 分期 IIIA 和 IIIB HCC 的益处。

讨论

我们最近的研究表明,接受直接切除术的 UICC7 分期 IIIA 和 IIIB 患者的 5 年总生存率(OS)仅为 16.5%。相比之下,在接受肝动脉灌注化疗成功将不可切除状态转化为可切除状态之前,最初被诊断为不可切除的 UICC7 分期 IIIA 和 IIIB 患者的 5 年 OS 高达 61.3%。此外,最近的研究报告称经动脉化疗栓塞的结果可与切除术相媲美。因此,我们认为 UICC7 分期 IIIA 和 IIIB 的患者应被视为边缘可切除。为了评估这一假设,我们注册了这项 II 期临床试验,以评估术前化疗联合肝切除术治疗潜在可切除的 UICC7 分期 IIIA 和 IIIB HCC 患者的疗效。

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