经皮肝灌注（化学饱和）用美法仑治疗肝内胆管细胞癌患者：欧洲多中心安全性、短期疗效和生存研究。

Percutaneous hepatic perfusion (chemosaturation) with melphalan in patients with intrahepatic cholangiocarcinoma: European multicentre study on safety, short-term effects and survival.

机构信息

Department of Diagnostic and Interventional Radiology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.

Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.

出版信息

Eur Radiol. 2019 Apr;29(4):1882-1892. doi: 10.1007/s00330-018-5729-z. Epub 2018 Sep 25.

DOI:10.1007/s00330-018-5729-z

PMID:30255257

Abstract

OBJECTIVES

Cholangiocarcinoma is the second most common primary liver tumour with a poor overall prognosis. Percutaneous hepatic perfusion (PHP) is a directed therapy for primary and secondary liver malignancies, and its efficacy and safety have been shown in different entities. The purpose of this study was to prove the safety and efficacy of PHP in patients with unresectable intrahepatic cholangiocarcinoma (iCCA).

PATIENTS AND METHODS

We retrospectively reviewed data from 15 patients with unresectable iCCA treated with PHP in nine different hospitals throughout Europe. Overall response rates (ORR) were assessed according to response evaluation criteria in solid tumours (RECIST1.1). Overall survival (OS), progression-free survival (PFS) and hepatic PFS (hPFS) were analysed using the Kaplan-Meier estimation. Adverse events (AEs) and toxicity were evaluated.

RESULTS

Fifteen patients were treated with 26 PHPs. ORR was 20%, disease control was achieved in 53% after the first PHP. Median OS was 26.9 months from initial diagnosis and 7.6 months from first PHP. Median PFS and hPFS were 122 and 131 days, respectively. Patients with liver-only disease had a significantly longer median OS compared to patients with locoregional lymph node metastases (12.9 vs. 4.8 months, respectively; p < 0.01). Haematological toxicity was common, but manageable. No AEs of grade 3 or 4 occurred during the procedures.

DISCUSSION

PHP is a standardised and safe procedure that provides promising response rates and survival data in patients with iCCA, especially in non-metastatic disease.

KEY POINTS

• Percutaneous hepatic perfusion (PHP) offers an additional locoregional therapy strategy for the treatment of unresectable primary or secondary intrahepatic malignancies. • PHP is a standardised and safe procedure that provides promising response rates and survival data in patients with intrahepatic cholangiocarcinoma (iCCA), especially in non-metastatic disease. • Side effects seem to be tolerable and comparable to other systemic or local treatment strategies.

摘要

目的

胆管癌是第二常见的原发性肝脏肿瘤，整体预后较差。经皮肝脏灌注（PHP）是一种针对原发性和继发性肝脏恶性肿瘤的靶向治疗方法，其在不同实体瘤中的疗效和安全性已得到证实。本研究旨在证明 PHP 在不可切除的肝内胆管癌（iCCA）患者中的安全性和有效性。

患者和方法

我们回顾性分析了欧洲 9 家不同医院的 15 例不可切除的 iCCA 患者接受 PHP 治疗的数据。根据实体瘤反应评估标准（RECIST1.1）评估总体缓解率（ORR）。采用 Kaplan-Meier 估计法分析总生存期（OS）、无进展生存期（PFS）和肝脏无进展生存期（hPFS）。评估不良事件（AEs）和毒性。

结果

15 例患者共接受 26 次 PHP 治疗。首次 PHP 后，ORR 为 20%，疾病控制率为 53%。从初始诊断到首次 PHP 的中位 OS 为 26.9 个月，中位 PFS 和 hPFS 分别为 122 和 131 天。仅肝脏疾病患者的中位 OS 明显长于局部淋巴结转移患者（分别为 12.9 和 4.8 个月；p < 0.01）。血液学毒性常见，但可管理。在治疗过程中未发生 3 级或 4 级 AE。