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腹腔内加压雾化化疗(PIPAC)作为腹膜转移性胆管癌挽救治疗的首批临床数据。

First Clinical Data of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) as Salvage Therapy for Peritoneal Metastatic Biliary Tract Cancer.

作者信息

Falkenstein Thomas A, Götze Thorsten O, Ouaissi Mehdi, Tempfer Clemens B, Giger-Pabst Urs, Demtröder Cédric

机构信息

Basic Research Laboratories of the Department of Surgery, St. Mary's Hospital, Ruhr University Bochum, Herne, Germany.

Institute of Clinical Cancer Research, UCT-University Cancer Center Frankfurt, Hospital Nordwest, Frankfurt, Germany.

出版信息

Anticancer Res. 2018 Jan;38(1):373-378. doi: 10.21873/anticanres.12232.

DOI:10.21873/anticanres.12232
PMID:29277797
Abstract

BACKGROUND

Patients suffering from peritoneal metastasis of biliary tract cancer were treated with pressurized intraperitoneal aerosol chemotherapy (PIPAC).

PATIENTS AND METHODS

This was a study carried out at a single institution, tertiary referral center certified for therapy of peritoneal disease. Retrospective data analysis was performed of prospective data for PIPAC with intra-peritoneal low-dose doxorubicin (1.5 mg/m) and cisplatin (7.5 mg/m) delivered at intervals of 6 weeks. The outcome criteria were microscopic pathological response, survival, and adverse events [Common Terminology Criteria of Adverse Events (v4.0)].

RESULTS

A total of 13 patients (male/female=8/5) with a mean age of 58 (range=37-75) years underwent 17 PIPAC procedures without intraoperative complications. The mean number of PIPAC applications was 1.3 (range=0-3). Due to non-accessibility of the abdominal cavity in two patients (15.4%) and rapid clinical deterioration in six patients (46%), five patients underwent two or more PIPAC applications and were, therefore, eligible for histological analysis to assess carcinoma regression. Overall tumor regression of any degree was determined in 4/5 patients. An overall median survival of 85 days (95% confidence interval(CI)=59.2-110.4 days) after the first PIPAC application was observed. No complications greater than Common Terminology Criteria of Adverse Events (v4.0) level 2 occurred.

CONCLUSION

PIPAC can induce objective regression of systemic chemotherapy-resistant peritoneal metastasis of biliary tract cancer. However, due to a rapid clinical deterioration of the patients, almost two-thirds of the patients cannot undergo repetitive PIPAC courses.

摘要

背景

患有胆道癌腹膜转移的患者接受了腹腔加压雾化化疗(PIPAC)。

患者与方法

本研究在一家单一机构进行,该机构是经认证的腹膜疾病治疗三级转诊中心。对前瞻性数据进行回顾性数据分析,这些数据来自接受腹腔内低剂量阿霉素(1.5mg/m)和顺铂(7.5mg/m)、间隔6周给药的PIPAC治疗。结局标准为微观病理反应、生存率和不良事件[不良事件通用术语标准(第4.0版)]。

结果

共有13例患者(男/女=8/5),平均年龄58岁(范围=37 - 75岁)接受了17次PIPAC治疗,无术中并发症。PIPAC应用的平均次数为1.3次(范围=0 - 3次)。由于两名患者(15.4%)腹腔无法进入,六名患者(46%)临床迅速恶化,五名患者接受了两次或更多次PIPAC治疗,因此有资格进行组织学分析以评估癌消退情况。4/5的患者确定有任何程度的总体肿瘤消退。首次PIPAC应用后观察到总体中位生存期为85天(95%置信区间(CI)=59.2 - 110.4天)。未发生大于不良事件通用术语标准(第4.0版)2级的并发症。

结论

PIPAC可诱导对全身化疗耐药的胆道癌腹膜转移出现客观消退。然而,由于患者临床迅速恶化,近三分之二的患者无法接受重复的PIPAC疗程。

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