腹腔内热灌注化疗（PIPAC）治疗方案的共识声明
Consensus statement for treatment protocols in pressurized intraperitoneal aerosol chemotherapy (PIPAC).
作者信息
Sgarbura Olivia, Eveno Clarisse, Alyami Mohammad, Bakrin Naoual, Guiral Delia Cortes, Ceelen Wim, Delgadillo Xavier, Dellinger Thanh, Di Giorgio Andrea, Kefleyesus Amaniel, Khomiakov Vladimir, Mortensen Michael Bau, Murphy Jamie, Pocard Marc, Reymond Marc, Robella Manuela, Rovers Koen P, So Jimmy, Somashekhar S P, Tempfer Clemens, Van der Speeten Kurt, Villeneuve Laurent, Yong Wei Peng, Hübner Martin
机构信息
Department of Surgical Oncology, Cancer Institute of Montpellier, University of Montpellier, Montpellier, France.
IRCM, Institut de Recherche en Cancérologie de Montpellier, INSERM U1194, Université de Montpellier, Institut régional du Cancer de Montpellier, Montpellier, France.
出版信息
Pleura Peritoneum. 2022 Mar 1;7(1):1-7. doi: 10.1515/pp-2022-0102.
OBJECTIVES
Safe implementation and thorough evaluation of new treatments require prospective data monitoring and standardization of treatments. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a promising alternative for the treatment of patients with peritoneal disease with an increasing number of suggested drug regimens. The aim was to reach expert consensus on current PIPAC treatment protocols and to define the most important research topics.
METHODS
The expert panel included the most active PIPAC centers, organizers of PIPAC courses and principal investigators of prospective studies on PIPAC. A comprehensive literature review served as base for a two-day hybrid consensus meeting which was accompanied by a modified three-round Delphi process. Consensus bar was set at 70% for combined (strong and weak) positive or negative votes according to GRADE. Research questions were prioritized from 0 to 10 (highest importance).
RESULTS
Twenty-two out of 26 invited experts completed the entire consensus process. Consensus was reached for 10/10 final questions. The combination of doxorubicin (2.1 mg/m) and cisplatin (10.5 mg/m) was endorsed by 20/22 experts (90.9%). 16/22 (72.7%) supported oxaliplatin at 120 with potential reduction to 90 mg/m (frail patients), and 77.2% suggested PIPAC-Ox in combination with 5-FU. Mitomycin-C and Nab-paclitaxel were favoured as alternative regimens. The most important research questions concerned PIPAC conditions (n=3), standard (n=4) and alternative regimens (n=5) and efficacy of PIPAC treatment (n=2); 8/14 were given a priority of ≥8/10.
CONCLUSIONS
The current consensus should help to limit heterogeneity of treatment protocols but underlines the utmost importance of further research.
目的
新治疗方法的安全实施和全面评估需要前瞻性数据监测和治疗标准化。腹腔内加压气雾化疗（PIPAC）是治疗腹膜疾病患者的一种有前景的替代方法，目前有越来越多的药物方案被提出。本研究旨在就当前的PIPAC治疗方案达成专家共识，并确定最重要的研究课题。
方法
专家小组包括最活跃的PIPAC中心、PIPAC课程组织者以及PIPAC前瞻性研究的主要研究者。全面的文献综述作为为期两天的混合共识会议的基础，该会议还伴随着改进的三轮德尔菲法。根据GRADE标准，合并（强和弱）赞成或反对票的共识门槛设定为70%。研究问题按0至10分进行优先级排序（10分表示最重要）。
结果
26位受邀专家中有22位完成了整个共识过程。对10个最终问题达成了共识。20/22位专家（90.9%）认可阿霉素（2.1mg/m）和顺铂（10.5mg/m）的联合使用。16/22位专家（72.7%）支持使用120mg/m的奥沙利铂，体弱患者可减至90mg/m，77.2%的专家建议将PIPAC - Ox与5 - FU联合使用。丝裂霉素 - C和纳米白蛋白结合型紫杉醇被认为是替代方案。最重要的研究问题涉及PIPAC条件（n = 3）、标准（n = 4）和替代方案（n = 5）以及PIPAC治疗的疗效（n = 2）；14个问题中有8个的优先级≥8/10。
结论
当前的共识应有助于限制治疗方案的异质性，但强调了进一步研究的至关重要性。
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