2022 年腹膜表面肿瘤学组腹膜恶性肿瘤 HIPEC 方案国际共识:结直肠癌。
2022 Peritoneal Surface Oncology Group International Consensus on HIPEC Regimens for Peritoneal Malignancies: Colorectal Cancer.
发表日期:2023 Nov 08
作者:
Martin Hübner, Kurt van Der Speeten, Kim Govaerts, Ignace de Hingh, Laurent Villeneuve, Shigeki Kusamura, Olivier Glehen
来源:
ANNALS OF SURGICAL ONCOLOGY
摘要:
选定的结直肠癌腹膜转移 (PM-CRC) 患者可以受益于潜在治愈性细胞减灭手术 (CRS) ± 腹腔热腹化疗 (HIPEC),中位总生存期 (OS) 超过 40 个月。该证据的目的共识指导委员会根据PICO(患者、患者、干预、比较、结果)方法,并根据建议分级、评估、发展和评估(GRADE)框架评估证据。标准化证据表被提交给国际专家小组,通过两轮德尔菲流程就 HIPEC 方案和研究重点达成共识(4 点、弱和强阳性/阴性)。共识被定义为 4 点共识分级的一致性≥ 50%,或者两种组合中的任何一个的一致性≥ 70%。9/10 临床问题的证据很弱或非常弱。总共有 70/90 的合格小组成员回答了两轮德尔菲 (78%),其中 10/10 的问题就 HIPEC 方案达成了共识。对于短期、高剂量奥沙利铂 (OX) 方案,存在强烈的负面共识 (55.7%),而微弱的正面投票 (53.8-64.3%) 支持基于丝裂霉素 C (MMC) 的 HIPEC(首选:荷兰方案:35 mg/m2,90 分钟,三部分),均用于原发性细胞减灭术和复发。确定 CRS 后 HIPEC 的作用被认为是最重要的研究问题,85.7% 的小组成员认为这是至关重要的。此外,超过 90% 的专家建议在初次和继发性 CRS 后针对初次手术后 1 年以上的复发进行 HIPEC。根据现有证据,尽管 PRODIGE 7 的结果为阴性,但仍可有条件地推荐给 PM-CRC 患者进行 HIPEC CRS之后。虽然迫切需要更多的临床前和临床数据来进一步协调该程序,但基于 MMC 的荷兰方案仍然是初次和二次 CRS 后的首选方案。© 2023。作者。
Selected patients with peritoneal metastases of colorectal cancer (PM-CRC) can benefit from potentially curative cytoreductive surgery (CRS) ± hyperthermic intraperitoneal chemotherapy (HIPEC), with a median overall survival (OS) of more than 40 months.The aims of this evidence-based consensus were to define the indications for HIPEC, to select the preferred HIPEC regimens, and to define research priorities regarding the use of HIPEC for PM-CRC.The consensus steering committee elaborated and formulated pertinent clinical questions according to the PICO (patient, intervention, comparator, outcome) method and assessed the evidence according to the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) framework. Standardized evidence tables were presented to an international expert panel to reach a consensus (4-point, weak and strong positive/negative) on HIPEC regimens and research priorities through a two-round Delphi process. The consensus was defined as ≥ 50% agreement for the 4-point consensus grading or ≥ 70% for either of the two combinations.Evidence was weak or very weak for 9/10 clinical questions. In total, 70/90 eligible panelists replied to both Delphi rounds (78%), with a consensus for 10/10 questions on HIPEC regimens. There was strong negative consensus concerning the short duration, high-dose oxaliplatin (OX) protocol (55.7%), and a weak positive vote (53.8-64.3%) in favor of mitomycin-C (MMC)-based HIPEC (preferred choice: Dutch protocol: 35 mg/m2, 90 min, three fractions), both for primary cytoreduction and recurrence. Determining the role of HIPEC after CRS was considered the most important research question, regarded as essential by 85.7% of the panelists. Furthermore, over 90% of experts suggest performing HIPEC after primary and secondary CRS for recurrence > 1 year after the index surgery.Based on the available evidence, despite the negative results of PRODIGE 7, HIPEC could be conditionally recommended to patients with PM-CRC after CRS. While more preclinical and clinical data are eagerly awaited to harmonize the procedure further, the MMC-based Dutch protocol remains the preferred regimen after primary and secondary CRS.© 2023. The Author(s).