10 Years of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC): A Systematic Review and Meta-Analysis.
10 Years of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC): A Systematic Review and Meta-Analysis.
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近年来，加压腹腔气溶胶化疗（PIPAC）已成为原发性或继发性腹膜癌患者腹腔内给药的可行方法。我们进行了系统回顾和荟萃分析，目的是评估PIPAC的可行性、安全性和有效性。背景：加压气雾剂腹腔化疗（PIPAC）是一种新型的低剂量腹腔化疗方法，作为加压气雾剂用于原发性或继发性腹膜癌患者。我们进行了系统回顾和荟萃分析，目的是评估PIPAC的可行性、安全性和有效性。方法：2011年1月1日至2021年12月31日，使用Medline和Web of Science数据库进行系统文献检索。数据由两位作者独立提取。纽卡斯尔-渥太华量表用于评估研究的质量和偏倚风险。对病理反应、放射反应、PCI随治疗的变化以及接受三次或三次以上PIPAC的患者进行meta分析。使用Freeman-Tukey双反正弦变换进行合并分析，在所有情况下使用Clopper-Pearson精确ci计算95% ci。结果：共纳入414篇关于PIPAC的论文，其中纳入53篇涉及1990例患者4719例PIPAC手术的研究进行分析。不可访问率或无法执行PIPAC合并率为所执行程序的4%。完成3个或更多周期PIPAC的患者的总比例为39%。考虑CTCAE 3-4的严重毒性为4%（0% ~ 38.5%）。总共有50项研究评估了术后前30天内的死亡情况。在纳入的1936例患者中，登记有26例死亡（1.3%）。所有报告病理反应的研究的合并分析为68% (95% CI 0.61-0.73)，具有可接受的异质性（I2 28.41%, p = 0.09）。总共有10篇论文报道了有关放射学反应的数据，具有高度的异质性，加权平均值为15%（0%至77.8%）。14项研究报告了PIPAC周期PCI变化。PCI分别在8项、1项和5项研究中减少、增加或保持稳定，在合并分析中具有高度异质性。关于生存率，存在高度异质性。结直肠癌、胃癌、妇科癌和肝胆/胰腺癌首次PIPAC的12个月估计生存率分别为53%、25%、59%和37%。结论：PIPAC可能是特定PM患者的有效治疗选择，具有可接受的3级和4级毒性和有希望的生存益处。荟萃分析显示，在最新可用的研究中，数据具有很高的异质性。在每个原发性肿瘤来源的亚群分析中，68%的研究记录了病理肿瘤消退，具有可接受的异质性。因此，病理回归似乎是PIPAC活性的可靠结果，也是治疗反应的潜在替代终点。我们建议为进入PIPAC项目的患者制定统一的选择标准，并强调对PIPAC报告和数据集的项目进行标准化的迫切需要。
In recent years, pressurized intraperitoneal aerosol chemotherapy (PIPAC) has emerged as a feasible method of intraperitoneal drug administration in patients affected by peritoneal cancer of primary or secondary origin. We performed a systematic review and meta-analysis with the aim of assessing the feasibility, safety, and efficacy of PIPAC. Background: Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel intraperitoneal drug delivery method of low-dose chemotherapy as a pressurized aerosol in patients affected by peritoneal cancer of primary or secondary origin. We performed a systematic review and meta-analysis with the aim of assessing the feasibility, safety, and efficacy of PIPAC. Methods: A systematic literature search was performed using Medline and Web of Science databases from 1 January 2011, to inception, to 31 December 2021. Data were independently extracted by two authors. The Newcastle-Ottawa Scale was used to assess the quality and risk of bias of studies. Meta-analysis was performed for pathological response, radiological response, PCI variation along treatment, and for patients undergoing three or more PIPAC. Pooled analyses were performed using the Freeman–Tukey double arcsine transformation, and 95% CIs were calculated using Clopper–Pearson exact CIs in all instances. Results: A total of 414 papers on PIPAC were identified, and 53 studies considering 4719 PIPAC procedure in 1990 patients were included for analysis. The non-access rate or inability to perform PIPAC pooled rate was 4% of the procedures performed. The overall proportion of patients who completed 3 or more cycles of PIPAC was 39%. Severe toxicities considering CTCAE 3–4 were 4% (0% to 38.5%). In total, 50 studies evaluated deaths within the first 30 postoperative days. In the included 1936 patients were registered 26 deaths (1.3%). The pooled analysis of all the studies reporting a pathological response was 68% (95% CI 0.61–0.73), with an acceptable heterogeneity (I2 28.41%, p = 0.09). In total, 10 papers reported data regarding the radiological response, with high heterogeneity and a weighted means of 15% (0% to 77.8%). PCI variation along PIPAC cycles were reported in 14 studies. PCI diminished, increased, or remained stable in eight, one and five studies, respectively, with high heterogeneity at pooled analysis. Regarding survival, there was high heterogeneity. The 12-month estimated survival from first PIPAC for colorectal cancer, gastric cancer, gynecological cancer and hepatobiliary/pancreatic cancer were, respectively, 53%, 25%, 59% and 37%. Conclusions: PIPAC may be a useful treatment option for selected patients with PM, with acceptable grade 3 and 4 toxicity and promising survival benefit. Meta-analysis showed high heterogeneity of data among up-to-date available studies. In a subset analysis per primary tumor origin, pathological tumor regression was documented in 68% of the studies with acceptable heterogeneity. Pathological regression seems, therefore, a reliable outcome for PIPAC activity and a potential surrogate endpoint of treatment response. We recommend uniform selection criteria for patients entering a PIPAC program and highlight the urgent need to standardize items for PIPAC reports and datasets.
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影响因子：
3.8
作者：
Giger-Pabst U;Demtröder C;Falkenstein TA;Ouaissi M;Götze TO;Rezniczek GA;Tempfer CB
通讯作者：
Tempfer CB
影响因子：
2.3
作者：
Di Giorgio, Andrea;Schena, Carlo Alberto;Rotolo, Stefano
通讯作者：
Rotolo, Stefano
影响因子：
3.8
作者：
Alyami, Mohammad;Bonnot, Pierre-Emmanuel;Glehen, Olivier
通讯作者：
Glehen, Olivier
影响因子：
1.9
作者：
Cuadrado Ayuso, Marta;Cabanas Montero, Jacobo;Galindo Alvarez, Julio
通讯作者：
Galindo Alvarez, Julio
影响因子：
51.1
作者：
Clamp, Andrew R.;James, Elizabeth C.;McNeish, Iain A.;Dean, Andrew;Kim, Jae-Won;O'Donnell, Dearbhaile M.;Gallardo-Rincon, Dolores;Blagden, Sarah;Brenton, James;Perren, Tim J.;Sundar, Sudha;Lord, Rosemary;Dark, Graham;Hall, Marcia;Banerjee, Susana;Glasspool, Rosalind M.;Hanna, C. Louise;Williams, Sarah;Scatchard, Kate M.;Nam, Helena;Essapen, Sharadah;Parkinson, Christine;McAvan, Lucy;Swart, Ann Marie;Popoola, Babasola;Schiavone, Francesca;Badrock, Jonathan;Fananapazir, Fuad;Cook, Adrian D.;Parmar, Mahesh;Kaplan, Richard;Ledermann, Jonathan A.
通讯作者：
Ledermann, Jonathan A.