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Body composition and immunonutritional status in patients treated with pressurized intraperitoneal aerosol chemotherapy (PIPAC) for gastrointestinal peritoneal metastases: a prospective single-center analysis 接受加压腹腔内气溶胶化疗(PIPAC)治疗胃肠道腹膜转移患者的体成分和免疫营养状况:一项前瞻性单中心分析
IF 1.8 Q4 ONCOLOGY Pub Date : 2022-03-01 DOI: 10.1515/pp-2021-0142
Stefano Rotolo, A. di Giorgio, M. Cintoni, E. Rinninella, M. Palombaro, G. Pulcini, C. Schena, V. Chiantera, G. Vizzielli, A. Gasbarrini, F. Pacelli, M. C. Mele
Abstract Objectives Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel drug administration method with promising efficacy for the treatment of peritoneal metastases (PM). This study aimed to evaluate the prognostic value of an immunonutritional assessment on the feasibility, safety, and survival in this setting. Methods Data of PM patients undergoing PIPAC between September 2018 and May 2020 were prospectively recorded. A CT scan-derived body composition assessment was performed for each patient. Results Fifty-one patients were enrolled, of which 30 (58%) underwent multiple PIPAC cycles, with a pathological response rate of 55%. Prognostic nutritional index (PNI) and neutrophil-to-lymphocytes predicted completion of more than one PIPAC cycle, with a cut off of 36.5 and 4.8 respectively. Muscle attenuation and body fat tissues were associated with pathological response. At multivariate Cox regression analysis, only the presence of a low PNI (HR 2.41, 95% CI 1.08–5.46) was significantly associated with a worse OS. Conclusions A pretreatment immunonutritional assessment may provide valuable information for PIPAC patients’ selection and survival, while body composition parameters are able to predict pathological response. Further larger studies are needed to validate the role of these biomarkers in tailoring the treatment and monitoring PM patients undergoing PIPAC.
【摘要】目的加压腹腔雾化化疗(PIPAC)是一种治疗腹膜转移瘤(PM)的新型给药方法。本研究旨在评估免疫营养评估在这种情况下的可行性、安全性和生存率的预后价值。方法前瞻性记录2018年9月至2020年5月接受PIPAC治疗的PM患者的数据。对每位患者进行CT扫描衍生的身体成分评估。结果纳入51例患者,其中30例(58%)接受了多个PIPAC周期,病理缓解率为55%。预后营养指数(PNI)和中性粒细胞转淋巴细胞预测完成一个以上的PIPAC周期,截断值分别为36.5和4.8。肌肉衰减和体脂肪组织与病理反应有关。在多变量Cox回归分析中,只有低PNI (HR 2.41, 95% CI 1.08-5.46)与较差的OS显著相关。结论预处理免疫营养评估可为PIPAC患者的选择和生存提供有价值的信息,而体成分参数可预测病理反应。需要进一步的大规模研究来验证这些生物标志物在定制治疗和监测接受PIPAC的PM患者中的作用。
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引用次数: 2
Consensus statement for treatment protocols in pressurized intraperitoneal aerosol chemotherapy (PIPAC) 加压腹腔内气雾化疗(PIPAC)治疗方案共识声明
IF 1.8 Q4 ONCOLOGY Pub Date : 2022-03-01 DOI: 10.1515/pp-2022-0102
O. Sgarbura, C. Eveno, M. Alyami, Naoual Bakrin, D. C. Guiral, W. Ceelen, X. Delgadillo, T. Dellinger, A. di Giorgio, A. Kefleyesus, V. Khomiakov, M. Mortensen, J. Murphy, M. Pocard, M. Reymond, M. Robella, K. Rovers, J. So, S. P. Somashekhar, C. Tempfer, K. van der Speeten, L. Villeneuve, W. Yong, M. Hübner
Abstract 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/m2) and cisplatin (10.5 mg/m2) was endorsed by 20/22 experts (90.9%). 16/22 (72.7%) supported oxaliplatin at 120 with potential reduction to 90 mg/m2 (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.
目的新疗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。加压腹膜内气溶胶化疗(PIPAC)是治疗腹膜疾病患者的一种很有前途的替代方案,建议的药物方案越来越多。目的是就目前的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课程组织者和PIPAC前瞻性研究的主要研究者。全面的文献综述作为基础,为期两天的混合共识会议,伴随着修改的三轮德尔菲过程。根据GRADE,赞成票或反对票的一致门槛设定为70%。研究问题的优先级从0到10(最高重要性)。结果26位受邀专家中有22位完成了整个共识过程。最后10个问题达成了共识。阿霉素(2.1 mg/m2)与顺铂(10.5 mg/m2)联合用药获得20/22位专家(90.9%)的认可。16/22(72.7%)的人支持奥沙利铂120,有可能降至90mg /m2(体弱患者),77.2%的人建议PIPAC-Ox联合5-FU。丝裂霉素- c和nab -紫杉醇是首选的替代方案。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);8/14被赋予≥8/10的优先级。目前的共识应该有助于限制治疗方案的异质性,但强调了进一步研究的重要性。
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引用次数: 11
Some pleural effusions labeled as idiopathic could be produced by the inhalation of silica 一些被标记为特发性的胸腔积液可能是由吸入二氧化硅引起的
IF 1.8 Q4 ONCOLOGY Pub Date : 2022-01-03 DOI: 10.1515/pp-2021-0135
S. Bielsa, A. Guitart, A. Esquerda, R. Fernandez-Pacheco, M. Baranguán, A. Ibarra, J. Porcel
Abstract Objectives Exposure to silica nanoparticles has been associated with pleural effusions (PEs) in animal models and case series. We hypothesized that some PEs labelled as “idiopathic” could, in fact, be secondary to inhalation of silica. Methods A retrospective case control study was designed utilizing a prospectively maintained pleural database. Cases, represented by idiopathic PEs, were matched by age and gender to control patients who had been diagnosed with malignant, cardiac, or infectious PEs. A survey consisting of questions about occupational life and possibility of silica inhalation was conducted. In a subgroup of patients, pleural fluid concentrations of silica were quantified by plasma atomic emission spectrometry analysis. Also, the pleural biopsy of a silica-exposed case was subjected to an energy dispersive X-ray spectroscopy (EDX) to identify the mineral, the size of which was determined by electron microscopy. Results A total of 118 patients (59 cases and 59 controls) completed the survey. There were 25 (42%, 95% CI 31–55%) and 13 (22%, 95% CI 13–34%) silica-exposed workers in case and control groups, respectively. The exposure attributable fraction was 0.62 (95% CI 0.14–0.83). Four of eight exposed cases showed detectable levels of silica in the pleural fluid (mean 2.37 mg/L), as compared to none of 16 tested controls. Silica nanoparticles of 6–7 nm were identified in the pleural biopsy of an exposed case patient. Conclusions It is plausible that some idiopathic PEs could actually be caused by occupational silica inhalation.
在动物模型和病例系列中,暴露于二氧化硅纳米颗粒与胸腔积液(PEs)有关。我们假设一些被标记为“特发性”的pe实际上可能是由吸入二氧化硅引起的。方法采用前瞻性胸膜数据库设计回顾性病例对照研究。以特发性pe为代表的病例按年龄和性别匹配,以控制诊断为恶性、心脏性或感染性pe的患者。对职业寿命和吸入二氧化硅的可能性进行了调查。在一个亚组的病人,胸膜液二氧化硅浓度定量等离子体原子发射光谱分析。此外,对二氧化硅暴露病例的胸膜活检进行了能量色散x射线光谱(EDX)鉴定,并通过电子显微镜确定了其大小。结果共118例患者完成调查,其中59例为病例,59例为对照组。病例组和对照组分别有25名(42%,95% CI 31-55%)和13名(22%,95% CI 13 - 34%)接触二氧化硅的工人。暴露归因分数为0.62 (95% CI 0.14-0.83)。8例暴露病例中有4例显示胸膜液中可检测到二氧化硅水平(平均2.37毫克/升),而16例测试对照组中没有检测到二氧化硅。在暴露病例患者的胸膜活检中发现了6-7 nm的二氧化硅纳米颗粒。结论一些特发性pe可能是职业性吸入二氧化硅所致。
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引用次数: 1
Characteristics of early pleural effusions after orthotopic heart transplantation: comparison with coronary artery bypass graft surgery. 原位心脏移植术后早期胸腔积液的特点:与冠状动脉搭桥手术的比较。
IF 1.8 Q4 ONCOLOGY Pub Date : 2021-12-13 eCollection Date: 2021-12-01 DOI: 10.1515/pp-2021-0143
Anant Jain, Anusha Devarajan, Hussein Assallum, Ramin Malekan, Gregg M Lanier, Oleg Epelbaum

Objectives: Pleural effusions appearing within the first 30 postoperative days following coronary artery bypass grafting (CABG) are classified as early and believed to be directly related to the surgery. The characteristics of such effusions are well-described. Orthotopic heart transplantation is also known to be complicated by pleural effusions; however, their characteristics have not been systematically reported. We assessed the features of early postoperative pleural effusions after heart transplantation and compared them to those of early effusions following CABG.

Methods: We retrospectively collected demographic, clinical, and laboratory data for patients who underwent either orthotopic heart transplantation (study group) or CABG (comparison group) at our institution and whose postoperative course within 30 days was complicated by new or worsening pleural effusion that prompted drainage. Patients subjected to analysis consisted only of those with sufficiently complete laboratory profiles to permit adequate characterization of the nature of their pleural fluid.

Results: Out of 251 orthotopic heart transplant recipients, seven (2.8%) were found to have sufficiently complete pleural fluid results to be included in the study group. Out of 1,506 patients who underwent CABG, 32 (2.1%) had sufficiently complete pleural fluid results and formed the comparison group. The radiological appearance of pleural effusions in both groups was similar: bilateral in at least half and exclusively moderate to large. Effusions complicating both surgeries were exudative in close to 90% of cases. For those with available leukocyte differential counts, the pleural fluid of the post-orthotopic heart transplantation group was more often neutrophilic (3/5, 60%), whereas the fluid of the post-coronary artery bypass grafting group was more often lymphocytic (22/32, 69%) and tended to be hemorrhagic (median RBC count 33,000 cells/µL vs. 10,000 cells/µL). None of the comparisons of pleural fluid characteristics between the two groups reached statistical significance.

Conclusions: This small, descriptive study is the first to systematically report the fluid characteristics of pleural effusions complicating orthotopic heart transplantation within the first 30 postoperative days and to compare this group to those who developed effusions after CABG. Our findings revealed both similarities and differences in the pleural fluid characteristics between these two types of patients.

目的:冠状动脉旁路移植术(CABG)术后30天内出现胸腔积液属于早期,认为与手术有直接关系。这种积液的特征已得到很好的描述。原位心脏移植也有胸腔积液的并发症;然而,它们的特点尚未有系统的报道。我们评估了心脏移植术后早期胸腔积液的特征,并将其与冠脉搭桥术后早期积液进行了比较。方法:我们回顾性收集本院接受原位心脏移植(研究组)或冠脉搭桥(对照组)的患者的人口统计学、临床和实验室资料,这些患者术后30天内出现新的或恶化的胸腔积液,需要引流。接受分析的患者仅包括那些具有足够完整的实验室资料以充分表征其胸膜液性质的患者。结果:251例原位心脏移植受者中,有7例(2.8%)发现胸膜液结果足够完整,可纳入研究组。在1,506例接受CABG的患者中,32例(2.1%)有足够完整的胸水结果,形成了对照组。两组胸膜积液的影像学表现相似:至少一半为双侧胸膜积液,均为中度至大量胸膜积液。在近90%的病例中,两种手术的积液均为渗出性。对于那些有白细胞差异计数的患者,原位心脏移植组的胸膜液更多是中性粒细胞(3/ 5,60 %),而冠状动脉旁路移植术组的胸膜液更多是淋巴细胞(22/ 32,69 %),并倾向于出血(中位RBC计数33,000细胞/µL对10,000细胞/µL)。两组间胸膜液特征比较均无统计学意义。结论:这项小型描述性研究首次系统地报道了原位心脏移植术后30天内并发胸腔积液的液体特征,并将该组与CABG后出现积液的患者进行了比较。我们的研究结果揭示了这两类患者胸膜液特征的异同。
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引用次数: 0
Frontmatter
IF 1.8 Q4 ONCOLOGY Pub Date : 2021-12-01 DOI: 10.1515/pp-2021-frontmatter4
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引用次数: 0
Risk factors and clinical outcomes in patients undergoing cytoreductive surgery with concomitant ureteric reimplantation. 输尿管再植术患者行细胞减少术的危险因素和临床结果。
IF 1.8 Q4 ONCOLOGY Pub Date : 2021-11-15 eCollection Date: 2021-12-01 DOI: 10.1515/pp-2021-0130
Anais Alonso, Shoma Barat, Helen Kennedy, Meredith Potter, Nayef Alzahrani, David Morris

Objectives: There are currently scarce data exploring ureteric reimplantation (UR) during cytoreductive surgery (CRS).

Methods: We identified patients undergoing CRS for peritoneal surface malignancies (PSM) of any origin at a single high-volume unit. UR was defined as ureteroureterostomy, transureterouretostomy, ureteroneocystostomy, ureterosigmoidostomy or ileal conduit performed during CRS. Peri-operative outcomes, long-term survival and risk factors for requiring UR were analysed.

Results: Seven hundred and sixty-seven CRSs were identified. Twenty-three (3.0%) procedures involved UR. Bladder resection and colorectal cancer (CRC) were associated with increased risk of UR (bladder resection: OR 12.90, 95% CI 4.91-33.90, p<0.001; CRC: OR 2.51, 95% CI 1.05-6.01, p=0.038). UR did not increase the risk of Grade III-IV morbidity or mortality. The rate of ureteric leak was 3/23 (13.0%) in the UR group. Mean survival was equivocal in patients with CRC (58.14 vs. 34.25 months, p=0.441) but significantly lower in those with high-grade appendiceal mucinous neoplasm (HAMN) undergoing UR (73.98 vs. 30.90 months, p=0.029).

Conclusions: UR during CRS does not increase major morbidity or mortality for carefully selected patients, and is associated with low rates of urologic complications. Whilst decreased survival was apparent in patients with HAMN undergoing UR, it is unclear whether this relationship is causal.

目的:目前关于细胞减少手术(CRS)中输尿管再植(UR)的研究资料很少。方法:我们在单个高容量单位中确定了任何来源的腹膜表面恶性肿瘤(PSM)接受CRS的患者。UR定义为CRS中进行的输尿管输尿管造口术、经输尿管输尿管造口术、输尿管膀胱造口术、输尿管乙状结肠造口术或回肠导管造口术。分析围手术期结局、长期生存和需要UR的危险因素。结果:共鉴定出767个crs。23例(3.0%)手术涉及UR。膀胱切除术和结直肠癌(CRC)与尿路风险增加相关(膀胱切除术:OR 12.90, 95% CI 4.91-33.90, p)结论:对于精心挑选的患者,CRS期间尿路不会增加主要发病率或死亡率,并且与泌尿系统并发症发生率低相关。虽然HAMN患者接受尿路治疗的生存率明显下降,但尚不清楚这种关系是否有因果关系。
{"title":"Risk factors and clinical outcomes in patients undergoing cytoreductive surgery with concomitant ureteric reimplantation.","authors":"Anais Alonso,&nbsp;Shoma Barat,&nbsp;Helen Kennedy,&nbsp;Meredith Potter,&nbsp;Nayef Alzahrani,&nbsp;David Morris","doi":"10.1515/pp-2021-0130","DOIUrl":"https://doi.org/10.1515/pp-2021-0130","url":null,"abstract":"<p><strong>Objectives: </strong>There are currently scarce data exploring ureteric reimplantation (UR) during cytoreductive surgery (CRS).</p><p><strong>Methods: </strong>We identified patients undergoing CRS for peritoneal surface malignancies (PSM) of any origin at a single high-volume unit. UR was defined as ureteroureterostomy, transureterouretostomy, ureteroneocystostomy, ureterosigmoidostomy or ileal conduit performed during CRS. Peri-operative outcomes, long-term survival and risk factors for requiring UR were analysed.</p><p><strong>Results: </strong>Seven hundred and sixty-seven CRSs were identified. Twenty-three (3.0%) procedures involved UR. Bladder resection and colorectal cancer (CRC) were associated with increased risk of UR (bladder resection: OR 12.90, 95% CI 4.91-33.90, p<0.001; CRC: OR 2.51, 95% CI 1.05-6.01, p=0.038). UR did not increase the risk of Grade III-IV morbidity or mortality. The rate of ureteric leak was 3/23 (13.0%) in the UR group. Mean survival was equivocal in patients with CRC (58.14 vs. 34.25 months, p=0.441) but significantly lower in those with high-grade appendiceal mucinous neoplasm (HAMN) undergoing UR (73.98 vs. 30.90 months, p=0.029).</p><p><strong>Conclusions: </strong>UR during CRS does not increase major morbidity or mortality for carefully selected patients, and is associated with low rates of urologic complications. Whilst decreased survival was apparent in patients with HAMN undergoing UR, it is unclear whether this relationship is causal.</p>","PeriodicalId":20231,"journal":{"name":"Pleura and Peritoneum","volume":"6 4","pages":"155-160"},"PeriodicalIF":1.8,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8719446/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39962922","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Consensus statement on safety measures for pressurized intraperitoneal aerosol chemotherapy. 关于加压腹腔喷雾化疗安全措施的共识声明。
IF 1.8 Q4 ONCOLOGY Pub Date : 2021-11-02 eCollection Date: 2021-12-01 DOI: 10.1515/pp-2021-0125
Arnaud Girardot-Miglierina, Daniel Clerc, Mohammad Alyami, Laurent Villeneuve, Olivia Sgarbura, Marc-André Reymond, Martin Hübner

Objectives: Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a promising treatment for peritoneal cancer that entails, however, potential risks for the caregivers in the operating room (OR). This study aimed to reach a consensus within the PIPAC community on a comprehensive safety protocol.

Methods: Active PIPAC centers were invited to participate in a two-round Delphi process on 43 predefined items: concise summaries of the existing evidence were presented together with questions formulated using the population, intervention, comparator, and outcome framework. According to the Grading of Recommendations Assessment, Development, and Evaluation, the strength of recommendation was voted by panelists, accepting a consensus threshold of ≥50% of the agreement for any of the four grading options, or ≥70% in either direction.

Results: Forty-seven out of 66 invited panelists answered both rounds (response rate 76%). The consensus was reached for 41 out of 43 items (95.3%). Strong and weak recommendations were issued for 30 and 10 items, respectively. A positive consensual recommendation was issued to activate laminar airflow without specific strength, neither strong nor weak. No consensus was reached for systematic glove change for caregivers with a high risk of exposure and filtering facepiece mask class 3 for caregivers with low risk of exposure.

Conclusions: A high degree of consensus was reached for a comprehensive safety protocol for PIPAC, adapted to the risk of exposure for the different caregivers in the OR. This consensus can serve as a basis for education and help reach a high degree of adherence in daily practice.

目的:加压腹膜内气溶胶化疗(PIPAC)是一种很有前景的腹膜癌治疗方法,但对手术室(OR)的护理人员有潜在的风险。本研究的目的是在PIPAC社区内就一个全面的安全协议达成共识。方法:邀请活跃的PIPAC中心参与针对43个预定义项目的两轮德尔菲过程:对现有证据进行简要总结,并使用人口、干预、比较物和结果框架制定问题。根据建议评估、发展和评价的分级,由小组成员投票决定推荐的强度,接受四种分级选项中任何一种≥50%的共识阈值,或任何一种≥70%的共识阈值。结果:66位受邀小组成员中有47位回答了两轮问题(回复率76%)。在43个问题中,有41个(95.3%)达成了一致意见。分别就30个和10个项目提出了强烈建议和弱建议。一项积极的共识建议发布,以激活层流气流没有特定的强度,既不强也不弱。对于暴露风险高的护理人员系统地更换手套,对于低暴露风险的护理人员系统地更换3级过滤面罩,尚未达成共识。结论:对于PIPAC的综合安全方案达成了高度共识,该方案适应了手术室中不同护理人员的暴露风险。这种共识可以作为教育的基础,并有助于在日常实践中达到高度的坚持。
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引用次数: 11
Acute respiratory distress syndrome (ARDS) after pressurized intraperitoneal aerosol chemotherapy with oxaliplatin: a case report. 奥沙利铂雾化加压腹腔化疗后急性呼吸窘迫综合征1例。
IF 1.8 Q4 ONCOLOGY Pub Date : 2021-10-05 eCollection Date: 2021-12-01 DOI: 10.1515/pp-2021-0126
Emilie Thibaudeau, Corinne Brianchon, Jean-Luc Raoul, Frédéric Dumont

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a new drug delivery method for intraabdominal cavity chemotherapy. It combines the benefits of a minimally invasive approach (low morbidity and easy to repeat) with the pharmacokinetic advantages of intraperitoneal administration and tolerance seems excellent. We would like to report one case of a serious adverse event, acute respiratory distress syndrome, which is likely related to oxaliplatin administration; all signs disappeared within a few days.

加压腹腔喷雾化疗(PIPAC)是一种新的腹腔化疗给药方式。它结合了微创方法的优点(低发病率和易于重复)与腹腔给药的药代动力学优势和耐受性似乎很好。我们想报告一例严重不良事件,急性呼吸窘迫综合征,这可能与奥沙利铂的使用有关;几天之内,所有的迹象都消失了。
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引用次数: 2
ISSPP 2021 2nd Congress of the International Society for the Study of Pleura and Peritoneum. ISSPP 2021第二届国际胸膜和腹膜研究学会大会。
IF 1.8 Q4 ONCOLOGY Pub Date : 2021-09-27 eCollection Date: 2021-09-01 DOI: 10.1515/pp-2021-0141
Janika Kugel
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引用次数: 4
Can pressurised intraperitoneal aerosol chemotherapy with oxaliplatin (PIPAC-O+) be added to standard treatment for resectable high-risk gastric cancer patients? A study protocol. 奥沙利铂加压腹腔雾化化疗(PIPAC-O+)能否加入可切除高危胃癌患者的标准治疗?研究方案。
IF 1.8 Q4 ONCOLOGY Pub Date : 2021-09-17 eCollection Date: 2021-12-01 DOI: 10.1515/pp-2021-0132
Jessica L Reid, Harsh A Kanhere, Peter J Hewett, Timothy J Price, Guy J Maddern, Markus I Trochsler

Objectives: Gastric cancer remains one of the most fatal cancers, despite an intensive treatment regime of chemotherapy-surgery-chemotherapy. Peritoneal metastatic disease is commonly diagnosed post treatment regime and once established, patients are likely to die in 3-9 months. Systemic chemotherapy does not increase survival for these patients due to the poor vascularisation of this area. We are proposing the addition of pressurised intraperitoneal aerosol chemotherapy (PIPAC) to the treatment regime for curative patients as a preventive measure to reduce the risk of peritoneal metastases occurring.

Methods: This is a prospective, single centre, non-randomised, open-label pilot trial evaluating the addition of PIPAC to the standard multimodal treatment pathway. Patients will undergo standard neoadjuvant chemotherapy with four cycles of fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT), then PIPAC, followed by gastrectomy. Four cycles of FLOT will be administered post-surgery. Primary outcome is safety and feasibility, assessed by perioperative morbidity and possible interruptions of the standard multimodal treatment pathway.

目的:尽管采用了化疗-手术-化疗的强化治疗方案,胃癌仍然是最致命的癌症之一。腹膜转移性疾病通常在治疗方案后诊断出来,一旦确诊,患者可能在3-9个月内死亡。由于该区域的血管化不良,全身化疗不能增加这些患者的生存。我们建议在治疗方案中增加加压腹腔内气溶胶化疗(PIPAC)作为预防措施,以减少腹膜转移发生的风险。方法:这是一项前瞻性、单中心、非随机、开放标签的试点试验,评估在标准多模式治疗途径中添加PIPAC的效果。患者将接受标准的新辅助化疗,包括四个周期的氟尿嘧啶、亚叶酸钙、奥沙利铂和多西紫杉醇(FLOT),然后是PIPAC,最后是胃切除术。术后给予4个周期的FLOT。主要结局是安全性和可行性,通过围手术期发病率和标准多模式治疗途径的可能中断来评估。
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引用次数: 2
期刊
Pleura and Peritoneum
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