intraperitoneal chemotherapy

腹腔化疗
  • 文章类型: Journal Article
    卵巢癌,以其在妇科癌症中的严重预后而著称,最近在治疗方法上取得了实质性进展。增强的化疗方案和引入聚(ADP-核糖)聚合酶(PARP)抑制剂用于维持治疗,对于具有特定遗传特征的患者,显着改善了预后。例如BRCA突变阳性或表现出同源重组缺陷(HRD)的那些。此外,腹膜内化疗的方法已成为传统经静脉途径的一种有价值的替代方法,显示出更广泛的临床采用的希望。外科领域也有所发展,随着越来越多地探索腹腔镜方法相对于更具侵入性的传统手术的益处和可行性,旨在完全切除肿瘤,但减少患者的影响。卵巢癌的遗传性突出了基因检测的重要性,这已经成为定制治疗策略不可或缺的一部分,特别是在确定PARP抑制剂的适用性。东亚妇科肿瘤试验组(EAGOT)的成立旨在优化整个日本的治疗,韩国,中国,和台湾。EAGOT的卵巢癌委员会分享了当前的政策,重点关注5个主题:1)初次手术和化疗后的维持治疗策略,2)铂敏感和铂耐药复发的药物方案,3)腹腔化疗,4)腹腔镜手术作为开腹手术的替代方法,5)基因检测的现状(BRCA,HRD,和小组测试)卵巢癌及其前景。EAGOT的跨国试验旨在协调这些不断发展的治疗策略,确保最新和最有效的协议可以在整个地区访问,从而显著影响东亚患者的预后。
    Ovarian cancer, notable for its severe prognosis among gynecologic cancers, has seen substantial progress in treatment approaches recently. Enhanced protocols in chemotherapy and the introduction of poly (ADP-ribose) polymerase (PARP) inhibitors for maintenance therapy have markedly improved outcomes for patients with specific genetic profiles, such as those positive for BRCA mutations or exhibiting homologous recombination deficiency (HRD). Additionally, the method of intraperitoneal chemotherapy administration has emerged as a valuable alternative to traditional transvenous routes, showing promise for wider clinical adoption. The field of surgery has also evolved, with increasing exploration into the benefits and feasibility of laparoscopic methods over more invasive traditional surgeries, aiming for complete tumor removal but with reduced patient impact. The hereditary nature of ovarian cancer underscores the importance of genetic testing, which has become integral in tailoring treatment strategies, particularly in determining suitability for PARP inhibitors. The formation of the East Asian Gynecologic Oncology Trial Group (EAGOT) aims to optimize treatment across Japan, Korea, China, and Taiwan. The ovarian cancer committee of EAGOT shared the current policies, focusing on 5 topics: 1) strategies for maintenance therapy after initial surgery and chemotherapy, 2) drug regimens for platinum-sensitive and platinum-resistant recurrence, 3) intraperitoneal chemotherapy, 4) laparoscopic surgery as an alternative to laparotomy, and 5) current status of genetic testing (BRCA, HRD, and panel tests) for ovarian cancer and its prospects. EAGOT\'s multi-national trials aim to harmonize these evolving treatment strategies, ensuring that the latest and most effective protocols are accessible across the region, thereby significantly impacting patient outcomes in East Asia.
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  • 文章类型: Journal Article
    腹膜转移癌是由癌细胞从原发部位通过血流直接生长引起的癌症,淋巴,或者腹膜,这是当前临床治疗的难点。在转移性腹膜癌患者的腹腔中,通常有各种大小的结节和恶性腹水。其中,不同大小的结节可阻碍肠道运动,形成肠梗阻,而恶性腹水可引起腹胀和不适,甚至导致患者呼吸困难。腹膜转移癌的病理和生理学是复杂的,尚未完全了解。主要假设是“种子”和“土壤”;即,来自原发肿瘤的细胞脱落并植入腹膜腔(腹膜转移)。在过去的二十年里,临床上使用的主要治疗方式是细胞减灭术(CRS),全身化疗,腹腔化疗,联合治疗,所有这些都有助于提高患者的生存率和生活质量(QOL)。然而,临床使用的小分子化疗药物仍存在药物代谢快、全身毒性等问题。随着近年来纳米技术的迅速发展,用于治疗腹膜转移癌的治疗性纳米药物已逐渐发展,在一定程度上提高了治疗效果,降低了小分子化疗药物的全身毒性。此外,纳米材料不仅被开发作为治疗药物,而且作为显像剂引导腹膜肿瘤CRS。在这次审查中,我们描述了腹膜转移癌的病因和病理特征,详细讨论已用于腹膜转移癌的临床治疗方法,并分析不同临床治疗方法的优缺点及患者的生活质量,随后是围绕进展的讨论,障碍,以及在腹膜转移性癌症中使用治疗性纳米药物的挑战。最后,对未来可能用于腹膜转移癌治疗的纳米药物和治疗工具进行了展望。
    Peritoneal metastatic cancer is a cancer caused by the direct growth of cancer cells from the primary site through the bloodstream, lymph, or peritoneum, which is a difficult part of current clinical treatment. In the abdominal cavity of patients with metastatic peritoneal cancer, there are usually nodules of various sizes and malignant ascites. Among them, nodules of different sizes can obstruct intestinal movement and form intestinal obstruction, while malignant ascites can cause abdominal distension and discomfort, and even cause patients to have difficulty in breathing. The pathology and physiology of peritoneal metastatic cancer are complex and not fully understood. The main hypothesis is \"seed\" and \"soil\"; i.e., cells from the primary tumor are shed and implanted in the peritoneal cavity (peritoneal metastasis). In the last two decades, the main treatment modalities used clinically are cytoreductive surgery (CRS), systemic chemotherapy, intraperitoneal chemotherapy, and combined treatment, all of which help to improve patient survival and quality of life (QOL). However, the small-molecule chemotherapeutic drugs used clinically still have problems such as rapid drug metabolism and systemic toxicity. With the rapid development of nanotechnology in recent years, therapeutic nanoagents for the treatment of peritoneal metastatic cancer have been gradually developed, which has improved the therapeutic effect and reduced the systemic toxicity of small-molecule chemotherapeutic drugs to a certain extent. In addition, nanomaterials have been developed not only as therapeutic agents but also as imaging agents to guide peritoneal tumor CRS. In this review, we describe the etiology and pathological features of peritoneal metastatic cancer, discuss in detail the clinical treatments that have been used for peritoneal metastatic cancer, and analyze the advantages and disadvantages of the different clinical treatments and the QOL of the treated patients, followed by a discussion focusing on the progress, obstacles, and challenges in the use of therapeutic nanoagents in peritoneal metastatic cancer. Finally, therapeutic nanoagents and therapeutic tools that may be used in the future for the treatment of peritoneal metastatic cancer are prospected.
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  • 文章类型: Journal Article
    患有结直肠癌(CRC)和弥漫性腹膜转移(PM)的患者不适合进行手术干预。因此,姑息治疗仍然是临床实践中的标准护理。全身化疗未能导致药物在病变部位积聚,而腹膜内化疗(IPC)受到高清除率和相关并发症的限制。鉴于预后不良,已经设计了定制的OxP/R848@PLEL水凝胶递送系统,以提高弥漫性PM晚期CRC的临床获益。这个系统的特点是简单,安全,和效率。具体来说,PLEL水凝胶具有优异的可注射性和热敏感性,能够在腹腔内形成药物库,使其成为IPC的最佳载体。奥沙利铂(OxP),晚期CRC的一线药物,具有细胞毒性并通过诱导免疫原性细胞死亡增强肿瘤的免疫原性。此外,OxP和瑞喹莫特(R848)协同增强树突状细胞的成熟,促进细胞毒性T淋巴细胞的扩增,并诱导中枢记忆T细胞的形成。此外,R848将巨噬细胞驯化为抗肿瘤表型。OxP/R848@PLEL可有效根除腹膜转移,完全抑制腹水的产生,并显著延长小鼠寿命。因此,它为无手术指征的CRC患者治疗弥漫性PM提供了一种有前景的方法.
    Patients with colorectal cancer (CRC) and diffuse peritoneal metastasis (PM) are not eligible for surgical intervention. Thus, palliative treatment remains the standard of care in clinical practice. Systemic chemotherapy fails to cause drug accumulation at the lesion sites, while intraperitoneal chemotherapy (IPC) is limited by high clearance rates and associated complications. Given the poor prognosis, a customized OxP/R848@PLEL hydrogel delivery system has been devised to improve the clinical benefit of advanced CRC with diffuse PM. This system is distinguished by its simplicity, security, and efficiency. Specifically, the PLEL hydrogel exhibits excellent injectability and thermosensitivity, enabling the formation of drug depots within the abdominal cavity, rendering it an optimal carrier for IPC. Oxaliplatin (OxP), a first-line drug for advanced CRC, is cytotoxic and enhances the immunogenicity of tumors by inducing immunogenic cell death. Furthermore, OxP and resiquimod (R848) synergistically enhance the maturation of dendritic cells, promote the expansion of cytotoxic T lymphocytes, and induce the formation of central memory T cells. Moreover, R848 domesticates macrophages to an anti-tumor phenotype. OxP/R848@PLEL effectively eradicates peritoneal metastases, completely inhibits ascites production, and significantly prolongs mice lifespan. As such, it provides a promising approach to managing diffuse PM in patients with CRC without surgical indications.
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  • 文章类型: Journal Article
    腹膜内散发性肿瘤是癌症中常见且复杂的综合征,导致高死亡率,人们发现腹腔化疗(IPC)比静脉化疗和手术治疗腹腔内散发性肿瘤更好。然而,IPC的有效性和副作用是有争议的,IPC的操作过程复杂。在这里,通过一系列静电纺丝工艺构建了可注射的载紫杉醇(PTX)电纺短纤维,均质化,交联,以及随后的聚多巴胺涂层和叶酸(FA)改性。均匀分散的短纤维显示出有效的肿瘤细胞杀伤和良好的注射能力,使用方便,大大提高了复杂的操作程序。贻贝类蛋白聚多巴胺涂层和FA修饰赋予短纤维靶向粘附肿瘤的能力,因此,短纤维进一步充当一种微膜,可以向肿瘤近距离释放药物,维持局部高药物浓度,防止紫杉醇杀死正常组织。因此,靶向粘合剂可注射电纺短纤维有望成为癌症治疗的潜在候选者,尤其是腹膜内散发的肿瘤,很难通过手术或静脉化疗来治疗。
    Intraperitoneal sporadic tumor is a common and complicated syndrome in cancers, causing a high rate of death, and people find that intraperitoneal chemotherapy (IPC) can treat intraperitoneal sporadic tumors better than intravenous chemotherapy and surgery. However, the effectiveness and side effects of IPC are controversial, and the operation process of IPC is complicated. Herein, the injectable paclitaxel-loaded (PTX-loaded) electrospun short fibers are constructed through a series process of electrospinning, homogenizing, crosslinking, and subsequent polydopamine coating and folate acid (FA) modification. The evenly dispersed short fibers exhibited effective tumor cell killing and good injectable ability, which is convenient to use and greatly improved the complex operation procedure. Mussel-like protein poly-dopamine coating and FA modification endowed short fibers with the ability of targeted adhesion to tumors, and therefore the short fibers further acted as a kind of micro membrane that could release drugs to tumors at close range, maintaining local high drug concentration and prevent paclitaxel killing normal tissues. Thus, the target-adhesive injectable electrospun short fibers are expected to be the potential candidate for cancer treatment, especially the intraperitoneal sporadic tumors, which are hard to treat by surgery or intravenous chemotherapy.
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  • 文章类型: Journal Article
    异常肿瘤微环境(TME),尤其是不成熟和漏水的血管,防止化疗药物的渗透和积累,并导致化疗治疗妇科癌症的失败。在这里,地塞米松(Dex),一种用于缓解肿瘤细胞外基质和使血管正常化的糖皮质激素类固醇,被封闭在生物相容性材料中,称为聚(乳酸-共-乙醇酸)(PLGA),并将获得的Dex@PLGA进一步用小鼠宫颈癌细胞膜(CM)包被。由于从源癌细胞遗传的同源靶向能力,配制的Dex@PLGA-CM纳米颗粒在肿瘤内显示出有效的血管外扩散。Dex@PLGA-CM纳米粒子极大地重塑了TME,增强Doxil的渗透,从而显着提高该药物对宫颈癌的治疗效果。令人兴奋的是,当腹膜内给药时,涂有小鼠卵巢癌细胞膜的Dex@PLGA-CM纳米颗粒也促进了Doxil介导的转移性卵巢癌化疗效果.这项工作提出了一种有效的纳米药物,用于有效修饰TME以增强妇科癌症化疗的效果。
    The aberrant tumor microenvironment (TME), especially immature and leaky vessels, prevents the penetration and accumulation of chemotherapeutics and results in the failure of chemotherapy to treat gynecologic cancer. Herein, dexamethasone (Dex), a glucocorticoid steroid used to moderate tumor extracellular matrix and normalize vessels, was enclosed within a biocompatible material known as poly(lactic-co-glycolic acid) (PLGA), and the obtained Dex@PLGA was further coated with a mouse cervical cancer cell membrane (CM). The formulated Dex@PLGA-CM nanoparticles showed efficient extravascular diffusion within the tumor owing to the homologous targeting abilities inherited from the source cancer cells. The Dex@PLGA-CM nanoparticles greatly reshaped the TME, enhancing the penetration of Doxil and thus markedly improving the therapeutic effect of this drug against cervical cancers. Excitingly, the Dex@PLGA-CM nanoparticles coated with mouse ovarian cancer cell membranes also promoted Doxil-mediated chemotherapy effects in metastatic ovarian cancer when administered intraperitoneally. This work presents an effective nanomedicine for the efficient modification of the TME to enhance the effects of gynecologic cancer chemotherapy.
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  • 文章类型: Systematic Review
    目标:复方苦参打针液(CKI)联合腹腔化疗(IPC)普遍运用于恶性腹水(MA)的医治。然而,关于其有效性和安全性的证据仍然有限.本综述旨在评价CKI联合IPC治疗MA的有效性和安全性。方法:本综述方案在PROSPERO(CRD42022304259)中注册。从开始到2023年1月20日,通过12个电子数据库和2个临床试验注册平台搜索了关于IPC与CKI治疗MA患者的有效性和安全性的随机对照试验(RCT)。使用Cochrane偏倚风险工具通过偏倚风险评估来评估纳入试验的质量。我们纳入了RCTs,这些RCTs比较了IPC单次使用或CKI与IPC联合使用的MA计划开始IPC的患者。主要结果确定为客观反应率(ORR),而次要结局被确定为生活质量(QoL),生存时间,免疫功能,药物不良反应(ADR)。Revman5.4和Stata17软件用于计算二元结局的95%置信区间(CI)的风险比(RR)和连续结局的95%CI的平均差(MD)。根据GRADE标准评估证据的确定性。结果:共评估17项RCT,其中包括1200名患者。Cochrane偏差风险评估工具的偏差风险表明,一项研究被评为高风险,其余为不清楚或低风险。Meta分析显示,与单独IPC相比,CKI联合IPC在增加ORR(RR=1.31,95%CI1.20至1.43,p<0.00001)和QoL(RR=1.50,95%CI1.23至1.83,p<0.0001)方面具有优势。此外,联合治疗组骨髓抑制发生率较低(RR=0.51,95CI0.40-0.64,p<0.00001),肝功能障碍(RR=0.33,95CI0.16至0.70,p=0.004),肾功能不全(RR=0.39,95CI0.17至0.89,p=0.02),和发烧(RR=0.51,95CI0.35至0.75,p=0.0007)与对照组相比。通过等级标准进行的证据评估质量表明,ORR,骨髓抑制,发烧被评为中度,肾功能不全和肝功能不全被评为低,QoL和腹痛评分非常低。结论:CKI联合IPC治疗MA的疗效和安全性均优于单纯IPC,这表明了治疗的潜力。然而,需要更多高质量的RCT来验证这一结论。系统审查注册:[https://www。crd.约克。AC.uk/prospro/display_record.php?ID=CRD42022304259],标识符[PROSPERO2022CRD42022304259]。
    Objectives: Compound Kushen injection (CKI) combined with intraperitoneal chemotherapy (IPC) is widely used in the treatment of malignant ascites (MA). However, evidence about its efficacy and safety remains limited. This review aimed to evaluate the efficacy and safety of CKI combined with IPC for the treatment of MA. Methods: Protocol of this review was registered in PROSPERO (CRD42022304259). Randomized controlled trials (RCTs) on the efficacy and safety of IPC with CKI for the treatment of patients with MA were searched through 12 electronic databases and 2 clinical trials registration platforms from inception until 20 January 2023. The Cochrane risk-of-bias tool was used to assess the quality of the included trials through the risk of bias assessment. We included RCTs that compared IPC single used or CKI combined with IPC for patients with MA schedule to start IPC. The primary outcome was identified as an objective response rate (ORR), while the secondary outcomes were identified as the quality of life (QoL), survival time, immune functions, and adverse drug reactions (ADRs). The Revman5.4 and Stata17 software were used to calculate the risk ratio (RR) at 95% confidence intervals (CI) for binary outcomes and the mean difference (MD) at 95% CI for continuous outcomes. The certainty of the evidence was assessed according to the GRADE criteria. Results: A total of 17 RCTs were assessed, which included 1200 patients. The risk of bias assessment of the Cochrane risk-of-bias tool revealed that one study was rated high risk and the remaining as unclear or low risk. Meta-analysis revealed that CKI combined with IPC had an advantage in increasing ORR (RR = 1.31, 95% CI 1.20 to 1.43, p < 0.00001) and QoL (RR = 1.50, 95% CI 1.23 to 1.83, p < 0.0001) when compared with IPC alone. Moreover, the combined treatment group showed a lower incidence of myelosuppression (RR = 0.51, 95%CI 0.40-0.64, p < 0.00001), liver dysfunction (RR = 0.33, 95%CI 0.16 to 0.70, p = 0.004), renal dysfunction (RR = 0.39, 95%CI 0.17 to 0.89, p = 0.02), and fever (RR = 0.51, 95%CI 0.35 to 0.75, p = 0.0007) compared to those of the control group. The quality of evidence assessment through GRADE criteria showed that ORR, myelosuppression, and fever were rated moderate, renal dysfunction and liver dysfunction were rated low, and QoL and abdominal pain were rated very low. Conclusion: The efficacy and safety of CKI combined with IPC were superior to that with IPC alone for the treatment of MA, which indicates the potentiality of the treatment. However, more high-quality RCTs are required to validate this conclusion. Systematic Review Registration: [https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022304259], identifier [PROSPERO 2022 CRD42022304259].
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  • 文章类型: Journal Article
    目的:我们旨在比较腹腔热化疗(HIPEC)的生存结果和不良事件,原发性晚期卵巢癌的腹腔化疗(IP)和静脉化疗(IP)。
    方法:PubMed,CENTRAL(Cochrane中央控制试验登记处),Embase,WebofScience和Scopus使用多个术语搜索原发性晚期卵巢癌,包括中文和英文的随机对照试验和比较研究(截止日期为2022年8月15日)。结果包括总体生存率,无进展生存期和不良事件。将数据汇总并报告为具有95%置信区间的风险比(HRs)。在纳入的比较研究中,使用纽卡斯尔-渥太华量表评估偏倚风险。Cochrane协作的风险偏差工具用于随机对照试验。
    结果:总计,32项研究,包括6347例患者和8种不同的铂类化疗方案,被包括在这个网络荟萃分析中。我们的分析结果表明,与IV相比,HIPEC2(具有曲线下面积的卡铂10)表现出统计学上显着的OS益处,每周剂量密集化疗和HIPEC1(顺铂75/100mg/m2)。与IV相比,腹膜内联合静脉化疗与统计学上显着更好的总体生存可能性相关。对于无进展生存期,我们的统计结果仅表明,与每周剂量密集化疗相比,接受HIPEC1治疗的卵巢癌患者的无进展生存期更好.在其他比较组之间没有观察到差异的证据。与非HIPEC组相比,HIPEC的电解质紊乱发生率较高(≥3级)。
    结论:我们的统计分析表明,接受HIPEC2的组的OS优于接受IV的组,每周剂量密集化疗和HIPEC1。对于PFS,我们的分析仅显示HIPEC1优于IV。此外,HIPEC可能导致更高的电解质紊乱发生率(≥3级)。HIPEC治疗晚期卵巢癌目前存在争议。
    OBJECTIVE: We aimed to compare the survival outcomes and adverse events of hyperthermic intraperitoneal chemotherapy (HIPEC), intraperitoneal chemotherapy (IP)and intravenous chemotherapy (IP)for primary advanced ovarian cancer.
    METHODS: PubMed, CENTRAL (Cochrane Central Registry of Controlled Trials), Embase, Web of Science and Scopus were searched using multiple terms for primary advanced ovarian cancer, including randomized controlled trials and comparative studies in both Chinese and English (up to date 15 August 2022). Outcomes include overall survival, progression-free survival and adverse events. The data were pooled and reported as hazard ratio (HRs) with 95% confidence intervals. The Newcastle-Ottawa Scales were used to assess the risk of bias in the included comparative study. The Cochrane Collaboration\'s Risk of Bias Tool was used for randomized controlled trials.
    RESULTS: In total, 32 studies, including 6347 patients and 8 different platinum-based chemotherapy regimens, were included in this network meta-analysis. Our analysis results showed that HIPEC2 (carboplatin with area under the curve 10) exhibited a statistically significant OS benefit compared to IV, weekly dose-dense chemotherapy and HIPEC1 (cisplatin with 75/100 mg/m2). Intraperitoneal plus intravenous chemotherapy was associated with a statistically significantly better likelihood of overall survival compared to IV. For progression-free survival, our statistical results only suggest a better progression-free survival in ovarian cancer patients treated with HIPEC1 compared with weekly dose-dense chemotherapy. No evidence of difference was observed between the other comparison groups. Compared with the non-HIPEC group, HIPEC may had a higher incidence of electrolyte disturbances (≥grade 3).
    CONCLUSIONS: Our statistical analysis suggests that the groups receiving HIPEC2 had a better OS than the groups receiving IV, weekly dose-dense chemotherapy and HIPEC1. For PFS, our analysis only showed HIPEC1 is better than IV. Moreover, HIPEC may lead to a higher incidence of electrolyte disturbances (≥grade 3). HIPEC therapy for advanced ovarian cancer is currently controversial.
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  • 文章类型: Journal Article
    尽管伴有主动脉旁淋巴结(PAN)转移的胃癌通常被认为是不可切除的,在过去的几十年中,外科医生已经探索了PAN转移患者的最佳治疗方法,仅限于16a2/b1。术前全身治疗联合D2胃切除术加PAN清扫术可以改善这些患者的预后。在这项多中心II期试验中,29例PAN转移局限于16a2/b1号的胃癌患者将接受nab-紫杉醇术前治疗,奥沙利铂,S-1(nab-POS:nab-紫杉醇,奥沙利铂,S-1)和sintilimab,然后进行D2胃切除术加PAN切除术;术后口服S-1,静脉注射sintilimab和腹膜内紫杉醇治疗。研究的终点是3年总生存期,3年无病生存期,病理反应率,术后并发症和不良事件的发生率。
    主动脉旁淋巴结转移的胃癌通常被认为是不可手术的。化疗结合胃切除和更广泛的淋巴结清扫术可以延长这些患者的生命。在这项多中心研究中,29例主动脉旁淋巴结转移的胃癌患者将接受nab-紫杉醇术前治疗,奥沙利铂,S-1和sintilimab,然后切除胃结合主动脉旁淋巴结清扫术,并使用持续口服,静脉和腹膜内化疗。该研究的终点是3年总生存期,3年无病生存期,病理反应率,术后并发症和不良事件的发生率。临床试验注册:ChiCTR2200061125(ChiCTR.org.cn)。
    Although gastric cancer with para-aortic lymph node (PAN) metastasis is commonly regarded as unresectable, surgeons have explored the optimal treatment for patients with PAN metastases limited to No.16a2/b1 in the past few decades. Preoperative systemic therapy combined with D2 gastrectomy plus PAN dissection may improve the prognosis of these patients. In this multicenter phase II trial, 29 gastric cancer patients with PAN metastasis limited to No.16a2/b1 will receive preoperative treatment with nab-paclitaxel, oxaliplatin, S-1 (nab-POS: nab-paclitaxel, oxaliplatin, S-1) and sintilimab followed by D2 gastrectomy plus PAN dissection; and postoperative treatment with oral S-1, intravenous sintilimab and intraperitoneal paclitaxel. The end points for the study are 3-year overall survival, 3-year disease-free survival, pathological response rate, incidence of postoperative complications and adverse events.
    Stomach cancer with metastases in the para-aortic lymph nodes is usually considered inoperable. Chemotherapy combined with resection of the stomach and more extensive lymph node dissection may prolong the life of these patients. In this multicenter study, 29 stomach cancer patients with para-aortic lymph node metastases will receive preoperative treatment with nab-paclitaxel, oxaliplatin, S-1 and sintilimab, followed by resection of the stomach combined with para-aortic lymph node dissection and use of continued oral, intravenous and intraperitoneal chemotherapy. The study’s end points are 3-year overall survival, 3-year disease-free survival, pathological response rate, incidence of postoperative complications and adverse events. Clinical Trial Registration: ChiCTR2200061125 (ChiCTR.org.cn).
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  • 文章类型: Journal Article
    探讨以TP为基础的腹腔热化疗(HIPEC)对晚期上皮性卵巢癌(EOC)患者血清抗原簇蛋白133(CD133)和人附睾分泌蛋白4(HE4)水平的影响。
    将2015年4月至2018年12月河北工程大学附属医院收治的104例晚期卵巢上皮癌患者采用随机数字表法分为两组。对照组(n=52)采用常规术后TP方案治疗,观察组(n=52)除常规术后TP方案外还接受HIPEC治疗。CD133和HE4在血清中的表达,总反应率(ORR),长期疗效,和药物毒性发生率进行比较分析。
    观察组血清CD133和HE4表达水平低于对照组(P<0.005);观察组ORR优于对照组,2年生存率,和无进展生存期(PFS)(分别为P<0.005);然而,两组药物毒性发生率差异无统计学意义(P>0.05)。
    基于TP的HIPEC可有效抑制晚期EOC中CD133和HE4的表达,从而提高了临床疗效并鼓励更长的生存期。
    UNASSIGNED: To investigate the clinical effects of TP-based hyperthermic intraperitoneal chemotherapy (HIPEC) on the levels of antigen cluster protein 133 (CD133) and human epididymal secretory protein 4 (HE4) in patients with advanced epithelial ovarian cancer (EOC).
    UNASSIGNED: A total of 104 patients with advanced EOC hospitalized in Affiliated Hospital of Hebei Engineering University from April 2015 to December 2018 were assigned to two groups using a random number table. A control group (n =52) treated by the conventional postoperative TP regimen and an observation group (n =52) receiving HIPEC in addition to the conventional postoperative TP regimen. CD133 and HE4 expression in serum, overall response rate (ORR), long-term efficacy, and incidence of drug toxicity were measured for comparative analysis.
    UNASSIGNED: The serum levels of CD133 and HE4 expression in the observation group were lower than in the control group (P < 0.005, respectively); the observation group surpassed the control group in ORR, 2-year survival, and progression-free survival (PFS) (P < 0.005, respectively); however, the two groups had no statistically significant difference in the incidence of drug toxicity (P > 0.05).
    UNASSIGNED: TP-based HIPEC can effectively inhibit CD133 and HE4 expression in advanced EOC, which thereby improves the clinical efficacy and encourages longer survival.
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  • 文章类型: Journal Article
    新辅助腹膜内和全身化疗(NIPS)在伴有腹膜转移的胃癌(GC)中显示出可喜的结果。然而,我国目前还缺乏NIPS的临床实践经验。在这项研究中,我们调查了NIPS在中国患者中的有效性和安全性。
    符合条件的患者每3周接受一次NIPS。对符合转换手术标准的患者进行胃切除术。主要终点是1年总生存率(OS)。次要终点是反应率,毒性作用,转换手术结果和中位生存时间(MST)。
    纳入67例患者。主要终点为1年OS率达到67.2%(95%CI,56.8%-79.4%)。42例患者(62.9%)进行了转换手术,23例患者(54.8%)完成R0切除,MST为31.3个月(95%CI,24.3-38.3)。所有患者的MST为19.3个月(95%CI,16.4-22.2)。毒性和手术并发症耐受性良好。此外,性别,R0切除,病理淋巴结分期和肿瘤消退分级(TRG)是中转手术患者的独立预后因素.
    NIPS在治疗有腹膜转移的GC患者中是有效且安全的。男性患者,接受R0切除的患者,转换手术后患有ypN0-1或TRG1的患者更有可能从NIPS中获益.
    http://www.chictr.org.cn/,标识符https://clinicaltrials.gov/()。
    UNASSIGNED: Neoadjuvant intraperitoneal and systemic chemotherapy (NIPS) has shown promising results in gastric cancer (GC) with peritoneal metastasis. However, clinical practice experience of NIPS is still lacking in China. In this study, we investigate the efficacy and safety of NIPS in Chinese patients.
    UNASSIGNED: Eligible patients received NIPS every 3 weeks. Gastrectomy was performed for patients who met the criteria of conversion surgery. The primary end point was 1-year overall survival (OS) rate. Secondary end points were the response rate, toxic effects, conversion surgery outcomes and median survival time (MST).
    UNASSIGNED: Sixty-seven patients were enrolled. The primary endpoint was achieved with 1-year OS rate reached 67.2% (95% CI, 56.8%-79.4%). Conversion surgery was performed in 42 patients (62.9%), and R0 resection was achieved in 23 patients (54.8%) with the MST of 31.3 months (95% CI, 24.3-38.3). And the MST was 19.3 months (95% CI, 16.4-22.2) for all patients. Toxicity and surgical complications were well-tolerated. Moreover, sex, R0 resection, pathological nodal stage and tumor regression grade (TRG) were independent prognostic factors for patients who underwent conversion surgery.
    UNASSIGNED: The NIPS is effective and safe in treating GC patients with peritoneal metastasis. Male patients, patients who underwent R0 resection, patients with ypN0-1 or TRG 1 after conversion surgery are more likely to benefit from the NIPS.
    UNASSIGNED: http://www.chictr.org.cn/, identifier https://clinicaltrials.gov/ ().
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