CEA, Carcinoembryonic antigen

CEA,癌胚抗原
  • 文章类型: Journal Article
    UNASSIGNED:原发性肝肉瘤样癌(PHSC)是肝脏中一种罕见的恶性肿瘤。然而,很少有研究集中在PHSC的影像学诊断上。在这项研究中,我们从两个机构收集了PHSC的临床和计算机断层扫描(CT)成像数据,目的探讨PHSC的临床和影像学特点。
    UNASSIGNED:我们回顾性调查了22例PHSC患者的临床特征和CT特征(男19例,女3例;平均年龄,63.4年;范围,49至76岁),95例肝细胞癌(HCC)患者和50例肝内胆管癌(ICC)患者。两名放射科医生独立评估了三组的CT特征。随后,我们分析了PHSC与对照组在临床特征和CT表现上的差异.
    未经证实:大多数PHSCs大于5cm(72.7%)。PHSC主要表现为不规则(81.8%),CT上具有边界不清(72.7%)的异质性(100%)肿块伴坏死(86.4%),与HCC相比,CT特征更常见(p<0.001)。在动脉期,PHSC总是表现出明显的异质增强(100.0%),主要表现为部分动脉期增快(APHE)(86.4%)。PHSC的增强模式主要包括延迟渐进增强(72.7%),非外周冲洗(22.7%),和未分类增强(4.5%),与HCC增强模式有显著差异,但与ICC增强模式相似。此外,静脉肿瘤血栓(18.2%),肝内转移(27.3%),淋巴结病(27.3%)在PHSC中相对常见。此外,大多数分类为LR-M的PHSC肿瘤(66.7%)与ICC相似.
    未经证实:PHSC通常表现为不规则的大肿块伴坏死,肝内转移,和淋巴结病。PHSC的CT增强主要是部分APHE和延迟的渐进增强。
    UNASSIGNED: Primary hepatic sarcomatoid carcinoma (PHSC) is a rare type of malignant tumor in the liver. Nevertheless, few studies have focused on the imaging diagnosis of PHSC. In this study, we collected clinical and computed tomography (CT) imaging data of PHSC from two institutions, aiming to investigate the clinical and radiological characteristics of PHSC.
    UNASSIGNED: We retrospectively investigated the clinical characteristics and CT features of 22 PHSC patients (19 males and 3 females; mean age, 63.4 years; range, 49 to 76 years), 95 hepatocellular carcinoma (HCC) patients and 50 intrahepatic cholangiocarcinoma (ICC) patients. Two radiologists independently evaluated the CT features of the three groups. Subsequently, we analyzed the differences in the clinical characteristics and CT features between the PHSC and control groups.
    UNASSIGNED: Most PHSCs were larger than 5 cm (72.7%). PHSC mainly showed irregular (81.8%), heterogeneous (100%) masses with ill-defined (72.7%) borders with necrosis (86.4%) on CT, which are more common CT features versus HCC (p < 0.001). In the arterial phase, PHSC always showed noticeable heterogeneous enhancement (100.0%), mainly manifesting as partial arterial phase hyperenhancement (APHE) (86.4%). The enhancement patterns of PHSC mainly included delayed progressive enhancement (72.7%), nonperipheral washout (22.7%), and unclassified enhancement (4.5%), which were significantly different from the HCC enhancement pattern but similar to the enhancement pattern of ICC. In addition, vein tumor thrombus (18.2%), intrahepatic metastasis (27.3%), and lymphadenopathy (27.3%) were relatively common in PHSC. Furthermore, most PHSC tumors classified as LR-M (66.7%) were similar to ICC.
    UNASSIGNED: PHSC generally presents as irregularly large masses with necrosis, intrahepatic metastasis, and lymphadenopathy. The CT enhancement of PHSC is mainly part of APHE and delayed progressive enhancement.
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  • 文章类型: Journal Article
    未经证实:舌头图像(颜色,舌头的大小和形状以及颜色,舌苔的厚度和水分含量),根据中医理论反映全身的健康状况,已经在中国广泛使用了数千年。在这里,我们调查了舌象和舌苔微生物组在胃癌(GC)诊断中的价值。
    UNASSIGNED:从2020年5月到2021年1月,我们同时收集了中国328名GC患者(所有新诊断为GC)和304名非胃癌(NGC)参与者的舌象和舌苔样本,和16SrDNA用于表征舌苔样品的微生物组。然后,建立人工智能(AI)深度学习模型,评估舌象和舌苔微生物组在GC诊断中的价值。考虑到舌成像作为诊断工具更方便、更经济,我们于2020年5月至2022年3月在中国进一步开展了一项前瞻性多中心临床研究,招募了来自中国10个中心的937例GC患者和1911例NGC患者,以进一步评估舌象在GC诊断中的作用.此外,我们在另一个独立的外部验证队列中验证了该方法,该队列包括来自7个中心的294例GC患者和521例NGC患者.这项研究在ClinicalTrials.gov注册,NCT01090362。
    未经评估:第一次,我们发现舌象和舌苔微生物组可以作为GC诊断的工具,基于舌象的诊断模型的曲线下面积(AUC)值为0.89。基于舌苔微生物组的模型的AUC值使用属数据达到0.94,使用物种数据达到0.95。前瞻性多中心临床研究结果表明,三种基于舌象的GCs模型的AUC值在内部验证中达到0.88-0.92,在独立外部验证中达到0.83-0.88,显着优于八种血液生物标志物的组合。
    UNASSIGNED:我们的结果表明,舌头图像可作为GC诊断的稳定方法,并且显着优于常规血液生物标志物。我们开发的三种基于舌图像的AI深度学习诊断模型可用于充分区分GC患者和NGC参与者,甚至早期GC和癌前病变,如萎缩性胃炎(AG)。
    未经批准:国家重点研发计划(2021YFA0910100),浙江省中医药科技计划方案(2018ZY006),浙江省医学科技项目(2022KY114,WKJ-ZJ-2104),浙江省上消化道肿瘤研究中心(JBZX-202006),浙江省自然科学基金(HDMY22H160008),浙江省科技项目(2019C03049),国家自然科学基金(82074245,81973634,82204828),中国博士后科学基金(2022M713203)。
    UNASSIGNED: Tongue images (the colour, size and shape of the tongue and the colour, thickness and moisture content of the tongue coating), reflecting the health state of the whole body according to the theory of traditional Chinese medicine (TCM), have been widely used in China for thousands of years. Herein, we investigated the value of tongue images and the tongue coating microbiome in the diagnosis of gastric cancer (GC).
    UNASSIGNED: From May 2020 to January 2021, we simultaneously collected tongue images and tongue coating samples from 328 patients with GC (all newly diagnosed with GC) and 304 non-gastric cancer (NGC) participants in China, and 16 S rDNA was used to characterize the microbiome of the tongue coating samples. Then, artificial intelligence (AI) deep learning models were established to evaluate the value of tongue images and the tongue coating microbiome in the diagnosis of GC. Considering that tongue imaging is more convenient and economical as a diagnostic tool, we further conducted a prospective multicentre clinical study from May 2020 to March 2022 in China and recruited 937 patients with GC and 1911 participants with NGC from 10 centres across China to further evaluate the role of tongue images in the diagnosis of GC. Moreover, we verified this approach in another independent external validation cohort that included 294 patients with GC and 521 participants with NGC from 7 centres. This study is registered at ClinicalTrials.gov, NCT01090362.
    UNASSIGNED: For the first time, we found that both tongue images and the tongue coating microbiome can be used as tools for the diagnosis of GC, and the area under the curve (AUC) value of the tongue image-based diagnostic model was 0.89. The AUC values of the tongue coating microbiome-based model reached 0.94 using genus data and 0.95 using species data. The results of the prospective multicentre clinical study showed that the AUC values of the three tongue image-based models for GCs reached 0.88-0.92 in the internal verification and 0.83-0.88 in the independent external verification, which were significantly superior to the combination of eight blood biomarkers.
    UNASSIGNED: Our results suggest that tongue images can be used as a stable method for GC diagnosis and are significantly superior to conventional blood biomarkers. The three kinds of tongue image-based AI deep learning diagnostic models that we developed can be used to adequately distinguish patients with GC from participants with NGC, even early GC and precancerous lesions, such as atrophic gastritis (AG).
    UNASSIGNED: The National Key R&D Program of China (2021YFA0910100), Program of Zhejiang Provincial TCM Sci-tech Plan (2018ZY006), Medical Science and Technology Project of Zhejiang Province (2022KY114, WKJ-ZJ-2104), Zhejiang Provincial Research Center for Upper Gastrointestinal Tract Cancer (JBZX-202006), Natural Science Foundation of Zhejiang Province (HDMY22H160008), Science and Technology Projects of Zhejiang Province (2019C03049), National Natural Science Foundation of China (82074245, 81973634, 82204828), and Chinese Postdoctoral Science Foundation (2022M713203).
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  • 文章类型: Journal Article
    未经证实:癌症抗原(CA)72-4测定广泛用于监测胃癌和卵巢癌。抗原是粘蛋白样的,肿瘤相关糖蛋白称为TAG-72。已使用两种不同的单克隆抗体对其进行了鉴定和表征,CC49和B72.3识别其糖链表位,Galβ(1-3)唾液酸-Tn和唾液酸-Tn抗原,分别。这项研究描述了新开发的CA72-4测定的定量分析性能,建筑师CA72-4。
    未经评估:和方法:使用ARCHITECTi2000SR和三个ARCHITECTi1000SR开发了ARCHITECTCA72-4测定。基于来自CLSI(临床和实验室标准研究所)的指导和与ElecsysCA72-4的相关性来评估测定性能。
    未经评估:在总精度研究中,超过4U/mL的对照/面板样品的最小变异系数(CV)为1.1%.测量间隔为0.95至200U/mL,线性良好;空白界限(LoB),检测(LoD),定量(LoQ)分别为0.09、0.18和0.95U/mL,分别。高剂量钩效应;标本管类型之间的差异;以及常见药物的干扰,潜在的交叉反应物,和内源性物质没有观察到。重要的是,该测定在4875mg/mL时具有高生物素耐受性,并且与ElecysCA72-4测定良好相关(相关系数:0.95)。
    UNASSIGNED:ARCHITECTCA72-4是用于人血清和血浆中CA72-4测量的高度灵敏和精确的测定法。
    UNASSIGNED: Cancer antigen (CA) 72-4 assay is widely used for monitoring gastric and ovarian cancers. The antigen is a mucin-like, tumor-associated glycoprotein known as TAG-72. It has been identified and characterized using two different monoclonal antibodies, CC49 and B72.3, which recognize its glycochain epitopes, Galβ(1-3) sialyl-Tn and sialyl-Tn antigens, respectively. This study describes the quantitative analytical performance of a newly developed CA 72-4 assay, ARCHITECT CA 72-4.
    UNASSIGNED: and Methods: The ARCHITECT CA 72-4 assay was developed using the ARCHITECT i2000SRs and three ARCHITECT i1000SRs. The assay performance was evaluated based on guidance from CLSI (Clinical and Laboratory Standards Institute) and correlation against Elecsys CA 72-4.
    UNASSIGNED: In the total precision study, the minimum coefficient of variation (CV) for Control/Panel samples over 4 U/mL was 1.1%. The measuring interval was from 0.95 to 200 U/mL with good linearity; and limits of blank (LoB), detection (LoD), and quantitation (LoQ) were 0.09, 0.18, and 0.95 U/mL, respectively. High dose hook effect; differences among specimen tube types; and interference of common drugs, potential cross-reactants, and endogenous substances were not observed. Significantly, this assay has high biotin tolerance at 4875 mg/mL and correlates well with the Elecys CA 72-4 assay (correlation coefficient: 0.95).
    UNASSIGNED: ARCHITECT CA 72-4 is a highly sensitive and precise assay for CA 72-4 measurement in human sera and plasma.
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  • 文章类型: Journal Article
    未经证实:预测肿瘤反应将有助于选择局部晚期直肠癌(LARC)患者的器官保存策略。我们旨在开发和验证新辅助放化疗后LARC患者T分期降低(ypT0-2)的预测模型,并确定可能从巩固化疗中受益的患者。
    UNASSIGNED:回顾性纳入了2012年1月至2019年1月在三个三级医疗中心的cT3-4LARC患者。而从2021年6月至2022年3月招募了一个前瞻性队列。八个滤波器(主成分分析,最小绝对收缩和选择运算符,偏最小二乘判别分析,随机森林)-分类器(支持向量机,逻辑回归)模型用于选择放射学特征。开发了结合影像组学和重要临床特征的列线图,并通过校准曲线和决策曲线分析进行了验证。进行相互作用测试以研究巩固化疗的益处。
    UNASSIGNED:共纳入634例患者(训练队列中426例,测试队列174人,前瞻性队列34人)。使用偏最小二乘判别分析和支持向量机的放射学预测模型显示出最佳性能(AUC:0.832[训练];0.763[测试])。结合影像组学和临床特征的列线图显示出比影像组学模型明显更好的预后表现(AUC:0.842[训练];0.809[测试])。还在AUC为0.727的前瞻性队列中测试了该模型。高概率组(评分>81.82)可能从≥4个周期的巩固化疗中获益(OR:4.173,95%CI:0.953-18.276,p=0.058,p相互作用=0.021)。
    UNASSIGNED:我们确定并验证了基于多中心治疗前影像组学的模型,以预测cT3-4LARC患者的ypT0-2,这可能有助于器官保存策略和巩固化疗的个性化治疗决策。
    UNASSIGNED: Predicting tumour response would be useful for selecting patients with locally advanced rectal cancer (LARC) for organ preservation strategies. We aimed to develop and validate a prediction model for T downstaging (ypT0-2) in LARC patients after neoadjuvant chemoradiotherapy and to identify those who may benefit from consolidation chemotherapy.
    UNASSIGNED: cT3-4 LARC patients at three tertiary medical centers from January 2012 to January 2019 were retrospectively included, while a prospective cohort was recruited from June 2021 to March 2022. Eight filter (principal component analysis, least absolute shrinkage and selection operator, partial least-squares discriminant analysis, random forest)-classifier (support vector machine, logistic regression) models were established to select radiomic features. A nomogram combining radiomics and significant clinical features was developed and validated by calibration curve and decision curve analysis. Interaction test was conducted to investigate the consolidation chemotherapy benefits.
    UNASSIGNED: A total of 634 patients were included (426 in training cohort, 174 in testing cohort and 34 in prospective cohort). A radiomic prediction model using partial least-squares discriminant analysis and a support vector machine showed the best performance (AUC: 0.832 [training]; 0.763 [testing]). A nomogram combining radiomics and clinical features showed significantly better prognostic performance (AUC: 0.842 [training]; 0.809 [testing]) than the radiomic model. The model was also tested in the prospective cohort with AUC 0.727. High-probability group (score > 81.82) may have potential benefits from ≥ 4 cycles consolidation chemotherapy (OR: 4.173, 95 % CI: 0.953-18.276, p = 0.058, pinteraction = 0.021).
    UNASSIGNED: We identified and validated a model based on multicenter pre-treatment radiomics to predict ypT0-2 in cT3-4 LARC patients, which may facilitate individualised treatment decision-making for organ-preservation strategies and consolidation chemotherapy.
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  • 文章类型: Journal Article
    UNASSIGNED: Nonsurgical treatment of colorectal cancer, the third most prevalent cancer worldwide, through chemoradiotherapy (CRT) has been suggested to induce complete remission. Carcinoembryonic antigen (CEA) has been used as a candidate marker to predict treatment response. In this study, we aimed to assess the applicability of plasma levels of CEAs in predicting the response to CRT, particularly complete pathological response.
    UNASSIGNED: We designed a retrospective, cross-sectional study in which tumor stage and plasma levels of CEAs before and after neoadjuvant CRT were extracted from the medical records of patients with rectal tumors who underwent neoadjuvant chemoradiotherapy before surgery at Sina Hospital, Tehran, Iran from 2010 to 2015.
    UNASSIGNED: Pre-CRT plasma levels of CEA positively correlated with tumor stage, and chemoradiotherapy significantly decreased plasma levels of CEA. Whereas lower pre-CRT plasma levels of CEA and tumor stage were significantly associated with complete response to CRT, post-CRT plasma levels of CEA showed no association with complete response. In addition, in ROC curve analysis, a CEA cut-off value of 2.6 ng/mL predicted complete response to CRT (specificity = 82.6%, sensitivity = 40.5%).
    UNASSIGNED: Although several factors other than plasma levels of CEA and tumor stage are important in determining the response to CRT, preliminary plasma levels of CEA and tumor stage can be used as factors for determining complete response to neoadjuvant chemoradiotherapy in rectal cancer.
    UNASSIGNED: تم اقتراح العلاج غير الجراحي لسرطان القولون والمستقيم، الذي يشكل ثالث أكثر أنواع السرطانات انتشارا في جميع أنحاء العالم، باستخدام العلاج الكيميائي الإشعاعي لتحقيق هدأة كاملة. في هذا الصدد، تم استخدام المستضد السرطاني الجنيني كعلامة مرشح. تهدف هذه الدراسة إلى تقييم قابلية تطبيق مستويات المستضد السرطاني الجنيني في التنبؤ بالاستجابة للعلاج الكيميائي الإشعاعي، وخاصة الاستجابة المرضية الكاملة.
    UNASSIGNED: تم تصميم دراسة مستعرضة بأثر رجعي، من خلال استخراج مرحلة الورم ومستويات CEA قبل وبعد العلاج الكيميائي الإشعاعي الجديد من السجلات الطبية للمرضى الذين يعانون من أورام المستقيم الذين خضعوا للعلاج الكيميائي الإشعاعي الجديد قبل الجراحة في مستشفى سينا، طهران، إيران من 2010م-2015م.
    UNASSIGNED: ارتبطت مستويات المستضد السرطاني الجنيني ما قبل العلاج الكيميائي الإشعاعي بشكل إيجابي بمرحلة الورم، كما أدى العلاج الكيميائي الإشعاعي إلى خفض مستويات المستضد السرطاني الجنيني بشكل كبير. في حين أن المستويات المنخفضة من المستضد السرطاني الجنيني قبل العلاج الكيميائي الإشعاعي ومرحلة الورم كانت مرتبطة بشكل كبير بالاستجابة الكاملة للعلاج الكيميائي الإشعاعي، ولم تظهر مستويات المستضد السرطاني الجنيني اللاحقة للعلاج الكيميائي الإشعاعي أي ارتباط مع الاستجابة الكاملة. بالإضافة إلى ذلك، في تحليل منحنى خصائص فعل المستقبلات، تم إظهار القيمة الحدية البالغة 2.6 لمستوى المستضد السرطاني الجنيني للتنبؤ بالاستجابة الكاملة للعلاج الكيميائي الإشعاعي (الخصوصية = 82.6٪ ، الحساسية = 40.5٪).
    UNASSIGNED: على الرغم من أن العديد من العوامل الأخرى غير مستويات المستضد السرطاني الجنيني ومرحلة الورم مهمة أيضا في تحديد الاستجابة للعلاج الكيميائي الإشعاعي، فقد أظهرت هذه الدراسة أنه يمكن استخدام مستويات المستضد السرطاني الجنيني الأولية ومرحلة الورم كعوامل لتحديد الاستجابة الكاملة للعلاج الكيميائي الإشعاعي الجديد في سرطان المستقيم.
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  • 文章类型: Journal Article
    暂无摘要。
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  • 文章类型: Case Reports
    子宫内膜异位症恶变引起的透明细胞癌是一种罕见但侵袭性的癌症,通常在围绝经期妇女中诊断出来。恶性转化是子宫内膜异位症的罕见并发症,医学文献中只有少数病例报道。透明细胞癌和子宫内膜样癌是与恶性子宫内膜异位症相关的两种最常见的组织学亚型。
    一名61岁的非洲-特立尼达妇女接受了全腹子宫切除术和双侧附件-卵巢切除术,以治疗退化的子宫平滑肌瘤。组织病理学表明,在子宫浆膜上的子宫内膜异位囊肿中发现了透明细胞癌。随后的手术分期显示与高风险组织学亚型相关的早期疾病,患者被转诊接受辅助放化疗。
    本病例重点介绍了早期高危亚型子宫内膜异位症相关癌症的临床表现和治疗方法。鉴于关于这个临床实体的出版物很少,我们希望提高对子宫内膜异位症这一独特并发症的认识,并为制定标准化治疗方案提供证据.
    UNASSIGNED: Clear cell carcinoma arising from the malignant transformation of endometriosis is a rare but aggressive cancer often diagnosed in perimenopausal women. Malignant transformation constitutes a rare complication of endometriosis, with only a few cases reported in the medical literature. Clear cell carcinoma and endometrioid carcinoma are the two most common histological subtypes associated with malignant endometriosis.
    UNASSIGNED: A 61-year-old Afro-Trinidadian woman underwent a total abdominal hysterectomy and bilateral salpingo-oophorectomy for a degenerated uterine leiomyoma. Histopathology demonstrated an isolated finding of clear cell carcinoma occurring within an endometriotic cyst on the uterine serosa. Subsequent surgical staging demonstrated early-stage disease associated with a high-risk histological subtype and the patient was referred for adjuvant chemoradiotherapy.
    UNASSIGNED: This case highlights the clinical manifestations and treatment modalities employed for an early-stage high-risk subtype of endometriosis-associated cancer. In light of the few publications on this clinical entity, we hope to raise awareness of this unique complication of endometriosis and contribute evidence to the development of standardized treatment protocols.
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  • 文章类型: Case Reports
    前列腺腺癌是男性癌症相关死亡率的第二大常见原因。机器人辅助腹腔镜前列腺切除术是局部疾病的标准治疗选择。我们介绍了一例63岁的男性,该男性同时患有前列腺癌和直肠癌,并接受了机器人前列腺切除术(RALP)和低位前切除术(LAR)的联合治疗。有趣的是,直肠系膜淋巴结包含转移性前列腺癌。
    Prostatic adenocarcinoma is the second most common cause of cancer related mortality in men. Robotic-assisted laparoscopic prostatectomy represents a standard treatment option for localized disease. We present a case of a 63-year-old male with synchronous presentation of prostate and rectal cancer treated with combined robotic prostatectomy (RALP) and low anterior resection (LAR). Interestingly, a mesorectal lymph node contained metastatic prostate cancer.
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  • 文章类型: Journal Article
    UNASSIGNED:局部晚期直肠癌(LARC)治疗算法的最新进展显着提高了完全缓解(CR)率和无病生存率(DFS),但是治疗抵抗,对结果和生存有重大影响,仍然是一个重大挑战。我们小组最近揭示了白细胞介素-1α(IL-1α)信号在激活炎性癌症相关成纤维细胞(iCAF)和介导辐射诱导的衰老中的关键作用,细胞外基质(ECM)积累,最终是治疗抵抗。我们在这里总结了最近启动的ACO/ARO/AIO-21第一阶段试验,检测IL-1受体拮抗剂(IL-1RA)与基于氟嘧啶的放化疗(CRT)联合治疗晚期直肠癌.
    未经批准:ACO/ARO/AIO-21是由调查员驱动的,prospective,开放标记的I期药物再利用试验,评估卡培他滨的最大耐受剂量(MTD)同时给予标准术前放疗(25分45Gy,然后5分9Gy增强)与固定剂量的IL1-RAanakinra(100mg,天-10到30)。卡培他滨将采用3+3剂量递增设计(500mg/m2bid;650mg/m2bid;825mg/m2bid,分别)从第1天到第30天。反应评估,包括直肠指检(DRE),在完成CRT后10周进行内窥镜检查和盆腔磁共振成像(MRI)。对于达到临床完全缓解(cCR)的患者,提供主要的非手术管理。在非cCR的情况下,将进行立即全直肠系膜切除术(TME)。该I期试验的主要终点是卡培他滨的MTD。
    未经评估:基于广泛的临床前研究,ACO/ARO/AIO-21I期试验将评估IL-1RAanakinra是否可以安全地联合基于氟嘧啶的CRT治疗直肠癌.它将进一步探索IL-1抑制克服治疗抗性和提高应答率的潜力。全面的转化研究计划将从临床角度扩大我们的理解,并可能有助于将结果转化为随机II期试验。
    UNASSIGNED: Recent advances in the treatment algorithm of locally advanced rectal cancer (LARC) have significantly improved complete response (CR) rates and disease-free survival (DFS), but therapy resistance, with its substantial impact on outcomes and survival, remains a major challenge. Our group has recently unraveled a critical role of interleukin-1α (IL-1α) signaling in activating inflammatory cancer-associated fibroblasts (iCAFs) and mediating radiation-induced senescence, extracellular matrix (ECM) accumulation, and ultimately therapy resistance. We here summarize the recently initiated ACO/ARO/AIO-21 phase I trial, testing the IL-1 receptor antagonist (IL-1 RA) anakinra in combination with fluoropyrimidine-based chemoradiotherapy (CRT) for advanced rectal cancer.
    UNASSIGNED: The ACO/ARO/AIO-21 is an investigator-driven, prospective, open-labeled phase I drug-repurposing trial assessing the maximum tolerated dose (MTD) of capecitabine administered concurrently to standard preoperative radiotherapy (45 Gy in 25 fractions followed by 9 Gy boost in 5 fractions) in combination with fixed doses of the IL1-RA anakinra (100 mg, days -10 to 30). Capecitabine will be administered using a 3 + 3 dose-escalation design (500 mg/m2 bid; 650 mg/m2 bid; 825 mg/m2 bid, respectively) from day 1 to day 30. Response assessment including digital rectal examination (DRE), endoscopy and pelvic magnetic resonance imaging (MRI) is scheduled 10 weeks after completion of CRT. For patients achieving clinical complete response (cCR), primary non-operative management is provided. In case of non-cCR immediate total mesorectal excision (TME) will be performed. Primary endpoint of this phase I trial is the MTD of capecitabine.
    UNASSIGNED: Based on extensive preclinical research, the ACO/ARO/AIO-21 phase I trial will assess whether the IL-1RA anakinra can be safely combined with fluoropyrimidine-based CRT in rectal cancer. It will further explore the potential of IL-1 inhibition to overcome therapy resistance and improve response rates. A comprehensive translational research program will expand our understanding from a clinical perspective and may help translate the results into a randomized phase II trial.
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  • 文章类型: Journal Article
    目的:晚期胆道癌(ABTC)与不良预后相关。关于ABTC患者接受序贯化疗的结果的真实数据仍然很少,除了既定的吉西他滨+顺铂和FOLFOX一线和二线治疗外,对治疗方案知之甚少。这项研究旨在评估患者对不同肿瘤治疗的结果,并确定预后因素。
    方法:从2010年1月至2019年12月,142例患者在我们的三级护理肝脏中心开始姑息性化疗。使用Kaplan-Meier图计算总生存期(OS)。使用cox比例风险评估预后因素。
    结果:患者接受2行化疗的中位数。接受1、2和3行化疗的患者的中位OS分别为6.7、15.2和18.2个月,分别。用FOLFIRINOX治疗的患者具有23.8个月的显著延长的OS(对数秩检验:p=0.018)。单变量cox回归分析确定了与生存相关的几个临床参数(例如白蛋白,胆红素,癌胚抗原,碳水化合物抗原19-9水平)。
    结论:我们的研究提供了ABTC预后的真实数据,包括接受第三行及以后行化疗患者的生存时间。
    背景:在对照试验框架之外描述晚期胆道癌患者预后的真实世界数据仍然很少见,尽管这对于临床决策非常重要。因此,这项研究提供了关于吉西他滨+顺铂和FOLFOX的一线和二线治疗的重要现实数据,以及其他化疗方案或后期化疗方案。它进一步证明FOLFIRINOX的使用与有希望的生存有关,并且各种临床参数之间存在关联,例如治疗前白蛋白,胆红素或碳水化合物抗原19-9水平和生存率。
    OBJECTIVE: Advanced biliary tract cancer (ABTC) is associated with a poor prognosis. Real-world data on the outcome of patients with ABTC undergoing sequential chemotherapies remain scarce, and little is known about treatment options beyond the established first- and second-line treatments with gemcitabine + cisplatin and FOLFOX. This study aimed to evaluate the outcome of patients with regard to different oncological therapies and to identify prognostic factors.
    METHODS: From January 2010 until December 2019, 142 patients started palliative chemotherapy at our tertiary care liver center. Overall survival (OS) was calculated using Kaplan-Meier plots. Prognostic factors were evaluated using cox proportional-hazards.
    RESULTS: Patients received a median number of 2 lines of chemotherapy. Median OS was 6.7, 15.2 and 18.2 months for patients who received 1, 2 and 3 lines of chemotherapy, respectively. Patients treated with FOLFIRINOX had a significantly extended OS of 23.8 months (log-rank test: p = 0.018). The univariate cox regression analysis identified several clinical parameters associated with survival (e.g. albumin, bilirubin, carcinoembryonic antigen, carbohydrate antigen 19-9 levels).
    CONCLUSIONS: Our study provides real-world data on the prognosis of ABTC including survival times for patients receiving third and later lines of chemotherapy.
    BACKGROUND: Real-world data depicting the outcome of patients with advanced biliary tract cancer outside the framework of controlled trials remain rare despite being extremely important for clinical decision-making. This study therefore provides important real-world data on the established first- and second-line treatments with gemcitabine + cisplatin and FOLFOX, as well as on other chemotherapy regimens or later lines of chemotherapy. It further demonstrates that the use of FOLFIRINOX is associated with promising survival and that there is an association between various clinical parameters such as pre-therapeutic albumin, bilirubin or carbohydrate antigen 19-9 levels and survival.
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