advanced gastric cancer

晚期胃癌
  • 文章类型: Journal Article
    比较新辅助放化疗(NCRT)和新辅助化疗(NCT)对晚期胃癌(AGC)患者并发症和复发的临床效果。
    这是一项回顾性研究。承德市中心医院1月之间共收治83例AGC患者2019年6月。选择2021年,采用随机数字表法分为观察组(n=41)和对照组(n=42)。对照组患者接受XELOX化疗,观察组接受调强放疗(IMRT)联合XELOX化疗.比较疗效,病理完全缓解率(pCR),R0切除率,不良反应,比较两组患者治疗前后的生活质量(QOL)。
    功效,pCR,与对照组相比,观察组的R0切除率明显升高。并发症的比较显示经历胃肠道(GI)反应的患者人数,增加BUN,GPT增加,脱发,与对照组相比,观察组的色素沉着减少,差异无统计学意义(p>0.05),两组患者发生骨髓抑制的人数差异有统计学意义(p<0.05)。物理子得分没有显着差异,角色,情感,认知,两组治疗前社会功能及生活质量总分比较(p>0.05)。
    与NCT相比,NCRT在AGC患者中更安全,更有效,能明显改善患者的生活质量。可广泛应用于临床。
    UNASSIGNED: To compare the clinical effects of neoadjuvant chemoradiotherapy (NCRT) and neoadjuvant chemotherapy (NCT) on complications and recurrence in patients with advanced gastric cancer (AGC).
    UNASSIGNED: This was a retrospective study. A total of 83 patients with AGC admitted to Chengde Central Hospital between Jan. 2019 and Jun. 2021 were selected and divided into the observation group(n=41) and the control group(n=42) using a random number table. Patients in the control group received XELOX chemotherapy, and those in the observation group received intensity-modulated radiotherapy (IMRT) with concurrent XELOX chemotherapy. Compared efficacy, pathological complete response rate (pCR), R0 resection rate, adverse reactions, and quality of life (QOL) before and after treatment between the two groups.
    UNASSIGNED: The efficacy, pCR, and R0 resection rate of the observation group were significantly increased compared with those of the control group. Comparison of complications showed the number of patients experiencing gastrointestinal (GI) reactions, increased BUN, increased GPT, alopecia, and pigmentation in the observation group was decreased compared with that in the control group, with no statistically significant differences(p>0.05), and the number of patients experiencing myelosuppression was statistically significant between the two groups(p<0.05). There were no significant differences in sub-scores of physical, role, emotional, cognitive, and social functions and the overall score of QOL between the two groups(p>0.05) before treatment.
    UNASSIGNED: NCRT is safer and more effective in patients with AGC compared with NCT, and can significantly improve the QOL of patients. It can be widely used in clinical practice.
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  • 文章类型: Journal Article
    背景:晚期胃癌是一种常见的恶性肿瘤,通常诊断为晚期,在根治性手术治疗后仍有复发的风险。放化疗,作为胃癌的重要治疗方法之一,对于提高患者的生存率具有重要意义。然而,胃癌患者放化疗后的肿瘤复发和生存预后仍不确定。
    目的:分析进展期胃癌根治性放化疗后肿瘤复发情况,为临床医生提供更深入的指导。
    方法:回顾性分析2021-2023年在我院接受术后辅助放化疗的171例胃癌患者的临床资料。采用Kaplan-Meier法计算复发率和生存率;采用log-rank法进行单因素预后分析;采用Cox模型进行多因素预后分析。
    结果:全组中位随访时间为63个月,随访率为93.6%。Ⅱ期和Ⅲ期患者分别占31.0%和66.7%,分别。3级及以上急性胃肠道反应和血液学不良反应发生率分别为8.8%和9.9%。分别。共有166名患者完成了整个放化疗方案,期间无不良反应相关死亡发生.就复发模式而言,17例患者局部复发,29例患者有远处转移,12例患者发生腹膜种植转移。1年,3年,5年总生存率(OS)为83.7%,66.3%,和60.0%,分别。1年,3年,5年无病生存率为75.5%,62.7%,56.5%,分别。多变量分析表明,T分期,周围神经侵犯,淋巴结转移率(LNR)是OS的独立预后因素。
    结论:胃癌术后调强放疗联合化疗治疗耐受性好,不良反应可接受。有利于肿瘤局部控制,提高患者的长期生存率。LNR是OS的独立预后因素。对于局部复发风险高的患者,应考虑术后辅助放化疗.
    BACKGROUND: Advanced gastric cancer is a common malignancy that is often diagnosed at an advanced stage and is still at risk of recurrence after radical surgical treatment. Chemoradiotherapy, as one of the important treatment methods for gastric cancer, is of great significance for improving the survival rate of patients. However, the tumor recurrence and survival prognosis of gastric cancer patients after radiotherapy and chemotherapy are still uncertain.
    OBJECTIVE: To analyze the tumor recurrence after radical radiotherapy and chemotherapy for advanced gastric cancer and provide more in-depth guidance for clinicians.
    METHODS: A retrospective analysis was performed on 171 patients with gastric cancer who received postoperative adjuvant radiotherapy and chemotherapy in our hospital from 2021 to 2023. The Kaplan-Meier method was used to calculate the recurrence rate and survival rate; the log-rank method was used to analyze the single-factor prognosis; and the Cox model was used to analyze the prognosis associated with multiple factors.
    RESULTS: The median follow-up time of the whole group was 63 months, and the follow-up rate was 93.6%. Stage II and III patients accounted for 31.0% and 66.7%, respectively. The incidences of Grade 3 and above acute gastrointestinal reactions and hematological adverse reactions were 8.8% and 9.9%, respectively. A total of 166 patients completed the entire chemoradiotherapy regimen, during which no adverse reaction-related deaths occurred. In terms of the recurrence pattern, 17 patients had local recurrence, 29 patients had distant metastasis, and 12 patients had peritoneal implantation metastasis. The 1-year, 3-year, and 5-year overall survival (OS) rates were 83.7%, 66.3%, and 60.0%, respectively. The 1-year, 3-year, and 5-year disease-free survival rates were 75.5%, 62.7%, and 56.5%, respectively. Multivariate analysis revealed that T stage, peripheral nerve invasion, and the lymph node metastasis rate (LNR) were independent prognostic factors for OS.
    CONCLUSIONS: Postoperative intensity-modulated radiotherapy combined with chemotherapy for gastric cancer treatment is well tolerated and has acceptable adverse effects, which is beneficial for local tumor control and can improve the long-term survival of patients. The LNR was an independent prognostic factor for OS. For patients with a high risk of local recurrence, postoperative adjuvant chemoradiation should be considered.
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  • 文章类型: Journal Article
    本研究旨在开发和验证基于临床和影像学的列线图,用于术前预测晚期胃癌的神经周浸润(PNI)。
    纳入351例接受手术切除的晚期胃癌患者的回顾性队列。进行多变量逻辑回归分析以确定PNI的独立危险因素并构建列线图。使用校准曲线评估列线图的性能,一致性指数(C指数),曲线下面积(AUC),和决策曲线分析(DCA)。使用Log-Rank检验和Kaplan-Meier分析评估了列线图预测的PNI阳性组与列线图预测的PNI阴性组之间的无病生存(DFS)差异。
    壁外血管侵犯(EMVI),Borrmann分类,肿瘤厚度,全身炎症反应指数(SIRI)是PNI的独立危险因素。列线图模型显示了0.838的值得推荐的AUC值。校准曲线表现出优异的一致性,C指数为0.814。DCA表明该模型提供了良好的临床净效益。列线图预测的PNI阳性组的DFS显著低于列线图预测的PNI阴性组(p<0.001)。
    这项研究成功地开发了一种术前列线图模型,该模型不仅有效地预测了胃癌中的PNI,而且促进了术后风险分层。
    UNASSIGNED: This study aimed to develop and validate a clinical and imaging-based nomogram for preoperatively predicting perineural invasion (PNI) in advanced gastric cancer.
    UNASSIGNED: A retrospective cohort of 351 patients with advanced gastric cancer who underwent surgical resection was included. Multivariable logistic regression analysis was conducted to identify independent risk factors for PNI and to construct the nomogram. The performance of the nomogram was assessed using calibration curves, the concordance index (C-index), the area under the curve (AUC), and decision curve analysis (DCA). The disparity in disease-free survival (DFS) between the nomogram-predicted PNI-positive group and the nomogram-predicted PNI-negative group was evaluated using the Log-Rank test and Kaplan-Meier analysis.
    UNASSIGNED: Extramural vascular invasion (EMVI), Borrmann classification, tumor thickness, and the systemic inflammation response index (SIRI) emerged as independent risk factors for PNI. The nomogram model demonstrated a commendable AUC value of 0.838. Calibration curves exhibited excellent concordance, with a C-index of 0.814. DCA indicated that the model provided good clinical net benefit. The DFS of the nomogram-predicted PNI-positive group was significantly lower than that of the nomogram-predicted PNI-negative group (p < 0.001).
    UNASSIGNED: This study successfully developed a preoperative nomogram model that not only effectively predicted PNI in gastric cancer but also facilitated postoperative risk stratification.
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  • 文章类型: Journal Article
    程序性死亡受体1(PD-1)抑制剂,当联合化疗时,在提高晚期胃癌患者的生存结局方面表现出显著的有效性。然而,重要的是要承认,并不是所有的患者都能从这种治疗方法中获得实质性的好处,强调确定有效的生物标志物以告知免疫治疗干预措施的关键必要性。在这项研究中,我们试图研究循环肿瘤DNA(ctDNA)作为生物标志物在30名诊断为晚期胃癌的患者队列中的预测效用。所有患者均接受了包括PD-1抑制剂给药和化疗的一线治疗.我们在基线和两个治疗周期完成后都获得了外周血样本。此外,收集基线组织标本用于基因组改变评估,采用47基因和737基因的下一代测序小组用于血浆和肿瘤组织,分别。我们将ctDNA应答描述为相对于基线水平的最大变异等位基因频率的根除。值得注意的是,与无反应者相比,显示ctDNA反应的个体的客观反应率显着优于无反应者(P=0.0073)。此外,与无ctDNA反应的患者并列时,表现出ctDNA反应的患者的无进展生存期(PFS)和总生存期(OS)显着延长(中位PFS:15.6vs.6.0个月,P=0.003;中位OS:未达到[NR]与9.0个月,P=0.011)。总之,接受PD-1抑制剂和化疗一线治疗的晚期胃癌患者,ctDNA的动态变化可作为预测治疗疗效和长期结局的潜在生物标志物.
    Programmed Death Receptor 1 (PD-1) inhibitors, when combined with chemotherapy, have exhibited notable effectiveness in enhancing the survival outcomes of patients afflicted with advanced gastric cancer. However, it is important to acknowledge that not all patients derive substantial benefits from this therapeutic approach, highlighting the crucial necessity of identifying efficacious biomarkers to inform immunotherapy interventions. In this study, we sought to investigate the predictive utility of circulating tumor DNA (ctDNA) as a biomarker in a cohort of 30 patients diagnosed with advanced gastric cancer, all of whom underwent first-line treatment involving PD-1 inhibitor administration alongside chemotherapy. We procured peripheral blood samples both at baseline and following the completion of two treatment cycles. Additionally, baseline tissue specimens were collected for the purpose of genomic alteration assessment, employing both 47-gene and 737-gene next-generation sequencing panels for plasma and tumor tissue, respectively. We delineated a ctDNA response as the eradication of maximum variant allele frequencies relative to baseline levels. Notably, the objective response rate among individuals exhibiting a ctDNA response proved significantly superior in comparison to non-responders (P = 0.0073). Furthermore, patients who manifested a ctDNA response experienced markedly prolonged progression-free survival (PFS) and overall survival (OS) when juxtaposed with those devoid of a ctDNA response (median PFS: 15.6 vs. 6.0 months, P = 0.003; median OS: not reached [NR] vs. 9.0 months, P = 0.011). In summation, patients with advanced gastric cancer receiving first-line treatment with PD-1 inhibitors and chemotherapy, dynamic changes in ctDNA can serve as a potential biomarker for predicting treatment efficacy and long-term outcomes.
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  • 文章类型: Journal Article
    目的:本研究旨在探讨影响晚期胃癌患者生存的主要因素。
    方法:对120例进展期胃癌患者的临床病理资料进行回顾性分析。收集临床和病理资料。重新评估肿瘤组织分期和分级,随访5年总生存率。分类数据以百分比表示,连续数据用标准差或中位数描述。单变量分析采用χ2检验或秩和检验,然后进行Kaplan-Meier生存分析,计算中位生存时间和5年累积生存时间.采用多因素Cox回归模型评价影响生存的独立危险因素。测试水平为α=0.05。
    结果:患者随访0~60个月,5年总生存率为36.2%,中位生存时间为53.0±1.461个月。K-M和对数秩检验结果显示,肿瘤的位置,分化程度,入侵深度,区域淋巴结受累,术后肿瘤分期与5年生存率降低相关(P<0.05)。采用多因素Cox风险回归模型分析组织学分化程度(HR=1.441;95%CI=1.049-1.979;P=0.024),区域淋巴结(HR=1.626;95%CI=1.160-2.279;P=0.005),和pTNM分期(HR=2.266;95%CI=1.335-3.847;P=0.002),这是生存率低下的独立危险因素。肿瘤部位(P=0.191),肿瘤浸润深度(P=0.579)和肿瘤大小(P=0.324)不是独立危险因素。
    结论:肿瘤的分化程度,发现区域淋巴结转移和术后病理分期是进展期胃癌患者5年总生存率的独立危险因素。规范合理的淋巴结清扫及准确的术后病理分期非常重要。
    The aim of this study was to investigate the main factors influencing the survival of patients with advanced gastric cancer.
    The clinicopathological data of 120 patients with advanced gastric cancer were analyzed retrospectively, and clinical and pathological data were collected. Tumor tissue staging and grading were re-evaluated, and 5-year overall survival was followed up. The classified data were described by percentages, and the continuous data were described by standard deviations or medians. Univariate analysis was performed using the χ2 test or rank-sum test, followed by Kaplan-Meier survival analysis to calculate the median survival time and 5-year cumulative survival. A multivariate Cox regression model was used to evaluate the independent risk factors affecting survival. The test level was α = 0.05.
    Patients were followed up for 0 to 60 months, the 5-year overall survival rate was 36.2%, and the median survival time was 53.0 ± 1.461 months. K-M and log-rank test results revealed that tumor location, degree of differentiation, depth of invasion, regional lymph node involvement, and postoperative tumor stage were correlated with a decreased 5-year survival rate (P < 0.05). A multivariate Cox risk regression model was used to analyze the degree of histological differentiation (HR = 1.441; 95% CI = 1.049-1.979; P = 0.024), regional lymph node (HR = 1.626; 95% CI = 1.160-2.279; P = 0.005), and pTNM stage (HR = 2.266; 95% CI = 1.335-3.847; P = 0.002), which are independent risk factors for poor survival. Tumor location (P = 0.191), invasion depth (P = 0.579) and tumor size (P = 0.324) were not found to be independent risk factors.
    The degree of tumor differentiation, regional lymph node metastasis and postoperative pathological stage were found to be independent risk factors for 5-year overall survival in patients with advanced gastric cancer. Standardized and reasonable lymph node dissection and accurate postoperative pathological staging were very important.
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  • 文章类型: Journal Article
    背景:晚期不可切除的胃癌(GC)患者以前曾单独使用化疗作为一线治疗。然而,随着食品和药物管理局(FDA)2022批准程序性细胞死亡蛋白1(PD-1)抑制剂联合化疗作为晚期不可切除的GC的第一个治疗方法,患者显著受益。然而,巨大的成本和潜在的不利影响需要精确的患者选择.近年来,深度学习(DL)的出现彻底改变了医学领域,特别是在预测肿瘤治疗反应。我们的研究利用DL分析病理图像,旨在预测一线PD-1联合化疗对晚期GC的反应。
    方法:在这项多中心回顾性分析中,从四个医疗中心的晚期GC患者收集苏木精和伊红(H&E)染色的载玻片。在综合一线PD-1免疫疗法联合化疗后,根据iRECIST1.1标准评估治疗反应。在集成方法中采用三个DL模型来创建免疫检查点抑制剂反应评分(ICIsRS)作为源自全幻灯片图像(WSI)的新型组织病理学生物标志物。
    结果:分析了264例晚期GC患者313个WSI的148,181个贴片,集成模型表现出优异的预测精度,导致ICIsNet的创建。该模型在四个测试数据集上表现出稳健的性能,AUC值分别为0.92、0.95、0.96和1。盒子情节,从ICIsRS建造,揭示了良好反应和不良反应之间的统计学显著差异(所有p值<=0.001)。
    结论:ICIsRS,来自WSI的DL衍生生物标志物,有效预测晚期GC患者对PD-1联合化疗的反应,为个性化治疗计划提供了一种新的方法,并允许根据患者的独特反应情况制定更个性化和潜在有效的治疗策略。
    BACKGROUND: Advanced unresectable gastric cancer (GC) patients were previously treated with chemotherapy alone as the first-line therapy. However, with the Food and Drug Administration\'s (FDA) 2022 approval of programmed cell death protein 1 (PD-1) inhibitor combined with chemotherapy as the first-li ne treatment for advanced unresectable GC, patients have significantly benefited. However, the significant costs and potential adverse effects necessitate precise patient selection. In recent years, the advent of deep learning (DL) has revolutionized the medical field, particularly in predicting tumor treatment responses. Our study utilizes DL to analyze pathological images, aiming to predict first-line PD-1 combined chemotherapy response for advanced-stage GC.
    METHODS: In this multicenter retrospective analysis, Hematoxylin and Eosin (H&E)-stained slides were collected from advanced GC patients across four medical centers. Treatment response was evaluated according to iRECIST 1.1 criteria after a comprehensive first-line PD-1 immunotherapy combined with chemotherapy. Three DL models were employed in an ensemble approach to create the immune checkpoint inhibitors Response Score (ICIsRS) as a novel histopathological biomarker derived from Whole Slide Images (WSIs).
    RESULTS: Analyzing 148,181 patches from 313 WSIs of 264 advanced GC patients, the ensemble model exhibited superior predictive accuracy, leading to the creation of ICIsNet. The model demonstrated robust performance across four testing datasets, achieving AUC values of 0.92, 0.95, 0.96, and 1 respectively. The boxplot, constructed from the ICIsRS, reveals statistically significant disparities between the well response and poor response (all p-values < = 0.001).
    CONCLUSIONS: ICIsRS, a DL-derived biomarker from WSIs, effectively predicts advanced GC patients\' responses to PD-1 combined chemotherapy, offering a novel approach for personalized treatment planning and allowing for more individualized and potentially effective treatment strategies based on a patient\'s unique response situations.
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  • 文章类型: Journal Article
    背景:近年来晚期胃癌的免疫治疗引起了广泛关注。然而,免疫治疗的不良反应及其与患者预后的关系仍需进一步研究。为了确定不良反应因素与预后之间的关系,本研究的目的是进行系统的预后分析.通过综合评价免疫治疗晚期胃癌患者的临床资料,将建立一个列线图模型来更准确地预测患者的生存状态。
    目的:探讨晚期胃癌患者接受程序性死亡蛋白-1(PD-1)抑制剂免疫治疗后免疫相关不良反应(irAEs)的特点及预测因素,分析irAEs与患者预后的相关性。
    方法:选择2021年6月至2023年10月在我院接受PD-1抑制剂治疗的晚期胃癌患者140例。根据是否发生irAE将患者分为irAE组和非irAE组。临床特征,表现,收集并分析两组患者的预后情况。采用多因素logistic回归模型分析影响IRAE发生的相关因素,建立了预测模型。采用受试者工作特征(ROC)曲线评价不同指标预测IRAE的能力。采用Kaplan-Meier生存曲线分析irAE与预后的相关性。采用Cox比例风险模型分析影响患者预后的相关因素。
    结果:共132例患者获得随访,其中63人(47.7%)发生了irAE。我们观察了两组的临床特征,发现两组在年龄≥65岁方面有统计学差异,Ki-67指数,白细胞计数,中性粒细胞计数,和调节性T细胞(Treg)计数(均P<0.05)。多因素logistic回归分析显示,Treg计数是影响irAE发生的保护因素(P=0.030)。ROC曲线显示Treg+Ki-67+年龄(≥65岁)联合应用能较好地预测IRAE(曲线下面积=0.753,95%置信区间为0.623~0.848,P=0.001)。Kaplan-Meier生存曲线的结果显示,与非irAEs组相比,irAEs组的无进展生存期(PFS)更长(P=0.001)。Cox比例风险回归分析显示,irAE的发生是影响PFS的独立因素(P=0.006)。
    结论:在接受PD-1抑制剂免疫治疗的晚期胃癌患者中,Treg细胞的数量是影响irAE的独立因素。irAE会影响患者的PFS并导致更长的PFS。Treg+Ki-67+年龄(≥65岁)联合应用能更好地预测不良反应的发生。
    BACKGROUND: Immunotherapy for advanced gastric cancer has attracted widespread attention in recent years. However, the adverse reactions of immunotherapy and its relationship with patient prognosis still need further study. In order to determine the association between adverse reaction factors and prognosis, the aim of this study was to conduct a systematic prognostic analysis. By comprehensively evaluating the clinical data of patients with advanced gastric cancer treated by immunotherapy, a nomogram model will be established to predict the survival status of patients more accurately.
    OBJECTIVE: To explore the characteristics and predictors of immune-related adverse reactions (irAEs) in advanced gastric cancer patients receiving immunotherapy with programmed death protein-1 (PD-1) inhibitors and to analyze the correlation between irAEs and patient prognosis.
    METHODS: A total of 140 patients with advanced gastric cancer who were treated with PD-1 inhibitors in our hospital from June 2021 to October 2023 were selected. Patients were divided into the irAEs group and the non-irAEs group according to whether or not irAEs occurred. Clinical features, manifestations, and prognosis of irAEs in the two groups were collected and analyzed. A multivariate logistic regression model was used to analyze the related factors affecting the occurrence of irAEs, and the prediction model of irAEs was established. The receiver operating characteristic (ROC) curve was used to evaluate the ability of different indicators to predict irAEs. A Kaplan-Meier survival curve was used to analyze the correlation between irAEs and prognosis. The Cox proportional risk model was used to analyze the related factors affecting the prognosis of patients.
    RESULTS: A total of 132 patients were followed up, of whom 63 (47.7%) developed irAEs. We looked at the two groups\' clinical features and found that the two groups were statistically different in age ≥ 65 years, Ki-67 index, white blood cell count, neutrophil count, and regulatory T cell (Treg) count (all P < 0.05). Multivariate logistic regression analysis showed that Treg count was a protective factor affecting irAEs occurrence (P = 0.030). The ROC curve indicated that Treg + Ki-67 + age (≥ 65 years) combined could predict irAEs well (area under the curve = 0.753, 95% confidence interval: 0.623-0.848, P = 0.001). Results of the Kaplan-Meier survival curve showed that progression-free survival (PFS) was longer in the irAEs group than in the non-irAEs group (P = 0.001). Cox proportional hazard regression analysis suggested that the occurrence of irAEs was an independent factor for PFS (P = 0.006).
    CONCLUSIONS: The number of Treg cells is a separate factor that affects irAEs in advanced gastric cancer patients receiving PD-1 inhibitor immunotherapy. irAEs can affect the patients\' PFS and result in longer PFS. Treg + Ki-67 + age (≥ 65 years old) combined can better predict the occurrence of adverse reactions.
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  • 文章类型: Journal Article
    Ramucirumab是VEGFR2拮抗剂。该试验的目的是评估雷莫西单抗联合nab-紫杉醇的疗效和安全性。洛铂和S-1在晚期胃癌新辅助和转化治疗中的应用。
    和分析:本研究是一项前瞻性单中心研究,随机对照和开放标签临床研究,共纳入140名晚期胃癌患者,分布在两个不同的队列中(队列An=70;队列Bn=70)。研究的中心焦点在于评估新辅助或转化治疗后癌症的病理完全反应(pCR)。次要终点包括评估上述治疗后的R0切除率,不良事件(AE)的发生,无进展生存期(PFS),总生存期(OS),客观反应率(ORR),总反应率及其持续时间,疾病控制率(DCR),和总体反应持续时间(DOR)。
    经空军军医大学第一附属医院(西京医院)伦理委员会批准(KY20232220-F-1)。
    该试验已在ClinicalTrials.gov:NCT06169410注册(注册日期:2023年12月5日)。
    UNASSIGNED: Ramucirumab is a VEGFR2 antagonist. The aim of this trial is to evaluate the efficacy and safety of ramucirumab combined with nab-paclitaxel, lobaplatin and S-1 in neoadjuvant and conversion therapy for advanced gastric cancer.
    UNASSIGNED: and analysis: This study is a prospective single-center, randomized controlled and open label clinical study, enrolling a total of 140 patients with advanced gastric cancer distributed across two distinct cohorts (Cohort A n = 70; Cohort B n = 70). The central focus of the study lies in evaluating the pathological complete response (pCR) of the cancer post-neoadjuvant or conversion therapy. Secondary endpoints encompass the assessment of the R0 resection rate subsequent to the aforementioned therapies, the occurrence of adverse events (AE), progression-free survival (PFS), overall survival (OS), the objective response rate (ORR), the total response rate and its duration, the disease control rate (DCR), and the duration of overall response (DOR).
    UNASSIGNED: Ethics approval has been obtained from the Ethics Committee at the First Affiliated Hospital (Xijing Hospital) of Air force Military Medical University (KY20232220-F-1).
    UNASSIGNED: This trial has been registered at the ClinicalTrials.gov: NCT06169410 (registration date: December 5, 2023).
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  • 文章类型: Journal Article
    背景:紫杉醇通常用作晚期胃癌(AGC)的二线治疗。对于一线化疗后AGC进展的脆弱患者,决定进行二线化疗并选择合适的方案至关重要。然而,不存在预测性生物标志物来识别AGC患者谁将受益于基于紫杉醇的化疗.
    方法:本研究纳入了2017年至2022年期间接受以紫杉醇为基础的二线化疗的288例AGC患者,作为K-MASTER项目的一部分,一项由政府资助的全国精准医疗计划。数据包括临床(年龄[年轻发病vs.其他],性别,组织学[肠vs.漫反射类型],先前使用曲妥珠单抗,一线化疗的持续时间),和基因组因素(致病性或可能的致病性变异)。将数据随机分为训练集和验证集(0.8:0.2)。四种机器学习(ML)方法,即随机森林(RF),逻辑回归(LR),人工神经网络(ANN),和具有遗传嵌入的ANN(ANN与GE),用于开发预测模型,并在验证集中进行验证。
    结果:患者年龄中位数为64岁(范围25-91),其中65.6%为男性。总共288名患者被分为训练组(n=230)和验证组(n=58)。训练集和验证集之间的基线特征没有显着差异。在训练集中,在RF中,预测基于紫杉醇的化疗的无进展生存期(PFS)更好的ROC曲线下面积(AUROC)分别为0.499、0.679、0.618和0.732,LR,ANN,和ANN与GE模型,分别。具有GE模型的ANN实现了最高的AUROC记录精度,灵敏度,特异性,和F1得分表现分别为0.458、0.912、0.724和0.579。在验证集中,GE模型的ANN预测紫杉醇敏感患者的PFS明显更长(PFS中位数为7.59vs.2.07个月,P=0.020)和总生存期(OS)(中位OS14.70vs.7.50个月,P=0.008)。LR模型预测对紫杉醇敏感的患者显示出更长PFS的趋势(PFS中位数为6.48vs.2.33个月,P=0.078)和OS(中位OS12.20与8.61个月,P=0.099)。
    结论:这些ML模型,结合临床和基因组因素,提供了帮助识别可能从紫杉醇化疗中受益的AGC患者的可能性。
    BACKGROUND: Paclitaxel is commonly used as a second-line therapy for advanced gastric cancer (AGC). The decision to proceed with second-line chemotherapy and select an appropriate regimen is critical for vulnerable patients with AGC progressing after first-line chemotherapy. However, no predictive biomarkers exist to identify patients with AGC who would benefit from paclitaxel-based chemotherapy.
    METHODS: This study included 288 patients with AGC receiving second-line paclitaxel-based chemotherapy between 2017 and 2022 as part of the K-MASTER project, a nationwide government-funded precision medicine initiative. The data included clinical (age [young-onset vs. others], sex, histology [intestinal vs. diffuse type], prior trastuzumab use, duration of first-line chemotherapy), and genomic factors (pathogenic or likely pathogenic variants). Data were randomly divided into training and validation sets (0.8:0.2). Four machine learning (ML) methods, namely random forest (RF), logistic regression (LR), artificial neural network (ANN), and ANN with genetic embedding (ANN with GE), were used to develop the prediction model and validated in the validation sets.
    RESULTS: The median patient age was 64 years (range 25-91), and 65.6% of those were male. A total of 288 patients were divided into the training (n = 230) and validation (n = 58) sets. No significant differences existed in baseline characteristics between the training and validation sets. In the training set, the areas under the ROC curves (AUROC) for predicting better progression-free survival (PFS) with paclitaxel-based chemotherapy were 0.499, 0.679, 0.618, and 0.732 in the RF, LR, ANN, and ANN with GE models, respectively. The ANN with the GE model that achieved the highest AUROC recorded accuracy, sensitivity, specificity, and F1-score performance of 0.458, 0.912, 0.724, and 0.579, respectively. In the validation set, the ANN with GE model predicted that paclitaxel-sensitive patients had significantly longer PFS (median PFS 7.59 vs. 2.07 months, P = 0.020) and overall survival (OS) (median OS 14.70 vs. 7.50 months, P = 0.008). The LR model predicted that paclitaxel-sensitive patients showed a trend for longer PFS (median PFS 6.48 vs. 2.33 months, P = 0.078) and OS (median OS 12.20 vs. 8.61 months, P = 0.099).
    CONCLUSIONS: These ML models, integrated with clinical and genomic factors, offer the possibility to help identify patients with AGC who may benefit from paclitaxel chemotherapy.
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  • 文章类型: Journal Article
    基于双能CT(DECT)影像组学探讨短轴直径≥6mm的淋巴结(LNs)特征对进展期胃腺癌(GAC)淋巴结转移(LNM)的预测价值。对
    行胃癌根治术和LN清扫术的GAC患者资料进行回顾性分析。为了确保影像学和病理学之间的对应关系,仅从pN3患者中选择转移性LN,从pN0患者中选择非转移性LN,纳入的LN的短轴直径均≥6mm.记录了LN的传统特征,包括短轴直径,长轴直径,长短轴比率,position,形状,密度,边缘,和强化程度;采用单因素和多因素logistic回归分析建立临床模型。在静脉阶段等效的120kV线性融合图像和碘图中提取了LN最大水平的影像组学特征。采用组内相关系数和Boruta算法筛选显著特征,并利用随机森林建立影像组学模型。要构建组合模型,我们在单变量分析中纳入了具有统计学意义的传统特征,在多变量逻辑回归分析中纳入了影像组学评分(Rad-score).使用受试者工作曲线(ROC)曲线和DeLong检验来评估和比较模型的诊断性能。使用决策曲线分析(DCA)来评估模型的临床益处。
    这项研究包括来自36个pN3病例的114个转移性LN和来自28个pN0病例的65个非转移性LN。以7:3的比率将样品分成训练集(n=125)和验证集(n=54)。长轴直径和LN形状是LNM的独立预测因子,用于建立临床模型;筛选出的27个影像组学特征用于建立影像组学模型。LN形状和Rad评分是LNM的独立预测因子,并用于构建组合模型。在预测训练和验证集的LNM方面,影像组学模型(曲线下面积[AUC]为0.986和0.984)和组合模型(AUC为0.970和0.977)均优于临床模型(AUC为0.772和0.820)。DCA从影像组学和组合模型中显示出优越的临床优势。
    基于DECTLN影像组学特征或组合的传统特征的模型在确定高级GAC中短轴直径≥6mm的每个LN的性质方面具有很高的诊断性能。
    UNASSIGNED: To explore the value of the features of lymph nodes (LNs) with a short-axis diameter ≥6 mm in predicting lymph node metastasis (LNM) in advanced gastric adenocarcinoma (GAC) based on dual-energy CT (DECT) radiomics.
    UNASSIGNED: Data of patients with GAC who underwent radical gastrectomy and LN dissection were retrospectively analyzed. To ensure the correspondence between imaging and pathology, metastatic LNs were only selected from patients with pN3, nonmetastatic LNs were selected from patients with pN0, and the short-axis diameters of the enrolled LNs were all ≥6 mm. The traditional features of LNs were recorded, including short-axis diameter, long-axis diameter, long-to-short-axis ratio, position, shape, density, edge, and the degree of enhancement; univariate and multivariate logistic regression analyses were used to establish a clinical model. Radiomics features at the maximum level of LNs were extracted in venous phase equivalent 120 kV linear fusion images and iodine maps. Intraclass correlation coefficients and the Boruta algorithm were used to screen significant features, and random forest was used to build a radiomics model. To construct a combined model, we included the traditional features with statistical significance in univariate analysis and radiomics scores (Rad-score) in multivariate logistic regression analysis. Receiver operating curve (ROC) curves and the DeLong test were used to evaluate and compare the diagnostic performance of the models. Decision curve analysis (DCA) was used to evaluate the clinical benefits of the models.
    UNASSIGNED: This study included 114 metastatic LNs from 36 pN3 cases and 65 nonmetastatic LNs from 28 pN0 cases. The samples were divided into a training set (n=125) and a validation set (n=54) at a ratio of 7:3. Long-axis diameter and LN shape were independent predictors of LNM and were used to establish the clinical model; 27 screened radiomics features were used to build the radiomics model. LN shape and Rad-score were independent predictors of LNM and were used to construct the combined model. Both the radiomics model (area under the curve [AUC] of 0.986 and 0.984) and the combined model (AUC of 0.970 and 0.977) outperformed the clinical model (AUC of 0.772 and 0.820) in predicting LNM in both the training and validation sets. DCA showed superior clinical benefits from radiomics and combined models.
    UNASSIGNED: The models based on DECT LN radiomics features or combined traditional features have high diagnostic performance in determining the nature of each LN with a short-axis diameter of ≥6 mm in advanced GAC.
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