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Efficacy of ctDNA methylation combined with traditional detection modality to detect liver cancer among high-risk patients: A multicenter diagnostic trial. ctDNA甲基化联合传统检测方式在高危患者中检测肝癌的疗效:一项多中心诊断试验
Pub Date : 2023-02-28 DOI: 10.21147/j.issn.1000-9604.2023.01.06
Maomao Cao, Jufang Shi, Changfa Xia, He Li, Wei Cai, Xianyun Qi, Chunyun Dai, Wanqing Chen

Objective: Circulating tumor DNA (ctDNA) and alpha-fetoprotein (AFP) plus ultrasound (US) have been considered to have high diagnostic accuracy for cancer detection, however, the efficacy of ctDNA methylation combined with the traditional detection modality of liver cancer has not been tested in a Chinese independent cohort.

Methods: The high-risk individuals aged between 35 and 70 years who were diagnosed with liver cirrhosis or had moderate and severe fatty liver were eligible for inclusion. All participants were invited to receive a traditional examination [referring to AFP plus US], and ctDNA methylation, respectively. The sensitivity and specificity of different diagnostic tools were calculated. The logistic regression model was applied to estimate the area under the curve (AUC), which was further validated by 10-fold internal cross-validation.

Results: A total of 1,205 individuals were recruited in our study, and 39 participants were diagnosed with liver cancer. The sensitivity of AFP, US, US plus AFP, and the combination of US, AFP, and ctDNA methylation was 33.33%, 56.41%, 66.67%, and 87.18%, respectively. The corresponding specificity of AFP, US, US plus AFP, and the combination of all modalities was 98.20%, 99.31%, 97.68%, and 97.68%, respectively. The AUCs of AFP, US, US plus AFP, and the combination of AFP, US, and ctDNA methylation were 65.77%, 77.86%, 82.18%, and 92.43%, respectively. The internally validated AUCs of AFP, US, US plus AFP, and the combination of AFP, US, and ctDNA methylation were 67.57%, 83.26%, 86.54%, and 93.35%, respectively.

Conclusions: The ctDNA methylation is a good complementary to AFP and US for the detection of liver cancer.

目的:循环肿瘤DNA (ctDNA)和甲胎蛋白(AFP)加超声(US)被认为对癌症检测具有较高的诊断准确性,但ctDNA甲基化联合传统肝癌检测方式的疗效尚未在中国独立队列中得到检验。方法:年龄在35 ~ 70岁、诊断为肝硬化或中重度脂肪肝的高危人群入选。所有参与者被邀请分别接受传统检查[参考AFP加US]和ctDNA甲基化。计算不同诊断工具的敏感性和特异性。采用logistic回归模型估计曲线下面积(AUC),并进行10次内部交叉验证。结果:我们的研究共招募了1205人,其中39人被诊断为肝癌。AFP、US、US + AFP以及US、AFP和ctDNA甲基化联合检测的敏感性分别为33.33%、56.41%、66.67%和87.18%。AFP、US、US + AFP及所有方式联合的特异性分别为98.20%、99.31%、97.68%、97.68%。AFP、US、US + AFP、AFP、US和ctDNA甲基化的auc分别为65.77%、77.86%、82.18%和92.43%。AFP、US、US + AFP以及AFP、US和ctDNA甲基化组合的内部验证auc分别为67.57%、83.26%、86.54%和93.35%。结论:ctDNA甲基化是AFP和US检测肝癌的良好补充。
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引用次数: 1
Is gastric cancer after bariatric surgery on the rise? Will history repeat itself? 减肥手术后胃癌发病率在上升吗?历史会重演吗?
Pub Date : 2023-02-28 DOI: 10.21147/j.issn.1000-9604.2023.01.02
Adriana Vaz Safatle-Ribeiro, Ulysses Ribeiro Jr
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引用次数: 0
Evolution of laparoscopic gastrectomy for cancer in the East and West. 东西方腹腔镜胃切除术治疗癌症的进展。
Pub Date : 2022-12-30 DOI: 10.21147/j.issn.1000-9604.2022.06.05
Eider Talavera-Urquijo, Bas P L Wijnhoven

Laparoscopic gastrectomy has evolved differently in Eastern and Western countries. Feasibility, safety and oncological outcomes of laparoscopic gastrectomy were addressed step-by-step by several randomized controlled trials from the East. Few phase III studies were published from the West that largely did not show a difference between the laparoscopic and open approach. Despite this, laparoscopic gastrectomy is seen as the standard for the surgical treatment of early and advanced gastric cancer in many European countries. Here, we review and comment on some important studies on laparoscopic gastrectomy for gastric cancer from Eastern and Western countries and also comment on current and future challenges.

腹腔镜胃切除术在东西方国家的发展方式不同。腹腔镜胃切除术的可行性、安全性和肿瘤学结果由几个来自东方的随机对照试验逐步解决。西方发表的一些III期研究基本上没有显示腹腔镜和开放入路之间的差异。尽管如此,在许多欧洲国家,腹腔镜胃切除术仍被视为早期和晚期胃癌手术治疗的标准。本文就东西方国家在腹腔镜胃癌切除术方面的一些重要研究进行综述和评述,并对当前和未来面临的挑战进行评述。
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引用次数: 0
Chinese quality control indices for standardized diagnosis and treatment of gastric cancer (2022 edition). 中国胃癌标准化诊疗质量控制指标(2022年版)。
Pub Date : 2022-12-30 DOI: 10.21147/j.issn.1000-9604.2022.06.10
Shen Li, Fei Shan, Xiaotian Zhang, Yongheng Li, Yu Sun, Lei Tang, Qi Wu, Wenjing Yang, Jincheng Yang, Yu An, Ming Deng, Jiafu Ji

Gastric cancer is one of the most common malignancies of the digestive system, and the number of deaths continues to increase. The standardized management of the diagnosis and treatment of gastric cancer is challenging due to the great differences in the diagnosis and treatment of gastric cancer in different regions. The Gastric Cancer Expert Committee of the National Cancer Quality Control Center (NCQCC) identified a lack of authoritative quality control standards as an opportunity to utilize its multidisciplinary membership to improve the standardized diagnosis and treatment of gastric cancer. The Gastric Cancer Expert Committee of the NCQCC aims to promote quality control and national standardization, uniformity, and normalization of gastric cancer diagnosis and treatment, which ultimately improved the survival rate and quality of life of gastric cancer patients. A panel of experts with gastrointestinal cancer surgery, gastrointestinal cancer medicine, medical imaging, pathology and radiotherapy were drawn together and determined the quality control standards for the standardized diagnosis and treatment of gastric cancer. The authors then utilized a modified Delphi approach to generate consensus recommendations.

胃癌是消化系统最常见的恶性肿瘤之一,死亡人数持续增加。由于不同地区对胃癌的诊断和治疗存在较大差异,对胃癌诊疗的规范化管理具有挑战性。国家癌症质量控制中心(NCQCC)胃癌专家委员会认为,缺乏权威的质量控制标准是利用其多学科成员资格来提高胃癌标准化诊断和治疗的机会。NCQCC胃癌专家委员会旨在促进质量控制和全国胃癌诊疗标准化、统一性、规范化,最终提高胃癌患者的生存率和生活质量。汇集胃肠肿瘤外科、胃肠肿瘤内科、医学影像学、病理学、放疗等专家,制定胃癌规范化诊疗的质量控制标准。然后,作者利用改进的德尔菲方法来产生一致的建议。
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引用次数: 0
Comments on National guidelines for diagnosis and treatment of pancreatic cancer 2022 in China (English version). 《中国胰腺癌诊疗指南2022》(英文版)评议
Pub Date : 2022-12-30 DOI: 10.21147/j.issn.1000-9604.2022.06.13
Kemin Jin, Baocai Xing
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引用次数: 1
Burden of liver cancer: From epidemiology to prevention. 肝癌的负担:从流行病学到预防。
Pub Date : 2022-12-30 DOI: 10.21147/j.issn.1000-9604.2022.06.02
Qianru Li, Maomao Cao, Lin Lei, Fan Yang, He Li, Xinxin Yan, Siyi He, Shaoli Zhang, Yi Teng, Changfa Xia, Wanqing Chen

In this review, we offer a concise overview of liver cancer epidemiology in China and worldwide from the official databases of GLOBOCAN 2020 and the National Cancer Registry in China. We also summarized the evidence for the main risk factors associated with liver cancer risk and discuss strategies implemented in China to control the liver cancer burden. Overall, liver cancer was the sixth most commonly diagnosed cancer and the third leading cause of cancer-related death worldwide in 2020. Although China contributed to nearly half of cases across the world alone, the incidence and mortality rates of liver cancer presented a declining trend owing to the persistent efforts from the governments at all levels. The current liver cancer burden in China still faces an arduous challenge due to the relatively large population base as well as the substantially low survival rate (12.1%). To better control the liver cancer burden with the lowest cost, specific measures should be conducted by reducing exposure to established risk factors such as hepatitis B infection and aflatoxin. The promotion of surveillance is also an important method to prolong the survival of liver cancer. This review will provide basic information for future direction on the control of liver cancer burden.

在这篇综述中,我们通过 GLOBOCAN 2020 和中国国家癌症登记中心的官方数据库,对中国和全球的肝癌流行病学进行了简要概述。我们还总结了与肝癌风险相关的主要风险因素的证据,并讨论了中国为控制肝癌负担而实施的策略。总体而言,肝癌是2020年全球第六大最常确诊的癌症,也是癌症相关死亡的第三大原因。虽然仅中国就占全球病例的近一半,但在各级政府的不懈努力下,肝癌的发病率和死亡率呈下降趋势。由于中国人口基数大,肝癌患者生存率低(12.1%),中国目前的肝癌负担仍然面临着艰巨的挑战。为了以最低成本更好地控制肝癌负担,应采取具体措施,减少暴露于乙肝病毒感染和黄曲霉毒素等既定风险因素。加强监测也是延长肝癌患者生存期的重要方法。本综述将为未来控制肝癌负担的方向提供基本信息。
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引用次数: 0
A multi-center, open-label, randomized, parallel-controlled phase II study comparing pharmacokinetic, pharmacodynamics and safety of ripertamab (SCT400) to rituximab (MabThera®) in patients with CD20-positive B-cell non-Hodgkin lymphoma. 一项多中心、开放标签、随机、平行对照的II期研究,比较利培他单抗(SCT400)和利妥昔单抗(MabThera®)治疗cd20阳性b细胞非霍奇金淋巴瘤患者的药代动力学、药效学和安全性。
Pub Date : 2022-12-30 DOI: 10.21147/j.issn.1000-9604.2022.06.08
Xiaohong Han, Mingzhi Zhang, Huaqing Wang, Qingyuan Zhang, Wei Li, Miaowang Hao, Yuhuan Gao, Jie Jin, Hanyun Ren, Yun Tang, Xiaonan Hong, Xiaoyan Ke, Hang Su, Lin Gui, Jianmin Luo, Liangzhi Xie, Wenlin Gai, Yuankai Shi

Objective: This multi-center, open-label, randomized, parallel-controlled phase II study aimed to compare the pharmacokinetics (PK), pharmacodynamics (PD) and safety profile of ripertamab (SCT400), a recombinant anti-CD20 monoclonal antibody, to rituximab (MabThera®) in patients with CD20-positive B-cell non-Hodgkin lymphoma (NHL).

Methods: Patients with CD20-positive B-cell NHL who achieved complete remission or unconfirmed complete remission after standard treatment were randomly assigned at a 1:1 ratio to receive a single dose of ripertamab (375 mg/m2) or rituximab (MabThera®, 375 mg/m2). PK was evaluated using area under the concentration-time curve (AUC) from time 0 to d 85 (AUC0-85 d), AUC from time 0 to week 1 (AUC0-1 w), AUC from time 0 to week 2 (AUC0-2 w), AUC from time 0 to week 3 (AUC0-3 w), AUC from time 0 to week 8 (AUC0-8 w), maximum serum concentration (Cmax), terminal half-life (T1/2), time to maximum serum concentration (Tmax) and clearance (CL). Bioequivalence was confirmed if the 90% confidence interval (90% CI) of the geometric mean ratio of ripertamab/rituximab was within the pre-defined bioequivalence range of 80.0%-125.0%. PD, immunogenicity, and safety were also evaluated.

Results: From December 30, 2014 to November 24, 2015, a total of 84 patients were randomized (ripertamab, n=42; rituximab, n=42) and the PK analysis was performed on 76 patients (ripertamab, n=38; rituximab, n=38). The geometric mean ratios of ripertamab/rituximab for AUC0-85 d, AUC0-inf, and Cmax were 96.1% (90% CI: 87.6%-105.5%), 95.9% (90% CI: 86.5%-106.4%) and 97.4% (90% CI: 91.6%-103.6%), respectively. All PK parameters met the pre-defined bioequivalence range of 80.0%-125.0%. For PD and safety evaluation, there was no statistical difference in peripheral CD19-positive B-cell counts and CD20-positive B-cell counts at each visit, and no difference in the incidence of anti-drug antibodies was observed between the two groups. The incidences of treatment-emergent adverse events and treatment-related adverse events were also comparable between the two groups.

Conclusions: In this study, the PK, PD, immunogenicity, and safety profile of ripertamab (SCT400) were similar to rituximab (MabThera®) in Chinese patients with CD20-positive B-cell NHL.

目的:这项多中心、开放标签、随机、平行对照的II期研究旨在比较重组抗cd20单克隆抗体利帕他单抗(SCT400)与利妥昔单抗(MabThera®)在cd20阳性b细胞非霍奇金淋巴瘤(NHL)患者中的药代动力学(PK)、药效学(PD)和安全性。方法:cd20阳性b细胞NHL患者在标准治疗后达到完全缓解或未证实完全缓解,按1:1的比例随机分配接受单剂量利培他抗(375 mg/m2)或利妥昔单抗(MabThera®,375 mg/m2)。采用浓度-时间曲线下面积(AUC) 0-85 d (AUC0-85 d)、0-1周(AUC0-1 w)、0-2周(AUC0-2 w)、0-3周(AUC0-3 w)、0-8周(AUC0-8 w)、最高血清浓度(Cmax)、终末半衰期(T1/2)、至最高血清浓度时间(Tmax)和清除率(CL)评估PK。如果利培他抗/利妥昔单抗几何平均比值的90%置信区间(90% CI)在预定义的80.0%-125.0%生物等效性范围内,则确认生物等效性。PD、免疫原性和安全性也进行了评估。结果:2014年12月30日至2015年11月24日,共随机纳入84例患者(利培他单抗,n=42;76例患者(利培他单抗,n=38;美罗华,n = 38)。利培他单/美罗华在AUC0-85 d、AUC0-inf和Cmax的几何平均比值分别为96.1% (90% CI: 87.6%-105.5%)、95.9% (90% CI: 86.5%-106.4%)和97.4% (90% CI: 91.6%-103.6%)。所有PK参数均满足80.0% ~ 125.0%的生物等效性范围。在PD和安全性评估方面,两组患者每次就诊时外周血cd19阳性b细胞计数和cd20阳性b细胞计数无统计学差异,两组患者抗药物抗体发生率无统计学差异。治疗后出现的不良事件和治疗相关不良事件的发生率在两组之间也具有可比性。结论:在本研究中,利培他单抗(SCT400)在中国cd20阳性b细胞NHL患者中的PK、PD、免疫原性和安全性与利妥昔单抗(MabThera®)相似。
{"title":"A multi-center, open-label, randomized, parallel-controlled phase II study comparing pharmacokinetic, pharmacodynamics and safety of ripertamab (SCT400) to rituximab (MabThera<sup>®</sup>) in patients with CD20-positive B-cell non-Hodgkin lymphoma.","authors":"Xiaohong Han,&nbsp;Mingzhi Zhang,&nbsp;Huaqing Wang,&nbsp;Qingyuan Zhang,&nbsp;Wei Li,&nbsp;Miaowang Hao,&nbsp;Yuhuan Gao,&nbsp;Jie Jin,&nbsp;Hanyun Ren,&nbsp;Yun Tang,&nbsp;Xiaonan Hong,&nbsp;Xiaoyan Ke,&nbsp;Hang Su,&nbsp;Lin Gui,&nbsp;Jianmin Luo,&nbsp;Liangzhi Xie,&nbsp;Wenlin Gai,&nbsp;Yuankai Shi","doi":"10.21147/j.issn.1000-9604.2022.06.08","DOIUrl":"https://doi.org/10.21147/j.issn.1000-9604.2022.06.08","url":null,"abstract":"<p><strong>Objective: </strong>This multi-center, open-label, randomized, parallel-controlled phase II study aimed to compare the pharmacokinetics (PK), pharmacodynamics (PD) and safety profile of ripertamab (SCT400), a recombinant anti-CD20 monoclonal antibody, to rituximab (MabThera<sup>®</sup>) in patients with CD20-positive B-cell non-Hodgkin lymphoma (NHL).</p><p><strong>Methods: </strong>Patients with CD20-positive B-cell NHL who achieved complete remission or unconfirmed complete remission after standard treatment were randomly assigned at a 1:1 ratio to receive a single dose of ripertamab (375 mg/m<sup>2</sup>) or rituximab (MabThera<sup>®</sup>, 375 mg/m<sup>2</sup>). PK was evaluated using area under the concentration-time curve (AUC) from time 0 to d 85 (AUC<sub>0-85 d</sub>), AUC from time 0 to week 1 (AUC<sub>0-1 w</sub>), AUC from time 0 to week 2 (AUC<sub>0-2 w</sub>), AUC from time 0 to week 3 (AUC<sub>0-3 w</sub>), AUC from time 0 to week 8 (AUC<sub>0-8 w</sub>), maximum serum concentration (C<sub>max</sub>), terminal half-life (T<sub>1/2</sub>), time to maximum serum concentration (T<sub>max</sub>) and clearance (CL). Bioequivalence was confirmed if the 90% confidence interval (90% CI) of the geometric mean ratio of ripertamab/rituximab was within the pre-defined bioequivalence range of 80.0%-125.0%. PD, immunogenicity, and safety were also evaluated.</p><p><strong>Results: </strong>From December 30, 2014 to November 24, 2015, a total of 84 patients were randomized (ripertamab, n=42; rituximab, n=42) and the PK analysis was performed on 76 patients (ripertamab, n=38; rituximab, n=38). The geometric mean ratios of ripertamab/rituximab for AUC<sub>0-85 d</sub>, AUC<sub>0-inf</sub>, and C<sub>max</sub> were 96.1% (90% CI: 87.6%-105.5%), 95.9% (90% CI: 86.5%-106.4%) and 97.4% (90% CI: 91.6%-103.6%), respectively. All PK parameters met the pre-defined bioequivalence range of 80.0%-125.0%. For PD and safety evaluation, there was no statistical difference in peripheral CD19-positive B-cell counts and CD20-positive B-cell counts at each visit, and no difference in the incidence of anti-drug antibodies was observed between the two groups. The incidences of treatment-emergent adverse events and treatment-related adverse events were also comparable between the two groups.</p><p><strong>Conclusions: </strong>In this study, the PK, PD, immunogenicity, and safety profile of ripertamab (SCT400) were similar to rituximab (MabThera<sup>®</sup>) in Chinese patients with CD20-positive B-cell NHL.</p>","PeriodicalId":9830,"journal":{"name":"Chinese journal of cancer research = Chung-kuo yen cheng yen chiu","volume":"34 6","pages":"601-611"},"PeriodicalIF":0.0,"publicationDate":"2022-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9829503/pdf/cjcr-34-6-601.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9137333","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: 1
Postoperative functional evaluation of gastrectomy for gastric cancer. 胃癌胃切除术后功能评价。
Pub Date : 2022-12-30 DOI: 10.21147/j.issn.1000-9604.2022.06.03
Eiji Nomura

To improve the quality of surgical procedures for gastric cancer, it is essential to consider many components comprehensively, including gastric motility, small intestinal absorption, hormones that affect gastric motility and appetite, presence or absence of vagus nerve preservation, esophageal regurgitation on endoscopic findings, in addition to whether or not there is a physiological route for food passage through the duodenum. Furthermore, proper functional evaluation cannot be performed without considering the form and amount of energy in the nutritional supplement to be loaded, and the posture at the time of investigation. The results of functional evaluation vary according to the method selected from many available options, but we believe that use of the most physiologically accurate, appropriate and selectable option will enable us to arrive at the best resection/reconstruction technique. We have reported that it is important to consider the preservation of three elements when performing gastrectomy: 1) reduction of the extent of gastrectomy, 2) preservation of the pylorus, and 3) preservation of the vagus nerve; among which preservation of the remnant stomach is the most important. Furthermore, the selection of a reconstruction method that maintains secretion of hormones beneficial to gastric motility preserves the energy balance inherent in the human body, and also provides better quality of life.

为了提高胃癌手术质量,需要综合考虑胃运动、小肠吸收、影响胃运动和食欲的激素、迷走神经保存是否存在、内镜下食管反流,以及食物通过十二指肠是否有生理途径等诸多因素。此外,如果不考虑要加载的营养补充剂中的能量形式和数量,以及调查时的姿势,就无法进行适当的功能评估。功能评估的结果因选择的方法不同而不同,但我们相信,使用生理上最准确、最合适、最可选择的方法将使我们能够达到最佳的切除/重建技术。我们已经报道过,在进行胃切除术时,重要的是要考虑保留三个因素:1)减少胃切除术的范围,2)保留幽门,3)保留迷走神经;其中,残胃的保存最为重要。此外,选择一种重建方法,维持有利于胃运动的激素分泌,保持人体固有的能量平衡,也提供了更好的生活质量。
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引用次数: 0
Adjuvant tamoxifen switched to exemestane treatment in postmenopausal women with estrogen receptor-positive early breast cancer: A pragmatic, multicenter, and prospective clinical trial in China. 绝经后雌激素受体阳性早期乳腺癌患者将他莫昔芬辅助治疗转为依西美坦治疗:中国一项实用、多中心、前瞻性临床试验
Pub Date : 2022-12-30 DOI: 10.21147/j.issn.1000-9604.2022.06.07
Binghe Xu, Huiping Li, Zefei Jiang, Lin Gu, Jinhai Tang, Hui Xie, Yueyin Pan, Yunjiang Liu, Shude Cui, Xiaojia Wang, Li Cai, Yiqiong Zhang, Huadong Zhao, Zhimin Shao

Objective: This post-approval safety study assessed the efficacy and safety of exemestane after 2-3 years of tamoxifen treatment among postmenopausal women with estrogen receptor-positive (ER+) early breast cancer in China.

Methods: Enrolled patients had received 2-3 years of tamoxifen and were then switched to exemestane for completion of 5 consecutive years of adjuvant endocrine therapy. The primary endpoint was the time from enrollment to the first occurrence of locoregional/distant recurrence of the primary breast cancer, appearance of a second primary or contralateral breast cancer, or death due to any cause. Other endpoints included the proportion of patients experiencing each event, incidence rate per annum, relationships between human epidermal growth factor receptor 2 status and time to event, and relationship between disease history variables and time to event.

Results: Overall, 558 patients were included in the full analysis set: 397 (71.1%) completed the study, 20 experienced an event, and 141 discontinued [47 owing to an adverse event (AE); 37 no longer willing to participate]. Median duration of treatment was 29.5 (range, 0.1-57.7) months. Median time to event was not reached. Event-free survival probability at 36 months was 91.4% (95% CI, 87.7%-95.1%). The event incidence over the total exposure time of exemestane therapy was 3.5 events/100 person-years (20/565). Multivariate analysis showed an association between tumor, lymph node, and metastasis stage at initial diagnosis and time to event [hazard ratio: 1.532 (95% CI, 1.129-2.080); P=0.006]. Most AEs were grade 1 or 2 in severity, with arthralgia (7.7%) being the most common treatment-related AE.

Conclusions: This study supports the efficacy and safety of exemestane in postmenopausal Chinese women with ER+ breast cancer previously treated with adjuvant tamoxifen for 2-3 years. No new safety signals were identified in the Chinese population.

目的:这项批准后的安全性研究评估了依西美坦在中国绝经后雌激素受体阳性(ER+)早期乳腺癌患者接受他莫昔芬治疗2-3年后的疗效和安全性。方法:入组患者接受2-3年的他莫昔芬治疗,然后切换到依西美坦,完成连续5年的辅助内分泌治疗。主要终点是从入组到首次发生原发性乳腺癌的局部/远处复发,出现第二原发性或对侧乳腺癌,或因任何原因死亡的时间。其他终点包括经历每种事件的患者比例、每年的发病率、人表皮生长因子受体2状态与事件发生时间之间的关系,以及病史变量与事件发生时间之间的关系。结果:总体而言,558例患者被纳入完整分析集:397例(71.1%)完成了研究,20例经历了不良事件,141例停止研究[47例由于不良事件(AE);[不再愿意参与]。治疗中位持续时间为29.5个月(范围0.1-57.7)。未达到事件发生的中位数时间。36个月无事件生存率为91.4% (95% CI, 87.7%-95.1%)。依西美坦治疗总暴露时间的事件发生率为3.5事件/100人年(20/565)。多因素分析显示,肿瘤、淋巴结和转移的初始诊断阶段与事件发生时间相关[风险比:1.532 (95% CI, 1.129-2.080);P = 0.006)。大多数AE的严重程度为1级或2级,其中关节痛(7.7%)是最常见的治疗相关AE。结论:本研究支持依西美坦治疗绝经后中国ER+乳腺癌患者2-3年辅助他莫昔芬治疗的有效性和安全性。在中国人群中没有发现新的安全信号。
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引用次数: 1
Advances in surgical techniques for gastric cancer: Indocyanine green and near-infrared fluorescence imaging. Is it ready for prime time? 胃癌手术技术的进展:吲哚菁绿和近红外荧光成像。它准备好黄金时段了吗?
Pub Date : 2022-12-30 DOI: 10.21147/j.issn.1000-9604.2022.06.06
Erica Sakamoto, Adriana Vaz Safatle-Ribeiro, Ulysses Ribeiro Jr

Surgery is still the primary curative treatment for gastric cancer, which includes resection of the tumor with adequate margins and extended lymphadenectomy. In order to improve the operative results and the quality of life of patients, several endeavors have been made toward precision medicine through image-guided surgery, allowing access to real-time intraoperative anatomy and accurate tumor staging. The goal of the surgeon is to achieve a more precise, individualized, and less invasive surgery without compromising oncological efficiency and safety. In this perspective, we have demonstrated the role of indocyanine green (ICG) and near-infrared (NIR) fluorescence imaging method in gastric cancer surgery. This technique may be used to improve localization of the tumor, detection of sentinel lymph nodes (SLN), real-time lymphatic mapping, and blood flow assessment (anastomosis perfusion).

手术仍然是胃癌的主要治疗方法,包括切除足够边缘的肿瘤和扩大淋巴结切除术。为了提高手术效果和患者的生活质量,通过图像引导手术,实现术中实时解剖和精确肿瘤分期的精准医学已经进行了一些努力。外科医生的目标是在不影响肿瘤治疗效率和安全性的前提下,实现更精确、个性化和侵入性更小的手术。从这个角度来看,我们已经证明了吲哚菁绿(ICG)和近红外(NIR)荧光成像方法在胃癌手术中的作用。该技术可用于改善肿瘤的定位、前哨淋巴结(SLN)的检测、实时淋巴作图和血流评估(吻合口灌注)。
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引用次数: 0
期刊
Chinese journal of cancer research = Chung-kuo yen cheng yen chiu
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