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A phase I study of Hemay022, an irreversible dual EGFR/HER2 tyrosine kinase inhibitor in Chinese patients with HER2-positive advanced breast cancer. Hemay022是一种不可逆的表皮生长因子受体/HER2酪氨酸激酶双重抑制剂,在中国HER2阳性晚期乳腺癌患者中的I期研究。
IF 5.1 2区 医学 Q1 ONCOLOGY Pub Date : 2024-02-29 DOI: 10.21147/j.issn.1000-9604.2024.01.05
Pin Zhang, Lin Wang, Yueying Zhen, Zhihong Wang, Hesheng Zhang, Richard Jones, Binghe Xu

Objective: Hemay022 is a novel small-molecule and an irreversible tyrosine kinase inhibitor with the target of epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor 2 (HER2), which demonstrated anti-tumor activity in preclinical studies. This first-in-human study evaluated the safety, pharmacokinetics, tolerability and preliminary anti-tumor activity of Hemay022 in HER2-positive advanced breast cancer patients.

Methods: Heavily pretreated patients with HER2-positive advanced breast cancer were assigned to eight dose cohorts in a 3+3 dose-escalation pattern at doses of 50-600 mg QD and 300 mg BID. Eligible patients were given a single dose of Hemay022 on d 1 in week 0, followed by once daily continuous doses for four weeks in 28-day cycles. Pharmacokinetic samples were obtained on d 1 and d 28. Clinical responses were assessed every eight weeks.

Results: Twenty-eight patients with advanced breast cancer were treated with Hemay022. The most frequently reported drug-related adverse events were diarrhoea (85.7%), vomiting (28.6%), nausea (25.0%) and decreased appetite (17.9%). No grade 4 drug-related adverse events were reported. At 50-600 mg doses, steady state areas under the concentration-time curve and peak concentrations increased with doses. One patient achieved complete response (CR), and three achieved partial response (PR). The objective response rate (ORR) and disease control rate (DCR) were 14.3% and 46.4% in 28 patients, respectively. The median progression-free survival (PFS) was 3.98 months.

Conclusions: Hemay022 at the dose of 500 mg once daily was well tolerated. The pharmacokinetic properties and encouraging anti-tumor activities of Hemay022 in advanced breast cancer patients warranted further evaluation of Hemay022 for treating breast cancer patients in the current phase III trial (No. NCT05122494).

目的:Hemay022是一种新型小分子、不可逆的酪氨酸激酶抑制剂,以表皮生长因子受体(EGFR)/人表皮生长因子受体2(HER2)为靶点,在临床前研究中显示出抗肿瘤活性。这项首次人体研究评估了Hemay022在HER2阳性晚期乳腺癌患者中的安全性、药代动力学、耐受性和初步抗肿瘤活性。方法:HER2阳性晚期乳腺癌重度预处理患者以3+3剂量递增模式被分配到8个剂量组群,剂量为50-600毫克QD和300毫克BID。符合条件的患者在第0周的第1天服用单剂量的Hemay022,然后以28天为一个周期,连续服用4周,每天1次。在第 1 天和第 28 天采集药代动力学样本。临床反应每八周评估一次:28名晚期乳腺癌患者接受了Hemay022治疗。最常报告的药物相关不良事件是腹泻(85.7%)、呕吐(28.6%)、恶心(25.0%)和食欲下降(17.9%)。没有四级药物相关不良事件的报告。在 50-600 毫克剂量下,稳态浓度-时间曲线下面积和峰值浓度随剂量增加而增加。一名患者获得了完全应答(CR),三名患者获得了部分应答(PR)。28名患者的客观反应率(ORR)和疾病控制率(DCR)分别为14.3%和46.4%。中位无进展生存期(PFS)为3.98个月:结论:Hemay022的耐受性良好,剂量为500毫克,每天一次。Hemay022在晚期乳腺癌患者中的药代动力学特性和令人鼓舞的抗肿瘤活性证明,在目前的III期试验(NCT05122494号)中,有必要进一步评估Hemay022治疗乳腺癌患者的效果。
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引用次数: 0
Sequential neoadjuvant chemotherapy using pegylated liposomal doxorubicin and cyclophosphamide followed by taxanes with complete trastuzumab and pertuzumab treatment for HER2-positive breast cancer: A phase II single-arm study. 针对 HER2 阳性乳腺癌,使用聚乙二醇多柔比星和环磷酰胺进行序贯新辅助化疗,然后使用紫杉类药物和曲妥珠单抗及百妥珠单抗进行完全治疗:II期单臂研究。
IF 5.1 2区 医学 Q1 ONCOLOGY Pub Date : 2024-02-29 DOI: 10.21147/j.issn.1000-9604.2024.01.06
Yaping Yang, Liang Jin, Yudong Li, Nanyan Rao, Chang Gong, Shunrong Li, Jiannan Wu, Jinghua Zhao, Linxiaoxiao Ding, Fengxia Gan, Jun Zhang, Ruifa Feng, Zhenzhen Liu, Qiang Liu

Objective: Despite cardiotoxicity overlap, the trastuzumab/pertuzumab and anthracycline combination remains crucial due to significant benefits. Pegylated liposomal doxorubicin (PLD), a less cardiotoxic anthracycline, was evaluated for efficacy and cardiac safety when combined with cyclophosphamide and followed by taxanes with trastuzumab/pertuzumab in human epidermal growth factor receptor-2 (HER2)-positive early breast cancer (BC).

Methods: In this multicenter, phase II study, patients with confirmed HER2-positive early BC received four cycles of PLD (30-35 mg/m2) and cyclophosphamide (600 mg/m2), followed by four cycles of taxanes (docetaxel, 90-100 mg/m2 or nab-paclitaxel, 260 mg/m2), concomitant with eight cycles of trastuzumab (8 mg/kg loading dose, then 6 mg/kg) and pertuzumab (840 mg loading dose, then 420 mg) every 3 weeks. The primary endpoint was total pathological complete response (tpCR, ypT0/is ypN0). Secondary endpoints included breast pCR (bpCR), objective response rate (ORR), disease control rate, rate of breast-conserving surgery (BCS), and safety (with a focus on cardiotoxicity).

Results: Between May 27, 2020 and May 11, 2022, 78 patients were treated with surgery, 42 (53.8%) of whom had BCS. After neoadjuvant therapy, 47 [60.3%, 95% confidence interval (95% CI), 48.5%-71.2%] patients achieved tpCR, and 49 (62.8%) achieved bpCR. ORRs were 76.9% (95% CI, 66.0%-85.7%) and 93.6% (95% CI, 85.7%-97.9%) after 4-cycle and 8-cycle neoadjuvant therapy, respectively. Nine (11.5%) patients experienced asymptomatic left ventricular ejection fraction (LVEF) reductions of ≥10% from baseline, all with a minimum value of >55%. No treatment-related abnormal cardiac function changes were observed in mean N-terminal pro-BNP (NT-proBNP), troponin I, or high-sensitivity troponin.

Conclusions: This dual HER2-blockade with sequential polychemotherapy showed promising activity with rapid tumor regression in HER2-positive BC. Importantly, this regimen showed an acceptable safety profile, especially a low risk of cardiac events, suggesting it as an attractive treatment approach with a favorable risk-benefit balance.

目的:尽管存在心脏毒性重叠,但曲妥珠单抗/培珠单抗和蒽环类药物的联合用药因其显著疗效而仍然至关重要。聚乙二醇脂质体多柔比星(PLD)是一种心脏毒性较低的蒽环类药物,在与环磷酰胺联合使用后,再用紫杉类药物与曲妥珠单抗/pertuzumab联合治疗人表皮生长因子受体-2(HER2)阳性早期乳腺癌(BC)时,对其疗效和心脏安全性进行了评估:在这项多中心II期研究中,确诊为HER2阳性的早期乳腺癌患者先接受4个周期的PLD(30-35毫克/平方米)和环磷酰胺(600毫克/平方米)治疗,然后接受4个周期的紫杉类药物治疗(多西他赛,90-100毫克/平方米或纳布紫杉醇,260毫克/平方米),同时每3周接受8个周期的曲妥珠单抗治疗(8毫克/公斤负荷剂量,然后6毫克/公斤)和百妥珠单抗治疗(840毫克负荷剂量,然后420毫克)。主要终点是总病理完全应答(tpCR,ypT0/is ypN0)。次要终点包括乳腺病理完全反应(bpCR)、客观反应率(ORR)、疾病控制率、保乳手术率(BCS)和安全性(重点关注心脏毒性):2020年5月27日至2022年5月11日期间,78名患者接受了手术治疗,其中42人(53.8%)接受了保乳手术。新辅助治疗后,47 名患者[60.3%,95% 置信区间(95% CI),48.5%-71.2%]获得了 tpCR,49 名患者(62.8%)获得了 bpCR。经过4个周期和8个周期的新辅助治疗后,ORR分别为76.9%(95% CI,66.0%-85.7%)和93.6%(95% CI,85.7%-97.9%)。9例(11.5%)患者的无症状左心室射血分数(LVEF)较基线下降≥10%,最低值均>55%。平均N-末端前BNP(NT-proBNP)、肌钙蛋白I或高敏肌钙蛋白均未观察到与治疗相关的心功能异常变化:这种HER2双阻断联合序贯多化疗方案在HER2阳性的BC中显示出良好的活性,肿瘤可迅速消退。重要的是,该方案具有可接受的安全性,尤其是发生心脏事件的风险较低,这表明它是一种具有吸引力的治疗方法,具有良好的风险-效益平衡。
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引用次数: 0
Clinicopathological significance and immunotherapeutic outcome of claudin 18.2 expression in advanced gastric cancer: A retrospective study. 晚期胃癌中Claudin 18.2表达的临床病理意义和免疫治疗结果:一项回顾性研究。
IF 5.1 2区 医学 Q1 ONCOLOGY Pub Date : 2024-02-29 DOI: 10.21147/j.issn.1000-9604.2024.01.08
Changsong Qi, Xiaoyi Chong, Ting Zhou, Mingyang Ma, Jifang Gong, Miao Zhang, Jian Li, Jun Xiao, Xiaohui Peng, Zhen Liu, Zonghai Li, Lin Shen, Xiaotian Zhang

Objective: Immunotherapeutic outcomes and clinical characteristics of claudin 18 isoform 2 positive (CLDN18.2-positive) gastric cancer (GC) vary in different clinical studies, making it difficult to optimize anti-CLDN18.2 therapy. We conducted a retrospective analysis to explore the association of CLDN18.2 expression with clinicopathological characteristics and immunotherapeutic outcomes in GC.

Methods: A total of 536 advanced GC patients from 2019 to 2021 in the CT041-CG4006 and CT041-ST-01 clinical trials were included in the analysis. CLDN18.2 expression on ≥40% of tumor cells (2+, 40%) and CLDN18.2 expression on ≥70% of tumor cells (2+, 70%) were considered the two levels of positively expressed GC. The clinicopathological characteristics and immunotherapy outcomes of GC patients were analyzed according to CLDN18.2 expression status.

Results: CLDN18.2 was expressed in 57.6% (cut-off: 2+, 40%) and 48.9% (cut-off: 2+, 70%) of patients. Programmed death-ligand 1 (PD-L1) and CLDN18.2 were co-expressed in 19.8% [combined positive score (CPS)≥1, CLDN18.2 (cut-off: 2+, 40%)] and 17.2% [CPS≥5, CLDN18.2 (cut-off: 2+, 70%)] of patients. CLDN18.2 expression positively correlated with younger age, female sex, non-gastroesophageal junction (non-GEJ), and diffuse phenotype (P<0.001). HER2 and PD-L1 expression were significantly lower in CLDN18.2-positive GC (both P<0.05). Uterine adnexa metastasis (P<0.001) was more frequent and liver metastasis (P<0.001) was less common in CLDN18.2-positive GC. Overall survival and immunotherapy-related progression-free survival (irPFS) were inferior in the CLDN18.2-positive group.

Conclusions: CLDN18.2-positive GC is associated with poor prognosis and worse immunotherapeutic outcomes. The combination of anti-CLDN18.2 therapy, anti-PD-L1/PD-1 therapy, and chemotherapy for GC requires further investigation.

目的在不同的临床研究中,克劳丁18同工酶2阳性(CLDN18.2阳性)胃癌(GC)的免疫治疗结果和临床特征各不相同,因此很难优化抗CLDN18.2治疗。我们进行了一项回顾性分析,探讨CLDN18.2表达与GC临床病理特征和免疫治疗结果的关系:分析纳入了2019年至2021年参加CT041-CG4006和CT041-ST-01临床试验的536例晚期GC患者。CLDN18.2表达≥40%的肿瘤细胞(2+,40%)和CLDN18.2表达≥70%的肿瘤细胞(2+,70%)被认为是GC阳性表达的两个水平。根据CLDN18.2的表达情况分析了GC患者的临床病理特征和免疫治疗结果:57.6%(临界值:2+,40%)和48.9%(临界值:2+,70%)的患者表达CLDN18.2。19.8%的患者[合并阳性评分(CPS)≥1,CLDN18.2(截止值:2+,40%)]和17.2%的患者[CPS≥5,CLDN18.2(截止值:2+,70%)]中程序性死亡配体1(PD-L1)和CLDN18.2共同表达。CLDN18.2的表达与年轻、女性、非胃食管交界处(non-GEJ)和弥漫表型呈正相关(P0.05)。子宫附件转移(PConclusions:CLDN18.2阳性GC与预后不良和免疫治疗效果较差有关。抗CLDN18.2疗法、抗PD-L1/PD-1疗法和化疗联合治疗GC需要进一步研究。
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引用次数: 0
Genomic characterization of peritoneal lavage cytology-positive gastric cancer. 腹腔灌洗细胞学阳性胃癌的基因组特征。
IF 5.1 2区 医学 Q1 ONCOLOGY Pub Date : 2024-02-29 DOI: 10.21147/j.issn.1000-9604.2024.01.07
Zhouqiao Wu, Tingfei Gu, Changxian Xiong, Jinyao Shi, Jingpu Wang, Ting Guo, Xiaofang Xing, Fei Pang, Ning He, Rulin Miao, Fei Shan, Yuan Zhou, Ziyu Li, Jiafu Ji

Objective: Positive peritoneal lavege cytology (CY1) gastric cancer is featured by dismal prognosis, with high risks of peritoneal metastasis. However, there is a lack of evidence on pathogenic mechanism and signature of CY1 and there is a continuous debate on CY1 therapy. Therefore, exploring the mechanism of CY1 is crucial for treatment strategies and targets for CY1 gastric cancer.

Methods: In order to figure out specific driver genes and marker genes of CY1 gastric cancer, and ultimately offer clues for potential marker and risk assessment of CY1, 17 cytology-positive gastric cancer patients and 31 matched cytology-negative gastric cancer patients were enrolled in this study. The enrollment criteria were based on the results of diagnostic laparoscopy staging and cytology inspection of exfoliated cells. Whole exome sequencing was then performed on tumor samples to evaluate genomic characterization of cytology-positive gastric cancer.

Results: Least absolute shrinkage and selection operator (LASSO) algorithm identified 43 cytology-positive marker genes, while MutSigCV identified 42 cytology-positive specific driver genes. CD3G and CDKL2 were both driver and marker genes of CY1. Regarding mutational signatures, driver gene mutation and tumor subclone architecture, no significant differences were observed between CY1 and negative peritoneal lavege cytology (CY0).

Conclusions: There might not be distinct differences between CY1 and CY0, and CY1 might represent the progression of CY0 gastric cancer rather than constituting an independent subtype. This genomic analysis will thus provide key molecular insights into CY1, which may have a direct effect on treatment recommendations for CY1 and CY0 patients, and provides opportunities for genome-guided clinical trials and drug development.

目的腹腔淋巴结细胞学(CY1)阳性胃癌预后不良,腹膜转移风险高。然而,关于 CY1 的致病机制和特征尚缺乏证据,关于 CY1 的治疗也一直存在争议。因此,探索CY1的发病机制对于CY1胃癌的治疗策略和靶点至关重要:为了找出 CY1 胃癌的特异性驱动基因和标记基因,并最终为 CY1 的潜在标记和风险评估提供线索,本研究招募了 17 例细胞学阳性胃癌患者和 31 例匹配的细胞学阴性胃癌患者。入组标准基于腹腔镜诊断分期和脱落细胞的细胞学检查结果。然后对肿瘤样本进行全外显子组测序,以评估细胞学阳性胃癌的基因组特征:结果:最小绝对收缩和选择算子(LASSO)算法确定了43个细胞学阳性标记基因,而MutSigCV确定了42个细胞学阳性特异性驱动基因。CD3G和CDKL2既是CY1的驱动基因,也是标记基因。在突变特征、驱动基因突变和肿瘤亚克隆结构方面,CY1与腹腔淋巴结细胞学阴性(CY0)之间未发现明显差异:结论:CY1和CY0之间可能没有明显差异,CY1可能代表CY0胃癌的进展,而不是构成一个独立的亚型。因此,该基因组分析将提供有关 CY1 的关键分子信息,这可能会直接影响对 CY1 和 CY0 患者的治疗建议,并为基因组指导的临床试验和药物开发提供机会。
{"title":"Genomic characterization of peritoneal lavage cytology-positive gastric cancer.","authors":"Zhouqiao Wu, Tingfei Gu, Changxian Xiong, Jinyao Shi, Jingpu Wang, Ting Guo, Xiaofang Xing, Fei Pang, Ning He, Rulin Miao, Fei Shan, Yuan Zhou, Ziyu Li, Jiafu Ji","doi":"10.21147/j.issn.1000-9604.2024.01.07","DOIUrl":"10.21147/j.issn.1000-9604.2024.01.07","url":null,"abstract":"<p><strong>Objective: </strong>Positive peritoneal lavege cytology (CY1) gastric cancer is featured by dismal prognosis, with high risks of peritoneal metastasis. However, there is a lack of evidence on pathogenic mechanism and signature of CY1 and there is a continuous debate on CY1 therapy. Therefore, exploring the mechanism of CY1 is crucial for treatment strategies and targets for CY1 gastric cancer.</p><p><strong>Methods: </strong>In order to figure out specific driver genes and marker genes of CY1 gastric cancer, and ultimately offer clues for potential marker and risk assessment of CY1, 17 cytology-positive gastric cancer patients and 31 matched cytology-negative gastric cancer patients were enrolled in this study. The enrollment criteria were based on the results of diagnostic laparoscopy staging and cytology inspection of exfoliated cells. Whole exome sequencing was then performed on tumor samples to evaluate genomic characterization of cytology-positive gastric cancer.</p><p><strong>Results: </strong>Least absolute shrinkage and selection operator (LASSO) algorithm identified 43 cytology-positive marker genes, while MutSigCV identified 42 cytology-positive specific driver genes. <i>CD3G</i> and <i>CDKL2</i> were both driver and marker genes of CY1. Regarding mutational signatures, driver gene mutation and tumor subclone architecture, no significant differences were observed between CY1 and negative peritoneal lavege cytology (CY0).</p><p><strong>Conclusions: </strong>There might not be distinct differences between CY1 and CY0, and CY1 might represent the progression of CY0 gastric cancer rather than constituting an independent subtype. This genomic analysis will thus provide key molecular insights into CY1, which may have a direct effect on treatment recommendations for CY1 and CY0 patients, and provides opportunities for genome-guided clinical trials and drug development.</p>","PeriodicalId":9882,"journal":{"name":"Chinese Journal of Cancer Research","volume":"36 1","pages":"66-77"},"PeriodicalIF":5.1,"publicationDate":"2024-02-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10915641/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140058775","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Molecular features of gastroenteropancreatic neuroendocrine carcinoma: A comparative analysis with lung neuroendocrine carcinoma and digestive adenocarcinomas. 胃肠胰神经内分泌癌的分子特征:与肺神经内分泌癌和消化道腺癌的比较分析。
IF 5.1 2区 医学 Q1 ONCOLOGY Pub Date : 2024-02-29 DOI: 10.21147/j.issn.1000-9604.2024.01.09
Jianwei Zhang, Hanxiao Chen, Junli Zhang, Sha Wang, Yanfang Guan, Wenguang Gu, Jie Li, Xiaotian Zhang, Jian Li, Xicheng Wang, Zhihao Lu, Jun Zhou, Zhi Peng, Yu Sun, Yang Shao, Lin Shen, Minglei Zhuo, Ming Lu

Objective: There is an ongoing debate about whether the management of gastroenteropancreatic (GEP) neuroendocrine carcinoma (NEC) should follow the guidelines of small-cell lung cancer (SCLC). We aim to identify the genetic differences of GEPNEC and its counterpart.

Methods: We recruited GEPNEC patients as the main cohort, with lung NEC and digestive adenocarcinomas as comparative cohorts. All patients undergone next-generation sequencing (NGS). Different gene alterations were compared and analyzed between GEPNEC and lung NEC (LNEC), GEPNEC and adenocarcinoma to yield the remarkable genes.

Results: We recruited 257 patients, including 99 GEPNEC, 57 LNEC, and 101 digestive adenocarcinomas. Among the mutations, KRAS, RB1, TERT, IL7R, and CTNNB1 were found to have different gene alterations between GEPNEC and LNEC samples. Specific genes for each site were revealed: gastric NEC ( TERT amplification), colorectal NEC ( KRAS mutation), and bile tract NEC ( ARID1A mutation). The gene disparities between small-cell NEC (SCNEC) and large-cell NEC (LCNEC) were KEAP1 and CDH1. Digestive adenocarcinoma was also compared with GEPNEC and suggested RB1, APC, and KRAS as significant genes. The TP53/ RB1 mutation pattern was associated with first-line effectiveness. Putative targetable genes and biomarkers in GEPNEC were identified in 22.2% of the patients, and they had longer progression-free survival (PFS) upon targetable treatment [12.5 months vs. 3.0 months, HR=0.40 (0.21-0.75), P=0.006].

Conclusions: This work demonstrated striking gene distinctions in GEPNEC compared with LNEC and adenocarcinoma and their clinical utility.

目的:关于胃肠胰腺(GEP)神经内分泌癌(NEC)的治疗是否应遵循小细胞肺癌(SCLC)的指南,一直存在争议。我们的目的是确定 GEPNEC 与其对应癌的遗传差异:我们招募了 GEPNEC 患者作为主要队列,肺部 NEC 和消化道腺癌作为对比队列。所有患者均接受了新一代测序(NGS)。比较分析了GEPNEC与肺NEC(LNEC)、GEPNEC与腺癌之间不同的基因改变,从而得出了显著的基因:我们共招募了 257 例患者,其中包括 99 例 GEPNEC、57 例 LNEC 和 101 例消化道腺癌。在基因突变中,发现 KRAS、RB1、TERT、IL7R 和 CTNNB1 在 GEPNEC 和 LNEC 样本中具有不同的基因改变。每个部位的特定基因也得到了揭示:胃网状细胞癌(TERT扩增)、结直肠网状细胞癌(KRAS突变)和胆道网状细胞癌(ARID1A突变)。小细胞 NEC(SCNEC)和大细胞 NEC(LCNEC)之间的基因差异是 KEAP1 和 CDH1。消化道腺癌也与 GEPNEC 进行了比较,结果表明 RB1、APC 和 KRAS 是重要的基因。TP53/RB1突变模式与一线疗效相关。在22.2%的患者中发现了GEPNEC的可能靶向基因和生物标志物,这些患者在接受靶向治疗后无进展生存期(PFS)更长[12.5个月 vs. 3.0个月,HR=0.40 (0.21-0.75),P=0.006]:这项研究表明,与LNEC和腺癌相比,GEPNEC的基因有显著的差异,而且这些差异在临床上很有用。
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引用次数: 0
Microbiota in colorectal cancer related to liver metastasis. 结直肠癌中与肝转移有关的微生物群。
IF 5.1 2区 医学 Q1 ONCOLOGY Pub Date : 2024-02-29 DOI: 10.21147/j.issn.1000-9604.2024.01.02
Peijun Wei, Weiming Han, Zitong Zhang, Xue Tian, Chen Yang, Qiaoxuan Wang, Weihao Xie, Ying Liu, Yuanhong Gao, Hui Chang

The prevalence of colorectal cancer (CRC) is increasing annually and metastasis is the principal cause of death in patients with CRC, with the liver being the most frequently affected site. Many studies have shown a strong interplay between the gut flora, particularly Fusobacterium nucleatum (F. nucleatum), Escherichia coli, and Bacteroides fragilis, and the development of gut tumors. Some strains can induce gut inflammation and produce toxins that directly harm gut epithelial cells, ultimately accelerating the onset and progression of CRC. However, little clinical evidence exists on the specific interplay between the gut microflora and colorectal cancer liver metastasis (CRLM). Some research showed the existence of viable F. nucleatum in distant metastasis of CRC. Subsequently, gut microbiota products, such as lipopolysaccharides, sodium butyrate, and protein cathepsin K, were also found to affect the development of CRC. This article summarizes the mechanism and research status of the interplay between gut microflora and CRLM, discusses the importance of gut microflora in the treatment of CRLM, and proposes a new approach to understanding the mechanism of CRLM and potential treatments for the microbiome. It is anticipated that the gut microbiota will be a formidable therapeutic and prophylactic tool for treating and preventing CRLM.

结肠直肠癌(CRC)的发病率逐年上升,转移是 CRC 患者死亡的主要原因,而肝脏是最常受影响的部位。许多研究表明,肠道菌群,尤其是核酸镰刀菌(F. nucleatum)、大肠杆菌和脆弱拟杆菌与肠道肿瘤的发生之间存在着密切的相互作用。某些菌株可诱发肠道炎症并产生毒素,直接伤害肠道上皮细胞,最终加速 CRC 的发生和发展。然而,关于肠道微生物菌群与结直肠癌肝转移(CRLM)之间具体相互作用的临床证据却很少。一些研究表明,在 CRC 的远处转移中存在有活力的 F. nucleatum。随后,人们又发现肠道微生物群产物,如脂多糖、丁酸钠和蛋白螯合酶K,也会影响 CRC 的发展。本文总结了肠道微生物群与 CRLM 相互作用的机制和研究现状,讨论了肠道微生物群在治疗 CRLM 中的重要性,并提出了一种理解 CRLM 机制和微生物群潜在治疗方法的新方法。预计肠道微生物群将成为治疗和预防 CRLM 的强大治疗和预防工具。
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引用次数: 0
Pattern of Neuroinflammatory miRNAs, C-reactive Protein and Alanine Aminotransferase in Hospitalization In Recovered or Not-recovered COVID-19 Patients. COVID-19康复或未康复患者住院期间神经炎症miRNA、C反应蛋白和丙氨酸氨基转移酶的模式
2区 医学 Q1 ONCOLOGY Pub Date : 2024-01-01 DOI: 10.32598/bcn.2022.3342.1
Reza Keikha, Seyed Mohammad Hashemi-Shahri, Ali Jebali

Introduction: Our aim was to investigate the expression of miRNAs, C-reactive protein as a blood inflammation marker, and alanine aminotransferase as a tissue inflammation marker, in recovered and not-recovered COVID-19 patients.

Methods: This cross-sectional project was conducted at three medical centers in Iran from December to March 2021. In total, 20 confirmed cases of COVID-19 with grade III severity and 20 healthy subjects were enrolled in the study. Subsequently, the neuroinflammatory expression of miRNAs (miR-199, miR-203, and miR-181), C-reactive protein, and alanine aminotransferase was investigated during hospitalization from week 0 to week 2.

Results: Among COVID-19 subjects who did not recover, the expression levels of miR-199, miR-203, and miR-181 were decreased, while the levels of C-reactive protein and alanine aminotransferase increased during hospitalization. Conversely, in recovered COVID-19 subjects, the relative expression of miR-199, miR-203, and miR-181 increased and the levels of C-reactive protein and alanine aminotransferase decreased during hospitalization.

Conclusion: The expression pattern of neuroinflammatory miRNAs depends on whether the COVID-19 patient is recovering or deteriorating. Their expression is downregulated in COVID-19 patients who do not recover and upregulated in those who do recover.

简介我们的目的是研究COVID-19康复者和未康复者体内的miRNAs、作为血液炎症标志物的C反应蛋白和作为组织炎症标志物的丙氨酸氨基转移酶的表达情况:该横断面项目于 2021 年 12 月至 3 月在伊朗的三个医疗中心进行。共有 20 名确诊的 COVID-19 病例(严重程度为 III 级)和 20 名健康受试者参与了研究。随后,研究人员对住院期间第 0 周至第 2 周的 miRNA(miR-199、miR-203 和 miR-181)、C 反应蛋白和丙氨酸氨基转移酶的神经炎症表达进行了调查:结果:在未康复的 COVID-19 受试者中,住院期间 miR-199、miR-203 和 miR-181 的表达水平下降,而 C 反应蛋白和丙氨酸氨基转移酶的水平上升。相反,COVID-19康复者在住院期间,miR-199、miR-203和miR-181的相对表达量增加,C反应蛋白和丙氨酸氨基转移酶的水平下降:结论:神经炎症 miRNA 的表达模式取决于 COVID-19 患者的病情是在恢复还是在恶化。结论:神经炎症 miRNAs 的表达模式取决于 COVID-19 患者的病情是恢复还是恶化,未恢复的 COVID-19 患者的 miRNAs 表达下调,而恢复的患者的 miRNAs 表达上调。
{"title":"Pattern of Neuroinflammatory miRNAs, C-reactive Protein and Alanine Aminotransferase in Hospitalization In Recovered or Not-recovered COVID-19 Patients.","authors":"Reza Keikha, Seyed Mohammad Hashemi-Shahri, Ali Jebali","doi":"10.32598/bcn.2022.3342.1","DOIUrl":"10.32598/bcn.2022.3342.1","url":null,"abstract":"<p><strong>Introduction: </strong>Our aim was to investigate the expression of miRNAs, C-reactive protein as a blood inflammation marker, and alanine aminotransferase as a tissue inflammation marker, in recovered and not-recovered COVID-19 patients.</p><p><strong>Methods: </strong>This cross-sectional project was conducted at three medical centers in Iran from December to March 2021. In total, 20 confirmed cases of COVID-19 with grade III severity and 20 healthy subjects were enrolled in the study. Subsequently, the neuroinflammatory expression of miRNAs (miR-199, miR-203, and miR-181), C-reactive protein, and alanine aminotransferase was investigated during hospitalization from week 0 to week 2.</p><p><strong>Results: </strong>Among COVID-19 subjects who did not recover, the expression levels of miR-199, miR-203, and miR-181 were decreased, while the levels of C-reactive protein and alanine aminotransferase increased during hospitalization. Conversely, in recovered COVID-19 subjects, the relative expression of miR-199, miR-203, and miR-181 increased and the levels of C-reactive protein and alanine aminotransferase decreased during hospitalization.</p><p><strong>Conclusion: </strong>The expression pattern of neuroinflammatory miRNAs depends on whether the COVID-19 patient is recovering or deteriorating. Their expression is downregulated in COVID-19 patients who do not recover and upregulated in those who do recover.</p>","PeriodicalId":9882,"journal":{"name":"Chinese Journal of Cancer Research","volume":"10 1","pages":"73-80"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11403103/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73551531","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Lung cancer burden and trends from 2000 to 2018 in China: Comparison between China and the United States. 2000-2018年中国肺癌负担和趋势:中美比较。
IF 7 2区 医学 Q1 ONCOLOGY Pub Date : 2023-12-30 DOI: 10.21147/j.issn.1000-9604.2023.06.06
Yi Teng, Changfa Xia, Maomao Cao, Fan Yang, Xinxin Yan, Siyi He, Mengdi Cao, Shaoli Zhang, Qianru Li, Nuopei Tan, Jiachen Wang, Wanqing Chen

Objective: This study aims to provide an analysis of the current status and trends of lung cancer incidence and mortality rates in China, comparing trends with those in the United States (U.S.).

Methods: Data on lung cancer incidence and mortality rates spanning 2000 to 2018 were extracted from the China Cancer Registry Annual Report and the Surveillance, Epidemiology, and End Results database for China and the U.S., respectively. Crude incidence and mortality rates were calculated by sex and age, with age-standardized incidence rates (ASIR) and mortality rates (ASMR) calculated using the Segi-Doll world standard population. Trend analyses employed Joinpoint regression models to determine average annual percentage change (AAPC). The study also assessed the proportion of new cases and deaths by sex and age.

Results: In 2018, the ASIR of lung cancer for males in China was 50.72 per 100,000 and the ASMR was 39.69 per 100,000, the ASIR for females was 26.25 per 100,000 and the ASMR was 15.24 per 100,000. Both ASIR and ASMR were higher in males and the highest in the population aged 65 years and older, with the lowest among those aged 20-49 years. In China, female ASIR demonstrated an increasing trend (AAPC: 1.16%), while ASMR decreased in both sexes (AAPCs: -0.48% for males, -1.00% for females). The U.S. exhibited decreasing trends in both ASIR and ASMR across sexes and age groups.

Conclusions: The study identified an increasing trend in lung cancer incidence among females and a decreasing mortality trend in both sexes in China. These trends are likely linked to factors such as smoking prevalence, advancements in cancer screening, and improved medical care. The findings underscore the need for tailored lung cancer prevention measures in China, particularly the reinforcement of anti-smoking policies.

目的:本研究旨在分析中国肺癌发病率和死亡率的现状和趋势,并与美国进行比较:本研究旨在分析中国肺癌发病率和死亡率的现状和趋势,并与美国的趋势进行比较:2000年至2018年的肺癌发病率和死亡率数据分别摘自《中国肿瘤登记年报》以及中国和美国的监测、流行病学和最终结果数据库。粗发病率和死亡率按性别和年龄计算,年龄标准化发病率(ASIR)和死亡率(ASMR)采用Segi-Doll世界标准人群计算。趋势分析采用 Joinpoint 回归模型来确定年平均百分比变化 (AAPC)。研究还按性别和年龄评估了新病例和死亡病例的比例:2018年,中国男性肺癌的ASIR为50.72/10万,ASMR为39.69/10万;女性的ASIR为26.25/10万,ASMR为15.24/10万。男性的 ASIR 和 ASMR 均较高,在 65 岁及以上人群中最高,在 20-49 岁人群中最低。在中国,女性的 ASIR 呈上升趋势(AAPC:1.16%),而男女的 ASMR 均呈下降趋势(AAPCs:男性-0.48%,女性-1.00%)。美国不同性别和年龄组的 ASIR 和 ASMR 均呈下降趋势:研究发现,中国女性肺癌发病率呈上升趋势,而男女死亡率均呈下降趋势。这些趋势可能与吸烟率、癌症筛查的进步和医疗水平的提高等因素有关。研究结果表明,中国有必要采取有针对性的肺癌预防措施,特别是加强禁烟政策。
{"title":"Lung cancer burden and trends from 2000 to 2018 in China: Comparison between China and the United States.","authors":"Yi Teng, Changfa Xia, Maomao Cao, Fan Yang, Xinxin Yan, Siyi He, Mengdi Cao, Shaoli Zhang, Qianru Li, Nuopei Tan, Jiachen Wang, Wanqing Chen","doi":"10.21147/j.issn.1000-9604.2023.06.06","DOIUrl":"10.21147/j.issn.1000-9604.2023.06.06","url":null,"abstract":"<p><strong>Objective: </strong>This study aims to provide an analysis of the current status and trends of lung cancer incidence and mortality rates in China, comparing trends with those in the United States (U.S.).</p><p><strong>Methods: </strong>Data on lung cancer incidence and mortality rates spanning 2000 to 2018 were extracted from the China Cancer Registry Annual Report and the Surveillance, Epidemiology, and End Results database for China and the U.S., respectively. Crude incidence and mortality rates were calculated by sex and age, with age-standardized incidence rates (ASIR) and mortality rates (ASMR) calculated using the Segi-Doll world standard population. Trend analyses employed Joinpoint regression models to determine average annual percentage change (AAPC). The study also assessed the proportion of new cases and deaths by sex and age.</p><p><strong>Results: </strong>In 2018, the ASIR of lung cancer for males in China was 50.72 per 100,000 and the ASMR was 39.69 per 100,000, the ASIR for females was 26.25 per 100,000 and the ASMR was 15.24 per 100,000. Both ASIR and ASMR were higher in males and the highest in the population aged 65 years and older, with the lowest among those aged 20-49 years. In China, female ASIR demonstrated an increasing trend (AAPC: 1.16%), while ASMR decreased in both sexes (AAPCs: -0.48% for males, -1.00% for females). The U.S. exhibited decreasing trends in both ASIR and ASMR across sexes and age groups.</p><p><strong>Conclusions: </strong>The study identified an increasing trend in lung cancer incidence among females and a decreasing mortality trend in both sexes in China. These trends are likely linked to factors such as smoking prevalence, advancements in cancer screening, and improved medical care. The findings underscore the need for tailored lung cancer prevention measures in China, particularly the reinforcement of anti-smoking policies.</p>","PeriodicalId":9882,"journal":{"name":"Chinese Journal of Cancer Research","volume":"35 6","pages":"618-626"},"PeriodicalIF":7.0,"publicationDate":"2023-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10774141/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139418742","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Estimation of economic burden throughout course of cervical squamous intraepithelial lesion and cervical cancer in China: A nationwide multicenter cross-sectional study. 中国宫颈鳞状上皮内病变和宫颈癌病程中的经济负担估算:全国多中心横断面研究。
IF 7 2区 医学 Q1 ONCOLOGY Pub Date : 2023-12-30 DOI: 10.21147/j.issn.1000-9604.2023.06.11
Hao Chen, Xuelian Zhao, Shangying Hu, Tingting You, Changfa Xia, Meng Gao, Mingjie Dong, Youlin Qiao, Fanghui Zhao

Objective: Cervical squamous intraepithelial lesion (SIL) and cervical cancer are major threats to females' health and life in China, and we aimed to estimate the economic burden associated with their diagnosis and treatment.

Methods: A nationwide multicenter, cross-sectional, hospital-based survey was conducted in 26 qualified hospitals across seven administrative regions of China. We investigated females who had been pathologically diagnosed with SIL and cervical cancer, and included five disease courses ("diagnosis", "initial treatment", "chemoradiotherapy", "follow-up" and "recurrence/progression/metastasis") to estimate the total costs. The median and interquartile range (IQR) of total costs (including direct medical, direct non-medical, and indirect costs), reimbursement rate by medical insurance, and catastrophic health expenditures in every clinical stage were calculated.

Results: A total of 3,471 patients in different clinical stages were analyzed, including low-grade SIL (LSIL) (n=549), high-grade SIL (HSIL) (n=803), cervical cancer stage IA (n=226), IB (n=610), IIA (n=487), IIB (n=282), III (n=452) and IV (n=62). In urban areas, the estimated total costs of LSIL and HSIL were [Formula: see text]1,637.7 (IQR: [Formula: see text]956.4-[Formula: see text]2,669.2) and [Formula: see text]2,467.1 (IQR: [Formula: see text]1,579.1-[Formula: see text]3,762.3), while in rural areas the costs were [Formula: see text]459.0 (IQR: [Formula: see text]167.7-[Formula: see text]1,330.3) and [Formula: see text]1,230.5 (IQR: [Formula: see text]560.6-[Formula: see text]2,104.5), respectively. For patients with cervical cancer stage IA, IB, IIA, IIB, and III-IV, the total costs were [Formula: see text]15,034.9 (IQR: [Formula: see text]11,083.4-[Formula: see text]21,632.4), [Formula: see text]19,438.6 (IQR: [Formula: see text]14,060.0-[Formula: see text]26,505.9), [Formula: see text]22,968.8 (IQR: [Formula: see text]16,068.8-[Formula: see text]34,615.9), [Formula: see text]26,936.0 (IQR: [Formula: see text]18,176.6-[Formula: see text]41,386.0) and [Formula: see text]27,332.6 (IQR: [Formula: see text]17,538.7-[Formula: see text]44,897.0), respectively. Medical insurance covered 43%-55% of direct medical costs for cervical cancer patients, while the coverage for SIL patients was 19%-43%. For most cervical cancer patients, the expense was catastrophic, and the extent of catastrophic health expenditure was about twice large for rural patients than that for urban patients in each stage.

Conclusions: The economic burden of SIL and cervical cancer in China is substantial, with a significant proportion of the costs being avoidable for patients with LSIL. Even for those with medical insurance, catastrophic health expenditures are also a major concern for patients with cervical cancer, particularly for those living in rural areas.

目的:宫颈鳞状上皮内病变(SIL)和宫颈癌是中国女性健康和生活的主要威胁,我们旨在估算与诊断和治疗相关的经济负担:我们在中国 7 个行政区域的 26 家有资质的医院开展了一项全国性的多中心、横断面、医院调查。我们对病理诊断为 SIL 和宫颈癌的女性进行了调查,包括五个病程("诊断"、"初始治疗"、"化放疗"、"随访 "和 "复发/进展/转移"),以估算总费用。计算了每个临床阶段总费用(包括直接医疗费用、直接非医疗费用和间接费用)的中位数和四分位距(IQR)、医疗保险报销比例以及灾难性医疗支出:共分析了 3471 名不同临床分期的患者,包括低分期 SIL(LSIL)(549 人)、高分期 SIL(HSIL)(803 人)、宫颈癌 IA 期(226 人)、IB 期(610 人)、IIA 期(487 人)、IIB 期(282 人)、III 期(452 人)和 IV 期(62 人)。在城市地区,LSIL 和 HSIL 的估计总费用分别为[计算公式:见正文]1,637.7(IQR:[计算公式:见正文]956.4-[计算公式:见正文]2,669.2)和[计算公式:见正文]2,467.1(IQR:[计算公式:见正文]1,579.1-[计算公式:见正文]3,762.3)。3),而农村地区的费用分别为[公式:见正文]459.0(IQR:[公式:见正文]167.7-[公式:见正文]1,330.3)和[公式:见正文]1,230.5(IQR:[公式:见正文]560.6-[公式:见正文]2,104.5)。宫颈癌IA、IB、IIA、IIB和III-IV期患者的总费用分别为[公式:见正文]15,034.9(IQR:[公式:见正文]11,083.4-[公式:见正文]21,632.4)、[公式:见正文]19,438.6(IQR:[公式:见正文]14,060.0-[公式:见正文]26,505.9)、[公式:见正文]22,968.8(IQR:[公式:见正文]16,068.8-[公式:见正文]34,615.9)、[公式:见正文]26,936.0(IQR:[公式:见正文]18,176.6-[公式:见正文]41,386.0)和[公式:见正文]27,332.6(IQR:[公式:见正文]17,538.7-[公式:见正文]44,897.0)。宫颈癌患者的直接医疗费用有 43%-55% 由医疗保险支付,而 SIL 患者的直接医疗费用有 19%-43% 由医疗保险支付。对于大多数宫颈癌患者来说,医疗费用是灾难性的,在每个阶段,农村患者的灾难性医疗支出约为城市患者的两倍:结论:在中国,SIL 和宫颈癌造成了巨大的经济负担,其中 LSIL 患者的大部分费用是可以避免的。即使是那些有医疗保险的宫颈癌患者,灾难性医疗支出也是一个主要问题,尤其是那些生活在农村地区的宫颈癌患者。
{"title":"Estimation of economic burden throughout course of cervical squamous intraepithelial lesion and cervical cancer in China: A nationwide multicenter cross-sectional study.","authors":"Hao Chen, Xuelian Zhao, Shangying Hu, Tingting You, Changfa Xia, Meng Gao, Mingjie Dong, Youlin Qiao, Fanghui Zhao","doi":"10.21147/j.issn.1000-9604.2023.06.11","DOIUrl":"10.21147/j.issn.1000-9604.2023.06.11","url":null,"abstract":"<p><strong>Objective: </strong>Cervical squamous intraepithelial lesion (SIL) and cervical cancer are major threats to females' health and life in China, and we aimed to estimate the economic burden associated with their diagnosis and treatment.</p><p><strong>Methods: </strong>A nationwide multicenter, cross-sectional, hospital-based survey was conducted in 26 qualified hospitals across seven administrative regions of China. We investigated females who had been pathologically diagnosed with SIL and cervical cancer, and included five disease courses (\"diagnosis\", \"initial treatment\", \"chemoradiotherapy\", \"follow-up\" and \"recurrence/progression/metastasis\") to estimate the total costs. The median and interquartile range (IQR) of total costs (including direct medical, direct non-medical, and indirect costs), reimbursement rate by medical insurance, and catastrophic health expenditures in every clinical stage were calculated.</p><p><strong>Results: </strong>A total of 3,471 patients in different clinical stages were analyzed, including low-grade SIL (LSIL) (n=549), high-grade SIL (HSIL) (n=803), cervical cancer stage IA (n=226), IB (n=610), IIA (n=487), IIB (n=282), III (n=452) and IV (n=62). In urban areas, the estimated total costs of LSIL and HSIL were [Formula: see text]1,637.7 (IQR: [Formula: see text]956.4-[Formula: see text]2,669.2) and [Formula: see text]2,467.1 (IQR: [Formula: see text]1,579.1-[Formula: see text]3,762.3), while in rural areas the costs were [Formula: see text]459.0 (IQR: [Formula: see text]167.7-[Formula: see text]1,330.3) and [Formula: see text]1,230.5 (IQR: [Formula: see text]560.6-[Formula: see text]2,104.5), respectively. For patients with cervical cancer stage IA, IB, IIA, IIB, and III-IV, the total costs were [Formula: see text]15,034.9 (IQR: [Formula: see text]11,083.4-[Formula: see text]21,632.4), [Formula: see text]19,438.6 (IQR: [Formula: see text]14,060.0-[Formula: see text]26,505.9), [Formula: see text]22,968.8 (IQR: [Formula: see text]16,068.8-[Formula: see text]34,615.9), [Formula: see text]26,936.0 (IQR: [Formula: see text]18,176.6-[Formula: see text]41,386.0) and [Formula: see text]27,332.6 (IQR: [Formula: see text]17,538.7-[Formula: see text]44,897.0), respectively. Medical insurance covered 43%-55% of direct medical costs for cervical cancer patients, while the coverage for SIL patients was 19%-43%. For most cervical cancer patients, the expense was catastrophic, and the extent of catastrophic health expenditure was about twice large for rural patients than that for urban patients in each stage.</p><p><strong>Conclusions: </strong>The economic burden of SIL and cervical cancer in China is substantial, with a significant proportion of the costs being avoidable for patients with LSIL. Even for those with medical insurance, catastrophic health expenditures are also a major concern for patients with cervical cancer, particularly for those living in rural areas.</p>","PeriodicalId":9882,"journal":{"name":"Chinese Journal of Cancer Research","volume":"35 6","pages":"675-685"},"PeriodicalIF":7.0,"publicationDate":"2023-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10774142/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139418739","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A multicenter study on efficacy of dual-target neoadjuvant therapy for HER2-positive breast cancer and a consistent analysis of efficacy evaluation of neoadjuvant therapy by Miller-Payne and RCB pathological evaluation systems (CSBrS-026). 一项关于 HER2 阳性乳腺癌双靶点新辅助疗法疗效的多中心研究,以及米勒-佩恩和 RCB 病理评估系统对新辅助疗法疗效评估的一致性分析(CSBrS-026)。
2区 医学 Q1 ONCOLOGY Pub Date : 2023-12-30 DOI: 10.21147/j.issn.1000-9604.2023.06.13
Hongyu Xiang, Ling Xin, Jingming Ye, Ling Xu, Hong Zhang, Shuang Zhang, Yinhua Liu

Objective: The aim of this study was to investigate the factors influencing pathological complete response (pCR) rate in early breast cancer patients receiving neoadjuvant dual-target [trastuzumab (H) + pertuzumab (P)] therapy combined with chemotherapy. Additionally, the consistency of the Miller-Payne and residual cancer burden (RCB) systems in evaluating the efficacy of neoadjuvant therapy for early human epidermal growth factor receptor-2 (HER2)+ breast cancer was analyzed.

Methods: The clinicopathological data of female patients with early-stage HER2+ breast cancer who received dual-target neoadjuvant therapy at 26 hospitals of the Chinese Society of Breast Surgery (CSBrS) from March 2019 to December 2021 were collected. Patients were allocated to four groups: the HER2 immunohistochemistry (IHC) 3+/hormone receptor (HR)-, IHC3+/HR+, IHC2+ in situ hybridization (ISH)+/HR- and IHC2+ ISH+/HR+ groups. The overall pCR rate for patients, the pCR rate in each group and the factors affecting the pCR rate were analyzed. The consistency between the Miller-Payne and RCB systems in assessing the efficacy of neoadjuvant therapy was analyzed.

Results: From March 1, 2019, to December 31, 2021, 77,376 female patients with early-stage breast cancer were treated at 26 hospitals; 18,853 (24.4%) of these patients were HER2+. After exclusion of unqualified patients, 2,395 patients who received neoadjuvant dual-target (H+P) therapy combined with chemotherapy were included in this study. The overall pCR rate was 53.0%, and the patients' HR statuses and different HER2+ statuses were significantly correlated with the pCR rate (P<0.05). The consistency of the pathological efficacy assessed by the Miller-Payne and RCB systems was 88.0% (κ=0.717, P<0.001).

Conclusions: Different HER2 expression statuses and HR expression statuses are correlated with the pCR rate after dual-target neoadjuvant therapy in HER2+ breast cancer patients. There is a relatively good consistency between Miller-Payne and RCB systems in evaluating the pathologic efficacy of neoadjuvant therapy for HER2+ breast cancer.

研究目的本研究旨在探讨影响接受新辅助双靶点[曲妥珠单抗(H)+百妥珠单抗(P)]疗法联合化疗的早期乳腺癌患者病理完全应答率(pCR)的因素。此外,还分析了米勒-佩恩(Miller-Payne)系统和残留癌负担(RCB)系统在评估早期人表皮生长因子受体-2(HER2)+乳腺癌新辅助治疗疗效方面的一致性:收集2019年3月至2021年12月在中华医学会乳腺外科学分会(CSBrS)26家医院接受双靶点新辅助治疗的早期HER2+乳腺癌女性患者的临床病理资料。患者被分为四组:HER2免疫组化(IHC)3+/激素受体(HR)-组、IHC3+/HR+组、IHC2+原位杂交(ISH)+/HR-组和IHC2+ ISH+/HR+组。分析了患者的总体 pCR 率、各组的 pCR 率以及影响 pCR 率的因素。分析了米勒-佩恩系统和RCB系统在评估新辅助治疗疗效方面的一致性:从2019年3月1日至2021年12月31日,26家医院共治疗了77376名早期乳腺癌女性患者,其中18853名(24.4%)患者为HER2+。在排除不合格患者后,本研究纳入了 2395 名接受新辅助双靶点(H+P)疗法联合化疗的患者。总的 pCR 率为 53.0%,患者的 HR 状态和不同的 HER2+ 状态与 pCR 率显著相关(P0.05)。Miller-Payne和RCB系统评估的病理疗效一致性为88.0%(κ=0.717,P0.001):不同的HER2表达状态和HR表达状态与HER2+乳腺癌患者接受双靶点新辅助治疗后的pCR率相关。在评估HER2+乳腺癌新辅助治疗的病理学疗效方面,Miller-Payne和RCB系统具有较好的一致性。
{"title":"A multicenter study on efficacy of dual-target neoadjuvant therapy for HER2-positive breast cancer and a consistent analysis of efficacy evaluation of neoadjuvant therapy by Miller-Payne and RCB pathological evaluation systems (CSBrS-026).","authors":"Hongyu Xiang, Ling Xin, Jingming Ye, Ling Xu, Hong Zhang, Shuang Zhang, Yinhua Liu","doi":"10.21147/j.issn.1000-9604.2023.06.13","DOIUrl":"10.21147/j.issn.1000-9604.2023.06.13","url":null,"abstract":"<p><strong>Objective: </strong>The aim of this study was to investigate the factors influencing pathological complete response (pCR) rate in early breast cancer patients receiving neoadjuvant dual-target [trastuzumab (H) + pertuzumab (P)] therapy combined with chemotherapy. Additionally, the consistency of the Miller-Payne and residual cancer burden (RCB) systems in evaluating the efficacy of neoadjuvant therapy for early human epidermal growth factor receptor-2 (HER2)+ breast cancer was analyzed.</p><p><strong>Methods: </strong>The clinicopathological data of female patients with early-stage HER2+ breast cancer who received dual-target neoadjuvant therapy at 26 hospitals of the Chinese Society of Breast Surgery (CSBrS) from March 2019 to December 2021 were collected. Patients were allocated to four groups: the HER2 immunohistochemistry (IHC) 3+/hormone receptor (HR)-, IHC3+/HR+, IHC2+ <i>in situ</i> hybridization (ISH)+/HR- and IHC2+ ISH+/HR+ groups. The overall pCR rate for patients, the pCR rate in each group and the factors affecting the pCR rate were analyzed. The consistency between the Miller-Payne and RCB systems in assessing the efficacy of neoadjuvant therapy was analyzed.</p><p><strong>Results: </strong>From March 1, 2019, to December 31, 2021, 77,376 female patients with early-stage breast cancer were treated at 26 hospitals; 18,853 (24.4%) of these patients were HER2+. After exclusion of unqualified patients, 2,395 patients who received neoadjuvant dual-target (H+P) therapy combined with chemotherapy were included in this study. The overall pCR rate was 53.0%, and the patients' HR statuses and different HER2+ statuses were significantly correlated with the pCR rate (P<i><</i>0.05). The consistency of the pathological efficacy assessed by the Miller-Payne and RCB systems was 88.0% (<i>κ</i>=0.717, P<i><</i>0.001).</p><p><strong>Conclusions: </strong>Different HER2 expression statuses and HR expression statuses are correlated with the pCR rate after dual-target neoadjuvant therapy in HER2+ breast cancer patients. There is a relatively good consistency between Miller-Payne and RCB systems in evaluating the pathologic efficacy of neoadjuvant therapy for HER2+ breast cancer.</p>","PeriodicalId":9882,"journal":{"name":"Chinese Journal of Cancer Research","volume":"35 6","pages":"702-712"},"PeriodicalIF":0.0,"publicationDate":"2023-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10774131/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139418734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Chinese Journal of Cancer Research
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