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Preoperative prediction of early mortality after surgery for spinal metastases. 脊柱转移手术后早期死亡率的术前预测。
IF 2.4 4区 医学 Q3 ONCOLOGY Pub Date : 2024-09-09 DOI: 10.1093/jjco/hyae125
Hiroto Kamoda,Toshinori Tsukanishi,Hideyuki Kinoshita,Yoko Hagiwara,Yuji Endo,Hiroki Takahashi,Kosuke Takeda,Tetsuya Hirashima,Takeshi Ishii,Tsukasa Yonemoto
OBJECTIVEThe objective of this study was to provide a convenient preoperative prediction of the risk of early postoperative mortality.MATERIALS AND METHODSThis retrospective study included patients who underwent surgery for spinal metastasis at our hospital between 2009 and 2021. Preoperative blood test data of all patients were collected, and the survival time was calculated by dividing the blood data. A multivariate analysis was conducted using a Cox proportional hazards model to identify prognostic factors.RESULTSThe study population included 83 patients (average: 64.5 years), 22 of whom died within 3 months. The most common lesion was the thoracic spine, and incomplete paralysis was observed in 57 patients. The surgical methods included posterior implant fixation (n = 17), posterior decompression (n = 31), and posterior decompression with fixation (n = 35). In the univariate analysis, the presence of abnormal values was significantly associated with postoperative survival in six preoperative blood collection items (hemoglobin, C-reactive protein, albumin, white blood cell, gamma-glutamyl transpeptidase, and lactate dehydrogenase). In a multivariate analysis, four test items (hemoglobin, C-reactive protein, white blood cell, and lactate dehydrogenase) were identified as independent prognostic factors.Comparing cases with ≥3 abnormal values among the above four items (high-risk group; n = 23) and those with ≤2 (low-risk group; n = 60), there was a significant difference in survival time. In addition, it was possible to predict cases of early death within 3 months after surgery with 73% sensitivity and 89% specificity.CONCLUSIONSThe study showed that four preoperative blood test abnormalities (hemoglobin, C-reactive protein white blood cell, and lactate dehydrogenase) indicated the possibility of early death within 3 months after surgery.
材料与方法这项回顾性研究纳入了 2009 年至 2021 年期间在我院接受脊柱转移手术的患者。收集所有患者的术前血液检测数据,并通过除以血液数据计算生存时间。结果研究对象包括 83 名患者(平均 64.5 岁),其中 22 人在 3 个月内死亡。最常见的病变部位是胸椎,57名患者出现不完全瘫痪。手术方法包括后路植入固定术(17 例)、后路减压术(31 例)和后路减压加固定术(35 例)。在单变量分析中,术前六项采血指标(血红蛋白、C 反应蛋白、白蛋白、白细胞、γ-谷氨酰转肽酶和乳酸脱氢酶)的异常值与术后存活率显著相关。在多变量分析中,四个检测项目(血红蛋白、C反应蛋白、白细胞和乳酸脱氢酶)被确定为独立的预后因素。将上述四个项目中异常值≥3个的病例(高危组,n = 23)与异常值≤2个的病例(低危组,n = 60)进行比较,生存时间有显著差异。结论该研究表明,术前血液检测的四项异常(血红蛋白、C 反应蛋白白细胞和乳酸脱氢酶)预示着术后 3 个月内早期死亡的可能性。
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引用次数: 0
Salvage radiotherapy for locoregional recurrence of esophageal cancer after surgery. 食管癌术后局部复发的挽救性放射治疗。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-09-06 DOI: 10.1093/jjco/hyae124
Akira Torii, Natsuo Tomita, Taiki Takaoka, Takuhito Kondo, Shintaro Yamamoto, Chikao Sugie, Aiko Nagai, Akifumi Miyakawa, Mayu Kuno, Kaoru Uchiyama, Shinya Otsuka, Yasutaka Ogawa, Seiya Takano, Nozomi Kita, Tatsuya Tanaka, Ryo Ogawa, Eiji Kubota, Shuji Takiguchi, Hiromi Kataoka, Akio Hiwatashi

Objective: There is no consensus on the optimal treatment for patients with locoregional recurrence of esophageal cancer after surgery. The objective of this study was to investigate the outcomes and prognostic factors associated with salvage radiotherapy in patients with locoregional recurrence of esophageal cancer after surgery.

Methods: We reviewed 80 patients with locoregional recurrence of esophageal cancer after surgery who were treated with radiotherapy. The median dose was 60 Gy, and 29 patients (36%) received elective nodal irradiation. Fifty-three patients (66%) received concurrent chemotherapy (mostly 5-fluorouracil and cisplatin) during radiotherapy. Overall survival, progression-free survival and in-field recurrence rate were assessed.

Results: The median follow-up period was 17 months. Two-year overall survival, progression-free survival and in-field recurrence rate were 50.3%, 23.5% and 41.3%, respectively. On multivariate analysis, a maximum diameter of locoregional recurrence lesions <30 mm was associated with higher overall survival (P = 0.044). Disease-free interval between surgery and locoregional recurrence >14 months was associated with higher PFS (P = 0.003). Late grade 3 toxicities occurred in three patients (3.8%). No grade 4 or higher toxicity was observed.

Conclusions: Salvage radiotherapy demonstrated efficacy in achieving in-field control with acceptable toxicity. However, the high rate of out-of-field metastases led to poor progression-free survival and overall survival, particularly in cases involving large lesions and a short disease-free interval. A prospective study is warranted to establish a treatment strategy, particularly considering the combined use of effective anti-cancer drugs.

目的:对于食管癌术后局部复发患者的最佳治疗方法尚未达成共识。本研究旨在探讨食管癌术后局部复发患者接受挽救性放疗的疗效及相关预后因素:我们对80例术后局部复发并接受放疗的食管癌患者进行了回顾性研究。中位剂量为 60 Gy,29 名患者(36%)接受了选择性结节照射。53名患者(66%)在放疗期间同时接受了化疗(主要是5-氟尿嘧啶和顺铂)。对总生存期、无进展生存期和现场复发率进行了评估:中位随访期为 17 个月。结果:中位随访期为 17 个月,两年总生存率、无进展生存率和现场复发率分别为 50.3%、23.5% 和 41.3%。多变量分析显示,局部复发病灶最大直径为14个月与较高的PFS相关(P = 0.003)。3名患者(3.8%)出现了晚期3级毒性反应。未观察到4级或以上毒性:抢救性放疗在实现场内控制和可接受毒性方面表现出疗效。然而,场外转移率较高,导致无进展生存期和总生存期较差,尤其是在涉及大病灶和无病间隔期较短的病例中。有必要进行前瞻性研究,以确定治疗策略,特别是考虑联合使用有效的抗癌药物。
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引用次数: 0
Protocol for a prospective multicenter randomized controlled trial to evaluate the efficacy of texture and color enhancement imaging (TXI) observation in the detection of colorectal lesions (deTXIon study). 评估纹理和颜色增强成像(TXI)观察对检测结直肠病变的疗效的前瞻性多中心随机对照试验(deTXIon 研究)方案。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-09-04 DOI: 10.1093/jjco/hyae063
Yutaka Saito, Naoya Toyoshima, Yasuhiko Mizuguchi, Taku Sakamoto, Toshio Uraoka, Hiroaki Ikematsu, Naoto Tamai, Takahisa Matsuda, Masashi Misawa, Kinichi Hotta, Taro Shibata

Colonoscopy is the gold standard for detecting and resecting adenomas or early stage cancers to reduce the incidence and mortality rates of colorectal cancer. In a recent observational study, texture and color enhancement imaging (TXI) was reported to improve polyp detection during colonoscopy. This randomized controlled trial involving six Japanese institutions aims to confirm the superiority of TXI over standard white-light imaging (WLI) in detecting colorectal lesions during colonoscopy. During the 1-year study period, 960 patients will be enrolled, with 480 patients in the TXI and WLI groups. The primary endpoint is the mean number of adenomas detected per procedure. The secondary endpoints include adenoma detection rate, advanced adenoma detection rate, polyp detection rate, flat polyp detection rate, depressed lesion detection rate, mean polyps detected per procedure, sessile serrated lesion (SSL) detection rate, mean SSLs detected per procedure and adverse events.

结肠镜检查是检测和切除腺瘤或早期癌症以降低结肠直肠癌发病率和死亡率的黄金标准。最近的一项观察性研究显示,纹理和颜色增强成像(TXI)可提高结肠镜检查中息肉的检出率。这项随机对照试验有六家日本医疗机构参与,旨在证实在结肠镜检查期间,纹理和颜色增强成像(TXI)在检测结肠直肠病变方面优于标准白光成像(WLI)。在为期一年的研究期间,将有 960 名患者参加试验,其中 TXI 组和 WLI 组各有 480 名患者。主要终点是每次手术检测到腺瘤的平均数量。次要终点包括腺瘤检出率、晚期腺瘤检出率、息肉检出率、扁平息肉检出率、凹陷病变检出率、每次手术检出的平均息肉数、无柄锯齿状病变(SSL)检出率、每次手术检出的平均锯齿状病变数和不良事件。
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引用次数: 0
Cholinesterase as a predictor of skeletal muscle loss after gastrectomy for gastric cancer. 胆碱酯酶是胃癌胃切除术后骨骼肌损失的预测指标。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-09-04 DOI: 10.1093/jjco/hyae065
Yasuhiro Takano, Wataru Kai, Hironori Kanno, Nobuyoshi Hanyu

Background: Cholinesterase is a classical nutritional and inflammatory marker. The aim of the present study was to evaluate the value of cholinesterase as a predictive marker for postoperative skeletal muscle loss after gastrectomy for gastric cancer.

Methods: The study comprised 68 patients who had undergone gastrectomy for gastric cancer. Skeletal muscle mass was evaluated using skeletal mass index, and major skeletal muscle loss was defined as less than or equal to the median change rate (1-year postoperative/preoperative) of skeletal mass index in all patients. We explored the relationship between postoperative major skeletal muscle loss and disease-free survival and overall survival. Then we investigated the relationship between change rate of skeletal muscle index and serum cholinesterase levels after gastrectomy.

Results: The median value of change rate of skeletal mass index was 0.93. Postoperative major skeletal muscle loss was significantly associated with disease-free survival after gastrectomy (P = 0.003). Although major skeletal muscle loss had worse overall survival, it was not significant (P = 0.058). The change rate of skeletal mass index and cholinesterase had a stronger positive correlation compared with other nutritional indices according to Spearman's rank correlation coefficient (r = 0.438, P ≤ 0.001).

Conclusion: Evaluation of serum cholinesterase levels may be valuable for predicting postoperative skeletal muscle loss after gastrectomy, suggesting the importance of cholinesterase in postoperative nutritional management of patients with gastric cancer.

背景:胆碱酯酶是一种经典的营养和炎症标志物。本研究旨在评估胆碱酯酶作为胃癌胃切除术后骨骼肌损失的预测指标的价值:研究对象包括 68 名接受胃癌胃切除术的患者。使用骨骼质量指数评估骨骼肌质量,所有患者的骨骼质量指数变化率(术后1年/术前)小于或等于中位数即为主要骨骼肌损失。我们探讨了术后主要骨骼肌损失与无病生存率和总生存率之间的关系。然后,我们研究了胃切除术后骨骼肌指数变化率与血清胆碱酯酶水平之间的关系:结果:骨骼肌指数变化率的中位值为 0.93。术后主要骨骼肌损失与胃切除术后无病生存率显著相关(P = 0.003)。虽然大块骨骼肌缺失会降低总生存率,但并不显著(P = 0.058)。根据斯皮尔曼秩相关系数(r = 0.438,P ≤ 0.001),骨骼质量指数和胆碱酯酶的变化率与其他营养指标相比具有更强的正相关性:结论:评估血清胆碱酯酶水平可能对预测胃切除术后骨骼肌损失有价值,这表明胆碱酯酶在胃癌患者术后营养管理中的重要性。
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引用次数: 0
Changes in the trends of initial treatment for newly diagnosed prostate cancer in Japan: a nationwide multi-institutional study. 日本新诊断前列腺癌初始治疗趋势的变化:一项全国性多机构研究。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-09-04 DOI: 10.1093/jjco/hyae079
Taketo Kawai, Mizuki Onozawa, Satoru Taguchi, Masaki Shiota, Shinichi Sakamoto, Yoshiyuki Yamamoto, Yasuhide Kitagawa, Tohru Nakagawa, Shiro Hinotsu, Haruki Kume

Background: In previous large-scale studies conducted through 2010, androgen deprivation therapy (ADT) was the most common initial treatment for prostate cancer patients in Japan. However, recent advancements in treatment technologies have significantly affected the management of prostate cancer in Japan. This study analyzed the trends in initial treatments for prostate cancer based on two nationwide surveys.

Methods: Two Japan-wide multi-institutional surveys, J-CaP2010 and J-CaP2016, were conducted to enroll patients newly histologically diagnosed with prostate cancer in 2010 and 2016-18, respectively. Both surveys included age at diagnosis, initial PSA level, ISUP Grade Group, TNM classification, and initial treatment for prostate cancer.

Results: J-CaP2010 included data from 8192 patients across 140 institutions, whereas J-CaP2016 included data from 21 841 patients across 186 institutions. In J-CaP2016, the proportion of radical prostatectomy (RP) and radiation therapy (RT) in the initial treatment increased (from 32% to 36% and 21% to 26%, respectively), whereas the proportion of ADT decreased (from 40% to 29%) compared with those in J-CaP2010. The increase in RP or RT was noticeable in patients aged 75 years and older (from 20% to 38%) and those with high-risk localized cancer (from 58% to 74%) or locally advanced cancer (from 38% to 56%). The proportion of active surveillance or watchful waiting increased in patients with low-risk localized cancer (from 21% to 41%). The proportion of robot-assisted RP within all RPs and the proportion of intensity-modulated RT within all RTs increased remarkably (from 2.3% to 78% and 20% to 50%, respectively).

Conclusions: In Japan, RP and RT have increased as initial treatments for prostate cancer, whereas ADT has decreased. Consequently, RP has emerged as the most commonly selected initial treatment, replacing ADT.

研究背景在 2010 年之前进行的大规模研究中,雄激素剥夺疗法(ADT)是日本前列腺癌患者最常见的初始治疗方法。然而,最近治疗技术的进步对日本前列腺癌的治疗产生了重大影响。本研究根据两项全国性调查分析了前列腺癌初始治疗的趋势:方法:分别于 2010 年和 2016-18 年对新近组织学诊断为前列腺癌的患者进行了两次日本全国多机构调查,即 J-CaP2010 和 J-CaP2016。两项调查均包括诊断时的年龄、初始 PSA 水平、ISUP 分级组、TNM 分类和前列腺癌的初始治疗:J-CaP2010包括来自140家机构的8192名患者的数据,而J-CaP2016包括来自186家机构的21841名患者的数据。与J-CaP2010相比,在J-CaP2016中,初始治疗中根治性前列腺切除术(RP)和放射治疗(RT)的比例有所增加(分别从32%增至36%和21%增至26%),而ADT的比例有所下降(从40%降至29%)。在 75 岁及以上患者(从 20% 增加到 38%)和高危局部癌症患者(从 58% 增加到 74%)或局部晚期癌症患者(从 38% 增加到 56%)中,RP 或 RT 的比例明显增加。在低风险局部癌症患者中,主动监测或观察等待的比例有所增加(从21%增至41%)。在所有 RP 中,机器人辅助 RP 的比例显著增加,在所有 RT 中,强度调节 RT 的比例显著增加(分别从 2.3% 增加到 78%,从 20% 增加到 50%):在日本,RP 和 RT 作为前列腺癌初始治疗方法的比例有所上升,而 ADT 则有所下降。因此,RP已取代ADT,成为最常选择的初始治疗方法。
{"title":"Changes in the trends of initial treatment for newly diagnosed prostate cancer in Japan: a nationwide multi-institutional study.","authors":"Taketo Kawai, Mizuki Onozawa, Satoru Taguchi, Masaki Shiota, Shinichi Sakamoto, Yoshiyuki Yamamoto, Yasuhide Kitagawa, Tohru Nakagawa, Shiro Hinotsu, Haruki Kume","doi":"10.1093/jjco/hyae079","DOIUrl":"10.1093/jjco/hyae079","url":null,"abstract":"<p><strong>Background: </strong>In previous large-scale studies conducted through 2010, androgen deprivation therapy (ADT) was the most common initial treatment for prostate cancer patients in Japan. However, recent advancements in treatment technologies have significantly affected the management of prostate cancer in Japan. This study analyzed the trends in initial treatments for prostate cancer based on two nationwide surveys.</p><p><strong>Methods: </strong>Two Japan-wide multi-institutional surveys, J-CaP2010 and J-CaP2016, were conducted to enroll patients newly histologically diagnosed with prostate cancer in 2010 and 2016-18, respectively. Both surveys included age at diagnosis, initial PSA level, ISUP Grade Group, TNM classification, and initial treatment for prostate cancer.</p><p><strong>Results: </strong>J-CaP2010 included data from 8192 patients across 140 institutions, whereas J-CaP2016 included data from 21 841 patients across 186 institutions. In J-CaP2016, the proportion of radical prostatectomy (RP) and radiation therapy (RT) in the initial treatment increased (from 32% to 36% and 21% to 26%, respectively), whereas the proportion of ADT decreased (from 40% to 29%) compared with those in J-CaP2010. The increase in RP or RT was noticeable in patients aged 75 years and older (from 20% to 38%) and those with high-risk localized cancer (from 58% to 74%) or locally advanced cancer (from 38% to 56%). The proportion of active surveillance or watchful waiting increased in patients with low-risk localized cancer (from 21% to 41%). The proportion of robot-assisted RP within all RPs and the proportion of intensity-modulated RT within all RTs increased remarkably (from 2.3% to 78% and 20% to 50%, respectively).</p><p><strong>Conclusions: </strong>In Japan, RP and RT have increased as initial treatments for prostate cancer, whereas ADT has decreased. Consequently, RP has emerged as the most commonly selected initial treatment, replacing ADT.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":"1045-1051"},"PeriodicalIF":1.9,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141330978","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Establishment of artificial intelligence model for precise histological subtyping of lung adenocarcinoma and its application to quantitative and spatial analysis. 建立肺腺癌组织学精准亚型的人工智能模型,并将其应用于定量和空间分析。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-09-04 DOI: 10.1093/jjco/hyae066
Eisuke Miura, Katsura Emoto, Tokiya Abe, Akinori Hashiguchi, Tomoyuki Hishida, Keisuke Asakura, Michiie Sakamoto

Background: The histological subtype of lung adenocarcinoma is a major prognostic factor. We developed a new artificial intelligence model to classify lung adenocarcinoma images into seven histological subtypes and adopted the model for whole-slide images to investigate the relationship between the distribution of histological subtypes and clinicopathological factors.

Methods: Using histological subtype images, which are typical for pathologists, we trained and validated an artificial intelligence model. Then, the model was applied to whole-slide images of resected lung adenocarcinoma specimens from 147 cases.

Result: The model achieved an accuracy of 99.7% in training sets and 90.4% in validation sets consisting of typical tiles of histological subtyping for pathologists. When the model was applied to whole-slide images, the predominant subtype according to the artificial intelligence model classification matched that determined by pathologists in 75.5% of cases. The predominant subtype and tumor grade (using the WHO fourth and fifth classifications) determined by the artificial intelligence model resulted in similar recurrence-free survival curves to those determined by pathologists. Furthermore, we stratified the recurrence-free survival curves for patients with different proportions of high-grade components (solid, micropapillary and cribriform) according to the physical distribution of the high-grade component. The results suggested that tumors with centrally located high-grade components had a higher malignant potential (P < 0.001 for 5-20% high-grade component).

Conclusion: The new artificial intelligence model for histological subtyping of lung adenocarcinoma achieved high accuracy, and subtype quantification and subtype distribution analyses could be achieved. Artificial intelligence model therefore has potential for clinical application for both quantification and spatial analysis.

背景:肺腺癌的组织学亚型是一个重要的预后因素。我们开发了一种新的人工智能模型,将肺腺癌图像分为七种组织学亚型,并将该模型用于全滑动图像,研究组织学亚型分布与临床病理因素之间的关系:方法:利用病理学家典型的组织学亚型图像,我们训练并验证了一个人工智能模型。然后,将该模型应用于 147 例切除的肺腺癌标本的全切片图像:结果:该模型在训练集中的准确率为 99.7%,在验证集中的准确率为 90.4%。当该模型应用于整张切片图像时,根据人工智能模型分类得出的主要亚型与病理学家确定的亚型相符的病例占 75.5%。人工智能模型确定的主要亚型和肿瘤分级(采用世界卫生组织第四和第五分级)与病理学家确定的无复发生存曲线相似。此外,我们还根据高级别成分的物理分布情况,对高级别成分(实性、微乳头状和楔形)比例不同的患者的无复发生存曲线进行了分层。结果表明,高级别成分位于中心位置的肿瘤具有更高的恶性潜能(P 结论):用于肺腺癌组织学亚型分析的新型人工智能模型具有较高的准确性,可实现亚型量化和亚型分布分析。因此,人工智能模型在量化和空间分析方面具有临床应用潜力。
{"title":"Establishment of artificial intelligence model for precise histological subtyping of lung adenocarcinoma and its application to quantitative and spatial analysis.","authors":"Eisuke Miura, Katsura Emoto, Tokiya Abe, Akinori Hashiguchi, Tomoyuki Hishida, Keisuke Asakura, Michiie Sakamoto","doi":"10.1093/jjco/hyae066","DOIUrl":"10.1093/jjco/hyae066","url":null,"abstract":"<p><strong>Background: </strong>The histological subtype of lung adenocarcinoma is a major prognostic factor. We developed a new artificial intelligence model to classify lung adenocarcinoma images into seven histological subtypes and adopted the model for whole-slide images to investigate the relationship between the distribution of histological subtypes and clinicopathological factors.</p><p><strong>Methods: </strong>Using histological subtype images, which are typical for pathologists, we trained and validated an artificial intelligence model. Then, the model was applied to whole-slide images of resected lung adenocarcinoma specimens from 147 cases.</p><p><strong>Result: </strong>The model achieved an accuracy of 99.7% in training sets and 90.4% in validation sets consisting of typical tiles of histological subtyping for pathologists. When the model was applied to whole-slide images, the predominant subtype according to the artificial intelligence model classification matched that determined by pathologists in 75.5% of cases. The predominant subtype and tumor grade (using the WHO fourth and fifth classifications) determined by the artificial intelligence model resulted in similar recurrence-free survival curves to those determined by pathologists. Furthermore, we stratified the recurrence-free survival curves for patients with different proportions of high-grade components (solid, micropapillary and cribriform) according to the physical distribution of the high-grade component. The results suggested that tumors with centrally located high-grade components had a higher malignant potential (P < 0.001 for 5-20% high-grade component).</p><p><strong>Conclusion: </strong>The new artificial intelligence model for histological subtyping of lung adenocarcinoma achieved high accuracy, and subtype quantification and subtype distribution analyses could be achieved. Artificial intelligence model therefore has potential for clinical application for both quantification and spatial analysis.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":"1009-1023"},"PeriodicalIF":1.9,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140957092","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
D-dimer cut-off value for predicting venous thromboembolism at the initial diagnosis in Japanese patients with advanced lung cancer. 日本晚期肺癌患者初诊时预测静脉血栓栓塞的D-二聚体临界值。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-09-04 DOI: 10.1093/jjco/hyae064
Keita Kawakado, Yukari Tsubata, Takamasa Hotta, Masahiro Yamasaki, Nobuhisa Ishikawa, Takeshi Masuda, Tetsuya Kubota, Kunihiko Kobayashi, Takeshi Isobe

Objective: Cancer is a well-known risk factor for venous thromboembolism. The D-dimer level is used to predict venous thromboembolism; however, reports on an appropriate D-dimer cut-off value in Japanese patients with advanced lung cancer are lacking. Therefore, this study aimed to calculate the D-dimer cut-off value for venous thromboembolism at the time of lung cancer diagnosis.

Methods: The Rising-venous thromboembolism/NEJ037 study was a multicenter, prospective observational study. Patients with lung cancer who were contraindicated for radical resection or radiation were enrolled and followed up for 2 years. In the present study (jRCT no. 061180025), a receiver operating characteristic curve for D-dimer levels was created using the dataset of the Rising-venous thromboembolism/NEJ037 study.

Results: The Rising-venous thromboembolism/NEJ037 study included a total of 1008 patients, of whom 976, whose D-dimer levels had been measured at the time of cancer diagnosis, were included in the present study. At the time of lung cancer diagnosis, 62 (6.3%) and 914 (93.7%) patients presented with and without venous thromboembolism, respectively. The D-dimer values ranged from 0.1 to 180.1 μg/ml and from 0.1 to 257.2 μg/ml in patients with and without venous thromboembolism, respectively. The receiver operating characteristic curve was discriminative with a cut-off value of 3.3 μg/ml and an area under the curve of 0.794 (sensitivity, 0.742; specificity, 0.782; 95% confidence interval, 0.725-0.863).

Conclusions: This is the first study to calculate the D-dimer cut-off value in Japanese patients with advanced lung cancer. Patients with D-dimer levels ≥3.3 μg/ml at the time of initial diagnosis may have coexisting venous thromboembolism.

目的:癌症是众所周知的静脉血栓栓塞风险因素。D-二聚体水平可用于预测静脉血栓栓塞;然而,有关日本晚期肺癌患者的适当 D-二聚体临界值的报告却缺乏。因此,本研究旨在计算肺癌诊断时静脉血栓栓塞的 D-二聚体临界值:Rising-venous thromboembolism/NEJ037 研究是一项多中心、前瞻性观察研究。有根治性切除术或放射治疗禁忌症的肺癌患者被纳入研究,并接受为期两年的随访。在本研究(jRCT 编号:061180025)中,利用 Rising-venous 血栓栓塞症/NEJ037 研究的数据集绘制了 D-二聚体水平的接收器操作特征曲线:Rising-静脉血栓栓塞症/NEJ037研究共纳入了1008名患者,其中976名患者在癌症诊断时测定了D-二聚体水平。在确诊肺癌时,分别有 62 名(6.3%)和 914 名(93.7%)患者出现和未出现静脉血栓栓塞。有静脉血栓栓塞和无静脉血栓栓塞患者的 D-二聚体值范围分别为 0.1 至 180.1 μg/ml 和 0.1 至 257.2 μg/ml。接收器操作特征曲线具有鉴别性,临界值为 3.3 μg/ml,曲线下面积为 0.794(灵敏度为 0.742;特异性为 0.782;95% 置信区间为 0.725-0.863):这是首个计算日本晚期肺癌患者D-二聚体临界值的研究。初步诊断时D-二聚体水平≥3.3 μg/ml的患者可能同时患有静脉血栓栓塞症。
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引用次数: 0
Elranatamab in Japanese patients with relapsed/refractory multiple myeloma: results from MagnetisMM-2 and MagnetisMM-3. 艾拉他单抗在日本复发/难治性多发性骨髓瘤患者中的应用:MagnetisMM-2 和 MagnetisMM-3 的结果。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-09-04 DOI: 10.1093/jjco/hyae068
Shinsuke Iida, Satoshi Ito, Hisayuki Yokoyama, Tadao Ishida, Yuya Nagai, Hiroshi Handa, Shigeki Ito, Yoichi Kamei, Masatoshi Nakamura, Kenshi Suzuki

Background: Despite advances, most patients with multiple myeloma (MM) experience relapse and repeat multiple treatment lines, highlighting an unmet need for patients with relapsed or refractory MM (RRMM). Bispecific antibodies are a new option, but their efficacy and safety in Japanese patients are unknown.

Methods: This was an analysis of Japanese patients receiving elranatamab monotherapy in MagnetisMM-2 (NCT04798586) and MagnetisMM-3 (NCT04649359). Both studies evaluated a priming dose regimen of elranatamab followed by weekly subcutaneous doses, in patients with disease progression while receiving or who were intolerant to ≥3 prior therapies (≥1 proteasome inhibitor, ≥1 immunomodulatory drug and ≥1 anti-CD38 monoclonal antibody). The primary endpoints were dose limiting toxicities (DLTs) in MagnetisMM-2 and confirmed objective response rate (ORR) in MagnetisMM-3. In both, key secondary endpoints included safety, tolerability, duration of response, time to response, progression-free survival and overall survival.

Results: In MagnetisMM-2 (N = 4) and MagnetisMM-3 (n = 12), median ages were 68.5 and 66.5 years, respectively. No DLTs were observed in MagnetisMM-2. ORRs were 50.0% (95% CI, 6.8-93.2) and 58.3% (95% CI, 27.7-84.8) in MagnetisMM-2 and MagnetisMM-3, respectively. All patients experienced treatment-emergent adverse events in MagnetisMM-2 (grade 3/4: 75.0%) and MagnetisMM-3 (grade 3/4: 100%); cytokine release syndrome occurred in 100% (grade 3/4: 25.0%) and 58.3% (no grade 3/4) of patients, respectively. Neither study reported immune effector cell-associated neurotoxicity syndrome.

Conclusions: No new safety signals were observed, and ORRs were similar to that of the overall MagnetisMM-3 trial population, supporting further studies of elranatamab in Japanese patients with RRMM. ClinicalTrials.gov identifier: NCT04798586 (MagnetisMM-2), NCT04649359 (MagnetisMM-3).

背景:尽管取得了进展,但大多数多发性骨髓瘤(MM)患者仍会复发并重复多种治疗方案,这凸显了复发或难治性MM(RRMM)患者的需求尚未得到满足。双特异性抗体是一种新的选择,但其在日本患者中的疗效和安全性尚不清楚:这是对在MagnetisMM-2(NCT04798586)和MagnetisMM-3(NCT04649359)中接受艾拉那单抗单药治疗的日本患者进行的分析。这两项研究都评估了艾拉那单抗的起始剂量方案,随后是每周皮下注射剂量,用于在接受或不耐受≥3种既往疗法(≥1种蛋白酶体抑制剂、≥1种免疫调节药物和≥1种抗CD38单克隆抗体)的同时疾病进展的患者。主要终点是MagnetisMM-2的剂量限制性毒性(DLT)和MagnetisMM-3的确诊客观反应率(ORR)。这两项研究的主要次要终点包括安全性、耐受性、反应持续时间、反应时间、无进展生存期和总生存期:MagnetisMM-2(4例)和MagnetisMM-3(12例)的中位年龄分别为68.5岁和66.5岁。MagnetisMM-2中未观察到DLT。MagnetisMM-2和MagnetisMM-3的ORR分别为50.0%(95% CI,6.8-93.2)和58.3%(95% CI,27.7-84.8)。在MagnetisMM-2(3/4级:75.0%)和MagnetisMM-3(3/4级:100%)中,所有患者都出现了治疗突发不良事件;分别有100%(3/4级:25.0%)和58.3%(无3/4级)的患者出现细胞因子释放综合征。两项研究均未报告免疫效应细胞相关神经毒性综合征:结论:未观察到新的安全性信号,ORR与MagnetisMM-3试验总体人群相似,支持在日本RRMM患者中进一步研究艾拉那单抗。ClinicalTrials.gov identifier:NCT04798586(MagnetisMM-2)、NCT04649359(MagnetisMM-3)。
{"title":"Elranatamab in Japanese patients with relapsed/refractory multiple myeloma: results from MagnetisMM-2 and MagnetisMM-3.","authors":"Shinsuke Iida, Satoshi Ito, Hisayuki Yokoyama, Tadao Ishida, Yuya Nagai, Hiroshi Handa, Shigeki Ito, Yoichi Kamei, Masatoshi Nakamura, Kenshi Suzuki","doi":"10.1093/jjco/hyae068","DOIUrl":"10.1093/jjco/hyae068","url":null,"abstract":"<p><strong>Background: </strong>Despite advances, most patients with multiple myeloma (MM) experience relapse and repeat multiple treatment lines, highlighting an unmet need for patients with relapsed or refractory MM (RRMM). Bispecific antibodies are a new option, but their efficacy and safety in Japanese patients are unknown.</p><p><strong>Methods: </strong>This was an analysis of Japanese patients receiving elranatamab monotherapy in MagnetisMM-2 (NCT04798586) and MagnetisMM-3 (NCT04649359). Both studies evaluated a priming dose regimen of elranatamab followed by weekly subcutaneous doses, in patients with disease progression while receiving or who were intolerant to ≥3 prior therapies (≥1 proteasome inhibitor, ≥1 immunomodulatory drug and ≥1 anti-CD38 monoclonal antibody). The primary endpoints were dose limiting toxicities (DLTs) in MagnetisMM-2 and confirmed objective response rate (ORR) in MagnetisMM-3. In both, key secondary endpoints included safety, tolerability, duration of response, time to response, progression-free survival and overall survival.</p><p><strong>Results: </strong>In MagnetisMM-2 (N = 4) and MagnetisMM-3 (n = 12), median ages were 68.5 and 66.5 years, respectively. No DLTs were observed in MagnetisMM-2. ORRs were 50.0% (95% CI, 6.8-93.2) and 58.3% (95% CI, 27.7-84.8) in MagnetisMM-2 and MagnetisMM-3, respectively. All patients experienced treatment-emergent adverse events in MagnetisMM-2 (grade 3/4: 75.0%) and MagnetisMM-3 (grade 3/4: 100%); cytokine release syndrome occurred in 100% (grade 3/4: 25.0%) and 58.3% (no grade 3/4) of patients, respectively. Neither study reported immune effector cell-associated neurotoxicity syndrome.</p><p><strong>Conclusions: </strong>No new safety signals were observed, and ORRs were similar to that of the overall MagnetisMM-3 trial population, supporting further studies of elranatamab in Japanese patients with RRMM. ClinicalTrials.gov identifier: NCT04798586 (MagnetisMM-2), NCT04649359 (MagnetisMM-3).</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":"991-1000"},"PeriodicalIF":1.9,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11374885/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141093629","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Franseen needle in endobronchial ultrasound-guided transbronchial needle aspiration: a phase II prospective study. 支气管内超声引导下经支气管针吸术中的 Franseen 针:II 期前瞻性研究。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-09-04 DOI: 10.1093/jjco/hyae077
Kohei Shikano, Jun Ikari, Takahiro Nakajima, Masayuki Ota, Yuki Shiko, Akira Naito, Mitsuhiro Abe, Takeshi Kawasaki, Jun-Ichiro Ikeda, Yoshihito Ozawa, Takuji Suzuki

Background: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) has been used to diagnose and stage lung cancer. Acquire™ Pulmonary and Expect™ Pulmonary dedicated EBUS-TBNA needles were introduced as the Franseen and Lancet needles, respectively. It is still unclear whether the Franseen or Lancet needles yield a higher quality specimen especially focusing on next-generation sequencing-based molecular testing.

Methods: A single-center, prospective study performed at the Chiba University Hospital randomly assigned patients to two groups: Group A, wherein the first and second EBUS-TBNA were performed using Lancet and Franseen needles, respectively, and Group B, wherein the first and second EBUS-TBNA were performed using Franseen and Lancet needles, respectively. Each specimen was compared and analyzed pathologically. The primary outcome was the histological tissue area except blood clot and the cellularity of each sample. We also examined the success rate of molecular testing.

Results: Twelve patients who underwent EBUS-TBNA between November 2022 and February 2023 were enrolled in this study. The tissue area of the specimens obtained by the Franseen and Lancet needles was 13.3 ± 6.4 mm2 and 10.6 ± 6.3 mm2, respectively (P = .355). The tumor cellularity in the specimens obtained using the Franseen and Lancet needles was 54.0 ± 30.3 and 46.2 ± 36.3%, respectively (P = .608). The success rate of molecular testing using the single-pass sample by Franseen needle was 85.7 and 57.1% by Lancet needle. No serious complications were reported.

Conclusions: The Franseen needle tended to show a greater amount of specimen with higher tumor cellularity than the Lancet needle which may contribute higher success rate of molecular testing. Further studies must be conducted to validate the results of this study.

Key findings: What is known and what is new?  What is the implication, and what should change now?

背景:支气管内超声引导下经支气管针吸术(EBUS-TBNA)已被用于肺癌的诊断和分期。Acquire™ Pulmonary 和 Expect™ Pulmonary 专用 EBUS-TBNA 针分别作为 Franseen 针和 Lancet 针问世。目前还不清楚 Franseen 针和 Lancet 针是否能产生更高质量的标本,尤其是基于下一代测序的分子检测:在千叶大学医院进行的一项单中心前瞻性研究将患者随机分为两组:A组分别使用Lancet针和Franseen针进行第一次和第二次EBUS-TBNA检查,B组分别使用Franseen针和Lancet针进行第一次和第二次EBUS-TBNA检查。对每个标本进行比较和病理分析。主要结果是每个样本的组织学组织面积(血块除外)和细胞度。我们还检查了分子检测的成功率:本研究共纳入了 2022 年 11 月至 2023 年 2 月期间接受 EBUS-TBNA 治疗的 12 例患者。弗兰森针和柳叶刀针获得的标本组织面积分别为(13.3 ± 6.4)平方毫米和(10.6 ± 6.3)平方毫米(P = .355)。使用弗朗森针和柳叶刀针获得的标本的肿瘤细胞度分别为 54.0 ± 30.3% 和 46.2 ± 36.3%(P = .608)。使用 Franseen 针进行单次样本分子检测的成功率为 85.7%,使用 Lancet 针的成功率为 57.1%。无严重并发症报告:与柳叶刀针相比,Franseen针往往能显示出更多肿瘤细胞度更高的标本,这可能有助于提高分子检测的成功率。必须开展进一步研究来验证本研究的结果:哪些是已知的,哪些是新的? 有什么影响,现在应该做些什么改变?
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引用次数: 0
Analysis of PIK3CA mutations in the primary and recurrent tumors of hormone receptor positive/human epidermal growth factor receptor 2 negative breast cancer. 激素受体阳性/人类表皮生长因子受体 2 阴性乳腺癌原发性和复发性肿瘤中 PIK3CA 基因突变的分析。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-09-04 DOI: 10.1093/jjco/hyae072
Yue Wang, Xin Li, Shuang Zhang, Li Liang, Ling Xu, Yinhua Liu, Ting Li

Objective: Our aim was to compare the PIK3CA mutation status in matched primary and recurrent tumors of hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer (BC) to gain insight into the optimization of patient selection and detection time for PIK3CA-targeted therapy.

Methods: The data were from 3035 patients with BC diagnosed at the Breast Disease Center, Peking University First Hospital, between January 2008 and December 2017. Matched primary and recurrent samples were profiled using amplification-refractory mutation system-polymerase chain reaction covering 11 mutational hotspots in PIK3CA.

Results: PIK3CA mutations were detected in 54.3% primary tumors and 48.6% corresponding recurrences. PIK3CA mutation was detected in 37.5% cases in the locoregional recurrent group and 40.0% of distant metastasis, without a statistical difference. Besides, PIK3CA mutations were concordant in 88.6% of the matched pairs. For patients treated with neoadjuvant chemotherapy, 100% concordance was observed. However, PIK3CA mutation was neither correlated with clinicopathological features nor associated with clinical outcomes.

Conclusions: Mutations in PIK3CA in HR+/HER2- BC generally progressed to recurrent tumors. The high concordance rate of PIK3CA mutation status between primary tumors and corresponding recurrences suggests that the detection of primary tumors could be a substitute approach when recurrent samples are not easily obtainable.

目的我们的目的是比较激素受体阳性/人表皮生长因子受体2阴性(HR+/HER2-)乳腺癌(BC)配对原发肿瘤和复发肿瘤的PIK3CA突变状态,以深入了解PIK3CA靶向治疗的患者选择和检测时间的优化:数据来自2008年1月至2017年12月在北京大学第一医院乳腺病中心确诊的3035例BC患者。采用扩增-难治性突变系统聚合酶链反应对匹配的原发和复发样本进行了分析,涵盖了PIK3CA的11个突变热点:结果:54.3%的原发肿瘤和48.6%的复发肿瘤检测到PIK3CA突变。局部复发组中有37.5%的病例检测到PIK3CA突变,远处转移组中有40.0%的病例检测到PIK3CA突变,两者无统计学差异。此外,88.6%的配对患者的PIK3CA突变是一致的。在接受新辅助化疗的患者中,一致性达到100%。然而,PIK3CA突变既与临床病理特征无关,也与临床结果无关:结论:在HR+/HER2- BC中,PIK3CA突变通常会发展为复发性肿瘤。原发肿瘤和相应复发肿瘤的PIK3CA突变状态的高一致性表明,在不易获得复发样本时,检测原发肿瘤可作为一种替代方法。
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引用次数: 0
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Japanese journal of clinical oncology
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