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Predictive Factors of Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer: A Decision Tree Model Approach. 乳腺癌化疗诱发周围神经病变的预测因素:决策树模型方法
IF 3.2 Q2 ONCOLOGY Pub Date : 2024-11-01 Epub Date: 2024-11-14 DOI: 10.1200/GO.24.00160
Juan Adrian Wiranata, Yufi Kartika Astari, Meita Ucche, Susanna Hilda Hutajulu, Dewi Kartikawati Paramita, Dian Caturini Sulistyoningrum, Yudiyanta Siswohadiswasana, Ahmad Asmedi, Mardiah Suci Hardianti, Kartika Widayati Taroeno-Hariadi, Johan Kurnianda, Ibnu Purwanto

Purpose: Chemotherapy-induced peripheral neuropathy (CIPN) poses a substantial challenge in breast cancer (BC) chemotherapy, affecting the patient's quality of life. Recent studies have focused on exploring predictors and patterns of CIPN occurrence. We aimed to develop a prediction model for CIPN occurrence using a classification and regression tree (CART) algorithm.

Methods: In this prospective study of 170 patients with BC undergoing chemotherapy, patient-reported adaptation of the Common Terminology Criteria for Adverse Events version 4.0 was used to assess CIPN occurrence. Multivariable analysis using the CART model was tuned using 10-fold cross-validation to identify baseline predictors for CIPN throughout chemotherapy. A receiver operating characteristic curve analysis was conducted for the CART model. A multivariable logistic regression was conducted from the variables included in the CART model to assess the strength and direction of the association.

Results: The prevalence of CIPN was 64.7% (n = 110). The most decisive predictor of CIPN occurrence in the CART model was the subject's C-reactive protein (CRP) level. CRP level >3.91 mg/dL, BMI >21.85 kg/m2, and a marital status of unmarried have predicted a probability of 100% in CIPN occurrence. The CART model showed an accuracy of 65.9%, sensitivity of 51.7%, specificity of 73.2%, and an area under the curve of 0.705. A CRP level of >3.91 mg/dL and a neutrophil-to-lymphocyte ratio (NLR) of >2.82 are significantly associated with the occurrence of CIPN (odds ratio [OR], 2.01 [95% CI, 1.01 to 4.01]; P = .046, OR, 2.09 [95%, CI, 1.02 to 4.24]; P = .042, respectively).

Conclusion: Baseline CRP, NLR, BMI level, and marital status are significant predictors of CIPN occurrence throughout chemotherapy. Our CART model was better at ruling out individuals who would not experience CIPN. The CART model may provide insight into the future development of individualized patient care and prevention strategies.

目的:化疗诱发的周围神经病变(CIPN)是乳腺癌(BC)化疗中的一大挑战,会影响患者的生活质量。最近的研究主要集中在探索 CIPN 发生的预测因素和模式。我们的目标是利用分类和回归树(CART)算法建立一个 CIPN 发生的预测模型:在这项对170名接受化疗的BC患者进行的前瞻性研究中,采用患者报告的《不良事件通用术语标准4.0版》来评估CIPN的发生情况。使用 10 倍交叉验证对 CART 模型进行了多变量分析,以确定整个化疗过程中 CIPN 的基线预测因素。对 CART 模型进行了接收者操作特征曲线分析。根据CART模型中的变量进行多变量逻辑回归,以评估关联的强度和方向:结果:CIPN的发病率为64.7%(n = 110)。在 CART 模型中,对 CIPN 发生率最具决定性的预测因素是受试者的 C 反应蛋白(CRP)水平。CRP水平>3.91 mg/dL、体重指数>21.85 kg/m2和未婚婚姻状况预测CIPN发生的概率为100%。CART 模型的准确率为 65.9%,灵敏度为 51.7%,特异性为 73.2%,曲线下面积为 0.705。CRP水平>3.91 mg/dL和中性粒细胞与淋巴细胞比值(NLR)>2.82与CIPN的发生显著相关(几率比[OR],2.01 [95% CI,1.01至4.01];P = .046;OR,2.09 [95% CI,1.02至4.24];P = .042):结论:基线CRP、NLR、BMI水平和婚姻状况是整个化疗过程中CIPN发生的重要预测因素。我们的 CART 模型能更好地排除不会出现 CIPN 的个体。CART 模型可为今后制定个体化患者护理和预防策略提供启示。
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引用次数: 0
Aftermath of Nuclear Testing in the Pacific Islands. 太平洋岛屿核试验的后果。
IF 3.2 Q2 ONCOLOGY Pub Date : 2024-11-01 Epub Date: 2024-11-27 DOI: 10.1200/GO-24-00455
Rohan Patel
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引用次数: 0
Global Disparities in the Characteristics and Outcomes of Leukemia Clinical Trials: A Cross-Sectional Study of the ClinicalTrials.gov Database. 白血病临床试验特征和结果的全球差异:ClinicalTrials.gov数据库的横断面研究
IF 3.2 Q2 ONCOLOGY Pub Date : 2024-11-01 Epub Date: 2024-12-02 DOI: 10.1200/GO-24-00316
Abdulrahman Alhajahjeh, Lara K Rotter, Jessica M Stempel, Alyssa A Grimshaw, Jan Philipp Bewersdorf, Ondrej Blaha, Tariq Kewan, Nikolai A Podoltsev, Rory M Shallis, Lourdes Mendez, Maximilian Stahl, Amer M Zeidan

Purpose: Most clinical trials are conducted exclusively in high-income countries (HICs), with only a small fraction involving centers from low-middle income countries (LMICs). However, studies evaluating the global distribution of clinical trials in leukemia are limited. Therefore, we sought to assess the present state of leukemia clinical trials that involve centers from LMICs and to compare those with trials conducted exclusively in HICs.

Materials and methods: We searched ClinicalTrials.gov to identify leukemia trials initiated between 2000 and 2020. In this cross-sectional study, the search strategy was developed by a medical librarian using controlled vocabulary and free-text terms. Data abstraction was independently executed by two reviewers. Trials were defined to be LMIC trials if they included centers from LMICs according to the World Bank Atlas country's income level classification for 2022-2023. Conversely, if a trial included centers from HICs only, the study was classified as a HIC trial.

Results: Of 3,345 leukemia-related clinical trials identified, only 160 (4.8%) included centers from LMICs. Compared with HIC trials, LMIC trials had lower termination rates (12.5% v 27.5%; P < .001) and were more likely randomized (52.5% v 18.2%; P < .001), larger (sample sizes >50 patients: 69.0% v 33.6%; P < .001), multicenter (81.9% v 47.9%; P < .001), and later phase (phase III: 36.2% v 8.98%; P < .001; phase IV: 6.25% v 2.17%; P < .001). There was an increase in the proportion of randomized and diseased-focused clinical trials within the trials that involved LMIC centers between 2000-2005 and 2010-2015 (57.1% v 47.1% and 85.7% v 52.9%; P = .013 and 0.014, respectively).

Conclusion: We found a marked underrepresentation of LMICs in leukemia clinical trials reflecting limited access to novel leukemia therapies in LMICs.

目的:大多数临床试验仅在高收入国家(HICs)进行,只有一小部分涉及中低收入国家(LMICs)的中心。然而,评估白血病临床试验的全球分布的研究是有限的。因此,我们试图评估涉及低收入国家中心的白血病临床试验的现状,并将其与仅在高收入国家进行的试验进行比较。材料和方法:我们检索ClinicalTrials.gov以确定2000年至2020年之间启动的白血病试验。在这个横断面研究中,搜索策略是由一个医学图书管理员使用受控词汇和自由文本术语开发的。数据抽象由两名评审人员独立执行。根据世界银行《地图集》国家2022-2023年收入水平分类,如果试验包括来自中低收入国家的中心,则试验被定义为中低收入国家试验。相反,如果一项试验只包括来自HIC的中心,则该研究被归类为HIC试验。结果:在3345个白血病相关临床试验中,只有160个(4.8%)纳入了低收入国家的研究中心。与HIC试验相比,LMIC试验的终止率较低(12.5% vs 27.5%;P < .001),随机化的可能性更大(52.5% v 18.2%;P < .001),更大(样本量50例:69.0% vs 33.6%;P < 0.001),多中心(81.9% vs 47.9%;P < 0.001),晚期(III期:36.2% v 8.98%;P < .001;第四相:6.25% v 2.17%;P < 0.001)。在2000-2005年和2010-2015年期间,涉及LMIC中心的试验中,随机和以疾病为重点的临床试验的比例有所增加(57.1% vs 47.1%和85.7% vs 52.9%;P = 0.013和0.014)。结论:我们发现低收入国家在白血病临床试验中的代表性明显不足,反映了低收入国家获得新型白血病治疗的机会有限。
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引用次数: 0
Teleophthalmology Through Online Mentorship Over a 20-Year Period: Education and Capacity Building. 20 年间通过在线指导实现远程眼科:教育和能力建设。
IF 3.2 Q2 ONCOLOGY Pub Date : 2024-11-01 Epub Date: 2024-11-14 DOI: 10.1200/GO-24-00297
Sarah E Huemmer, Jennifer L Patnaik, Susan Ybarra, Nathan Congdon, David H Cherwek, Matthew W Wilson

Purpose: Telemedicine is widely used for diabetic retinopathy, retinopathy of prematurity, and other ophthalmic diseases. However, there is limited research on the use of teleophthalmology in retinoblastoma. The goal of this study was to explore how Orbis Cybersight affected the capacity for treatment and management of children with retinoblastoma through online mentorship and to assess the efficacy of online mentoring through disease-specific knowledge change over time.

Methods: A retrospective review of Orbis Cybersight retinoblastoma consultations from 2004 to 2023 was conducted. Each participant was scored from 0 to 39 points on the basis of information provided throughout the consultation. These points were separated into six categories: patient history, clinical findings, grouping/staging, diagnostic findings, treatment plan, and patient and ocular outcomes. Data were analyzed by linear regression models to identify changes over time.

Results: Among 653 patients from 38 different mentees, significant improvement in total points over time was observed (β = .012 [SE, 0.004]; P = .009). The mean score for total points at first consult was 17.7 (standard deviation [SD], 3.5) and at fifth consult was 19.8 (SD, 5.2). Three management categories showed significant improvement: clinical findings (P = .005), grouping/staging (P < .0001), and patient and ocular outcomes (P = .002). However, there was a significant decline in patient history points over time (P = .0006).

Conclusion: Mentorship via Orbis Cybersight improved retinoblastoma disease-specific knowledge and management over a 20-year period. Tele-education provides an opportunity for disease-specific capacity building in low- and middle-income countries for the treatment of retinoblastoma.

目的:远程医疗被广泛应用于糖尿病视网膜病变、早产儿视网膜病变和其他眼科疾病。然而,有关远程眼科在视网膜母细胞瘤中应用的研究却十分有限。本研究旨在探讨 Orbis Cybersight 如何通过在线指导影响视网膜母细胞瘤患儿的治疗和管理能力,并通过特定疾病知识随时间的变化评估在线指导的效果:对2004年至2023年的Orbis Cybersight视网膜母细胞瘤咨询进行了回顾性审查。根据咨询过程中提供的信息,为每位参与者打 0 到 39 分。这些分数被分为六个类别:患者病史、临床发现、分组/分期、诊断结果、治疗计划以及患者和眼部结果。数据通过线性回归模型进行分析,以确定随时间的变化:结果:在来自 38 个不同被指导者的 653 名患者中,观察到总分随着时间的推移有显著提高(β = .012 [SE, 0.004]; P = .009)。首次咨询时总分的平均值为 17.7(标准差 [SD],3.5),第五次咨询时总分的平均值为 19.8(标准差,5.2)。三个管理类别有明显改善:临床结果(P = .005)、分组/分期(P < .0001)以及患者和眼部结果(P = .002)。然而,随着时间的推移,患者病史点数明显下降(P = .0006):结论:通过 Orbis Cybersight 进行的指导在 20 年间改善了视网膜母细胞瘤疾病的特定知识和管理。远程教育为中低收入国家提高治疗视网膜母细胞瘤的特定疾病能力提供了机会。
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引用次数: 0
Deep Diving Into the Fusion Across Cancer Types in the Indian Population From Formalin-Fixed Paraffin-Embedded RNA-Exome Data: A Road to Discovering Novel Rearrangements With Clinical Relevance. 从福尔马林固定石蜡包埋 RNA-Exome 数据深入研究印度人口中不同癌症类型的融合:发现具有临床意义的新型基因重组之路。
IF 3.2 Q2 ONCOLOGY Pub Date : 2024-11-01 Epub Date: 2024-11-21 DOI: 10.1200/GO-24-00289
Satya Prakash Khuntia, Nilesh Mukherjee, Vyomesh Javle, Nishtha AjitSingh Tanwar, Peddagangannagari Sreekanthreddy, Linu Varghese, Pooja Gowda, Anju Kottlahouse, Pratik Chandrani, Anuradha Choughule, Priyanka Pange, Vinod Gupta, Vanita Noronha, Vijay Maruti Patil, Raja Pramanik, Sunil Kumar, Sandeep Peraje Nayak, Suresh Babu, Rohan Shetty, Madan Kantharaju, Pramod Shekarappa Chinder, Aruna Korlimarla, B S Srinath, Kumar Prabhash, Giridharan Periyasamy, Kshitij Datta Rishi, Hitesh Madan Goswami, Vidya Harini Veldore

Purpose: Gene fusions are critical oncogenic mutations that drive cancer development and serve as diagnostic and prognostic biomarkers. Despite the increasing cancer burden in India, large-scale analyses of molecular landscapes, particularly gene fusions, have been relatively scarce.

Materials and methods: This retrospective study used RNA-exome data from 1,392 Indian patients with cancer across 15 major cancer types to explore gene fusions. The study used a comprehensive framework that integrated open-source and proprietary tools to detect gene fusions from formalin-fixed paraffin-embedded tumor samples. The process involved RNA extraction, RNA-exome library preparation, and analysis using tools such as FastQC, DRAGEN RNA Pipeline, STAR-Fusion, and FusionInspector. We validated and filtered potential false-positive fusion calls using AGFusion and FusionAnnotator to annotate fusion breakpoints and their functional impact through various in silico tools.

Results: The study found a notable prevalence of FGFR fusions across cancer types, especially FGFR3, with FGFR3::TACC3 as the most recurrent. Kinase fusions were prevalent in the cohort accounting for 37% of incidence in the patients. We also identified 91 novel potential driver fusions, including those involving FGFR2, MET, ESR1, and PDGFRA.

Conclusion: This study underscores the critical role of gene fusions as biomarkers in cancer, extending beyond fusion-driven malignancies to encompass all cancer types. Gene fusions serve as both diagnostic markers and tumor-agnostic therapeutic targets within the current cancer treatment paradigm. Our insights into the prevalence of oncogenic drivers and novel targets expand the understanding of gene fusions, shedding new light on their mechanisms and clinical implications.

目的:基因融合是关键的致癌突变,可推动癌症的发展,并可作为诊断和预后的生物标志物。尽管印度的癌症负担日益加重,但对分子图谱,尤其是基因融合的大规模分析却相对较少:这项回顾性研究使用了 1,392 名印度癌症患者的 RNA 外显子组数据,涉及 15 种主要癌症类型,以探索基因融合。研究采用了一个综合框架,整合了开源和专有工具,从福尔马林固定石蜡包埋的肿瘤样本中检测基因融合。这一过程涉及 RNA 提取、RNA-外显子组文库制备,以及使用 FastQC、DRAGEN RNA Pipeline、STAR-Fusion 和 FusionInspector 等工具进行分析。我们使用 AGFusion 和 FusionAnnotator 验证并过滤了潜在的假阳性融合调用,通过各种硅学工具注释融合断点及其功能影响:研究发现,FGFR融合在各种癌症类型中非常普遍,尤其是FGFR3,FGFR3::TACC3是最常见的融合。激酶融合在队列中很普遍,占患者发病率的37%。我们还发现了91种新的潜在驱动因子融合,包括涉及FGFR2、MET、ESR1和PDGFRA的融合:这项研究强调了基因融合作为生物标记物在癌症中的关键作用,其范围已从融合驱动的恶性肿瘤扩展到所有癌症类型。在目前的癌症治疗模式中,基因融合既是诊断标志物,也是肿瘤诊断治疗目标。我们对致癌驱动因素和新靶点的深入研究拓展了对基因融合的认识,为其机制和临床意义提供了新的启示。
{"title":"Deep Diving Into the Fusion Across Cancer Types in the Indian Population From Formalin-Fixed Paraffin-Embedded RNA-Exome Data: A Road to Discovering Novel Rearrangements With Clinical Relevance.","authors":"Satya Prakash Khuntia, Nilesh Mukherjee, Vyomesh Javle, Nishtha AjitSingh Tanwar, Peddagangannagari Sreekanthreddy, Linu Varghese, Pooja Gowda, Anju Kottlahouse, Pratik Chandrani, Anuradha Choughule, Priyanka Pange, Vinod Gupta, Vanita Noronha, Vijay Maruti Patil, Raja Pramanik, Sunil Kumar, Sandeep Peraje Nayak, Suresh Babu, Rohan Shetty, Madan Kantharaju, Pramod Shekarappa Chinder, Aruna Korlimarla, B S Srinath, Kumar Prabhash, Giridharan Periyasamy, Kshitij Datta Rishi, Hitesh Madan Goswami, Vidya Harini Veldore","doi":"10.1200/GO-24-00289","DOIUrl":"https://doi.org/10.1200/GO-24-00289","url":null,"abstract":"<p><strong>Purpose: </strong>Gene fusions are critical oncogenic mutations that drive cancer development and serve as diagnostic and prognostic biomarkers. Despite the increasing cancer burden in India, large-scale analyses of molecular landscapes, particularly gene fusions, have been relatively scarce.</p><p><strong>Materials and methods: </strong>This retrospective study used RNA-exome data from 1,392 Indian patients with cancer across 15 major cancer types to explore gene fusions. The study used a comprehensive framework that integrated open-source and proprietary tools to detect gene fusions from formalin-fixed paraffin-embedded tumor samples. The process involved RNA extraction, RNA-exome library preparation, and analysis using tools such as FastQC, DRAGEN RNA Pipeline, STAR-Fusion, and FusionInspector. We validated and filtered potential false-positive fusion calls using AGFusion and FusionAnnotator to annotate fusion breakpoints and their functional impact through various in silico tools.</p><p><strong>Results: </strong>The study found a notable prevalence of FGFR fusions across cancer types, especially FGFR3, with <i>FGFR3::TACC3</i> as the most recurrent. Kinase fusions were prevalent in the cohort accounting for 37% of incidence in the patients. We also identified 91 novel potential driver fusions, including those involving <i>FGFR2</i>, <i>MET</i>, <i>ESR1</i>, and <i>PDGFRA.</i></p><p><strong>Conclusion: </strong>This study underscores the critical role of gene fusions as biomarkers in cancer, extending beyond fusion-driven malignancies to encompass all cancer types. Gene fusions serve as both diagnostic markers and tumor-agnostic therapeutic targets within the current cancer treatment paradigm. Our insights into the prevalence of oncogenic drivers and novel targets expand the understanding of gene fusions, shedding new light on their mechanisms and clinical implications.</p>","PeriodicalId":14806,"journal":{"name":"JCO Global Oncology","volume":"10 ","pages":"e2400289"},"PeriodicalIF":3.2,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142687114","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Low-Dose Anti-PD(L)1 for the Treatment of Solid Malignancies. 治疗实体恶性肿瘤的低剂量抗-PD(L)1。
IF 3.2 Q2 ONCOLOGY Pub Date : 2024-11-01 Epub Date: 2024-11-21 DOI: 10.1200/GO.24.00122
Iza Andrade de A Souza, Beatriz de M Dobbert, Barbara G Sao Jose, Joao Pedro Homse-Netto, Larissa L Furlan, Maira S Abreu, Camila Ferrari, Bruno Uchoa, Kathia Abdallah, Stephano N Lucio, Joao A Soler, Fabio L C Fernandez, Luiza Ferreira, Joao D Guedes, Aline F Fares, Daniel V Araujo

Purpose: Mounting data suggest that lower doses of anti-PD(L)1 agents can be as efficacious as label-approved doses at a fraction of its cost. We compare the outcomes of patients treated with low-dose (LD) and with conventional-dose (CD) anti-PD(L)1 agents.

Methods: This observational study evaluates the outcomes of patients with solid malignancies treated with anti-PD(L)1 agents (LD or CD) at Hospital de Base, Brazil. Patients were classified as receiving LD if the dose administered in the first cycle was below the label-approved dose. Efficacy outcomes, including best clinical overall response rate (cORR), clinical progression-free survival (cPFS), and overall survival (OS), were evaluated.

Results: From January 2020 to May 2023, 71 patients were included: 49 (69%) with LD and 22 (31%) with CD agents. The most frequent tumor sites were the lung (41% LD, 22.9% CD) and skin (melanoma; 24.6% LD, 50% CD). Most of the patients were treated with pembrolizumab (65% LD and 72% CD). The mean dose of pembrolizumab was 95.3 mg (1.5 mg/kg) in LD and 168.7 mg (2.12 mg/kg) in CD groups, once a day, q21d (every 21 days). After a median follow-up of 10.9 months, there were no significant differences between LD versus CD in cORR (38.1% v 35.2%, P = .31), cPFS (5.3 m v 7 m, P = .36), and OS (12.8 m v not reached, P = .17). A subgroup analysis with patients receiving pembrolizumab was performed, and similar results were obtained.

Conclusion: Our study found no differences in cORR, cPFS, and OS between patients treated with LD and CD anti-PD(L)1. LD anti-PD(L)1 could be an alternative to promote accessibility, which warrants further investigation in randomized trials.

目的:越来越多的数据表明,低剂量抗PD(L)1药物的疗效可与标签批准的剂量相媲美,而成本仅为标签批准剂量的一小部分。我们比较了接受低剂量(LD)和常规剂量(CD)抗 PD(L)1 药物治疗的患者的疗效:这项观察性研究评估了巴西基地医院使用抗PD(L)1药物(低剂量或常规剂量)治疗实体恶性肿瘤患者的疗效。如果患者第一周期的用药剂量低于标签批准的剂量,则将其归类为接受LD治疗的患者。疗效结果包括最佳临床总反应率(cORR)、临床无进展生存期(cPFS)和总生存期(OS):结果:2020 年 1 月至 2023 年 5 月,共纳入 71 例患者:49人(69%)使用LD药物,22人(31%)使用CD药物。最常见的肿瘤部位是肺部(41%为LD,22.9%为CD)和皮肤(黑色素瘤;24.6%为LD,50%为CD)。大多数患者接受了pembrolizumab治疗(65%为LD,72%为CD)。LD 组和 CD 组的 pembrolizumab 平均剂量分别为 95.3 毫克(1.5 毫克/千克)和 168.7 毫克(2.12 毫克/千克),每天一次,q21d(每 21 天一次)。中位随访 10.9 个月后,LD 组与 CD 组在 cORR(38.1% 对 35.2%,P = .31)、cPFS(5.3 m 对 7 m,P = .36)和 OS(12.8 m 对未达到,P = .17)方面无显著差异。对接受pembrolizumab治疗的患者进行了亚组分析,结果相似:我们的研究发现,接受LD抗PD(L)1和CD抗PD(L)1治疗的患者在cORR、cPFS和OS方面没有差异。LD anti-PD(L)1 可能是促进可及性的一种替代方法,值得在随机试验中进一步研究。
{"title":"Low-Dose Anti-PD(L)1 for the Treatment of Solid Malignancies.","authors":"Iza Andrade de A Souza, Beatriz de M Dobbert, Barbara G Sao Jose, Joao Pedro Homse-Netto, Larissa L Furlan, Maira S Abreu, Camila Ferrari, Bruno Uchoa, Kathia Abdallah, Stephano N Lucio, Joao A Soler, Fabio L C Fernandez, Luiza Ferreira, Joao D Guedes, Aline F Fares, Daniel V Araujo","doi":"10.1200/GO.24.00122","DOIUrl":"10.1200/GO.24.00122","url":null,"abstract":"<p><strong>Purpose: </strong>Mounting data suggest that lower doses of anti-PD(L)1 agents can be as efficacious as label-approved doses at a fraction of its cost. We compare the outcomes of patients treated with low-dose (LD) and with conventional-dose (CD) anti-PD(L)1 agents.</p><p><strong>Methods: </strong>This observational study evaluates the outcomes of patients with solid malignancies treated with anti-PD(L)1 agents (LD or CD) at Hospital de Base, Brazil. Patients were classified as receiving LD if the dose administered in the first cycle was below the label-approved dose. Efficacy outcomes, including best clinical overall response rate (cORR), clinical progression-free survival (cPFS), and overall survival (OS), were evaluated.</p><p><strong>Results: </strong>From January 2020 to May 2023, 71 patients were included: 49 (69%) with LD and 22 (31%) with CD agents. The most frequent tumor sites were the lung (41% LD, 22.9% CD) and skin (melanoma; 24.6% LD, 50% CD). Most of the patients were treated with pembrolizumab (65% LD and 72% CD). The mean dose of pembrolizumab was 95.3 mg (1.5 mg/kg) in LD and 168.7 mg (2.12 mg/kg) in CD groups, once a day, q21d (every 21 days). After a median follow-up of 10.9 months, there were no significant differences between LD versus CD in cORR (38.1% <i>v</i> 35.2%, <i>P</i> = .31), cPFS (5.3 m <i>v</i> 7 m, <i>P</i> = .36), and OS (12.8 m <i>v</i> not reached, <i>P</i> = .17). A subgroup analysis with patients receiving pembrolizumab was performed, and similar results were obtained.</p><p><strong>Conclusion: </strong>Our study found no differences in cORR, cPFS, and OS between patients treated with LD and CD anti-PD(L)1. LD anti-PD(L)1 could be an alternative to promote accessibility, which warrants further investigation in randomized trials.</p>","PeriodicalId":14806,"journal":{"name":"JCO Global Oncology","volume":"10 ","pages":"e2400122"},"PeriodicalIF":3.2,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142687117","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Radiation Therapist Education and Training: An International Survey. 放射治疗师教育与培训:国际调查。
IF 3.2 Q2 ONCOLOGY Pub Date : 2024-11-01 Epub Date: 2024-11-27 DOI: 10.1200/GO.23.00317
Michelle Leech, Mary Coffey, Jihad Jeha, Gregorius Ben Prajogi, Kimyakhanim Bakhishova, Katie Wakeham

Purpose: This study reports on the current status of Radiation Therapist (RTT) education and training globally. RTTs are the health professionals responsible for the preparation and delivery of courses of radiation therapy, the latter being indicated in the management of 50%-60% of patients with cancer globally. Therefore, high standards of education of these professionals are paramount to safe and high-quality cancer care.

Methods: In total, 195 responses were received to a survey sent via the International Atomic Energy Agency International Research Integration System to all member states. This represented 90 countries across all regions.

Results: The survey indicated a significant deficit in RTT education globally. Many regions report that limited radiation therapy-specific education is available and there is a paucity of assessed practice education. Radiation therapy-specific professional issues are the major barriers to curricula implementation globally.

Conclusion: This survey highlights the considerable issues that prevail in the provision of high-quality education for RTTs globally. A collaborative global effort is required by the oncology community and other stakeholders to overcome this significant deficit.

目的:本研究报告了全球放射治疗师(RTT)教育和培训的现状。放射治疗师是负责准备和提供放射治疗课程的专业医护人员,全球 50%-60%的癌症患者都需要接受放射治疗。因此,对这些专业人员进行高标准的教育对安全和高质量的癌症治疗至关重要:通过国际原子能机构的国际研究集成系统向所有成员国发出调查问卷,共收到 195 份回复。结果:调查结果表明,所有地区的 90 个国家都严重缺乏研究与培训人员:调查显示,全球在放射治疗教育方面存在严重不足。许多地区报告称,放射治疗专业教育有限,而且缺乏经过评估的实践教育。针对放射治疗的专业问题是全球课程实施的主要障碍:这项调查凸显了全球在为放射治疗专业人员提供高质量教育方面普遍存在的大量问题。肿瘤学界和其他利益相关者需要共同努力,克服这一重大缺陷。
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引用次数: 0
Indonesian Society of Gynecologic Oncology Cancer Registration Information System: 10 Years of Implementation, Challenge, and Future. 印度尼西亚妇科肿瘤学会癌症登记信息系统:10 年的实施、挑战与未来》(Indonesian Society of Gynecologic Oncology Cancer Registration Information System: 10 Years of Implementation, Challenge, and Future.
IF 3.2 Q2 ONCOLOGY Pub Date : 2024-11-01 Epub Date: 2024-11-21 DOI: 10.1200/GO.24.00176
Tricia Dewi Anggraeni, Hari Nugroho, Ali Budi Harsono, Tofan Widya Utami, Brahmana Askandar Tjokroprawiro

Purpose: Indonesia still faces high disease burden from cancer and needs valid gynecologic cancer epidemiology data. The Indonesian Society of Gynecologic Oncology (INASGO) established a web-based gynecologic cancer registry. This research aims to observe and report the situation of INASGO cancer registration information system from 2011 to 2021 and provide the most recent data.

Methods: This is a quality assurance research using nonexperimental design and did not perform data manipulation. This study will evaluate comparability, validity, and completeness of cancer registry data. Information was obtained by registration files, direct observation, and interviewing cancer registry supervisors in Cipto Mangunkusumo Hospital, Jakarta.

Results: This cancer registry coded its data according to international standards with many participants and large cases registered. A total of 28,692 cases were reported to the cancer registry. Cervical cancer ranked highest (68.6%) with stage III being the most common found. The most frequent age group at diagnosis is 36-55 years. The most valid basic diagnostic of gynecologic cancer is histology of primary malignancy. The main challenge of the INASGO cancer registry is the lack of data validity and completeness because of poor coordination and financial support.

Conclusion: INASGO cancer registration information system has good prospects to provide data information of patients with gynecologic cancer in policy or research matters. Poor coordination and limited financial support have to be anticipated for the sake of this cancer registry existence in the future.

目的:印尼仍然面临着癌症带来的沉重疾病负担,需要有效的妇科癌症流行病学数据。印度尼西亚妇科肿瘤学会(INASGO)建立了一个基于网络的妇科癌症登记系统。本研究旨在观察和报告2011年至2021年INASGO癌症登记信息系统的情况,并提供最新数据:本研究是一项质量保证研究,采用非实验设计,不进行数据处理。本研究将评估癌症登记数据的可比性、有效性和完整性。信息通过登记档案、直接观察和采访雅加达 Cipto Mangunkusumo 医院癌症登记处主管获得:结果:该癌症登记处按照国际标准对数据进行编码,登记了许多参与者和大型病例。癌症登记处共登记了 28,692 例病例。宫颈癌发病率最高(68.6%),其中最常见的是 III 期宫颈癌。最常见的确诊年龄段为 36-55 岁。妇科癌症最有效的基本诊断方法是原发恶性肿瘤的组织学诊断。INASGO 癌症登记处面临的主要挑战是,由于协调不力和财政支持不足,数据缺乏有效性和完整性:结论:全国非政府组织协会癌症登记信息系统在提供妇科癌症患者的数据信息以用于政策或研究方面具有良好的前景。结论:INASGO 癌症登记信息系统具有良好的前景,可以为政策或研究事项提供妇科癌症患者的数据信息。
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引用次数: 0
Clip and Blue-An Easy and Cost-Effective Prechemotherapy Localization Technique in Patients With Breast Cancer Planned for Breast Conservation. 夹子和蓝光--计划进行乳房保存术的乳腺癌患者简便且经济有效的化疗前定位技术。
IF 3.2 Q2 ONCOLOGY Pub Date : 2024-11-01 Epub Date: 2024-11-27 DOI: 10.1200/GO-24-00242
Teena Sleeba, Subi Ts, Latha Abraham, Sanju Cyriac, Arun Philip, Aswin Joy, Anju Prathap, Naveen George, Susan John, Anand Ebin Thomas

Purpose: Breast conservation after systemic therapy requires accurate localization of the lesion and its margins, especially in nonpalpable tumors. The present study aims to describe a cost-effective technique of tumor localization using the combination of surgical clips and methylene blue.

Methods: A minimum of three or four clips were inserted into the tumor to allow easy visualization of the clip mass. After insertion, measurements of the clips from the nipple and pectoral muscles were recorded to assess for clip migration. After chemotherapy, the disease and clip mass were localized intra-operatively using blue dye. A single-center review of breast conservations performed after neoadjuvant chemotherapy that used the above-described localization technique was undertaken. The primary aim was to assess successful detection and margin-negative resection rates.

Results: The study included 65 patients, and the clip mass was detected on ultrasound following chemotherapy in all patients without clip migration. This detection was accurate even in cases of complete pathological and radiological response. Importantly, there were no procedure-related complications. Postchemotherapy disease localization was successfully achieved in all patients using the readily available and cost-effective methylene blue dye. No patient had an invasive margin positive at resection.

Conclusion: The combination of using multiple surgical clips and methylene blue is not only an extremely cheap and accurate technique for tumor site localization but also ensures precise surgical removal. The technique allows tumor localization even in low-income economies.

目的:全身治疗后的乳房保护需要对病灶及其边缘进行准确定位,尤其是对于无法触及的肿瘤。本研究旨在介绍一种结合使用手术夹和亚甲蓝的经济有效的肿瘤定位技术:方法:在肿瘤中至少插入三到四个夹子,以便于观察夹子块。插入后,记录乳头和胸肌对夹片的测量值,以评估夹片是否移位。化疗后,在术中使用蓝色染料对疾病和夹块进行定位。我们对使用上述定位技术进行新辅助化疗后的保乳手术进行了单中心回顾。主要目的是评估成功检测率和边缘阴性切除率:该研究共纳入 65 例患者,所有患者在化疗后都能通过超声波检测到夹子肿块,且夹子未发生移位。即使在病理和放射学完全反应的病例中,这种检测也是准确的。重要的是,没有出现与手术相关的并发症。所有患者在化疗后都成功地使用了成本低廉的亚甲蓝染料进行了疾病定位。没有患者在切除时出现侵袭性边缘阳性:结论:结合使用多个手术夹和亚甲蓝不仅是一种极其廉价和准确的肿瘤部位定位技术,而且还能确保手术切除的精确性。即使在低收入国家,也能通过该技术进行肿瘤定位。
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引用次数: 0
Cross-Sectional National Survey of Practice Patterns in Radiotherapy for Rectal Cancer: A Snapshot of India. 全国直肠癌放射治疗实践模式横断面调查:印度掠影
IF 3.2 Q2 ONCOLOGY Pub Date : 2024-11-01 Epub Date: 2024-11-21 DOI: 10.1200/GO-24-00410
Rahul Krishnatry, Ashwathy Mathew, Sayan Das, Shagun Misra, Divya Khosla, Jeba Karunya Ramireddy, Shirley Lewis

Purpose: The information on the practice of radiotherapy, including intensity-modulated radiotherapy (IMRT) use for rectal cancer in India, is lacking. This national survey was planned to understand the current status of knowledge, attitudes, and practice among radiation oncologists, specifically concerning the practice of IMRT for rectal cancers.

Materials and methods: A national survey was sent to radiation oncologists through e-mail or a WhatsApp message, where feasible, with a request letter containing the link to the survey questionnaire. The survey questionnaire was adapted from the UK IMRT survey with permission from the authors. It explored rectal cancer management, IMRT use, reasons for nonadoption, total neoadjuvant therapy (TNT), dose fractionation schedules and radiotherapy processes like radiotherapy simulation, target volume/organ at risk definition, and treatment planning, evaluation, and verification. Descriptive statistics is used to present the results.

Results: Over 300 radiation oncologists were approached, and 182 (60.6%) of the 153 institutes responded. Around 88% (160 of 182) indicated using IMRT or volumetric modulated arc therapy (VMAT) to treat rectal cancer, of whom 32% used exclusively IMRT/VMAT in all their patients. The reasons for not adopting IMRT were affordability/lack of insurance, resource constraints, and lack of guidelines. Long-course chemoradiation (capecitabine-based) followed by surgery was the most common neoadjuvant approach, with short course and TNT in less than a third of patients. Daily verification feasibility was reported by 60%. Seventy-three percent emphasized the need for a national IMRT guidance document.

Conclusion: This national survey from India indicates a scope of routine implementation of IMRT in rectal cancer, highlighting the urgent need for a national IMRT guidance document, which could significantly enhance the quality of care for patients with rectal cancer in India.

目的:印度缺乏有关放射治疗实践的信息,包括直肠癌的调强放射治疗(IMRT)。这项全国性调查旨在了解放射肿瘤学家的知识、态度和实践现状,特别是有关直肠癌的调强放射治疗实践:在可行的情况下,通过电子邮件或 WhatsApp 消息向放射肿瘤学家发送全国调查问卷,并附上一封包含调查问卷链接的请求信。调查问卷由英国 IMRT 调查改编而成,并获得了作者的许可。调查内容包括直肠癌的管理、IMRT 的使用、不采用的原因、新辅助治疗(TNT)、剂量分次计划和放疗过程,如放疗模拟、靶体积/危险器官定义、治疗计划、评估和验证。结果采用了描述性统计方法:结果:我们联系了 300 多名放射肿瘤专家,153 家机构中有 182 家(60.6%)做出了回应。约 88% 的医生(182 家中的 160 家)表示使用 IMRT 或容积调制弧形疗法 (VMAT) 治疗直肠癌,其中 32% 的医生在治疗所有患者时完全使用 IMRT/VMAT。未采用 IMRT 的原因包括经济承受能力/缺乏保险、资源限制以及缺乏指南。长程化疗(以卡培他滨为基础)后手术是最常见的新辅助治疗方法,短程化疗和TNT在不到三分之一的患者中使用。60%的患者报告了每日核查的可行性。73%的人强调需要一份全国性的 IMRT 指导文件:这项来自印度的全国性调查表明,IMRT 在直肠癌中的常规实施范围很广,突出表明迫切需要一份全国性的 IMRT 指导文件,这将大大提高印度直肠癌患者的治疗质量。
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引用次数: 0
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JCO Global Oncology
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