Pub Date : 2024-11-01Epub Date: 2024-11-14DOI: 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.
{"title":"Predictive Factors of Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer: A Decision Tree Model Approach.","authors":"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","doi":"10.1200/GO.24.00160","DOIUrl":"https://doi.org/10.1200/GO.24.00160","url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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/m<sup>2</sup>, 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]; <i>P</i> = .046, OR, 2.09 [95%, CI, 1.02 to 4.24]; <i>P</i> = .042, respectively).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":14806,"journal":{"name":"JCO Global Oncology","volume":"10 ","pages":"e2400160"},"PeriodicalIF":3.2,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142621081","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}
Pub Date : 2024-11-01Epub Date: 2024-11-27DOI: 10.1200/GO-24-00455
Rohan Patel
{"title":"Aftermath of Nuclear Testing in the Pacific Islands.","authors":"Rohan Patel","doi":"10.1200/GO-24-00455","DOIUrl":"https://doi.org/10.1200/GO-24-00455","url":null,"abstract":"","PeriodicalId":14806,"journal":{"name":"JCO Global Oncology","volume":"10 ","pages":"e2400455"},"PeriodicalIF":3.2,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142739235","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}
Pub Date : 2024-11-01Epub Date: 2024-12-02DOI: 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。
{"title":"Global Disparities in the Characteristics and Outcomes of Leukemia Clinical Trials: A Cross-Sectional Study of the ClinicalTrials.gov Database.","authors":"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","doi":"10.1200/GO-24-00316","DOIUrl":"10.1200/GO-24-00316","url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Materials and methods: </strong>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.</p><p><strong>Results: </strong>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% <i>v</i> 27.5%; <i>P</i> < .001) and were more likely randomized (52.5% <i>v</i> 18.2%; <i>P</i> < .001), larger (sample sizes >50 patients: 69.0% <i>v</i> 33.6%; <i>P</i> < .001), multicenter (81.9% <i>v</i> 47.9%; <i>P</i> < .001), and later phase (phase III: 36.2% <i>v</i> 8.98%; <i>P</i> < .001; phase IV: 6.25% <i>v</i> 2.17%; <i>P</i> < .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% <i>v</i> 47.1% and 85.7% <i>v</i> 52.9%; <i>P</i> = .013 and 0.014, respectively).</p><p><strong>Conclusion: </strong>We found a marked underrepresentation of LMICs in leukemia clinical trials reflecting limited access to novel leukemia therapies in LMICs.</p>","PeriodicalId":14806,"journal":{"name":"JCO Global Oncology","volume":"10 ","pages":"e2400316"},"PeriodicalIF":3.2,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142769051","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}
Pub Date : 2024-11-01Epub Date: 2024-11-14DOI: 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.
{"title":"Teleophthalmology Through Online Mentorship Over a 20-Year Period: Education and Capacity Building.","authors":"Sarah E Huemmer, Jennifer L Patnaik, Susan Ybarra, Nathan Congdon, David H Cherwek, Matthew W Wilson","doi":"10.1200/GO-24-00297","DOIUrl":"https://doi.org/10.1200/GO-24-00297","url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>Among 653 patients from 38 different mentees, significant improvement in total points over time was observed (β = .012 [SE, 0.004]; <i>P</i> = .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 (<i>P</i> = .005), grouping/staging (<i>P</i> < .0001), and patient and ocular outcomes (<i>P</i> = .002). However, there was a significant decline in patient history points over time (<i>P</i> = .0006).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":14806,"journal":{"name":"JCO Global Oncology","volume":"10 ","pages":"e2400297"},"PeriodicalIF":3.2,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142621141","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}
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.
{"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}
Pub Date : 2024-11-01Epub Date: 2024-11-21DOI: 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.
{"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}
Pub Date : 2024-11-01Epub Date: 2024-11-27DOI: 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.
{"title":"Radiation Therapist Education and Training: An International Survey.","authors":"Michelle Leech, Mary Coffey, Jihad Jeha, Gregorius Ben Prajogi, Kimyakhanim Bakhishova, Katie Wakeham","doi":"10.1200/GO.23.00317","DOIUrl":"10.1200/GO.23.00317","url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":14806,"journal":{"name":"JCO Global Oncology","volume":"10 ","pages":"e2300317"},"PeriodicalIF":3.2,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142739457","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}
Pub Date : 2024-11-01Epub Date: 2024-11-21DOI: 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.
{"title":"Indonesian Society of Gynecologic Oncology Cancer Registration Information System: 10 Years of Implementation, Challenge, and Future.","authors":"Tricia Dewi Anggraeni, Hari Nugroho, Ali Budi Harsono, Tofan Widya Utami, Brahmana Askandar Tjokroprawiro","doi":"10.1200/GO.24.00176","DOIUrl":"https://doi.org/10.1200/GO.24.00176","url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":14806,"journal":{"name":"JCO Global Oncology","volume":"10 ","pages":"e2400176"},"PeriodicalIF":3.2,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142687116","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}
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.
{"title":"Clip and Blue-An Easy and Cost-Effective Prechemotherapy Localization Technique in Patients With Breast Cancer Planned for Breast Conservation.","authors":"Teena Sleeba, Subi Ts, Latha Abraham, Sanju Cyriac, Arun Philip, Aswin Joy, Anju Prathap, Naveen George, Susan John, Anand Ebin Thomas","doi":"10.1200/GO-24-00242","DOIUrl":"https://doi.org/10.1200/GO-24-00242","url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":14806,"journal":{"name":"JCO Global Oncology","volume":"10 ","pages":"e2400242"},"PeriodicalIF":3.2,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142739244","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}
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.
{"title":"Cross-Sectional National Survey of Practice Patterns in Radiotherapy for Rectal Cancer: A Snapshot of India.","authors":"Rahul Krishnatry, Ashwathy Mathew, Sayan Das, Shagun Misra, Divya Khosla, Jeba Karunya Ramireddy, Shirley Lewis","doi":"10.1200/GO-24-00410","DOIUrl":"https://doi.org/10.1200/GO-24-00410","url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Materials and methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":14806,"journal":{"name":"JCO Global Oncology","volume":"10 ","pages":"e2400410"},"PeriodicalIF":3.2,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142687113","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}