JCO oncology practicePub Date : 2025-03-01Epub Date: 2024-10-01DOI: 10.1200/OP.24.00334
Renata Iskander, Adele Magnan Robart, Hannah Moyer, Ryan Nipp, Arjun Gupta, Jonathan Kimmelman
{"title":"Time Burdens for Participants With Advanced Cancer in Phase I Trials: A Cross-Sectional Study.","authors":"Renata Iskander, Adele Magnan Robart, Hannah Moyer, Ryan Nipp, Arjun Gupta, Jonathan Kimmelman","doi":"10.1200/OP.24.00334","DOIUrl":"10.1200/OP.24.00334","url":null,"abstract":"<p><strong>Purpose: </strong>Participating in phase I cancer clinical trials often entails extra visits and procedures. We describe the planned time and procedures associated with phase I trial participation.</p><p><strong>Methods: </strong>We searched ClinicalTrials.gov for phase I cancer trials of new drugs with assessment schedules and results posted between 2020 and 2022. Trials were included if participants had advanced or metastatic disease. Our primary analysis measured the number of planned research days (PRDs; each day a clinic visit is required) per participant up to the first month of trial participation and for the entire trial duration. Secondarily, we estimated the number of research procedures.</p><p><strong>Results: </strong>Our sample included 71 phase I trials comprising 302 cohorts. These trials enrolled 3,904 participants; the median participation duration was 2.5 months. During screening and up to the first month of participation, the median PRDs per participant was 7 (IQR, 7-10). Across the entire trial, the median PRDs per participant was 4.5 days per month (IQR, 3.30-6.20). Participants spent 15% of trial days attending planned appointments. Per trial cohort, participants were given a median of 8 (IQR, 7-11) physical examinations, 6 (IQR, 3-10) infusions, 6 (IQR, 3-12) electrocardiograms, and 1 (IQR, 1-3) biopsy.</p><p><strong>Conclusion: </strong>Participants commit a substantial amount of time to planned visits in phase I cancer trials, especially in the first month. Overall, they invest 15% of trial days attending planned research activities. These estimates provide a lower bound to the time participants in phase I trials donate to drug development, as our analysis excluded unplanned visits.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"391-399"},"PeriodicalIF":4.7,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142365238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JCO oncology practicePub Date : 2025-03-01Epub Date: 2024-10-15DOI: 10.1200/OP-24-00538
Chirag Shah, Megan Kruse, Zahraa Al-Hilli
{"title":"Reimagining Deintensification for Low-Risk Breast Cancer.","authors":"Chirag Shah, Megan Kruse, Zahraa Al-Hilli","doi":"10.1200/OP-24-00538","DOIUrl":"10.1200/OP-24-00538","url":null,"abstract":"<p><p>As outcomes for low-risk breast cancer continue to improve, research and clinical paradigms are increasingly focused on appropriate deintensification with the goal of improving the therapeutic ratio of breast cancer treatment. These deintensification approaches span across disciplines including breast surgery, radiation therapy, and systemic therapy. With regard to breast surgery, studies have continued to push deintensification when it comes to surgical margins with breast conservation, reducing re-excision rates, whereas deintensification of axillary surgery has reduced the rates of axillary lymph node dissection and increasingly the need for any axillary surgery, including sentinel lymph node biopsy for low-risk patients. With regard to radiation therapy, studies have allowed for a drastic reduction in treatment duration, whereas approaches that reduce the target of treatment have led to a change from from treatment daily for 5-7 weeks to many low-risk patients completing treatment in just five treatments. With regard to systemic therapy, use of genomic assays and tumor biology has led to reduced utilization of cytotoxic chemotherapy, with studies also allowing for dose reduction of endocrine therapy for patients with ductal carcinoma in situ. Moving forward, greater focus should be placed on interdisciplinary deintensification approaches such as the consideration of radiation therapy alone as compared with endocrine therapy alone for low-risk breast cancers.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"323-332"},"PeriodicalIF":4.7,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142465664","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JCO oncology practicePub Date : 2025-03-01Epub Date: 2024-10-02DOI: 10.1200/OP.24.00261
M Kelsey Kirkwood, Caroline Schenkel, Dominique C Hinshaw, Suanna S Bruinooge, David M Waterhouse, Jeffrey M Peppercorn, Ishwaria M Subbiah, Laura A Levit
{"title":"State of Geographic Access to Cancer Treatment Trials in the United States: Are Studies Located Where Patients Live?","authors":"M Kelsey Kirkwood, Caroline Schenkel, Dominique C Hinshaw, Suanna S Bruinooge, David M Waterhouse, Jeffrey M Peppercorn, Ishwaria M Subbiah, Laura A Levit","doi":"10.1200/OP.24.00261","DOIUrl":"10.1200/OP.24.00261","url":null,"abstract":"<p><strong>Purpose: </strong>In this study, we describe the geographic distribution of US cancer treatment trials to identify disparities and opportunities for targeted improvements in access to research for people with cancer.</p><p><strong>Methods: </strong>US-based phase I-III cancer treatment trials registered on ClinicalTrials.gov were tabulated for the years they were open to enrollment (2017-2022), overall and by county, and supplemented with data from the US Census Bureau, National Cancer Institute, Centers for Disease Control and Prevention, and US Department of Agriculture. We evaluated geographic differences in trial availability. We assessed 5-year trends in trials per capita and mapped 1-hour drive time areas around sites.</p><p><strong>Results: </strong>A total of 6,710 trials were open to enrollment in 2022 across 1,836 sites. Trials increased by 4%, whereas sites decreased by 3% annually per capita from 2017. Seventy percent of US counties had no reported active trials in 2022 (2,211/3,143), representing 19% of people age ≥55 years. Eighty-six percent of nonmetropolitan counties had no trials versus 44% of metropolitan counties. Trial availability varied by county-level cancer mortality and social vulnerability (an index derived from demographic and socioeconomic data from the US Census). Eighteen percent of counties without trials had oncologist care sites (n = 618). Notably, 26% of people age ≥55 years lived beyond an hour drive of a site with ≥100 trials.</p><p><strong>Conclusion: </strong>Most US counties have limited to no trial offerings, a disparity magnified in counties that are nonmetropolitan, with high social vulnerability, and with high cancer mortality. Effort to facilitate diverse site participation is needed to promote equitable access to trials and to ensure patients participating in trials match the characteristics of patients who will receive interventions once approved. Counties with oncology care sites but no trials provide potential expansion areas.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"427-437"},"PeriodicalIF":4.7,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11925346/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142365236","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JCO oncology practicePub Date : 2025-03-01Epub Date: 2024-07-22DOI: 10.1200/OP.24.00042
Romain Varnier, Clara Fontaine-Delaruelle, Nathalie Freymond, Aurore Essongue, Anissa Bouali, Gilles Boschetti, Fanny Lebosse, Sophie Tartas, Sarah Milley, Christine Cugnet-Anceau, Etienne Novel-Catin, Bastien Joubert, Emmanuel Massy, Stéphane Dalle, Denis Maillet
{"title":"Evolving Practices in Immune-Related Adverse Event Management: Insights From the IMMUCARE Multidisciplinary Board.","authors":"Romain Varnier, Clara Fontaine-Delaruelle, Nathalie Freymond, Aurore Essongue, Anissa Bouali, Gilles Boschetti, Fanny Lebosse, Sophie Tartas, Sarah Milley, Christine Cugnet-Anceau, Etienne Novel-Catin, Bastien Joubert, Emmanuel Massy, Stéphane Dalle, Denis Maillet","doi":"10.1200/OP.24.00042","DOIUrl":"10.1200/OP.24.00042","url":null,"abstract":"<p><strong>Purpose: </strong>The management of immune-related adverse events (irAEs) requires multidisciplinary boards to handle complex cases. This study aimed to examine the evolving practices of the IMMUCARE board and to evaluate its impact on clinical practices.</p><p><strong>Materials and methods: </strong>The IMMUCARE board gathers oncologists and organ specialists from the Cancerology Institute of the Lyon University Hospital since 2018. We conducted a retrospective analysis of its activity (participants' specialty, referred cases, and recommendations) from 2018 to 2021, coupled with a survey among the physicians who participated.</p><p><strong>Results: </strong>Across 68 board meetings, 245 cases from 195 patients were discussed. Each board had a median of six participants (IQR, 5-8). Participation rates varied across specialties and also over time (participation of nephrologists and rheumatologists significantly increased over time, whereas it decreased for endocrinologists). Most of the referred patients (89%) were treated at our center. Only 4% of referrals concerned eligibility for immune checkpoint inhibitor (ICI), whereas the majority pertained to irAEs. The board recommended ICI interruption for 56% and steroids for 41% of them. Immunosuppressants were recommended in 17% of cases, with a notable increase over time. ICI reintroduction was debated in 50% of cases, and the board identified a definitive contraindication in 26% of them. The survey of 49 of 98 physicians showed that the board significantly affected immunosuppressant introduction and ICI rechallenge decisions. The board's educational and collaborative benefits were highlighted, but time constraints posed challenges.</p><p><strong>Conclusion: </strong>Our 4-year analysis of irAE management practices reveals changing patterns in the distribution of cases presented and in specialists' involvement. Dedicated multidisciplinary boards remain essential, particularly for intricate cases. Expanding access to these boards is crucial to ensure comprehensive care for all patients.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"342-350"},"PeriodicalIF":4.7,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141748162","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JCO oncology practicePub Date : 2025-03-01Epub Date: 2024-09-12DOI: 10.1200/OP.24.00277
Joseph G Schroers-Martin, Ranjana Advani
{"title":"Integrating Novel Agents Into the Clinical Management of Classic Hodgkin Lymphoma.","authors":"Joseph G Schroers-Martin, Ranjana Advani","doi":"10.1200/OP.24.00277","DOIUrl":"10.1200/OP.24.00277","url":null,"abstract":"<p><p>Classic Hodgkin lymphoma (cHL) is highly curable at all stages. Research efforts over the past few decades have largely focused on interim PET-adapted strategies for therapy de-escalation or intensification. The overarching goals have been to increase cure rates, minimize potential therapy-related effects, and optimize survivorship. Better understanding of the biology of cHL has led to the development and approval of effective novel agents including the antibody-drug conjugate brentuximab vedotin and the checkpoint inhibitor immunotherapies. In this review, we discuss recent trial results and how these agents are integrated into clinical practice with the goal of further optimizing outcomes.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"300-312"},"PeriodicalIF":4.7,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142287403","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JCO oncology practicePub Date : 2025-03-01Epub Date: 2024-11-22DOI: 10.1200/OP-24-00870
Atif J Khan, Giacomo Montagna
{"title":"Contextual Framework for Understanding Treatment De-Escalation in Patients With Breast Cancer.","authors":"Atif J Khan, Giacomo Montagna","doi":"10.1200/OP-24-00870","DOIUrl":"10.1200/OP-24-00870","url":null,"abstract":"","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"278-280"},"PeriodicalIF":4.7,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142693008","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JCO oncology practicePub Date : 2025-03-01Epub Date: 2024-09-20DOI: 10.1200/OP-24-00663
Jennifer L Caswell-Jin, Rachel A Freedman, Michael J Hassett, Hao Tang, Elizabeth Garrett-Mayer, Mark R Somerfield, Sharon H Giordano
{"title":"Optimal Adjuvant Chemotherapy and Targeted Therapy for Early Breast Cancer-CDK4/6 Inhibitors: ASCO Rapid Guideline Update Clinical Insights.","authors":"Jennifer L Caswell-Jin, Rachel A Freedman, Michael J Hassett, Hao Tang, Elizabeth Garrett-Mayer, Mark R Somerfield, Sharon H Giordano","doi":"10.1200/OP-24-00663","DOIUrl":"10.1200/OP-24-00663","url":null,"abstract":"","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"287-291"},"PeriodicalIF":4.7,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142287406","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JCO oncology practicePub Date : 2025-03-01Epub Date: 2024-10-10DOI: 10.1200/OP.24.00389
Anne M Walling, Karl A Lorenz, Anita Yuan, Claire E O'Hanlon, Michael McClean, Benjamin Fayyazuddin Ljungberg, Karleen F Giannitrapani, Selen Bozkurt, Sidharth Anand, John Glaspy, Neil S Wenger, Charlotta Lindvall
{"title":"Creating a Learning Health System in a Cancer Center: Generalizability of an Electronic Health Record Phenotype for Advanced Solid Cancer.","authors":"Anne M Walling, Karl A Lorenz, Anita Yuan, Claire E O'Hanlon, Michael McClean, Benjamin Fayyazuddin Ljungberg, Karleen F Giannitrapani, Selen Bozkurt, Sidharth Anand, John Glaspy, Neil S Wenger, Charlotta Lindvall","doi":"10.1200/OP.24.00389","DOIUrl":"10.1200/OP.24.00389","url":null,"abstract":"<p><strong>Purpose: </strong>To test the generalizability of an electronic health record (EHR) phenotype for patients with advanced solid cancer, which was previously developed in a single cancer center.</p><p><strong>Methods: </strong>We compared an algorithm to identify patients with advanced solid cancer from a random sample of patients with active cancer in the Veterans Health Administration (VA) and an academic cancer center with a human-coded reference standard between January 1, 2016, and December 31, 2019.</p><p><strong>Results: </strong>Compared with the human-coded reference standard, the algorithm had high specificity (93%; 95% CI, 87 to 99 and 97%; 95% CI, 93 to 100) and reasonable sensitivity (85%; 95% CI, 76 to 94 and 87%; 95% CI, 77 to 97) in the VA and academic cancer center populations, respectively. Patients with advanced cancer (compared with those with active nonadvanced cancer) had higher mortality at the VA and academic cancer center (29.2% and 17.0% 6-month mortality <i>v</i> 6.8% and 3.5%), respectively.</p><p><strong>Conclusion: </strong>This EHR phenotype can be used to measure and improve the quality of palliative care for patients with advanced cancer within and across health care settings.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"373-379"},"PeriodicalIF":4.7,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142400277","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}