American Journal of Clinical Oncology-Cancer Clinical Trials最新文献

{"title":"Unlocking the Mysteries of Breast Cancer: The Role of Epigenetics in Diagnosis, Treatment, and Beyond.","authors":"Zaheer Qureshi, Faryal Altaf, Abdur Jamil, Rimsha Siddique","doi":"10.1097/COC.0000000000001177","DOIUrl":"10.1097/COC.0000000000001177","url":null,"abstract":"<p><strong>Objectives: </strong>Breast cancer is an intricate and varied disease exhibiting a range of molecular subgroups and clinical consequences. Epigenetic alterations have become essential players in the pathophysiology of breast cancer because they control gene expression without changing the DNA sequence. This review provides a comprehensive overview of epigenetics' diagnostic, prognostic, and therapeutic implications in breast cancer. This review aims to present a comprehensive study of the function of epigenetics in breast cancer, emphasizing current developments and potential avenues for future research.</p><p><strong>Methods: </strong>A narrative review methodology involved an extensive literature search and selection to gather relevant studies and trial data. PubMed, Embase, and Web of Science databases were searched using relevant keywords such as \"epigenetics,\" \"breast cancer,\" \"DNA methylation,\" \"histone modification,\" \"noncoding RNA,\" and \"linical trials.\" Relevant studies and clinical trial data were selected and synthesized to summarize the topic comprehensively.</p><p><strong>Results: </strong>The review synthesizes critical findings from current research, underscoring the pivotal role of epigenetic mechanisms in breast cancer initiation, progression, and therapeutic response. It highlights the potential of epigenetic biomarkers for diagnosis and prognosis and the promise of epigenetic-targeted therapies in breast cancer management. Furthermore, the review outlines future directions for research, emphasizing the importance of elucidating the dynamic interplay between epigenetic alterations and tumor microenvironments in shaping breast cancer phenotypes.</p><p><strong>Conclusions: </strong>Epigenetic modifications influence breast cancer progression, diagnosis, and therapy. Emerging biomarkers and targeted treatments hold promise, but further research is essential to refine their clinical application and improve personalized cancer management strategies.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"276-282"},"PeriodicalIF":1.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143538058","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Statewide Social Vulnerability Index (SVI) in Human Papillomavirus-Associated Oropharyngeal Squamous Cell Carcinoma.","authors":"Asher C Park, Shravan Asthana, Abhinav Talwar, Kirsten Burdett, Laila Gharzai, Urjeet Patel, Sandeep Samant, Katelyn O Stepan","doi":"10.1097/COC.0000000000001216","DOIUrl":"https://doi.org/10.1097/COC.0000000000001216","url":null,"abstract":"<p><strong>Objectives: </strong>To investigate the association between social determinants of health, as measured by the social vulnerability index (SVI), with outcomes in patients with human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC).</p><p><strong>Methods: </strong>This study included patients from Illinois with HPV-OPSCC from 2007 to 2022. State-level SVI measured neighborhood-level disadvantage and associations between SVI and clinicodemographic factors, clinical presentation, and outcomes were analyzed using logistic regression for advanced preliminary staging, while survival and recurrence were assessed within the framework of a Cox proportional hazards model.</p><p><strong>Results: </strong>Higher overall (high vulnerability) and racial-ethnicity SVI scores were significantly associated with increased odds of advanced clinical staging (OR=1.12, P=0.041; OR=1.16, P=0.026) on univariable analysis. Multivariable analysis showed that minority race was significantly associated with advanced clinical staging (OR=5.50, P<0.001). Overall survival was significantly associated with insurance payer type and age, where Medicaid/uninsured status had higher mortality compared with Medicare in both the univariable and multivariable setting (HR=4.47, P=0.006; HR=7.93, P=0.019). The same held for age, where increased age at diagnosis was significantly associated with higher mortality (HR=1.07, P<0.001; HR=1.10, P<0.001). Recurrence-free survival was significantly associated with age (HR=1.04, P=0.004) and payer type, with Medicaid/uninsured patients having 4 times the hazard of patients with Medicare (HR=4.16, P=0.009).</p><p><strong>Conclusions: </strong>Higher overall and racial ethnicity SVI may be associated with advanced clinical staging upon presentation. Individual factors such as race, age, and insurance status are significantly associated with patient prognosis.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144121456","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Metabolic Plasticity in Prostate Cancer: The Warburg Effect and Its Clinical Relevance.","authors":"Arielle Sabbah, Guila Delouya, Mikhael Laskine, Daniel Taussky","doi":"10.1097/COC.0000000000001215","DOIUrl":"https://doi.org/10.1097/COC.0000000000001215","url":null,"abstract":"<p><strong>Objectives: </strong>This paper examines the life and research of Otto Warburg (1883 to 1970), who identified the so-called Warburg effect. Warburg personal life and scientific career were notable.</p><p><strong>Methods: </strong>This study summarizes the key aspects of his life, the Warburg effect, and its significance in prostate cancer.</p><p><strong>Results: </strong>Despite being classified as non-Aryan, Warburg continued his research as the director of the Kaiser Wilhelm Institute for Cell Physiology during World War II. He also cohabited openly with a male partner. The Warburg effect is a metabolic hallmark of cancer, where cells preferentially utilize glycolysis over oxidative phosphorylation, even in the presence of oxygen. This metabolic shift confers key advantages to tumor survival, including rapid ATP production, biosynthetic support for proliferation, and resistance to apoptosis. In prostate cancer, the metabolism undergoes a unique transformation. Normal prostate cells are characterized by citrate secretion; however, as malignancy develops, the cells adapt to oxidative metabolism. At the metastatic stage, the Warburg effect becomes more pronounced and is influenced by the tumor microenvironment and interactions with cancer-associated fibroblasts and bone marrow adipocytes. These metabolic changes have significant clinical implications. While FDG-PET scans serve as a diagnostic tool in many cancers, their utility in early-stage prostate cancer is limited owing to its delayed metabolic shift. Metabolic-targeted therapies, such as dichloroacetate (DCA) and glycolysis inhibitors, are emerging as promising strategies to enhance the efficacy of chemotherapy and radiotherapy.</p><p><strong>Conclusions: </strong>Elucidating the role of metabolic reprogramming in prostate cancer could reveal new avenues for treatment, particularly for castration-resistant and metastatic diseases.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144081854","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and Safety of Chimeric Antigen Receptor (CAR)-T Cell Therapy in Patients with Non-Hodgkin Lymphoma: A Systematic Review and Meta-Analysis.","authors":"Abdur Jamil, Zaheer Qureshi, Rimsha Siddique, Faryal Altaf, Hamzah Akram, Rohma Jamil, Shehroz Aslam, Insija I Selene","doi":"10.1097/COC.0000000000001171","DOIUrl":"10.1097/COC.0000000000001171","url":null,"abstract":"<p><strong>Objectives: </strong>Non-Hodgkin lymphomas (NHL) are a diverse group of lymphoproliferative malignancies, often more unpredictable than Hodgkin lymphomas, with a higher likelihood of extranodal spread. NHL's resistance to standard chemotherapy has increased, leading to a growing interest in personalized treatments like chimeric antigen receptor T-cell therapies (CAR-TCT).</p><p><strong>Methods: </strong>A literature search was conducted across PubMed, ScienceDirect, Google Scholar, and the Cochrane Library for studies on CAR-TCT in NHL treatment published until July 2024. The outcomes assessed included overall survival (OS), event-free survival (EFS), progression-free survival (PFS), objective response rate (ORR), and adverse events (AEs). Data were pooled using RevMan 5.41 and Comprehensive Meta-analysis 3.</p><p><strong>Results: </strong>Out of 532 articles, 8 met the inclusion criteria. CAR-TCT significantly improved OS (HR: 0.79; 95% CI: 0.63-1.00; P =0.05) and PFS (HR: 0.46; 95% CI: 0.36-0.58; P <0.00001) compared with standard chemotherapy. However, EFS was not significantly different (HR: 0.54; 95% CI: 0.26-1.09; P =0.09). About 76.6% of NHL patients responded to CAR-TCT, but the ORR was similar between CAR-TCT and standard therapy (MD: 19.23%; 95% CI: -11.34% to 49.80%; P =0.22). Safety analysis found a grade ≥3 AEs incidence comparable to CAR-TCT and standard care. However, CAR-TCT was associated with higher neutropenia risk but lower thrombocytopenia, anemia, and nausea risks.</p><p><strong>Conclusion: </strong>CAR-TCT significantly improves OS and PFS in refractory NHL but does not notably impact EFS. While its ORR is comparable to standard chemotherapy, CAR-TCT has a better safety profile, making it a promising treatment option.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"262-270"},"PeriodicalIF":1.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143383999","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Trends and Disparities in Acute Lymphoblastic Leukemia-Related Mortality in the United States from 1999 to 2020: Insights From the Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research Database.","authors":"Shahzaib Ahmed, Eeman Ahmad, Hamza Ashraf, Haider Ashfaq, Umar Akram, Shoaib Ahmad","doi":"10.1097/COC.0000000000001162","DOIUrl":"10.1097/COC.0000000000001162","url":null,"abstract":"<p><strong>Objectives: </strong>The incidence of acute lymphoblastic leukemia (ALL) shows a bimodal distribution, with the first peak in children under 10 years old and the second in adults. It is imperative to understand disparities in ALL-related mortality.</p><p><strong>Methods: </strong>ALL-related mortality trends in the United States from 1999 to 2020 were studied by extracting age-adjusted mortality rates (AAMRs) from the Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research database. Changes in AAMR were evaluated by calculating annual percentage change (APC) and average APC using Joinpoint regression.</p><p><strong>Results: </strong>A total of 35,056 ALL-related deaths were reported. The AAMR declined from 1999 to 2020 (APC: -0.65). Men exhibited a higher AAMR (0.59) than women (0.43). Hispanic or Latinos exhibited the highest AAMR (0.75), followed by non-Hispanic (NH) whites (0.47), NH black or African Americans (0.37), and NH Asian or Pacific Islanders (0.35). Among census regions, the West was observed to have the highest AAMR (0.59), followed by the South (0.49), the Midwest (0.47), and the Northeast (0.45). California had the highest AAMR (0.64), while the District of Columbia had the lowest (0.40). Stratification by urbanization revealed a higher overall AAMR in rural areas (0.52) than in urban areas (0.48). A majority of the deaths occurred in medical facilities (63.52%).</p><p><strong>Conclusions: </strong>Even though a decrease was observed in ALL-related mortality in the United States from 1999 to 2020, disparities were identified in trends stratified by sex, race, census regions, and urbanization. It is essential to direct efforts towards high-risk populations to ensure a decrease in ALL-related mortality across the board.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"215-221"},"PeriodicalIF":1.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143069325","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bruton Tyrosine Kinase Degraders: Current Concepts.","authors":"Giorgi Sabakhtarishvili, Mouza Alshebli, Omer Bajwa, Imad A Tabbara","doi":"10.1097/COC.0000000000001170","DOIUrl":"10.1097/COC.0000000000001170","url":null,"abstract":"<p><p>Bruton tyrosine kinase (BTK) is a key enzyme involved in B-cell development and signaling, making it a crucial target in the treatment of B-cell malignancies, such as chronic lymphocytic leukemia and non-Hodgkin lymphoma. While BTK inhibitors (BTKi), such as ibrutinib, have been effective, resistance-both intrinsic and acquired-poses a significant challenge, often associated with BTK mutations like C481S. To address this, novel BTK degraders have been developed, leveraging proteolysis-targeting chimeras to selectively degrade both wild-type and mutant BTK forms. This approach offers a promising strategy to overcome BTKi resistance. Agents such as NRX-0492, BGB-16673, NX-5948, NX-2127, HZ-Q1060, ABBV-101, and AC676 have shown significant BTK degradation in preclinical and early clinical trials. NRX-0492 demonstrated over 90% BTK degradation with sustained pharmacodynamic effects, whereas BGB-16673 achieved clinical responses in 67% of patients with relapsed/refractory B-cell malignancies. Similarly, NX-5948 and NX-2127 showed potent BTK degradation, with NX-2127, in addition, targeting immunomodulatory proteins, resulting in partial and stable responses in chronic lymphocytic leukemia and non-Hodgkin lymphoma patients. HZ-Q1060, a preclinical candidate, displayed rapid and sustained BTK degradation in vivo. Early-phase trials of ABBV-101 and AC676 are also showing promising results. These BTK degraders have demonstrated favorable safety profiles, with manageable adverse events, and offer a novel therapeutic avenue for patients with BTKi-resistant malignancies. As clinical trials progress, these degraders hold the potential to significantly enhance treatment outcomes, offering a new frontier in personalized cancer therapy.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"257-261"},"PeriodicalIF":1.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143416113","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cardiovascular Risk Profile of Nivolumab Anti-cancer Therapy: A Review of Current Literature.","authors":"Zaheer Qureshi, Zaofashan Zaheer, Zoha Asghar, Muhammad Bakhtiar, Eeshal Fatima, Faryal Altaf","doi":"10.1097/COC.0000000000001166","DOIUrl":"10.1097/COC.0000000000001166","url":null,"abstract":"<p><strong>Objectives: </strong>Immune checkpoint inhibitors (ICI) upregulate host antitumor immunity, proving efficacy across diverse tumor types. Currently approved ICI treatment primarily targets the programmed cell death receptor 1 (PD-1) and its ligand PD-L1, and cytotoxic T lymphocyte-antigen 4 (CTLA-4). Nivolumab is a monoclonal antibody that targets the human PD-1 receptor and is an entirely human immunoglobulin G4 (IgG4), approved by the FDA for various cancers like advanced melanoma, metastatic renal cell carcinoma, Hodgkin lymphoma, and advanced lung carcinoma. This review will summarise and discuss the recent literature on cardiotoxicity associated with nivolumab therapy.</p><p><strong>Methods: </strong>We searched online databases like PubMed, Scopus, Google Scholar, and Embase for articles related to Nivolumab.</p><p><strong>Results: </strong>Cardiotoxicity with ICI use is most commonly represented as myocarditis. Patients present with complaints of shortness of breath, palpitations, edema, and fatigue. Takotsubo cardiomyopathy, or broken heart syndrome, is characterized by systolic dysfunction of the left ventricle, mimicking a myocardial infarction but without associated coronary ischemia and with minimal elevation of cardiac enzymes. In the CHECKMATE-037 trial, ventricular arrhythmias occurred in <10% of those who received nivolumab. In a retrospective analysis of patients treated with ICI (predominantly nivolumab monotherapy) for lung cancer, 11% of the patients developed major adverse cardiac events, including myocarditis, non-ST-segment elevated myocardial infarction, supraventricular tachycardia, and pericardial disorders.</p><p><strong>Conclusion: </strong>Close collaboration between cardiology and oncology specialists is crucial for early detection and effective management of cardiac complications, enhancing the safety of nivolumab anticancer therapy.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"235-241"},"PeriodicalIF":1.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143505843","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Meta-analysis of Therapeutic Approaches in Acute Myeloid Leukemia: Unveiling Trends and Predictors of Treatment Response.","authors":"Zaheer Qureshi, Abdur Jamil, Faryal Altaf, Rimsha Siddique","doi":"10.1097/COC.0000000000001169","DOIUrl":"10.1097/COC.0000000000001169","url":null,"abstract":"<p><strong>Objective: </strong>To elucidate emerging trends and predictors for optimizing treatment strategies for acute myeloid leukemia (AML).</p><p><strong>Method: </strong>A literature search was conducted on PubMed, Embase, Web of Science, and Google Scholar databases. Bias assessment was conducted using Cochrane's risk of bias tool, while statistical analyses were performed using Review Manager and Comprehensive Meta-Analysis software.</p><p><strong>Results: </strong>We included 44 studies and the pooled results showed that high-dose cytarabine (HDAC) in induction therapy significantly improved the complete remission (CR) rate than standard-dose cytarabine (SDAC) in younger adults but not older adults (OR: 1.29, 95% CI: 1.12-1.49, P =0.0004 and OR: 1.02, 95% CI: 0.80-1.29, P =0.87, respectively). In consolidation therapy, HDAC showed a significant benefit in event-free survival (EFS) over SDAC (RR: 1.30, 95% CI: 1.04-1.62, P =0.02). The pooled analysis also revealed that idarubicin (IDR) was associated with improved CR rates than daunorubicin (DNR) (OR: 1.34, 95% CI: 1.02-1.76, P =0.04). However, the results do not substantiate the claim that IDR is better than mitoxantrone (MTZ) or that DNR is superior to MTZ in inducing CR (OR: 0.88, 95% CI: 0.72-1.08, P =0.22 and OR: 0.85, 95% CI: 0.72-1.01, P =0.06, respectively). The evidence has also shown that the pooled composite complete response (CRc) rates for FLT3 inhibitors such as sorafenib, gilteritinib, and quizartinib were 56%, 31%, and 36%, respectively. The pooled results further showed that the overall CRc for patients receiving IDH inhibitors and immune checkpoint inhibitors were 49.6% (95% CI: 37-63) and 26% (95% CI: 18.7-35), respectively.</p><p><strong>Conclusion: </strong>Chemotherapy, targeted therapy, and immunotherapy are valuable treatment options for AML patients. However, the efficacy of these AML treatments may vary depending on AML status and patient characteristics such as age and cytogenetic risk.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"242-256"},"PeriodicalIF":1.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143755684","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of Control Arm Quality in Recent Radiation Oncology Randomized Clinical Trials.","authors":"Ifeanyi O Ekpunobi, Laura E Flores, Reshma Jagsi, Shearwood McClelland","doi":"10.1097/COC.0000000000001168","DOIUrl":"10.1097/COC.0000000000001168","url":null,"abstract":"<p><strong>Background: </strong>For randomized controlled trials (RCTs) to provide the highest levels of evidence for clinical practice, it is ethically imperative for patients assigned to the control arm to receive standard-of-care treatment. Oncologic medical trials investigating new systemic agents have demonstrated a high proportion of RCTs with inadequate control arms. It is unknown whether this finding is prevalent in oncologic trials investigating radiation therapy (RT) for cancer.</p><p><strong>Methods: </strong>ClinicalTrials.gov was queried for registered clinical trials investigating RT in patients with cancer from 2013 to 2023. Each control arm was analyzed, with the standard of care determined by National Comprehensive Cancer Center Network (NCCN) guidelines at the time of initial trial posting.</p><p><strong>Results: </strong>Five hundred eight interventional studies with results registered were included, of which 12 met inclusion criteria for final analysis. Two trials each investigated RT usage in central nervous system, prostate, head and neck, and breast disease sites, and 1 each for lung, hepatobiliary, rectal, and bone disease sites. Most trials were industry-funded (83%); 75% of studies took place in the United States. Hundred percent of trials had an adequate control arm per the corresponding NCCN guidelines.</p><p><strong>Conclusion: </strong>All recently completed oncologic RCTs investigating RT for cancer involved an adequate control arm. This finding contrasts with the high proportion of inadequate control arms in medical oncology trials. These findings suggest that adequate control arm treatments are feasible to achieve in trial design, emphasizing both the need for continued focus on improving the quality of ethical oncologic research trials and a possible subspecialty that may serve as an exemplar.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"230-234"},"PeriodicalIF":1.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143383984","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Consensus Guidelines, Clinical Trials, and COVID-19 on Fractionation Practices for Node-negative Intact Breast Cancer.","authors":"Jessica Cruttenden, Jonathan Grant, Jaden Evans, George Cannon, David K Gaffney, Matthew Poppe, Lindsay M Burt, Vilija Avizonis, Dustin Boothe","doi":"10.1097/COC.0000000000001167","DOIUrl":"10.1097/COC.0000000000001167","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate whether hypofractionated radiotherapy (HF-RT) in node-negative intact breast cancer significantly increased after guideline updates, trial publications, and COVID-19.</p><p><strong>Methods: </strong>Patients with node-negative breast cancer undergoing lumpectomy and adjuvant RT were identified in the National Cancer Database. Receiving ≥25 and <50 Gy in 5-20 fractions defined HF-RT. Receiving 50 to 66 Gy in >20 fractions defined conventional RT (CF-RT). Patient characteristics were compared with X 2 testing. Joinpoint analysis identified when fractionation significantly changed. Variables associated with HF-RT were identified by univariate and multivariate (MVA) logistic regression. Two-sided P -value <0.05 was significant.</p><p><strong>Results: </strong>Patients meeting criteria totaled 236,336; 54.8% received CF-RT and 45.2% HF-RT. HF-RT and 5-fraction RT significantly increased after 2015 and 2019, respectively ( P <0.05). On MVA, HF-RT was positively associated with: age older than or equal to 65 years (OR 2.14, P <0.001); private insurance (OR 1.27, P =0.03); treatment in Midwest (OR 1.66, P <0.001) or Western United States (US) (OR 3.77, P <0.001); distance ≥50 miles (OR 1.16, P =0.001); later year of diagnosis (OR 1.44, P <0.001); and partial breast irradiation (OR 2.08, P <0.001). HF-RT was negatively associated with: community (OR 0.49, P <0.001) or integrated network (0.55, P <0.001) centers; grade 2 (OR 0.83, P <0.001) or 3 (OR 0.49, P <0.001), hormone receptor negative (OR 0.66, P <0.001), and HER2+ (OR 0.74, P <0.001) disease; positive surgical margins (OR 0.61, P <0.001); and presence of lympho-vascular invasion (OR 0.86, P <0.001).</p><p><strong>Conclusions: </strong>HF-RT in node-negative intact breast cancer increased after 2015, coinciding with US and European guideline updates. Five-fraction RT increased after 2019, coinciding with COVID-19 and FAST-Forward trial results.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"222-229"},"PeriodicalIF":1.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143124051","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}