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

{"title":"A Phase II Trial to Assess the Evolution of the KRAS Mutation Load by Liquid Biopsy in Patients With Resectable Pancreatic Ductal Adenocarcinoma Treated With Neoadjuvant NALIRIFOX.","authors":"Rafael Álvarez-Gallego, Teresa Macarulla, Berta Laquente, Paloma Peinado, Florian Castet, Cesar Muñoz, Carles Fabregat-Franco, Lisardo Ugidos, Sharela Vega, Juli Busquets, Enrique Sanz-García, Carmen Toledano, Yolanda Quijano, Emilio Vicente, Antonio Cubillo","doi":"10.1097/COC.0000000000001253","DOIUrl":"10.1097/COC.0000000000001253","url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate the association between the KRAS mutational load and the histologic tumor response in patients with resectable pancreatic ductal adenocarcinoma (PDAC) who received neoadjuvant treatment (NAC) with pegylated liposomal irinotecan in combination with oxaliplatin, 5-fluorouracil, and leucovorin (NALIRIFOX).</p><p><strong>Methods: </strong>This was a multicenter, single-arm, interventional, open-label, phase 2 trial in patients 18 years or older who had histologically or cytologically confirmed PDAC and were candidates for surgery and received neoadjuvant NALIRIFOX. The primary outcome was determination of the association between the KRAS mutational load and the histologic tumor response after chemotherapy.</p><p><strong>Results: </strong>Twenty patients were included in the study. Before initiating NAC, 11 patients were KRAS+, 6 were KRAS-, and 3 were not evaluable for KRAS mutation status. Eight of the 11 (72.7%) patients changed from KRAS+ at baseline to KRAS- after treatment, and none of the 6 (0.0%) patients changed from KRAS- at baseline to KRAS+ after treatment. A good histopathologic response after NAC was observed in 3 (15%) of the 20 patients, with a greater proportion of good responses among patients who were KRAS- (3 out of 16 [18.8%]) than among those who were KRAS+ (0 out of 1 [0.0%]) after NAC, although the differences were not statistically significant ( P =0.633).</p><p><strong>Conclusions: </strong>Our results indicate that patients with potentially resectable PDAC tend to have detectable KRAS in the blood if the disease is locally more advanced and that most patients who are treated with neoadjuvant NALIRIFOX are negative for KRAS at the end of therapy.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"157-162"},"PeriodicalIF":1.8,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145031162","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 Neutrophil to Lymphocyte Ratio in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma Treated With a Combination of Cetuximab and Nivolumab in a Phase II Clinical Trial.","authors":"Robin Park, Fahad Rind, Tyler Kristoff, Jiannong Li, Michael Schell, Robbert J C Slebos, Sowjanya Thatikonda, Ritu Chaudhary, Maria I Biernacki, Yeva Meshkovska, David Kaldas, Hyun-Su Kim, Joaquim Farinhas, Juan Hernandez-Prera, Kedar Kirtane, MacLean S Hall, Antonio L Amelio, James W Rocco, Priyanka Bhateja, Conor Steuer, Marcelo Bonomi, Nabil F Saba, Christine H Chung","doi":"10.1097/COC.0000000000001255","DOIUrl":"10.1097/COC.0000000000001255","url":null,"abstract":"<p><strong>Objectives: </strong>We report on the biomarker analyses focusing on neutrophil-to-lymphocyte ratios (NLR) in patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) treated with combined cetuximab and nivolumab.</p><p><strong>Methods: </strong>Data were obtained from a phase II trial (NCT03370276). Peripheral blood NLR was obtained at baseline (B-NLR) and on-treatment (OT-NLR; 1 mo from treatment initiation). Tumor NLR (T-NLR) was determined by staining of immune cells in primary tumors. Patients were stratified into high (≥median) or low NLR (<median). The association between NLR with survival outcomes was evaluated.</p><p><strong>Results: </strong>While B-NLR did not correlate with survival or responses, low OT-NLR was associated with superior overall survival (OS; P <0.0001), progression-free survival (PFS; P =0.0002), and overall response ( P <0.001) compared with high OT-NLR. Multivariable analysis further demonstrated that low OT-NLR was associated with superior OS (HR 0.32, 95% CI, 0.17-0.61) and PFS (HR 0.45, 95% CI, 0.25-0.81). Compared with patients with high OT-NLR, a higher proportion of patients with low OT-NLR had OS≥24 months ( P =0.0001). Low OT-NLR was associated with higher baseline PD-L1 combined positive scores ( P =0.037). Low pretreatment T-NLR was associated with superior OS and PFS in multivariable analysis and correlated with superior overall response ( P =0.011).</p><p><strong>Conclusions: </strong>Low OT-NLR and pretreatment T-NLR correlated with superior treatment outcomes in patients with R/M HNSCC treated with cetuximab and nivolumab. Further evaluation of T-NLR to improve patient selection and peripheral blood OT-NLR as a dynamic biomarker contributing to clinical benefit assessment given cetuximab and nivolumab is warranted.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"176-187"},"PeriodicalIF":1.8,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13011960/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144994170","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and Safety of Immune Checkpoint Inhibitors in Hepatocellular Carcinoma: A Systematic Review and Meta-Analysis.","authors":"Muhammad A B Naeem, Muhammad R Paracha, Ahmad Noor, Muhammad H A Khalid, Hafiza K Shahid, Maaz Khan, Moeaza R Rizvi, Javeeria Arshad, Talha Abbas, Azeem Saeed, Hamza Ashraf, Minahil Ali, Mishal Asif, Aanusha Ghouri","doi":"10.1097/COC.0000000000001278","DOIUrl":"10.1097/COC.0000000000001278","url":null,"abstract":"<p><strong>Objectives: </strong>Previous meta-analyses have assessed the benefits and safety profile of immune checkpoint inhibitors in hepatocellular carcinoma patients. This meta-analysis provides an updated synthesis by incorporating the newly published studies and previous studies with the revised data.</p><p><strong>Methods: </strong>A systematic review and meta-analysis were conducted following PRISMA guidelines. Databases (PubMed, Google Scholar, and Cochrane Library) were searched for randomized controlled trials (RCTs) comparing Immune Checkpoint Inhibitors to Standard Therapy or Placebo in patients with Hepatocellular Carcinoma. Studies were selected based on predefined eligibility criteria, and odds ratios (ORs) and hazard ratios (HRs) for outcomes were calculated using a random effects model.</p><p><strong>Results: </strong>Eighteen RCTs involving 9244 patients were included in this study. Compared with the control group, ICIs were associated with a significantly improved objective response rate (ORR) (OR=3.20, 95% CI: 2.44-4.20, P =<0.00001), disease control rate (DCR) (OR=1.40, 95% CI: 1.08-1.81, P =0.01), stable disease (SD) (OR=2.15, 95% CI: 1.16-3.98, P =0.02), overall survival (OS) (HR=0.79, 95% CI: 0.73-0.86, P =<0.00001), progression-free survival (PFS) (HR=0.77, 95% CI: 0.69-0.87, P =<0.00001) and all-cause grade ≥3 adverse events (OR=1.36, 95% CI: 1.10-1.67, P =0.005). No significant differences were observed between the 2 groups in terms of progressive disease (PD) (OR=0.88, 95% CI: 0.67-1.15, P =0.34), all-cause any-grade adverse events (OR=1.04, 95% CI: 0.51-2.11, P =0.91), treatment-related any-grade adverse events (OR=1.32, 95% CI: 0.67-2.59, P =0.42), and treatment-related grade ≥3 adverse events (OR=1.16, 95% CI: 0.65-2.09, P =0.61).</p><p><strong>Conclusions: </strong>By incorporating the most recent data and the newly published studies, this updated meta-analysis offers a clearer understanding of immune checkpoint inhibitors and reinforces their advantage over other therapeutic options in the treatment of hepatocellular carcinoma. Continued research is encouraged that will further validate these findings.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"196-204"},"PeriodicalIF":1.8,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145806379","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":"Demographic and Regional Trends in Mortality Related to Cholangiocarcinoma in the United States: 1999 to 2020.","authors":"Adeena Jamil, Nouman Aziz, Zunaira Saeed, Abdul Ahad, Muhammad M Ashrafi, Owais Ahmad, Eyman Wasim, Lama Qadri, Anusha A M Farid, Muhammad A Mushtaq, Quratulain J Narejo, Muhammad Huzaifa, Abdur Rehman","doi":"10.1097/COC.0000000000001258","DOIUrl":"10.1097/COC.0000000000001258","url":null,"abstract":"<p><strong>Objectives: </strong>Cholangiocarcinoma is the second most common primary liver tumor with a highly aggressive course and poor prognosis (5-year survival ≤15%). Here, we assessed trends in regional and demographic differences in cholangiocarcinoma-related mortality in the United States from 1999 to 2020.</p><p><strong>Methods: </strong>The CDC WONDER (Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research) database was utilized to examine death certificates (1999-2020) for cholangiocarcinoma-related mortality. Age-adjusted mortality rates were extracted per 100,000 individuals, and their associated annual percent changes with 95% CIs were calculated. To identify overall trends for demographic (sex, race, ethnicity, and age) and regional groups, Joinpoint regression (NCI, version 5.0.2) was utilized.</p><p><strong>Results: </strong>One lakh forty-eight thousand eight hundred fifty-one cholangiocarcinoma-related deaths occurred between 1999 and 2020. The overall age-adjusted mortality rate has increased from 1.9 in 1999 to 3.2 in 2020. Higher mortality rates were observed for males (males: 2.9 vs. females: 2.3), non-Hispanic Asian or Pacific Islander patients (3.3), and metropolitan area residents (2.6). African Americans exhibited the highest annual percent increase since 1999 (3.47; 95% CI: 3.01-4.12). Rhode Island, Connecticut, Massachusetts, Minnesota, Wisconsin, Illinois, Washington, Alaska, and Hawaii ranked in the top 90th percentile, and the northeast region had the highest overall age-adjusted mortality rates.</p><p><strong>Conclusions: </strong>In the last 2 decades, Cholangiocarcinoma-related mortality has increased overall in the United States. Demographic and geographic disparities persist, with higher age-adjusted mortality rates observed in males, Asians, and individuals residing in the northeast region and metropolitan areas. Further research and targeted strategies for different demographics are needed to curb increasing levels of Cholangiocarcinoma-related mortality in the United States.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"163-170"},"PeriodicalIF":1.8,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145304128","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":"The Landscape of Clinical Trials for Targeting c-MET Therapy.","authors":"Xingcan Fan, Yulin Song, Qiuyu Liao, Jinyang Qi, Gang Liu","doi":"10.1097/COC.0000000000001319","DOIUrl":"https://doi.org/10.1097/COC.0000000000001319","url":null,"abstract":"<p><p>Mesenchymal-epithelial transition factor (c-MET) is a pivotal receptor tyrosine kinase that mediates tumor initiation, progression and metastasis through abnormal signaling activation, representing a promising therapeutic target across malignancies. This study systematically summarizes the global landscape of c-MET-targeted clinical trials to inform future drug development and clinical practice. On the basis of rigorous screening of multiple international clinical trial databases, 1,389 eligible trials were included and analyzed in terms of phase, distribution, indications, and therapeutic agents. Overall, c-MET-targeted clinical research is expanding rapidly, dominated by early-phase trials (phase I/II, 70.12%), with a notable increase since 2017. Geographically, trials are concentrated in North America, Asia and Europe, with the United States and China as the major contributors and key collaborative hubs. Non-small cell lung cancer is the most extensively studied indication, followed by unspecified solid tumors. Tyrosine kinase inhibitors, particularly cabozantinib, remain the most investigated agents, while antibody-drug conjugates, immune checkpoint inhibitors and combination strategies have emerged as major research focuses. Recent advances reported at the 2025 ASCO meeting highlight encouraging activity of novel c-MET-targeted ADCs in lung and gastrointestinal cancers, as well as promising potential of tetra-specific T-cell engagers. Collectively, c-MET is a core target in oncology, with rapidly evolving therapeutic agents and strategies. The development of innovative drugs and rational combinations will continue to refine c-MET-targeted therapy and expand treatment options for patients with c-MET-aberrant tumors.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147582605","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":"Endpoint Governance and Reporting Transparency in Biomarker-Guided Oncology Trials: A Systematic Review, 2015 to 2024.","authors":"Fidelis Nwachukwu, Mary Obimma","doi":"10.1097/COC.0000000000001320","DOIUrl":"https://doi.org/10.1097/COC.0000000000001320","url":null,"abstract":"<p><p>Biomarker-guided oncology trials frequently prioritize surrogate endpoints to enable efficient development in molecularly defined populations, often before mature overall survival (OS) data are available. We conducted a PRISMA 2020-guided systematic review of prospective interventional biomarker-guided oncology trials published between 2015 and 2024 to evaluate endpoint governance structure (prespecified primary endpoint selection and hierarchy) and endpoint transparency (ability to unambiguously identify prespecified primary endpoint from the full text). Endpoint-opaque trials were retained to quantify opacity but excluded from endpoint-type classification analyses. Among endpoint-transparent trials, we evaluated primary endpoint selection, OS reporting at primary publication, and OS maturity (mature/final vs. immature/interim), and used penalized logistic regression to assess predictors of objective response rate (ORR) primacy and OS immaturity. Among 242 eligible full texts, 166 (68.6%) were endpoint-opaque. Seventy endpoint-transparent trials comprised the analytic cohort: ORR and progression-free survival (PFS) were the prespecified primary endpoints in 23/70 (32.9%) and 33/70 (47.1%) trials, respectively, while OS was the sole primary endpoint in 2/70 (2.9%). OS was reported at primary publication in 62/70 trials (88.6%); among OS-reported trials with classifiable maturity (n=61), OS was mature/final in 30/61 (49.2%) and immature/interim in 31/61 (50.8%). ORR primacy was associated with lower odds of immature OS at primary publication (OR: 0.58; 95% CI: 0.37-0.90). In biomarker-guided oncology, surrogate endpoints commonly serve as decision-defining primary outcomes, while OS is frequently reported but often immature at first publication. Endpoint opacity is prevalent and limits transparent evaluation of evidentiary sufficiency, underscoring the need for explicit endpoint hierarchy reporting.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147582523","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":"Clinical Features, Treatment Patterns, and Outcomes of Solitary Plasmacytoma in the United States: A National Cancer Database (NCDB) Analysis of Years 2004 to 2020.","authors":"Ludovic Saba, Gaelle C Haddad, John Greskovich, Kaylee Sarna, Hong Liang, Chieh-Lin Fu, Chakra P Chaulagain","doi":"10.1097/COC.0000000000001321","DOIUrl":"https://doi.org/10.1097/COC.0000000000001321","url":null,"abstract":"<p><strong>Objectives: </strong>Solitary plasmacytoma is a rare plasma cell neoplasm with varying outcomes. This large IRB-approved retrospective analysis used the National Cancer Database (NCDB) to assess prognostic factors, treatment patterns, and overall survival (OS) among patients treated at Commission on Cancer-accredited facilities in the United States.</p><p><strong>Methods: </strong>Plasmacytoma patients (N=9427) from 2004 to 2020 were identified using the NCDB, excluding multiple myeloma. Descriptive statistics, Kaplan-Meier curves, and multivariate Cox regression analysis were used to evaluate survival outcomes by primary site, radiation dosage, and treatment modality. SAS version 9.4 was used to analyze the data.</p><p><strong>Results: </strong>Among 9427 patients, solitary plasmacytoma of bone (P-Bone) comprised 73% and extramedullary plasmacytoma (P-EM) 27%. Median OS was 106 months for P-Bone versus 146 months for P-EM (P<0.0001). Combined radiation therapy and surgery achieved the longest median OS (181 mo) versus surgery alone (137 mo) and radiation alone (116 mo; P<0.0001). OS increased with higher radiation dose: <35 Gy (46.6 mo) to ≥50 Gy (176.4 mo; P<0.0001). Among P-Bone sites, skull/mandible lesions showed the best outcomes (122.3 mo). Radiation doses of 45 to 49.9 Gy predominated across most sites.</p><p><strong>Conclusions: </strong>This real-world study analyzes treatment patterns and overall survival in the largest plasmacytoma database to date. Combined surgery and radiation therapy show improved survival outcomes, emphasizing the need for personalized treatment approaches and the strength of combined modality therapy. Considering the primary bone site and radiation dosage aids prognostic assessment and treatment decision-making, contributing to plasmacytoma management and personalized care.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147516371","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":"Conditional Survival Estimates for Malignant Glioma Patients: Secondary Analysis of RTOG 9006.","authors":"Matthew H Brown, Hua-Ren R Cherng, James W Assif, Kai Sun, Mark V Mishra","doi":"10.1097/COC.0000000000001296","DOIUrl":"https://doi.org/10.1097/COC.0000000000001296","url":null,"abstract":"<p><strong>Objectives: </strong>Conditional survival (CS) provides estimates of how survival changes over time. The primary objective of this secondary analysis is to report CS estimates for patients with malignant gliomas enrolled on RTOG 9006.</p><p><strong>Methods: </strong>A post hoc analysis of RTOG 9006 was performed using data obtained from the NCI NCTN Data Archive. Eligible patients included those enrolled on RTOG 9006 (n=632). CS estimates from the time of diagnosis and following 1, 3, and 5 years of survival were calculated using Kaplan-Meier. Multivariable Cox proportional hazards modeling multivariate analysis (MVA) was performed to evaluate the prognostic significance of age, KPS, treatment arm, histology, and extent of surgical resection following 1, 3, and 5 years of survival. The RPA class was evaluated on univariate analysis following the same initial survival periods.</p><p><strong>Results: </strong>Among 632 patients, OS at 1 and 3 years was 50.9% and 17.3%, respectively. CS improved over time, with patients who survived the first year having a 46.4% chance of surviving an additional year and 82.9% chance for those who had already survived 3 years. Age, KPS, and extent of surgical resection were significant predictors of OS at diagnosis but prognostic value declined over time. Glioblastoma multiforme (GBM) histology was significant at all time points. Patients who survived 3 years had significantly improved additional survival with conventional fractionation compared with hyperfractionation. In addition, RPA lost prognostic significance over time.</p><p><strong>Conclusions: </strong>Given the diminishing influence of KPS and surgical resection, treatment decisions should be based on individualized approaches considering evolving survival probabilities, not solely initial prognosis.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147482309","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 Pulsed Low-Dose Rate Radiotherapy in Re-Irradiation of Recurrent Solid Tumors: A Single-Center Retrospective Study.","authors":"Xinyan Zhang, Zifang Liu, Huacong Jin, Wenjing Cao, Hui Qiu, Xin Ding","doi":"10.1097/COC.0000000000001317","DOIUrl":"https://doi.org/10.1097/COC.0000000000001317","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the efficacy and safety of pulsed low-dose rate (PLDR) radiotherapy in the re-irradiation of recurrent solid tumors.</p><p><strong>Methods: </strong>This retrospective analysis was conducted on 64 patients with recurrent solid tumors who received PLDR re-irradiation. The treatment regimen consisted of 0.4 Gy per pulse, administered 5 times daily with a 5-minute interval, to a total dose of 20 to 66 Gy. Objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and treatment-related toxicities were assessed, with subgroup analysis performed by cancer type.</p><p><strong>Results: </strong>As of May 2025, the ORR was 53.13% (34/64), and the DCR was 85.94% (55/64). The median OS and PFS were 12.80 months and 7.10 months, respectively. Treatment-related toxicities were primarily grades 1 to 2, with a low incidence of grade 3 events and no grade ≥4 events. In the glioma subgroup (n=27), ORR reached 62.96% with a 14.81% complete response rate. Univariate analysis identified IDH1 mutation, nontemporal lobe recurrence, and a re-irradiation interval >24 months as favorable prognostic factors. Multivariate Cox regression confirmed IDH1 mutation as an independent protective factor for both OS (HR=0.15, P<0.01) and PFS (HR=0.24, P<0.01). A re-irradiation interval >24 months was protective for OS (HR=0.23, P=0.02), while temporal lobe recurrence was a risk factor for PFS (HR=4.00, P=0.03).</p><p><strong>Conclusion: </strong>PLDR re-irradiation demonstrates favorable efficacy and safety in recurrent solid tumors. For recurrent glioma, patients with IDH1 mutation, nontemporal lobe recurrence, and a re-irradiation interval >24 months appear to derive greater benefit from PLDR radiotherapy.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147445767","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":"Radiotherapy Utilization Patterns Among Patients With Metastatic Renal Cell Carcinoma of the Spine: A National Claims Database Study.","authors":"Tobechukwu C Ndika, Emily J Luo, Joshua Woo, Ramzy Ahmed, Nicole Rivera, Emanuel J Ray, Kerri-Anne Crowell, Eli Johnson, Trey C Mullikin, Melissa Erickson, C Rory Goodwin","doi":"10.1097/COC.0000000000001318","DOIUrl":"https://doi.org/10.1097/COC.0000000000001318","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to identify sociodemographic predictors of stereotactic body radiotherapy (SBRT) use and assess temporal trends in first-line SBRT use among patients with spinal metastatic renal cell carcinoma (mRCC) in relation to National Comprehensive Cancer Network guidelines.</p><p><strong>Methods: </strong>Using the PearlDiver Database, adults with spinal mRCC were identified. The database includes patients from 2010 to 2023. Patients with documented first-line radiotherapy were grouped as either receiving SBRT or conventional external beam radiation therapy (EBRT). Cohorts were compared using the χ2 tests for categorical variables and independent-samples t tests for continuous variables (P<0.05). Utilization trends were examined before versus after guideline implementation in 2019, and predictors of SBRT utilization were evaluated using multivariate logistic regression.</p><p><strong>Results: </strong>Of 86,482 patients with spinal metastatic RCC, 10,988 met the inclusion criteria (SBRT=453; EBRT=10,535). Cohorts differed significantly by age, sex, insurance coverage, and US region. After multivariate analysis, younger age, male sex, commercial insurance, and Midwest or Northeast residence were associated with higher odds of receiving first-line SBRT (P<0.05). SBRT use decreased after 2019, while EBRT use exceeded SBRT in every study year.</p><p><strong>Conclusions: </strong>From 2010 to 2023, EBRT remained the predominant first-line radiotherapy for spinal mRCC. Higher commercial insurance rates among SBRT recipients and regional variability in SBRT use suggest that payer mechanisms and institutional variation may influence first-line SBRT use. Policy alignment with contemporary evidence and expansion of SBRT infrastructure may enhance patient access.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147476246","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}