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

{"title":"Impact of Sequencing of Treatment Modalities on Survival in Nonmetastatic Hepatocellular Carcinoma.","authors":"Bakr Alhayek, Firas Baidoun, Danny Hadidi, Muhamad A Moustafa, Omar Abdel-Rahman","doi":"10.1097/COC.0000000000001221","DOIUrl":"https://doi.org/10.1097/COC.0000000000001221","url":null,"abstract":"<p><strong>Objectives: </strong>Hepatocellular carcinoma (HCC) is the most common type of liver malignancy and the third leading cause of cancer-related death in the world. Liver transplant is a cornerstone in treating nonmetastatic disease, but a significant portion of patients miss the opportunity of upfront liver transplant given the long waiting time for donor organs. Herein, we compare the survival outcomes between upfront liver transplant, liver transplant with bridge systemic therapy, and systemic therapy only.</p><p><strong>Methods: </strong>The National Cancer Database was queried for patients diagnosed with non-metastatic hepatocellular carcinoma (HCC) between 2004 and 2017. After including only patients with clinical N0 stage who received either systemic therapy alone, liver transplant alone or liver transplant with bridge systemic therapy, we split the cohort into 3 groups: systemic therapy only (including intra-arterial chemotherapy eg, TACE) group, upfront liver transplant group and liver transplant with bridge systemic therapy group. We evaluated overall survival (OS) among the three groups. We studied the OS using Kaplan-Meier estimates and multivariate Cox regression analyses to evaluate factors associated with overall survival (OS).</p><p><strong>Results: </strong>A total of 29,691 patients with nonmetastatic HCC were included for analysis, of which 25,122 (84.6%) were treated with systemic therapy only, 2513 (8.5%) were treated with bridge systemic therapy followed by liver transplant, and 2056 (6.9%) were treated with upfront liver transplant without systemic therapy bridge. We found that patients who were treated with bridge systemic therapy followed by liver transplant and patients who were treated with upfront liver transplant had a statistically significantly better OS compared to patients who were treated with systemic therapy only (mean OS was 101.9 mo and 98.2 vs. 39.4 mo, respectively, with P<0.001 for all). Whereas there was no significant difference in OS between patients who were treated with bridge systemic therapy followed by liver transplant and patients who were treated with upfront liver transplant (mean OS was 101.9 vs. 98.2 months, P=0.187). On multivariate analysis, factors associated with worse OS were older age (HR: 1.011; 95% CI: 1.010-1.013; P<0.001), Male sex (HR: 1.048; 95% CI: 1.014-1.084; P=0.006), White compared with African American race (HR: 1.055; 95% CI: 1.012-1.099; P=0.011), no insurance status (HR: 1.155; 95% CI: 1.079-1.237; P<0.001), clinical T4 stage compared with T0 stage (HR: 1.366; 95% CI: 1.257-1.483, P<0.001), and systemic therapy alone compared with upfront liver transplant and liver transplant with bridge systemic therapy (HR for upfront liver transplant and transplant with bridge systemic therapy vs. systemic therapy was 0.202; 95% CI: 0.184-0.223, and HR: 0.194, 95% CI: 0.178-0.212, respectively, with P<0.001 for all).</p><p><strong>Conclusions: </strong>Patients with nonmetastati","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144235849","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":"Effect of Rectal Cancer Treatment Timing Standardization on Patient Outcomes.","authors":"James Sun, Jordan D Fredette, Jill S Hasler, Joceline V Vu, Matthew Philp, Juan L Poggio, Andrea S Porpiglia, Stephanie H Greco, Sanjay S Reddy, Jeffrey M Farma, Anthony M Villano","doi":"10.1097/COC.0000000000001173","DOIUrl":"10.1097/COC.0000000000001173","url":null,"abstract":"<p><strong>Objectives: </strong>The National Accreditation Program for Rectal Cancer (NAPRC) was established in 2017 to decrease rectal cancer treatment variation and improve oncologic outcomes. Initiating curative intent treatment <60 days of first evaluation is one NAPRC standard. We evaluated whether oncologic outcomes improved with timely treatment and factors associated with its receipt.</p><p><strong>Methods: </strong>Using the NCDB, we identified stage I to III rectal cancer patients treated from 2004 to 2020 treated with curative-intent surgery. Patients were stratified into 2 cohorts (timely [<60 d], delayed [≥60 d]) for survival analysis and exploration of variables associated with timely treatment.</p><p><strong>Results: </strong>We included 117,459 patients with a median age of 61 years (interquartile range: 52 to 70 y). Most patients were male (61.1%), White (86.2%), Charlson 0 (77.1%) with stage II (33.5%) or III (44.3%) cancer treated with chemoradiation (58.1%), or surgery (27.0%) first. Timely treatment was associated with improved overall survival (OS; median OS: 153.26 vs. 128.59 m). Patients in the highest income bracket (odds ratio [OR] 1.30) with stage II (OR: 1.27) or III (OR: 1.50) cancer receiving neoadjuvant chemotherapy (OR: 2.24) or chemoradiation (OR: 1.73) as the first treatment received more timely treatment. Patients with Charlson ≥2 (OR: 0.83) of Black (OR: 0.56) or Hispanic (OR: 0.73) race received more delayed treatment (all P <0.01).</p><p><strong>Conclusions: </strong>Timely rectal cancer treatment is associated with improved survival. Socioeconomic disparities limit timely treatment with attendant worse survival, supporting national homogenization of care. As multimodal care for rectal cancer becomes increasingly complex, timely treatment remains paramount.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"302-309"},"PeriodicalIF":1.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143383995","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":"Effect of Continuous Nutritionist-led Guidance on Bowel Preparation in Patients Undergoing Prostate Stereotactic Body Radiation Treatment With Endorectal Spacing: A Prospective Pilot Trial.","authors":"Yonatan Carmeli, Yael Shpatz, Iris Oren-Ivry, Anat Mansano, Ron Lewin, Idan BarOrian, Jacob Mattout, Ilana Weiss, Ory Haisraely, Yaacov Richard Lawrence, Zvi Symon","doi":"10.1097/COC.0000000000001178","DOIUrl":"10.1097/COC.0000000000001178","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the effect of a daily nutritionist consultation on rectal volume, gas, and prostate displacement during Stereotactic Body Radiation Treatment (SBRT) with an endorectal spacer.</p><p><strong>Methods: </strong>Twenty-six consecutive patients receiving 5 fraction SBRT with endorectal spacing were prospectively enrolled for an intensive daily nutritionist intervention utilizing biofeedback based on image guidance from each fraction. A retrospective control cohort receiving a standard bowel preparation was compared. Rectal volume, rectal gas, and prostate displacement were assessed by analysis of cone beam computed tomography. Data was analyzed using the SPSS statistics software.</p><p><strong>Results: </strong>Intense dietary intervention with biofeedback led to a consistently lower rectal gas score over 5 fractions ( P <0.001) and less variability in rectal volume during prostate SBRT indicating a nonsignificant trend for superior preparation in the intervention group compared with controls, particularly for the first 2 fractions. However, there was no significant impact on prostate displacement as measured by couch correction.</p><p><strong>Conclusions: </strong>Intense dietary consultations effectively reduce rectal gas and variation of rectal volume during prostate SBRT with endorectal spacing. However, there was no advantage in reducing prostate displacement. Thus, labor-intensive daily nutritionist intervention with biofeedback is not cost-effective in reducing organ motion in patients with endorectal spacers compared with standard pretreatment dietary advice and is not recommended.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"314-318"},"PeriodicalIF":1.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143442692","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":"A Meta-analysis on Effects of Chimeric Antigen Receptor T-cell Therapy in Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia.","authors":"Abdur Jamil, Zaheer Qureshi, Rimsha Siddique, Faryal Altaf, Rohma Jamil, Neehal Wali","doi":"10.1097/COC.0000000000001176","DOIUrl":"10.1097/COC.0000000000001176","url":null,"abstract":"<p><strong>Objectives: </strong>This review evaluates the long-term outcomes and adverse events associated with chimeric antigen receptor (CAR) T-cell therapy in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).</p><p><strong>Methods: </strong>We conducted the search in relevant databases up to June 2024. We included clinical trials on CAR T-cell therapy for patients with r/r B-ALL. Meta-analyses were conducted using Comprehensive Meta-Analysis V3 and Review Manager 5.4.</p><p><strong>Results: </strong>Out of 2659 identified studies, 10 were included in this review. The pooled analysis demonstrated a high minimal residual disease-negative complete remission, with an overall event rate (ER) of 70% (95% CI: 61%-78%, I2 =8 8.35%). Anti-CD19 CAR T-cell therapy showed the highest efficacy with an ER of 74.75% (95% CI: 61%-80%, I2 = 89.84%). Combination therapies targeting CD19 and CD22 had an ER of 69% (95% CI: 53%-83%, I2 = 82.56%). Significant adverse effects included cytokine release syndrome with a mean incidence of 81.8% (95% CI: 76.7%-86.9%), neurotoxicity at 33.2% (95% CI: 28.1%-38.3%), and hematologic toxicities at 71.9% (95% CI: 66.4%-77.4%).</p><p><strong>Conclusions: </strong>CAR T-cell therapy is a groundbreaking advancement in treating r/r B-ALL, offering high rates of durable remissions.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"283-289"},"PeriodicalIF":1.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143434199","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":"Censoring Analysis of the INvestigating VorasiDenib In GliOma (INDIGO) Phase III Randomized Controlled Trial.","authors":"Jessica Y Aduwo, Shearwood McClelland","doi":"10.1097/COC.0000000000001175","DOIUrl":"10.1097/COC.0000000000001175","url":null,"abstract":"","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"271-272"},"PeriodicalIF":1.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143416151","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":"Establishing Feasibility of the Navigator-assisted Hypofractionation (NAVAH) Program to Address Radiation Therapy Access Disparities Facing African-Americans With Prostate Cancer.","authors":"Shearwood McClelland, Erica Fleming-Hall, Tamika K Smith, Louisa Onyewadume, Ursula J Burnette, Dante A Sanders, Abizairie Sanchez-Feliciano, Maya J Stephens, Daniel E Spratt, Angela Y Jia, Chesley W Cheatham","doi":"10.1097/COC.0000000000001172","DOIUrl":"https://doi.org/10.1097/COC.0000000000001172","url":null,"abstract":"","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":"48 6","pages":"325-326"},"PeriodicalIF":1.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144121458","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 Minimal Residual Diseases Status and Depth of Response on Survival Outcomes in Blinatumomab-Treated Acute Lymphoblastic Leukemia: A Systematic Review and Meta-Analysis.","authors":"Abdur Jamil, Zaheer Qureshi, Rida Riaz, Hamzah Akram, Rohma Jamil, Asim Kichloo, Insija Ilyas Selene","doi":"10.1097/COC.0000000000001179","DOIUrl":"10.1097/COC.0000000000001179","url":null,"abstract":"<p><strong>Objectives: </strong>Acute lymphoblastic leukemia (ALL) is a common hematological malignancy that occurs due to blockage of B-lymphocyte maturation at an early stage of development and differentiation. The Food and Drug Administration approved blinotumomab to manage relapsed/refractory ALL (R/R ALL). This review aimed to determine the comparative efficacy of blinatumomab in treating R/R ALL.</p><p><strong>Methods: </strong>Two reviewers searched 3 electronic databases, PubMed, ScienceDirect, and CENTRAL, for all relevant articles published until July 2024. All the articles that met the inclusion criteria were included in the review.</p><p><strong>Results: </strong>Four hundred thirty-seven articles were found from the electronic search; however, only 21 articles met the inclusion criteria. A pooled analysis of the outcomes found that blinatumomab resulted in an improvement in both the OS (HR: 0.65; 95% CI: 0.51, 0.82; P =0.0003) and the DFS (HR: 0.57; 95% CI: 0.41, 0.80; P =0.001). Further analysis showed that the CR rate and MRD response of ALL patients to blinatumomab was 51.6% (95% CI: 48.5%, 54.6%; P =0.319) and 64.6% (95% CI: 53.4%, 74.3%; P =0.011), respectively. The safety analysis indicated that the incidence of serious AEs was comparable in patients receiving blinotumomab and those receiving standard chemotherapy (OR: 1.34; 95% CI; 0.91, 1.97; P =0.14).</p><p><strong>Conclusions: </strong>The findings show that blinatumomab is superior to standard chemotherapy in improving the OS and DFS of patients with R/R ALL. Furthermore, it has a more favorable safety profile, making it an effective alternative to conventional chemotherapy for managing R/R ALL.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"290-301"},"PeriodicalIF":1.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143505845","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":"On the Origin of Treatment Paradigms.","authors":"Matthew McFarlane, Whitney Beeler, Matthew Ward, Chirag Shah","doi":"10.1097/COC.0000000000001181","DOIUrl":"10.1097/COC.0000000000001181","url":null,"abstract":"","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"273-275"},"PeriodicalIF":1.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143460510","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":"Establishing a Protocol to Increase Racial/Ethnic Under-Represented Minority Enrollment on an Active Radiation Oncology Multicenter Randomized Clinical Trial.","authors":"Ulysses G Gardner, Otis W Brawley, Elizabeth E Obi, Kristin J Redmond, Shearwood McClelland","doi":"10.1097/COC.0000000000001174","DOIUrl":"10.1097/COC.0000000000001174","url":null,"abstract":"<p><strong>Objectives: </strong>In the United States, under-represented racial/ethnic groups lack ample enrollment in clinical trials, yielding ungeneralizable trial results. Barriers to increasing minority enrollment include decreased awareness of clinical trials, lack of access, financial burden and toxicity, medical system mistrust, and discordant physician-patient demographics.The ongoing Spine Patient Optimal Radiosurgery Treatment for Symptomatic MEtastatic Neoplasms (SPORTSMEN) clinical trial (NCT05617716 on clinicaltrials.gov) has a study design to actively accrue minority patients. We present our protocol addressing key targets to increase minority enrollment on this randomized, phase II clinical trial.</p><p><strong>Methods: </strong>Adults with evidence of symptomatic spine metastases are eligible. Baseline demographics (including race/ethnicity) are reported for statistical analysis. Our protocol seeks to minimize barriers to minority enrollment and targets 5 key areas including clinical trial design, access to care, financial toxicity, community engagement, and patient-centered care.</p><p><strong>Results and conclusions: </strong>Increasing clinical trial diversity is a challenge that must be addressed with meaningful intent to present robust level I data that broadens the understanding of treatment response in all demographics. Our protocol takes a patient-centered approach to achieve the objective of concordant racial/ethnic representation in a randomized clinical trial.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"310-313"},"PeriodicalIF":1.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143392276","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":"Outcome Predictors of Hardware Complications in Head and Neck Free Flap Reconstruction.","authors":"Abhinav Talwar, Shravan Asthana, Jennifer Silva-Nash, Laila A Gharzai, Sandeep Samant, Urjeet Patel, Katelyn Stepan","doi":"10.1097/COC.0000000000001180","DOIUrl":"10.1097/COC.0000000000001180","url":null,"abstract":"<p><strong>Objectives: </strong>Osteocutaneous free flap reconstruction can be complicated by hardware failure. The present study investigates the frequency and predictors of hardware failure in head and neck osteocutaneous reconstruction.</p><p><strong>Methods: </strong>Patients who underwent osteocutaneous head and neck free flap reconstruction between the years of 2014 and 2022 were identified at our institution. Hardware failure was defined as hardware infection, screw plate loosening, exposed hardware, migration, deformation, or fracture.</p><p><strong>Results: </strong>We identified 47 patients who met the inclusion criteria for this study. Common indications for intervention included squamous cell carcinoma (35, 74%) and osteoradionecrosis (8, 17%). Most operations used fibular flaps (31, 66%) or osteocutaneous radial forearm flaps (12, 26%). The median age at the time of reconstruction was 66 years (IQR: 59 to 72). In total, 17 (36%) patients experienced hardware failure in the postoperative period. On univariable analysis, estimated blood loss ( P =0.01) and early postoperative infectious complication ( P =0.03) were the only significant predictors of hardware failure. On multivariable analysis, these factors retained significance. Estimated blood loss had an OR of 1.004 (95% CI: 1.001-1.008; P =0.01), and infectious complication had an OR of 5.22 (95% CI: 1.28-24.84; P =0.03).</p><p><strong>Conclusion: </strong>The incidence of hardware failure among patients who undergo head and neck osteocutaenous free flap reconstruction is high (36%). Patients with infectious complications and high estimated blood loss may be more likely to develop hardware failure.</p><p><strong>Level of evidence: </strong>Level III.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"319-324"},"PeriodicalIF":1.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143450882","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}