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

Objectives: This study aimed to investigate how social determinants of health (SDoH) influence health disparities in pediatric central nervous system (CNS) tumor outcomes by integrating individual and community-level data.

Methods: Retrospective cohort study. Individual-level electronic health record data from the Indiana Health Information Exchange were linked with community-level data from the Social Assets and Vulnerabilities Indicators using a record linkage method. Associations between CNS tumor diagnoses and SDoH factors were analyzed, as well as the descriptive characteristics of SDoH factors and demographic characteristics of CNS tumor patients.

Results: The analysis revealed significant disparities in CNS tumor prevalence and treatment protocols based on SDoH factors. Areas with higher median household income and lower rates of poverty, unemployment, uninsured status, and lack of high school education showed a higher prevalence of CNS-PNET and Meningioma, lower incidence of high-grade glioma, low-grade glioma, and Medulloblastoma. In addition, the use of VP shunts was associated with lower poverty and unemployment rates and higher median household income, whereas Brain Biopsy with Stealth was linked to higher rates of uninsurance, poverty, and lack of a high school diploma.

Conclusions: Significant correlations were found between SDoH factors and both CNS tumor outcomes. These findings suggest that integrating community-level SDoH data with individual health records can provide valuable insights and should be leveraged to address health care disparities and improve outcomes in pediatric CNS tumor patients.

The systematic literature review was performed on the use of artificial intelligence (AI) algorithms in nonsmall cell lung cancer (NSCLC) prognostication. Studies were evaluated for the type of input data (histology and whether CT, PET, and MRI were used), cancer therapy intervention, prognosis performance, and comparisons to clinical prognosis systems such as TNM staging. Further comparisons were drawn between different types of AI, such as machine learning (ML) and deep learning (DL). Syntheses of therapeutic interventions and algorithm input modalities were performed for comparison purposes. The review adheres to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The initial database identified 3880 results, which were reduced to 513 after the automatic screening, and 309 after the exclusion criteria. The prognostic performance of AI for NSCLC has been investigated using histology and genetic data, and CT, PET, and MR imaging for surgery, immunotherapy, and radiation therapy patients with and without chemotherapy. Studies per therapy intervention were 13 for immunotherapy, 10 for radiotherapy, 14 for surgery, and 34 for other, multiple, or no specific therapy. The results of this systematic review demonstrate that AI-based prognostication methods consistently present higher prognostic performance for NSCLC, especially when directly compared with traditional prognostication techniques such as TNM staging. The use of DL outperforms ML-based prognostication techniques. DL-based prognostication demonstrates the potential for personalized precision cancer therapy as a supplementary decision-making tool. Before it is fully utilized in clinical practice, it is recommended that it be thoroughly validated through well-designed clinical trials.

Objectives: Triple-negative breast cancer (TNBC) accounts for ∼15% of invasive breast cancers and is associated with a poor prognosis. The introduction of pembrolizumab in both neoadjuvant and adjuvant settings, as established by the KEYNOTE-522 trial, has improved event-free survival and is now considered standard of care. Postoperative adjuvant radiotherapy remains essential in reducing recurrence and mortality. However, combining radiotherapy with pembrolizumab may increase the risk of toxicities, particularly cardiac, and its long-term safety profile remains poorly characterized. This study aims to assess the safety of this combination in TNBC patients.

Methods: This monocentric retrospective study, conducted at Institut Curie in Paris, included patients with locally advanced TNBC treated according to the KEYNOTE-522 protocol-neoadjuvant chemotherapy and immunotherapy, followed by surgery and adjuvant therapy, including radiotherapy with or without pembrolizumab. Patients were divided into 2 groups: those receiving concurrent radiotherapy and pembrolizumab (RT-P), and those receiving radiotherapy alone (RT). The primary endpoint was treatment tolerance. Secondary endpoints included overall survival and cancer-specific survival. A P -value <0.05 was considered statistically significant.

Results: A total of 89 patients were included, with a median follow-up of 16 months. Forty-one patients received radiotherapy alone, and 48 received concurrent radiotherapy and pembrolizumab. No significant differences were observed between groups in baseline characteristics or overall toxicity, except for grade 1 radiodermatitis, which was more frequent in the RT-P group (83.3% vs. 43.9%). No grade ≥3 toxicities were reported. Two cases of grade 1 pulmonary toxicity occurred in the RT-P group. The mean heart dose was 1.8 Gy (range: 0.01-7.9), with no cardiac toxicity attributable to radiotherapy.

Conclusion: Adjuvant radiotherapy can be safely administered concurrently with pembrolizumab in TNBC patients without increasing radiation-related adverse events, supporting the continuation of systemic therapy in this high-risk population. Nevertheless, larger prospective studies are needed to assess long-term toxicity.

Objectives: Gastric cancer mortality has declined in recent decades, yet sociodemographic disparities remain. This study analyzed national trends in gastric cancer mortality among US adults, with stratification by demographic and geographic factors.

Methods: We examined gastric cancer deaths (ICD-10 C16) in adults aged ≥25 years using CDC WONDER data from 1999 to 2020. Mortality trends were analyzed by age, sex, race/ethnicity, region, and urbanization using joinpoint regression to calculate annual and average annual percent changes (APC, AAPC).

Results: From 1999 to 2020, there were 276,023 gastric cancer deaths. Mortality declined more in males (AAPC: -2.97 [95% CI: -3.15 to -2.79]) than females (-2.42 [-2.64 to -2.21]). The largest declines were among Asians (-3.83 [-4.08 to -3.56]) and Blacks (-3.25 [-3.49 to -3.02]), followed by Whites (-2.96 [-3.13 to -2.87]) and Hispanics (-2.31 [-2.58 to -2.06]). Metropolitan areas saw greater declines (-2.72 [-2.83 to -2.62]) than rural areas (-2.41 [-2.68 to -2.12]). By region, the Northeast showed the steepest decline (-3.16 [-3.34 to -2.99]), followed by the Midwest, South, and West. Notably, mortality increased among adults aged 25 to 34 years (AAPC: 0.38 [-1.24 to 2.70]) and 35 to 44 years (0.87 [0.12 to 1.73]).

Conclusions: Gastric cancer mortality declined overall but with persistent disparities. Rising rates among younger adults and slower declines in rural and western regions warrant further investigation and targeted interventions.

Objectives: Alveolar soft part sarcoma (ASPS) is a rare sarcoma affecting the deep soft tissues of the extremities in young adults and the head/trunk in children. This population-based study investigates demographics and factors influencing survival outcomes in ASPS.

Methods: The data for this study were collected from the SEER databases from 2000 to 2020.

Results: A total of 277 cases with ASPS were extracted from the database with a median age of 25 years and slight female predilection (52.3%). ASPS has a higher incidence in black (24.2%) and Hispanic (23.1%) races. Tumor location varied by age group: the head and neck were most commonly affected in younger patients (36.2%), while the lower extremities and hip region were predominant in older patients (68.8%). In most cases, the tumor size was >4 cm. When known, and majority were distant metastases (50.7%), and lung being the most common metastatic. The 5-year CSS with distant metastases was 33.0% (95% CI: 24.7-44.0). The highest 5-year CSS was observed with surgery with adjuvant radiation 86.7% (95% CI: 78.0-96.4). Multivariate analysis revealed that male sex was associated with worse survival (hazard ratio [HR] = 2.22), while surgery with adjuvant radiation was significantly associated with improved survival (HR = 0.36).

Conclusions: This study found that the male sex and larger tumors predict poorer ASPS outcomes, while surgery with adjuvant radiation improves survival. Future prospective clinical trials should focus on genomic mutation analysis for a personalized therapeutic approach.

Objectives: This practice parameter was developed collaboratively by the American College of Radiology (ACR), the American College of Nuclear Medicine (ACNM), the American Radium Society (ARS), the Society of Nuclear Medicine and Molecular Imaging (SNMMI), and the Society for Pediatric Radiology (SPR). This practice parameter is intended to guide appropriately trained and licensed physicians in the oral administration of I-131 sodium iodide for the treatment of benign and malignant thyroid diseases.

Methods: This practice parameter was revised according to the process described under the heading The Process for Developing ACR Practice Parameters and Technical Standards on the ACR website ( https://www.acr.org/Clinical-Resources/Practice-Parameters-and-Technical-Standards ) by the Committee on Practice Parameters-Nuclear Medicine and Molecular Imaging of the ACR Commissions on Nuclear Medicine and Molecular Imaging, the Committee on Practice Parameters-Radiation Oncology of the ACR Commission on Radiation Oncology, the Committee on Practice Parameters-Pediatric Radiology of the ACR Commission on Pediatric Radiology in collaboration with the ACNM, the ARS, the SNMMI, and the SPR.

Results: I-131 sodium iodide is used for the treatment of hyperthyroidism and differentiated thyroid cancer. The therapeutic effect of I-131 sodium iodide is achieved by the emission of ionizing radiation in the form of high-energy beta particles. I-131 sodium iodide therapy requires close cooperation and communication between the clinicians who are responsible for the clinical management of the patient and the physicians who administer radiopharmaceutical therapy. This document provides guidance regarding optimal therapy procedures, appropriate precautions, and therapy in unique situations.

Conclusions: This practice parameter is designed to assist practitioners in providing appropriate radiologic care for treating benign and malignant thyroid disease with I-131 sodium iodide.

Objectives: Malignant melanoma, although less frequent than other skin cancers, accounts for most skin cancer deaths due to its aggressive and metastatic nature. Despite therapeutic progress, its global distribution remains uneven. Comparative analyses of United States and worldwide melanoma trends, particularly by sex, are limited.

Methods: We analyzed melanoma incidence, prevalence, and mortality from 1990 to 2023 using Global Burden of Disease (GBD) 2023 data. Age-standardized rates per 100,000 population were obtained for the United States and globally. Temporal patterns were examined using joinpoint regression to estimate annual percent change (APC) and average annual percent change (AAPC) with 95% CIs. Pairwise tests compared US and global trajectories. Future mortality was projected through 2050 using autoregressive integrated moving average (ARIMA) modeling.

Results: From 1990 to 2023, US age-standardized mortality declined by 28% (2.38 to 1.72 per 100,000; AAPC: -0.96*; 95% CI: -1.21 to -0.71), whereas global mortality decreased modestly (0.82 to 0.74; AAPC: -0.29*; 95% CI: -0.46 to -0.12). US incidence declined (AAPC: -0.41*; 95% CI: -0.65 to -0.16), contrasting with a global rise (AAPC: 0.54*; 95% CI: 0.38 to 0.70). Prevalence fell in the United States (AAPC: -0.39*; 95% CI: -0.62 to -0.16) but increased globally (AAPC: 0.80*; 95% CI: 0.55 to 1.04). Males consistently exhibited higher incidence and mortality than females. All pairwise comparisons between US and global trajectories were significant (P<0.001*). ARIMA projections indicate a slight increase in US male mortality by 2050, whereas female and global rates are expected to continue declining.

Conclusions: Between 1990 and 2023, melanoma incidence and mortality declined in the United States but rose or plateaued globally, with persistent male predominance. Sustaining global progress requires strengthened prevention, early detection, and equitable access to effective treatment.

Objectives: The role of camrelizumab in combination therapy for triple-negative breast cancer (TNBC) is unclear. This systematic review and meta-analysis aimed to evaluate the efficacy and safety of camrelizumab combination therapy in women with TNBC.

Methods: We electronically searched MEDLINE, Embase, Scopus, Cochrane CENTRAL, and Clinicaltrials.gov from inception till March 2024. We performed a meta-analysis on the R version 4.3.3 using the "meta" and "metasens" packages through RStudio. Proportions were pooled using a random effects model. The between-study heterogeneity was assessed by Higgins I² statistics.

Results: A total of 9 studies comprising 357 patients were pooled. We observed an overall low risk of bias in the included studies. The results revealed an overall response rate of 58% (95% CI: 30%-84%, I2=94%), a 1-year survival rate of 71% (95% CI: 54%-85%, I2=49%), a 1-year progression free survival rate of 22% (95% CI: 0%-25%; I2=93%), stable disease in 25% (95% CI: 10%-44%, I2=85%) of participants at last follow-up and progressive disease in 11% (95% CI: 2%-25%, I2=79%) with camrelizumab combination therapy. Several treatment-related adverse events were reported in the included studies. Neutropenia was most common in 66% patients, followed by leukopenia in 59% patients. Among general AEs, asthenia was reported by 32% and fatigue was reported by 51% of the patients.

Conclusions: Camrelizumab combination therapy showed promising results in TNBC treatment, with good survival outcomes. Depending upon the outcomes of future phase III trials, factors influencing the efficacy of camrelizumab might be explored.

Objectives: Targeted immunotherapies have significantly revolutionized the treatment of hematologic malignancies. Among the most promising immunotherapies are bispecific T-cell engagers (BiTEs) and immune checkpoint inhibitors (ICIs). We aim to comprehensively evaluate the efficacy and safety of BiTEs and ICIs in the treatment of various hematologic malignancies.

Methods: An extensive literature search from inception until January 2025 was conducted in PubMed, Web of Science, Cochrane Library, and Google Scholar. The primary outcomes of our study were objective response rate (ORR) and treatment-related adverse events (AEs) of grade 3 or above.

Results: Thirty-one clinical trials involving 2507 patients with hematologic malignancies were included in our analysis. For patients with non-Hodgkin lymphoma (NHL), multiple myeloma, and myeloid malignancies, the pooled data showed that BiTEs resulted in ORRs of 34.1%, 60%, and 18.5%, whereas ICIs resulted in ORRs of 21.9%, 4.2%, and 13.8%, respectively. Furthermore, our statistical analysis demonstrated a pooled ORR of 47.1% for acute lymphoblastic leukemia (ALL) patients treated with BiTEs. The most common treatment-related AEs of grade 3 or greater in NHL patients treated with BiTEs and ICIs were neutropenia (17.1% and 7.2%, respectively). Similarly, the most common AEs of grade 3 or above in multiple myeloma, myeloid malignancy, and ALL patients treated with BiTEs were neutropenia (45.2%), CRS (12.9%), and anemia (21.4%).

Conclusions: BiTEs and ICIs are promising therapeutic strategies for patients with hematologic malignancies. However, BiTEs seem more effective than ICIs, especially in the treatment of NHL and multiple myeloma.

Background: Currently, cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors combined with hormone therapy are the standard treatment for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer. It remains unclear which patients benefit most from CDK4/6 inhibitors and whether predictive biomarkers exist to guide treatment decisions. Therefore, we evaluate the association between phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) mutation status and treatment response to CDK4/6 inhibitors in patients with HR+/HER2- metastatic breast cancer.

Methods: We extensively searched PubMed, Web of Science, Cochrane Library, and Google Scholar databases for articles published until December 2024. The primary outcome of our study was progression-free survival (PFS), and the secondary outcomes included overall survival (OS) and objective response rate (ORR).

Results: Seven studies-involving 2221 women with HR+/HER2 metastatic breast cancer-were systematically analyzed. The pooled results showed that patients with PIK3CA mutation had significantly poorer PFS than those with PIK3CA wild-type (hazard ratio [HR]: 1.47; 95% CI: 1.22-1.77; P<0.0001). Similarly, PIK3CA mutation was associated with significantly poorer OS than PIK3CA wild-type (HR: 1.42; 95% CI: 1.06-1.89; P=0.02). ORR was only reported in one study, with the results showing that the ORR was higher in patients with wild-type PIK3CA than in patients with PIK3CA alteration (53/180 (29%) versus 13/85 (15%).

Conclusions: PIK3CA mutation correlates with poor PFS and OS in patients with HR+/HER2- metastatic breast cancer receiving CDK4/6 inhibitors. Therefore, PIK3CA mutation status should be considered a potential predictive biomarker of resistance to CDK4/6 inhibitors.