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

Objectives: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Objective: To evaluate the efficacy and safety of pulsed low-dose rate (PLDR) radiotherapy in the re-irradiation of recurrent solid tumors.

Methods: 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.

Results: 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).

Conclusion: 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.

Objectives: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Primary central nervous system melanoma (pCNSM) is an exceptionally rare malignancy arising from melanocytes of neural crest origin, with an annual incidence of just 0.005 per 100,000 individuals. Due to its rarity and the heterogeneity in tumor biology, no standardized treatment protocol currently exists. Immunotherapy has emerged as a promising approach, though its role in pCNSM remains underinvestigated. We conducted an extensive literature review spanning 1980 to 2023, analyzing data from PubMed, Google Scholar, published case reports, and the Archives of the American Institute for Radiologic Pathology. A total of 138 articles covering 148 pCNSM cases were included-77 involving primary brain melanomas and 71 involving primary spinal melanomas. Surgical resection, either gross total or partial, was performed in 95% of cases and typically followed by radiotherapy. Only 2 cases of brain melanoma received immunotherapy. Treatment approaches were largely similar between brain and spinal melanomas; however, primary spinal melanoma (PSM) cases showed better outcomes. Our review suggests that a multimodal strategy involving surgical resection followed by adjuvant radiotherapy and, where applicable, immunotherapy may offer improved outcomes, especially in spinal cases. However, the limited use of immunotherapy in brain cases and the overall rarity of pCNSM highlight the need for further multicenter research to identify more effective and tailored treatment protocols.

Objectives: To evaluate the value of incorporating multiplex nucleic acid aptamer detection into conventional serum tumor marker testing for improving the early diagnosis of lung cancer.

Methods: This prospective observational study enrolled 158 participants, including patients with pathologically confirmed lung cancer (n=82), individuals with benign pulmonary lesions (n=26), and healthy controls (n=50). Serum levels of 5 conventional tumor markers, neuron-specific enolase (NSE), carcinoembryonic antigen (CEA), squamous cell carcinoma antigen (SCCAg), pro-gastrin-releasing peptide (ProGRP), and cytokeratin 19 fragment 21-1 (CYFRA21-1) were examined. Nucleic acid aptamer signals (ΔCt values and positivity rates) were measured in all participants. A conventional model, an aptamer-based model, and a combined model integrating both approaches were constructed. Diagnostic performance for early lung cancer was compared using receiver operating characteristic (ROC) curve analysis.

Results: Serum levels of all 5 conventional tumor markers and nucleic acid aptamer signals differed significantly among the 3 groups. For lung cancer diagnosis, the combined model (conventional tumor markers plus nucleic acid aptamer detection) demonstrated higher area under the ROC curve (AUC), sensitivity, and specificity than the conventional model alone. In diagnosing early lung cancer, the combined model achieved the best discriminative performance. The combined model improved discrimination and reclassification for early lung cancer.

Conclusions: Integrating nucleic acid aptamer detection with conventional tumor marker testing enhances the diagnostic accuracy and discriminative ability for early lung cancer. The incremental value of this combined approach suggests a potential optimized strategy for early lung cancer detection.

As artificial intelligence (AI) has been proposed to aid in the clinical management of leukemia, we sought to summarize the most relevant, current literature concerning this topic. PubMed was indexed from January 2022 to November 2025 using the search terms "artificial intelligence" AND "leukemia," and 55 papers were deemed relevant and included in this review. We determined AI to be of clinical utility in 3 major areas of leukemia management: detection, risk stratification/treatment planning, and relapse surveillance/management. The application of AI in leukemia management is largely limited to diagnosis-the use of AI in leukemia risk stratification and treatment planning, and relapse detection is largely unexplored. AI has great potential to improve aspects of leukemia management. However, it is currently underutilized and primarily focused on initial diagnosis. The real power of AI lies in optimizing treatment intensity to reduce toxicity and the likelihood of relapse.

Cancer persists as a formidable adversary to human health, with its early-stage detection posing a persistent and intricate challenge. While radiologic imaging serves as a cornerstone in the diagnostic arsenal for oncological conditions, the incipient manifestations of malignancies frequently present with such subtlety that they elude recognition, resulting in missed opportunities for timely and potentially life-saving interventions. Several radiodiagnostic agents have received regulatory approval from the US FDA for clinical application in the oncological domain, specifically to facilitate the detection, localization, and characterization of malignant neoplasms through advanced imaging techniques. With the FDA approvals of [18F]F-rhPSMA-7.3, [18F]F-piflufolastat, [68Ga]Ga-PSMA-11, [18F]F-fluoroestradiol, and [64Cu]Cu-dotatate into clinical oncology practice, marking the beginning of a new era in cancer care. This manuscript provides a comprehensive overview of a 5-year review of FDA-approved diagnostic radiopharmaceuticals in oncology, highlighting the clinical studies that supported their approval and additional clinical trials evaluating their use in PET imaging.

Objective: This study analyzed mortality trends for pancreatic adenocarcinoma among individuals with type 2 diabetes mellitus (T2DM) in the United States from 2000 to 2024 and forecasted the future burden.

Methods: This population-based, retrospective cohort study used the CDC WONDER database to identify deaths among US residents aged 25 years and older (2000 to 2024) with ICD-10 codes for pancreatic adenocarcinoma (C25.0-C25.9) and T2DM (E11.0-E11.9). Age-adjusted mortality rates (AAMRs) were calculated per 1,000,000 population. Joinpoint regression estimated annual percentage changes (APCs) and ARIMA modeling forecasted mortality through 2034.

Results: We identified 28,206 deaths. The overall AAMR increased from 2.39 in 2000 to 9.17 in 2024, with accelerated growth from 2012 to 2024 (APC: 8.13%). Males had higher mortality than females (11.15 vs. 7.50 in 2024). Black/African Americans had elevated rates, reaching 9.97 in 2024. The Western US reported the highest AAMR (13.35 in 2024). Mortality was highest in adults aged 65 years and older (38.20 in 2024) versus those aged 45 to 64 (4.81). ARIMA modeling forecasts an AAMR of 14.63 by 2034.

Conclusion: Mortality from concurrent pancreatic adenocarcinoma and T2DM has risen, with marked disparities by sex, race, age, and region, and the projected increase underscores the need for targeted prevention and early detection in high-risk diabetic populations.

Objectives: KRAS G12C mutations are key oncogenic drivers in multiple solid tumors. Adagrasib, a selective KRAS G12C inhibitor, has demonstrated promising efficacy and safety in clinical studies. This single-arm meta-analysis comprehensively evaluates key clinical outcomes of Adagrasib, including survival benefits and adverse events, in patients with KRAS G12C-mutant solid tumors.

Methods: Literature search was conducted across 4 databases to identify clinical trials and observational studies evaluating Adagrasib performance in patients with KRAS G12C-mutant solid tumors. A single-arm analysis was performed using the inverse variance method in the "meta" package of RStudio. Log Proportion and standardised mean difference (SMD) with a 95% CI were pooled using a random-effects model. Heterogeneity was assessed using I ² statistics.

Results: Six studies involving 400 patients were included in our analysis. Adagrasib showed a median overall survival (OS) of 14.74 months (95% CI: 12.06-17.42, I ²=40.4%) and progression-free survival (PFS) of 6.80 months (95% CI: 6.14-7.46, I ²=0%), indicating significant survival benefits. The disease control rate (DCR) was 83%, reflecting robust tumor response and stabilization. Safety analysis revealed that 97% of patients experienced at least one adverse event of varying grades.

Conclusions: Adagrasib demonstrated robust efficacy in KRAS G12C-mutant solid tumors, with significant survival benefits and high response rates. However, frequent adverse events and dose modifications, along with variability in response rates, highlight tolerability challenges. Further studies are needed to optimize dosing, improve patient selection, and explore combination strategies to enhance outcomes and minimize unwanted effects.

Objectives: Black breast cancer patients have substantially decreased access to optimal breast-conserving cancer care than white patients. Patient navigation has never been formally implemented into the receipt of radiation therapy (RT) for black patients. We present initial results from an ongoing phase I trial assessing the impact of patient navigation on RT completion in this patient population.

Methods: The Navigator-Assisted Hypofractionation (NAVAH) program is a phase I trial (clinicaltrials.gov, NCT05978232) involving black breast cancer patients consented for postlumpectomy RT. Participants were assigned a patient navigator throughout the course of RT and post-RT care, and provided travel vouchers to offset RT transportation cost. Patients refusing trial participation were assessed to determine RT completion rate. The primary trial endpoint is RT completion rate following initiation of patient navigation.

Results: Of 54 trial-eligible patients, 36 accepted and 18 declined; no patient had received navigation before being offered trial enrollment. Of those declining enrollment 12/18 (66.7%) completed RT; of these 12, 9 (75%) completed RT without delay. 34/36 patients (94.4%) who enrolled completed RT, of whom 19 (55.9%) completed RT without delay. The differences in RT completion between patients having accepted versus declined trial enrollment were statistically significant ( P = 0.0124).

Conclusions: Early results of an ongoing phase I trial reveal that incorporation of patient navigation following initial radiation oncology consultation significantly improves adjuvant RT completion rates in early-stage black breast cancer patients. Further work examining patient navigation is ongoing.