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

Humanization in oncology patient care represents a significant innovation in health care practice, shifting the traditional focus solely on treating physical conditions to encompass the emotional and psychosocial dimensions of patient experience. This study aimed to explore the importance of humanization in oncology and the application of practices that promote a patient-centered approach. Through a narrative review of the past 2 decades, the objective was to analyze the practices, benefits, and challenges of humanization in the oncology context. The methodology involved reviewing the relevant literature on empathetic communication, psychological support, and the integration of these aspects into oncology care. The results indicated that humanization significantly contributes to improving patients' quality of life, increasing treatment adherence, and fostering a more satisfying work environment for health care teams. However, effective implementation faces challenges, such as the need for ongoing training, resource limitations, and resistance to change. Despite these obstacles, humanization is essential to provide more comprehensive and patient-centered care. The adoption of humanized practices transforms the oncology care experience, making it more empathetic and holistic.

Objectives: Liquid biopsy, with its noninvasive nature and ability to detect tumor-specific genetic alterations, emerges as an ideal biomarker for monitoring recurrences for locally advanced rectal cancer (LARC). Completed studies have small sample sizes and different experimental methods. To consolidate and assess the collective evidence regarding the prognostic role of circulating DNA (ctDNA) detection in LARC patients undergoing neoadjuvant chemoradiotherapy (nCRT).

Methods: Computerized bibliographic searches of MEDLINE and CANCERLIT (2000 to 2023) were supplemented with hand searches of reference lists. Study selection: studies evaluating oncological outcomes of patients with LARC treated with a nCRT comparing patients with positive and negative liquid biopsy at baseline and after nCRT. Data extraction: data on population, intervention, and outcomes were extracted from each study, in accordance with the intention to treat method, by 2 independent observers, and combined using the DerSimonian method and Laird method.

Results: Nine studies follow inclusion criteria including 678 patients treated with nCRT. The pooled RD rate of ctDNA negative between measure at baseline and after nCRT is statistically significant 61% (95% CI: 53-70, P =0.0002). The hazard ratio (HR) of progression-free survival between ct-DNA negative and positive is significant 7.41 (95% CI: 4.87-11.289, P <0.00001).

Conclusions: ctDNA can identify patients with different recurrence risks following nCRT and assess prognosis in patients with LARC. Further prospective study is necessary to determine the utility of ctDNA in personalised therapy for patients with LARC.

Objective: This meta-analysis evaluates the efficacy and safety of lenvatinib, both as monotherapy and in combination with other (tyrosine kinase inhibitors) TKIs, compared with other TKIs in metastatic renal cell carcinoma (RCC) treatment.

Methods: We searched for relevant studies from inception to February 2024 using PubMed, Web of Science, Cochrane Library, and Scopus. Eligible studies reported on the efficacy and safety of lenvatinib alone or in combination with other TKIs versus other TKIs for metastatic RCC. Primary outcomes included progression-free survival (PFS) and overall survival (OS). Secondary outcomes included objective response rate (ORR), adverse events (AEs), and health-related quality of life (HRQOL).

Results: Seventeen studies met the inclusion criteria. Lenvatinib, especially in combination therapies, significantly improved PFS (HR: 0.46, 95% CI: 0.38-0.54, P <0.001) and OS (HR: 0.80, 95% CI: 0.70-0.91, P <0.001) compared with other TKIs. Quality of life analyses showed mixed results, with EQ-5D demonstrating significant improvement (HR: 1.21, 95% CI: 0.90-1.53, P <0.001), while EORTC QLQ-C30 was not statistically significant. ORR analysis indicated a higher likelihood of achieving a complete or partial response with lenvatinib (OR: 2.04, 95% CI: 1.15-2.93, P =0.00). The analysis of total AEs above grade 3 showed no significant difference between lenvatinib and other TKIs (OR: -0.08, 95% CI: -0.21 to 0.06, P =0.26).

Conclusions: Lenvatinib significantly enhances survival outcomes in metastatic RCC patients compared with other TKIs. While associated with various adverse events, its safety profile is comparable to other TKIs.

Objectives: The aim of this retrospective multicenter study was to evaluate the prognostic significance of low muscle mass, and inflammatory markers in patients with stage III nonsmall cell lung cancer (NSCLC) who received definitive chemoradiotherapy (CRT). Furthermore, the study aimed to determine the threshold value of disease-specific low muscle mass.

Methods: A total of 461 patients with stage III NSCLC were evaluated. Low muscle mass, prognostic nutritional index (PNI), and biochemical inflammatory markers were assessed. The Kaplan-Meier method and Cox regression analysis were used to analyze overall survival (OS) and progression-free survival (PFS).

Results: This study found a disease-specific low muscle mass threshold of LSMI <38.7 cm²/m² for women and <45.1 cm²/m² for men, with 25.2% of patients having disease-specific low muscle mass. Multivariate cox regression analysis revealed that low PNI was found to be an independent unfavorable prognostic factor for both PFS (HR=0.67; 95% CI: 0.48-0.92, P = 0.015) and OS (HR=0.67; 95% CI: 0.50-0.91, P =0.008). Other factors including ECOG PS 3 (HR=7.76; 95% CI: 1.73-34.76, P =0.007), induction CT (HR=0.66; 95% CI: 0.49-0.88, P = 0.004), and disease-specific low muscle mass (HR=1.40; 95% CI: 1.02-1.92, P = 0.038) also had independent effects on prognosis.

Conclusions: The present study provides evidence that the presence of low muscle mass and low PNI significantly impacts the prognosis of patients with stage III NSCLC who undergo definitive CRT. Furthermore, our study is notable for being the first multicenter investigation to identify a disease-specific low muscle mass threshold.

Objectives: Approximately 15% of patients with localized prostate cancer are at high risk for disease recurrence. Many clinical trials have evaluated the impact of neoadjuvant therapy before radical prostatectomy with mixed results (NCT00321698).

Methods: This phase I/II clinical trial evaluated the tolerability and preliminary efficacy of neoadjuvant radiation therapy and docetaxel before prostatectomy in 25 men with high-risk prostate cancer. The treatment regimen included 45 Gy radiotherapy in 25 fractions to the prostate and seminal vesicles over 5 weeks, along with weekly dose-escalated docetaxel up to 30 mg/m², followed by prostatectomy and bilateral lymph node dissection. The primary endpoint was the rate of pathologic complete response (pCR). Secondary endpoints included adverse events, symptom and quality of life measures, and prostate-specific antigen metrics.

Results: All 25 patients completed the planned treatment. The primary endpoint of pCR was not achieved. Lymphopenia was the most common grade 3 or higher toxicity, with no grade 3 or higher genitourinary or gastrointestinal toxicities observed. With a median follow-up of 11.6 years, the 10-year biochemical recurrence-free survival was 60%, and distant metastasis-free survival was 80%. Prostate cancer-specific survival and overall survival at 10 years were 84% and 60%, respectively.

Conclusions: Although pCR was not met, the treatment demonstrated a modest toxicity profile and reasonable long-term outcomes, suggesting feasibility and safety. Further studies are needed to optimize endpoints and assess the efficacy of neoadjuvant treatments compared with standard approaches in high-risk prostate cancer patients.

Objectives: Esophageal cancer (EC) is the sixth leading cause of cancer-related deaths in the United States, with a mere 20% survival rate in the first 5 years, making it a significant public health concern. Considering the lack of comprehensive evaluations of mortality trends, this study aims to provide an update on the mortality rates of esophageal cancer and its trends in the United States.

Methods: The mortality trends among adults with EC were analyzed using data from the CDC WONDER database. Crude and age-adjusted mortality rates (AAMRs) per 100,000 people were extracted. Annual percent changes (APCs) in AAMRs with 95% CI were obtained using joinpoint regression analysis across different demographic (sex, race/ethnicity, and age) and geographic (state, urban-rural, and regional) subgroups.

Results: Between 1999 and 2020, 309,725 documented deaths were attributed to esophageal cancer. The overall AAMR decreased from 1999 to 2020 (6.69 to 5.68). Males had higher consistently higher AAMRs than females (10.96 vs. 2.24). NH White had the highest overall AAMR (6.88), followed by NH Black (6.46), NH American Indian (4.95), Hispanic or Latino (3.31), and NH Asian or Pacific Islander (2.57). AAMR also varied by region (overall AAMR: Midwest: 7.18; Northeast: 6.75; South: 6.07; West: 5.76), and nonmetropolitan areas had higher AAMR (non-core areas: 7.09; micropolitan areas: 7.19) than metropolitan areas (large central metropolitan areas: 5.75; large fringe areas: 6.33). The states in the upper 90th percentile of esophageal cancer-related AAMR were Vermont, District of Columbia, West Virginia, Ohio, New Hampshire, and Maine, and exhibited an approximately two-fold increase in AAMRs, compared with states falling in the lower 10th percentile.

Conclusions: Over the last 2 decades, there has been an overall decline in mortality related to EC in the United States. However, demographic and geographic discrepancies in EC-related mortality persist, necessitating additional exploration and development of specifically directed treatments.

Objectives: To determine if piecemeal separation surgery, in conjunction with smaller treatment volumes utilized with spine stereotactic radiation therapy (S-SBRT), increased the risk of adjacent level progression (ALP).

Methods: We performed a retrospective analysis of a prospectively maintained database of adult spine oncologic patients who underwent SBRT to the spine at University of Michigan from 2010 to 2021. We compared ALP in patients undergoing SBRT who had pretreatment surgery with those who did not.

Results: Four hundred and ninety-eight treatment sites were identified in 417 patients. Of these, 366 (73.5%) were treated with SBRT alone and 132 (26.5%) were treated with surgery followed by S-SBRT. Patients treated with SBRT alone were significantly older (63.3 y) compared with the surgery plus SBRT group (60.2 y; P=0.02). More radiosensitive histologies were treated with SBRT alone (34%) compared with 11% for the surgery plus SBRT group (P<0.001). Lesions treated in the surgery plus SBRT group had significantly more severe metastatic epidural spinal cord compression (65%) compared with the SBRT only group (8%) (P<0.001). Both infield progression (9.3% vs. 7.6%; P=0.43) and ALP (21.3% vs. 18.9%; P=0.37) were not significantly different between groups.

Conclusions: Spine oncology patients treated with surgery followed by conformal postoperative S-SBRT had similar infield and ALP compared with patients receiving SBRT alone, suggesting that piecemeal separation surgery does not locally spread tumor cells, leading to an increased risk of ALP failure, and supporting the use of conformal postoperative S-SBRT.

Objectives: Cancer accounts for 22% of all mortality and is the leading cause of death among Hispanic and/or Latinx patients in the United States. The disparities in access to radiation therapy (RT), mortality rates, and treatment outcomes among Hispanic-American breast cancer patients compared with other populations highlight the urgent need for targeted interventions. The Navigator-Assisted Hypofractionation (NAVAH) program, with its innovative patient navigation approach and culturally sensitive survey, aims to better identify the specific barriers faced by this population. This study is a report of the NAVAH program experience piloting a Spanish-language culturally sensitive survey in Hispanic-American volunteers.

Methods: Hispanic-American volunteers with fluency in Spanish were recruited to participate in survey conduction, identified from local networks. Survey information was assessed by topic category, and survey responses were amalgamated into a representative score for each category. Survey categories include acceptability (comfort and prejudice among interactions with the system), accessibility (transportation, distance to care, and health care literacy), accommodation (access to the internet, navigating transportation), affordability (financial considerations, employment, and level of education), and availability (access to a medical center, coordinating care, and overall quality of care).

Results: A total of 6 volunteers meeting inclusion criteria completed the survey; 4 in person and 2 by telephone. The median survey completion time was 12 minutes 38 seconds. Respondents noted satisfaction and trust in their interactions with medical providers; however, responses in the acceptability category highlighted a high perception of disparities in the medical system, including a high prevalence of racial and ethnic prejudice and a high prevalence of treatment differences between high-income and low-income patients in clinical settings.

Conclusions: In the first Spanish-language survey of its kind, our findings indicate that this survey design is feasible in the Hispanic-American population. Implementation of this survey in breast cancer patients will provide more definitive and comprehensive answers regarding other categories in the survey, including financial challenges during treatment, access to accommodations, and perception of treatment during cancer care. The investigation involving patients actively receiving breast cancer RT is currently underway.