Assessment of eligibility criteria in renal cell carcinoma trials evaluating systemic therapy.

OBJECTIVES: To characterise the restrictiveness of eligibility criteria in contemporary renal cell carcinoma (RCC) trials, using recommendations from the American Society of Clinical Oncology (ASCO)-Friends of Cancer Research (FCR) initiative. METHODS: vPhase I-III trials assessing systemic therapies in patients with RCC starting between 30 June 2012 and 30 June 2022 were identified. Eligibility criteria regarding brain metastases, prior or concurrent malignancies, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, and human immunodeficiency virus (HIV) infection were identified and stratified into three groups: exclusion, conditional inclusion, and not reported. Descriptive statistics were used to determine the frequency of eligibility criteria. Fisher's exact test or chi-square test were used to calculate their associations with certain trial characteristics. RESULTS: A total of 423 RCC trials were initially identified of which 112 (26.5%) had sufficient accessible information. Exclusion of patients with HIV infection, HBV/HCV infection, brain metastases, and prior or concurrent malignancies were reported in 74.1%, 53.6%, 33.0%, and 8.0% of trials, respectively. In the context of HIV and HBV/HCV infection, patients were largely excluded from trials evaluating immunotherapy (94.4% and 77.8%, respectively). In addition, brain metastases were excluded in trials assessing targeted therapy (36.4%), combined therapy (33.3%), and immunotherapy (22.2%). Exclusion of patients with prior or concurrent malignancies was less frequently reported, accounting for 9.1%, 8.3%, and 5.6% targeted therapy, combined therapy and immunotherapy trials, respectively. CONCLUSION: A substantial proportion of RCC trials utilise restrictive eligibility criteria, excluding patients with fairly prevalent comorbidities. Implementing the ASCO-FCR recommendations will ensure resulting data are more inclusive and aligned with patient populations in the real-world.

Examining Exclusion Criteria in Advanced Prostate Cancer Clinical Trials: An Assessment of recommendations From the American Society Of Clinical Oncology and Friends of Cancer Research.

PURPOSE: Eligibility criteria illustrate the characteristics of the study population and promote the safety of participants. However, overreliance on restrictive eligibility criteria may limit the generalizability of outcomes. As a result, the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (Friends) issued statements to curtail these challenges. In this study, we aimed to assess restrictiveness in eligibility criteria across advanced prostate cancer clinical trials. MATERIALS AND METHODS: We identified all phase I, II, and III advanced prostate cancer clinical trials between June 30, 2012, and June 30, 2022, through Clinicaltrials.gov. We evaluated whether a clinical trial excluded, conditionally included, or did not report 4 common criteria: brain metastases, prior or concurrent malignancies, HIV infection, and hepatitis B virus (HBV)/hepatitis C virus (HCV) infection. Performance status (PS) criteria were recorded based on the Eastern Cooperative Oncology Group (ECOG) scale. RESULTS: Out of 699 clinical trials within our search strategy, 265 (37.9%) trials possessed all the required data and were included in our analysis. The most common excluded condition of our interest was brain metastases (60.8%), followed by HIV positivity (46.4%), HBV/HCV positivity (46.0%), and concurrent malignancies (15.5%). Additionally, 50.9% of clinical trials only included patients with ECOG PS 0 to 1. HIV and HBV/HCV infection were exclusion criteria of 22 (80.8%) and 19 (73.1%) immunotherapy trials, respectively. CONCLUSION: Patients with brain metastases, prior or concurrent malignancies, HIV infection, HBV/HCV infection, or low-functioning PS were overly restricted from participating in advanced prostate clinical trials. Advocating for broader criteria may ameliorate generalizability.

Perceptions of COVID-19 Vaccination in Patients with Genitourinary Cancers: A Survey Study.

Since the approval of the COVID-19 vaccines, their safety and efficacy has been widely demonstrated in patients with cancer. However, there remain patients with reservations regarding vaccination. We aimed to assess genitourinary cancer patients' perceptions of the vaccines as well as barriers and influencers of decision-making through the completion of a questionnaire. While vaccine-associated concerns were observed, most patients with genitourinary cancers were willing to receive the vaccine. Moving forward, differing strategies could be considered to enhance patient education on the utility of vaccination in the setting of cancer and beyond.

Cultural adaptation process of cancer-related interventions: A step-by-step guide.

INTRODUCTION: To contribute to the reduction and elimination of cancer-related local and global health disparities, interventions must be culturally adapted to reach diverse cultural groups and demonstrate success in improving clinical and psychosocial outcomes. We provide step-by-step information on the conceptual and methodological challenges involved in culturally adapting interventions and provide guidelines, suggestions, tools, and concrete steps for implementing the process. METHODS: This article provides information, guidelines, suggestions, tools, and concrete steps, based on three rigorous models of cultural adaptations, for implementing this process, followed with examples from the field, to illustrate the conceptual and methodological challenges involved in culturally adapting interventions. CONCLUSION: Our systematic step-by-step approach recommends (1) the guidance of well-established research models; (2) use of multiple data sources and input from various stakeholders (i.e., from patients and providers); (3) qualitative and quantitative data usage and integration; (4) a steering committee with multiple perspectives, stakeholders assessments, and qualitative analyses; (5) consensus meetings; and (6) diverse representation on the steering committee and/or research team.

Psycho-Oncology and the Relevance of a Biopsychosocial Screening Program.

A 40-year-old unmarried Brazilian woman, Ms A, received a diagnosis of papillary renal cell carcinoma (RCC) in February 2020; she underwent nephrectomy the following month. In August, she began to experience generalized pain with subsequent scans revealing metastatic disease to the supraclavicular lymph node, liver, and vagina. In October 2020, Ms A started first-line systemic combination treatment with nivolumab (Opdivo; 3 mg/kg) plus ipilimumab (Yervoy; 1 mg/kg) every 3 weeks for 4 doses, followed by nivolumab (3 mg/kg) every 2 weeks, to be taken for 2 years. In April 2021, follow-up testing revealed a partial response to therapy, and a complete response was evident in August 2021. Ms A was first screened for biopsychosocial distress by the supportive care team in October 2020, and she completed the Edmonton Symptom Assessment System (ESAS) evaluation.During her fourth cycle of treatment in October 2020, the patient was assessed with the ESAS. During her medical visits, Ms A also expressed concern regarding her physical symptoms and admitted frequent self-monitoring for signs of recurrence or progression. Her oncologist prescribed tramadol for pain and the supportive care team recommended increased engagement in physical activity. Upon further assessment, the patient reported a belief that her psychosocial symptoms, worry about recurrence or progression, and time spent self-monitoring were a normal part of her cancer experience.

Use of psychotropic drugs among older patients with bladder cancer in the United States.

OBJECTIVE: Older patients diagnosed with cancer are at increased risk of physical and emotional distress; however, prescription utilization patterns largely remain to be elucidated. Our objective was to comprehensively assess prescription patterns and predictors in older patients with bladder cancer. METHODS: A total of 10,516 older patients diagnosed with clinical stage T1-T4a, N0, M0 bladder urothelial carcinoma from 1 January 2008 to 31 December 2012 from the Surveillance, Epidemiology, and End Results (SEER)-Medicare were analyzed. We used multivariable analysis to determine predictors associated with psychotropic prescription rates (one or more). Medication possession ratio (MPR) was used as an index to measure adherence in intervals of 3 months, 6 months, 1 year, and 2 years. Evaluation of psychotropic prescribing patterns and adherence across different drugs and demographic factors was done. RESULTS: Of the 10,516 older patients, 5621 (53%) were prescribed psychotropic drugs following cancer diagnosis. Overall, 3972 (38%) patients had previous psychotropic prescriptions prior to cancer diagnosis, and these patients were much more likely to receive a post-cancer diagnosis prescription. Prescription rates for psychotropic medications were higher among patients with higher stage BC (p < 0.001). Gamma aminobutyric acid modulators/stimulators and serotonin reuptake inhibitors/stimulators were the highest prescribed psychotropic drugs in 21% of all patients. Adherence for all drugs was 32% at 3 months and continued to decrease over time. CONCLUSION: Over half of the patients received psychotropic prescriptions within 2 years of their cancer diagnosis. Given the chronicity of psychiatric disorders with observed significantly low adherence to medications that warrants an emphasis on prolonged patient monitoring and further investigation.

Association between hospital anxiety and depression scale and problem-related distress in patients with cancer in a Brazilian private institution.

OBJECTIVE: Emotional symptoms are frequently reported among patients with cancer. We evaluated the association between emotional symptoms and problem-related distress in a sample of patients with cancer about to initiate chemotherapy within a private hospital in Brazil. METHODS: Patients were assessed before initiating chemotherapy, treatment mid-point, and on the last day of treatment for anxiety and depression (Hospital Anxiety and Depression Scale [HADS]) and for problem-related distress (Distress Thermometer Problem List). Problem-related distress variable was computed as the sum of practical, physical, spiritual and familial problems. Mixed-model analysis was applied to determine the association between HADS and problem-related distress, adjusting for age and gender. RESULTS: A total of 655 consecutive patients were enrolled. There was a significant main effect of time (F = 8.99, p = 0.0001), showing that emotional symptoms improve over time. A significant main effect was observed for problem-related distress (F = 371.56, p < 0.0001) revealing that patients with elevated problem-related distress at baseline tend to have higher HADS across the three time points, compared to patients with lower problem-related distress. There was an interaction effect between problem-related distress and time (F = 85.22, p < 0.0001), suggesting that HADS scores decreased differently over time, depending on patients' initial level of problem-related distress. CONCLUSION: Overall, emotional symptoms, while decreasing over time, remained associated with problem-related distress after chemotherapy in Brazil. The potential benefit of implementing a psychosocial intervention remains high throughout cancer treatment.

COVID-19 and financial toxicity in patients with renal cell carcinoma.

PURPOSE: To ascertain renal cell carcinoma (RCC) financial toxicity on COVID-19 during the COVID-19 crisis as patients are struggling with therapeutic and financial implications. METHODS: An online survey was conducted from March 22 to March 25, 2020. It included baseline demographic, clinicopathologic, treatment-related information, anxiety levels related to COVID-19, questions related to financial concerns about COVID-19 as well as the validated 11-item COST measure. RESULTS: Five-hundred-and-thirty-nine patients (39%:58% male:female) from 14 countries responded. 23% of the patients did not feel in control of their financial situation but 8% reported being very satisfied with their finances. The median COST score was 21.5 (range 1-44). Metastatic patients who have not started systemic therapy had a COST score (19.8 range 2-41) versus patients on oral systemic therapy had a COST score (23.9 range 4-44). Patients in follow-up after surgery had a median COST score at 20.8 (range 1-40). A low COST scores correlated (p < 0.001) were female gender (r = 0.108), younger age (r = 0.210), urban living situation (r = 0.68), a lower educational level (r = 0.155), lower income (r = 0.165), higher anxiety about acquiring COVID-19 (r = 0.198), having metastatic disease (r = 0.073) and a higher distress score about cancer progression (r = 0.224). CONCLUSION: Our data highlight severe financial impact of COVID-19. Acknowledging financial hardship and thorough counseling of cancer patients should be part of the conversation during the pandemic. Treatment and surveillance of RCC patients might have to be adjusted to contemplate financial and medical needs.

Impact of Alzheimer's disease and related dementia diagnosis following treatment for bladder cancer.

OBJECTIVES: Our objective was to assess the incidence of Alzheimer's Disease and related dementia diagnosis following treatment for muscle-invasive bladder cancer and impact on survival outcomes. MATERIALS AND METHODS: A total of 4814 patients diagnosed with clinical stage T2-T4a, N0, M0 bladder cancer between January 1, 2002 to December 31, 2011 using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database were identified. Alzheimer's disease and related dementia diagnosis was identified using International Statistical Classification of Disease-Ninth Edition outpatient and inpatient codes. Incidence of dementia following treatment were calculated and reported as dementia cases per 10,000 person-years. Cox proportional hazards models were used to assess the impact of dementia on survival outcomes. RESULTS: Of the 4814 patients, 2403 (49.9%) underwent radical cystectomy (RC) and 2411 (50.1%) underwent radiotherapy (RTX) and/or chemotherapy (CTX). Overall, 837 (17.4%) patients developed Alzheimer's disease and related dementia following bladder cancer treatment. There was no significant difference in the incidence of Alzheimer's disease and related dementia following either treatment. Patients diagnosed with Alzheimer's disease and related dementia had worse overall (Hazard Ratio (HR), 2.64; 95% Confidence Interval (CI), 2.41-2.89) and cancer-specific (HR, 2.45; 95% CI, 2.18-2.76) survival than those without a dementia diagnosis following treatment. CONCLUSION: While we observed no difference in new-onset Alzheimer's disease and related dementia diagnosis following RC or RTX and/or CTX, patients with a Alzheimer's and related dementia diagnosis was associated with worse overall and cancer-specific survival. These findings have important implications for screening and the development of targeted interventions for improving outcomes in older adults following complex cancer treatments, as observed in this bladder cancer population.

Adjuvant treatment in renal cell carcinoma.

In parallel with advances in the treatment of metastatic renal cell carcinoma (RCC), multiple adjuvant treatments have been tested for RCC. Adjuvant approaches now extend beyond conventional immunotherapies, such as interferon alfa and interleukins, to targeted therapies and immune checkpoint inhibitors. Most treatment approaches before the targeted treatment era did not improve patient outcomes, or study results were mixed. For example, a recent study found that disease-free survival was longer with sunitinib than with placebo in high-risk clear cell RCC, which led to the regulatory approval of sunitinib. However, another large study of adjuvant sunitinib in a slightly different patient population did not confirm these results. Ongoing studies of targeted treatments and immune checkpoint inhibitors may clarify the effectiveness of these agents in the near future. This review presents a comprehensive, chronologic examination of studies addressing adjuvant treatment in RCC, focusing on the key differences between similar approaches. It also discusses the future of adjuvant treatment in RCC.

Assessment of Treatment Patterns for Metastatic Renal Cell Carcinoma in Brazil.

BACKGROUND: Although multiple therapies have emerged for the treatment of metastatic renal cell carcinoma (mRCC), it is unclear whether application of these agents is consistent in developed and developing countries. We sought to determine patterns of care for mRCC in Brazil as a representative developing country. MATERIAL AND METHODS: A commercial database was used to acquire information pertaining to patients with mRCC receiving treatment at private or public hospitals in Brazil between March 2013 and October 2016. Basic clinical and demographic criteria were available, as well as information to ascertain the International Metastatic Renal Cell Carcinoma Database Consortium risk. Treatment-related data across multiple lines of therapy were collected. RESULTS: Of 4,379 patients assessed, 3,990 (91%) had metastatic disease, and 26%, 48%, and 26% of patients had good, intermediate, and poor International Metastatic Renal Cell Carcinoma Database Consortium risk disease, respectively. Although 3,149 patients (79%) received first-line therapy, only 641 (20%) and 152 (5%) received second- and third-line therapy, respectively. In the first-line setting, vascular endothelial growth factor-directed agents represented the most commonly used therapy, whereas in the second-line setting, vascular endothelial growth factor- and mammalian target of rapamycin-directed agents were used with similar frequency. Marked differences were seen in receipt of systemic therapy on the basis of treatment in private or public hospitals. CONCLUSION: Relative to developed countries, marked attrition is noted between each subsequent line of therapy in Brazil. Patterns of care also vary greatly in private and public settings, pointing to financial constraints as a potential cause for discordances in treatment.