Search

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.

Stereotactic body radiation therapy (SBRT) has been shown to be safe and effective for delaying systemic treatment change among patients with metastatic renal cell carcinoma (mRCC). In this study, we sought to assess the genomic signatures of patients with mRCC who underwent SBRT for oligoprogression. A total of 30 patients with oligoprogressive disease were identified, the majority of whom had clear cell renal cell carcinoma (83.3%) and were receiving first-line treatment (53.3%). Genomic and transcriptomic sequencing were available in 20 and 16 patients, respectively. Duration of systemic treatment (DOT) was categorized as that prior (DOT[P]) and subsequent (DOT[S]) to radiation treatment. The median DOT(P) and DOT(S) were 15.1 and 18.3 mo, respectively, with a median DOT(S)/DOT(P) ratio of 1.4. Patients who had a DOT(S)/DOT(P) ratio of ≥1 had increased expression in pathways related to cell proliferation and development. In contrast, among patients with a ratio of ≤1, the reactive oxygen species pathway was enriched. This study highlights the potential role of genomics and transcriptomics to refine radiation treatment selection in patients with mRCC. PATIENT SUMMARY: In this study, we looked at mutations and genomic expressions among kidney cancer patients who responded better to stereotactic body radiotherapy. We found that enriched expression of certain pathways might play a role in response to radiotherapy.

34 Background: The American Society of Clinical Oncology (ASCO) and the Friends of Cancer Research (FCR) published a joint statement addressing clinical eligibility for characteristics lacking adequate representation in recent studies (Kim et al., Clin Cancer Res 2021). Herein, we aimed to identify the frequency of other potentially excessive exclusion criteria in the context of metastatic prostate cancer. Methods: The eligibility criteria of advanced prostate cancer studies with start dates between June 30, 2012 and June 30, 2022 were identified through Clinicaltrials.gov. MeSH (Medical Subject Headings) terms in our query were “(metastatic OR advanced OR stage IV OR unresectable) AND (prostate cancer OR prostate adenocarcinoma)”. Our study included trials conducted worldwide and examined patients aged 18 and over in phase I-III trials. To narrow the scope of study, trials including more than one cancer type (basket trials) as well as those focusing on radiation therapy were not included in the study. Descriptive statistics were used to determine the frequency of eligibility criteria while the Fisher’s exact test or chi-square test were performed to demonstrate association between type of treatment and exclusion criteria. Results: 265 of 699 (37.9%) clinical trials within the specified search had sufficiently available data for evaluation. Of these, 136 (51.3%), 51 (19.2%), 26 (9.8%), 20 (7.5%), 19 (7.2%), and 7 (2.6%) of trials investigated treatment with combination therapy, hormone therapy, targeted therapy, immunotherapy, radioligand therapy, and chemotherapy, respectively. The most common ASCO-FCR-cited exclusion criteria in the studies were brain metastases (161/265, 60.8 %), HIV positivity (123/265, 46.4%), HBV/HCV positivity (122/265, 46.0%), and concurrent malignancies (41/265, 16.6%). Statistically significant relationships were identified between type of treatment along with status of brain metastases, HIV, and HBV/HCV (p=0.011

612 Background: A consensus statement from the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (FCR) collaboration highlights the importance of expanding eligibility criteria in cancer trials to more accurately reflect the real-world population (Kim et al., Clin Cancer Res 2021). We sought to characterize use of overly restrictive eligibility criteria in renal cell carcinoma (RCC) trials in the context of ASCO-FCR recommendations. Methods: Studies containing the MeSH terms “(metastatic OR advanced OR stage IV or unresectable) AND (kidney cancer OR renal cell carcinoma OR renal cell cancer)” from June 30, 2012 to June 30, 2022 were identified on the ClinicalTrials.gov platform. Our search query’s inclusion criteria identified international studies examining adult patients aged ≥ 18 in phase I-III trials. Exclusion criteria comprised pan-cancer studies, trials involving localized treatments, radiation therapy, and prognostic tools. Descriptive statistics were used to characterize the frequency of restrictive eligibility criteria across studies, while Fisher’s exact test or chi-square test were utilized to determine the association between treatment type and exclusion criteria. Results: The content of 423 RCC trials were analyzed, of which 112 (26.5%) had adequate data available. 48 (42.9%), 44 (39.3%) and 18 (16.1%) studies examined combination therapy, targeted therapy, and immunotherapy, respectively. The presence of HIV positivity, HBV/HCV positivity, brain metastases, and concurrent malignancies accounted for the most frequently cited exclusionary criteria, seen in 83/112 (74.1%), 60/112 (53.6%), 37/112 (33.0%), and 9/112 (8.0%) studies respectively. Differences in the use of HIV positivity (p

662 Background: Mounting data suggests that dietary modification and supplement use, including probiotics, may modulate outcomes with immunotherapy in cancer therapy (Spencer CN et al. Science 2021; Dizman N et al. Nature Medicine 2022). For the first time, we sought to quantify the use of these measures among patients with metastatic renal cell carcinoma (mRCC). Methods: An online survey was administered by Kidney Cancer Research Alliance (KCCure), a non-profit patient advocacy group, between July 22 and Sept 22 to a patient mailing list (N=1,532). Only patients diagnosed with mRCC and under active systemic therapy were included for analysis in the current study. Select questions were directed at dietary modification patterns and supplement usage. Patients were additionally surveyed regarding out-of-pocket spending patterns related to supplement purchases and to what extent they shared information about their supplement intake with their physicians. The student's t-test and Chi-square test were used to compare sociodemographic characteristics between participants who did and did not report supplement intake. Results: Out of 1,062 patients with renal cell carcinoma who participated in this survey, 289 met the inclusion criteria (M:F, 145:143). The median age was 61. The majority of patients identified themselves as white (91%), were from the US (86.8%), and had completed a bachelor's degree (52.9%). 21.1%, 46.1%, and 32.6% lived in urban, suburban, and rural locations, respectively. The most common reported first-line treatments were nivolumab/ipilimumab (32.4%) and axitinib/pembrolizumab (13.1%). 22.4% of respondents reported spending >$100/month on supplements, and 8.3% reported spending >$250/mo. Dietary modifications following a cancer diagnosis were reported by 34.9% of respondents, out of which 19.8% followed the Mediterranean diet and 18.8% adopted a ketogenic diet. 50.8% of respondents reported supplement intake. The most widely utilized supplements were cannabidiol (CBD) oil/marijuana, probiotics, and Vitamin C, reported by 28.0%, 24.2%, and 18.6% of respondents, respectively. 83.4% of respondents noted that they consistently report supplement usage to their physicians. There were no statistically significant associations between supplement use and age, sex, living area, or education. Conclusions: A substantial proportion of patients with mRCC use dietary modification and supplements as an adjunct to their antineoplastic treatment. Interventions such as probiotic use and ketogenic diets, which are the subject of a prospective study in mRCC (NCT05119010; NCT05122546), may already be used by many patients. More careful attention to nutrition and supplement use in clinical trial candidates may minimize the impact of these potential confounders.

453 Background: American Society of Clinical Oncology (ASCO) and the Friends of Cancer Research (FCR) underscored the need to broaden eligibility criteria in cancer trials to increase patient accrual, expand access to investigational treatments, and enhance generalizability of study results (Kim et al., Clin Cancer Res 2021). While eligibility criteria intend to prioritize patient safety and define a specific study population, these criteria are often based on outdated standards and may not be reflective of real-world practice. Our study aimed to characterize the proportion of aUC trial eligibility criteria according to the ASCO-FCR statement. Methods: Protocols indexed on ClinicalTrials.gov with start dates from June 30, 2012 to June 30, 2022 were evaluated. MeSH terms used in our query were “(metastatic OR advanced OR stage IV OR unresectable) AND (bladder cancer OR upper tract urothelial carcinoma OR upper tract urothelial cancer)”. International studies enrolling patients aged 18 and over in phases I-III were included. Studies examining multiple cancer types as well as those involving localized treatments (e.g., surgery or ablation), radiation therapy, and prognostic tools were excluded. Analyses of eligibility criteria focused on those highlighted in the ASCO-FCR statement; descriptive statistics were used to define the frequency of eligibility criteria and chi-square and Fisher’s exact test were used to determine their association with treatment type. Results: Overall, 205 urothelial cancer trials were assessed, with 37 (18.0%) having publicly accessible data. Of these, 13 (35.1%) evaluated combination therapy, 11 (29.7%) evaluated immunotherapy, 8 (21.6%) evaluated targeted therapy, and 5 (13.5%) evaluated chemotherapy. HIV positivity, HBV/HCV positivity, brain metastases, and concurrent malignancies were found to be exclusion criteria in 89.2% (33/37), 56.8% (21/37), 35.1% (13/37), and 5.4% (2/37) of studies, respectively. While brain metastases, concurrent malignancies, and HBV/HCV positivity were found to be independent of the class of therapy, a statistically significant association was observed with HIV positivity. Specifically, trials evaluating combination therapy (100.0%), immunotherapy (100.0%) and targeted therapy (87.5%) more frequently included HIV positivity as an exclusion criterion as compared to chemotherapy trials (40.0%). Conclusions: A modest percentage of a UC studies from the last decade were observed to report overly restrictive eligibility criteria as defined by the ASCO-FCR statement. HIV positivity and HBV/HCV positivity were commonly identified exclusion criteria, despite limited evidence that these criteria significantly impact drug efficacy and tolerability. Reassessing and updating eligibility criteria will ensure that the resulting data is more reflective and inclusive of a real-world population.

Chemotherapy and radiotherapy are first-line treatments in the management of advanced solid tumors. Whereas these treatments are directed at eliminating cancer cells, they cause significant adverse effects that can be detrimental to a patient’s quality of life and even life-threatening. Diet is a modifiable risk factor that has been shown to affect cancer risk, recurrence, and treatment toxicity, but little information is known how diet interacts with cancer treatment modalities. Although dietary interventions, such as intermittent fasting and ketogenic diets, have shown promise in pre-clinical studies by reducing the toxicity and increasing the efficacy of chemotherapeutics, there remains a limited number of clinical studies in this space. This review surveys the impact of dietary interventions (caloric restriction, intermittent and short-term fasting, and ketogenic diet) on cancer treatment outcomes in both pre-clinical and clinical studies. Early studies support a complementary role for these dietary interventions in improving patient quality of life across multiple cancer types by reducing toxicity and perhaps a benefit in treatment efficacy. Larger, phase III, randomized clinical trials are ultimately necessary to evaluate the efficacy of these dietary interventions in improving oncologic or quality of life outcomes for patients that are undergoing chemotherapy or radiotherapy.