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Background Glutamate signaling activates MAPK and PI3K/AKT pathways in tumor cells. Treatment with riluzole, a glutamate release inhibitor, has been previously shown to be safe in melanoma patients and produced biologic effects, but did not lead to radiographic responses, possibly due to poor pharmacokinetic properties. Therefore, we conducted a phase Ib trial to determine the safety and tolerability of the combination of the riluzole prodrug troriluzole (BHV-4157, trigriluzole) and the PD-1 antibody nivolumab in patients with advanced solid tumors. Methods Patients with advanced or refractory solid tumors and measurable disease per RECIST 1.1 were treated with increasing doses of troriluzole using a semi-Bayesian modified toxicity probability interval dose escalation procedure. Troriluzole monotherapy was orally self-administered for a 14-day lead-in period followed by continuation of troriluzole in combination with nivolumab 240 mg IV every 2 weeks. Endpoints included safety, pharmacokinetics (PK) and efficacy. Results We enrolled 14 patients with advanced solid tumors (melanoma = 3, NSCLC = 3, renal cell carcinoma = 2, bladder/urothelial = 2, ovarian cancer = 1, adenoid cystic carcinoma = 1, pleural mesothelial = 1, head and neck cancer = 1). Eleven patients had cancer progression on prior therapy with PD-1 or PD-L1 agent. Patients received troriluzole total daily doses from 140 to 560 mg (divided). The most common treatment-related adverse events (TRAE) occurring in ≥ 5 patients (> 35%) were transaminitis and increased lipase. DLT (dose-limiting toxicity) occurred in 3 patients: (1) grade 3 anorexia, (2) grade 3 fatigue and, (3) grade 3 atrial fibrillation. Six patients were treated at the MTD (maximum tolerated dose). No subjects discontinued treatment due to AEs. One response occurred (7%), which was a partial response in a subject who had PD-1 refractory disease. The 6-month PFS rate was 21%. PK data showed that the prodrug troriluzole was efficiently cleaved into riluzole by 2-h post-dosing in all dose cohorts tested. Conclusion The combination of troriluzole and nivolumab was safe and well-tolerated. The MTD of troriluzole was determined to be 420 mg total daily dose. The observed antitumor activity, primarily disease stabilization, is of interest in patients with PD-1 resistant tumors. Trial Registration ClinicalTrials.gov Identifier NCT03229278.

PurposeTo identify predictors of financial hardship, operationalized as foregoing health care, making financial sacrifices, and being concerned about having inadequate financial and insurance information.MethodsCancer survivors (n = 346) identified through the New Jersey State Cancer Registry were surveyed from August 2018 to September 2019. Multivariable logistic regression analyses were performed.ResultsCancer survivors with household incomes less than $50,000 annually were more likely than those earning $50,0000–$90,000 to report foregoing health care (15.8 percentage points, p < 0.05). Compared to retirees, survivors who were currently unemployed, disabled, or were homemakers were more likely to forego doctor’s visits (11.4 percentage points, p < 0.05), more likely to report borrowing money (16.1 percentage points, p < 0.01), and more likely to report wanting health insurance information (25.7 percentage points, p < 0.01). Employed survivors were more likely than retirees to forego health care (16.8 percentage points, p < 0.05) and make financial sacrifices (20.0 percentage points, p < 0.01). Survivors who never went to college were 9.8 percentage points (p < 0.05) more likely to borrow money compared to college graduates. Black survivors were more likely to want information about dealing with financial and insurance issues (p < 0.01); men were more likely to forego health care (p < 0.05).ConclusionFindings highlight the role of employment status and suggest that education, income, race, and gender also shape cancer survivors’ experience of financial hardship. There is a need to refine and extend financial navigation programs. For employed survivors, strengthening family leave policies would be desirable.

Positron emission tomography (PET) radiotracers targeting prostate‐specific membrane antigen (PSMA) are now widely used in the evaluation of prostate cancer. However, PSMA activity has also been described in several nonprostatic malignancies, where PSMA is primarily expressed in tumor neovasculature. Here, we describe to the best of our knowledge the first case of a PSMA‐avid Merkel cell carcinoma (MCC) inguinal lymph node metastasis, detected incidentally in an 80‐year‐old man with advanced metastatic prostate adenocarcinoma. Clinical history and disease distribution prompted the need for a diagnostic biopsy, confirming PSMA‐avid metastatic MCC. This case highlights the importance of recognizing nonprostatic causes of PSMA uptake, as synchronous malignancies can alter diagnostic interpretation and treatment planning.

Background Fatigue is often one of the most commonly reported symptoms in older male cancer survivors, but it is also one of the least understood cancer-related symptoms. Fatigue is associated with psychological distress, disruptions in sleep quality, and impairments in health-related quality of life. Thus, elective treatments for fatigue in older male cancer survivors represent a current unmet need. Prior research has shown that Tai Chi Qigong (TCQ), a mind-body exercise intervention, can improve physical and emotional health. Therefore, we compared the efficacy of Tai Chi Qigong (TCQ) versus exercise intensity-matched (EIM) and usual care in older, male cancer survivors with fatigue. Methods We conducted a three-arm, single-blind randomized controlled trial where older (55 + years), male cancer survivors with fatigue participated in usual care or one of two supervised group exercise programs: TCQ or EIM twice weekly for 12 weeks. Participants were followed up for 12 months. The primary outcome was patient-reported fatigue at 3-months post-intervention. Results A cohort of men ( n  = 113) were enrolled (mean age: 69.1 (±7.0) years. In the primary outcome analysis, there were no significant within-arm or between-arm differences in fatigue ( p- value, NS). However, the TCQ and EIM arms showed significant within-arm improvement in fatigue immediately post-intervention ( p- value < 0.05). There were no differences in class attendance for either TCQ or EIM, with an average attendance rate of 78.4% and 76.8%, respectively. Conclusion We found no significant or clinically meaningful improvements in fatigue for TCQ or EIM relative to usual care at the 3-month follow-up. However, significant improvements in fatigue were observed immediately after completion of the 12-week TCQ and EIM programs. This study suggests that TCQ and light intensity activity may lead to improvements in fatigue immediately after the group exercise program among older, fatigued male cancer survivors. However, the observed improvements did not persist beyond the program, suggesting that long-term maintenance may be required. Further testing is warranted in larger trials that include strategies to sustain both the behavior and the effects. Trial registration This study was registered at the NIH clinical trial registry on November 17, 2017 (NCT03345563).

Chromophobe renal cell carcinoma (chRCC) is one of the less common types of kidney cancer and generally portends a more favorable prognosis. RCC with sarcomatoid differentiation has a more aggressive clinical course with poor outcomes. Four cases of chRCC with varying degrees of sarcomatoid differentiation were retrospectively reviewed at our institution, and clinicopathologic data as well as clinical courses were reported. Patients with higher degrees of sarcomatoid differentiation and larger tumors at presentation generally had and worse overall survival. chRCC with sarcomatoid differentiation portends a poor prognosis with limited data on systemic treatment options for metastatic disease.

Background In this era of precision medicine, the DNA damage response (DDR) pathway has been shown to be a viable target of intervention in metastatic castration-resistant prostate cancer (CRPC) as approximately one-third of CRPC patients harbor DDR pathway mutations. To determine whether DDR pathway is a potential therapeutic target in localized disease, we analyzed The Cancer Genome Atlas (TCGA) in the present study. Methods TCGA is a publically available cancer genome database that is sponsored by the United States National Cancer Institute. Total of 455 cases were available in the database at the time of this analysis. Results DDR pathway gene mutations or copy number alterations were present in 136 (29.9%) of the 455 cases. On a univariate analysis, DDR pathway status did not correlate with serum prostate specific antigen, tumor stage or grade. However, among patients with high-risk features post-operatively (pathologic stage ≥ T3, Gleason score ≥ 8, or PSA > 20 ng/ml), DDR pathway alteration was associated with a lower overall survival ( p  = 0.0291). Conclusions Collectively these results suggest that DDR pathway alterations may also be significant in localized prostate cancer and agents such as PARP inhibitors should be considered in patients with a high-risk disease.

Cardiac metastases from renal cell carcinoma (RCC) are very rare. We describe the case of a woman with RCC with cardiac metastases involving the entire right atrium, penetrating through the myocardium, with extension into the tricuspid valve and right ventricle. This report highlights the unique challenge of the diagnosis and treatment of cardiac metastases in RCC.

During ASCO Annual Meeting, Bossi presented the results of a second preplanned primary endpoint analysis to assess the effect of prostate irradiation on safety and outcomes among men with low-volume disease receiving intensified systemic therapy. The 2x2 factorial design study randomly assigned participants in a 1:1:1:1 ratio to standard of care (ADT plus docetaxel), standard of care plus abiraterone, standard of care plus radiotherapy of the primary tumor, or standard of care plus abiraterone and radiotherapy of the primary tumor. In terms of incorporating prostate radiation into treatment for lowvolume de novo metastatic prostate cancer, we must be careful when interpreting the data in current practice conditions with routine use of much more sensitive imaging tests, such as PSMA PET.

To identify symptom profiles (e.g., fatigue, sleep disturbance, depression, anxiety, cognitive impairment) among prostate cancer survivors, examine factors associated with the identified symptom profiles, and compare quality-of-life outcomes. 98 prostate cancer survivors who completed primary treatment were enrolled in a randomized parent trial. Established scales were used to measure symptoms and quality of life. Latent profile analysis was employed to classify patient groups based on symptom experiences. Logistic regression assessed factors associated with symptom profiles. The mean age of participants was 69 years (SD = 6.8). A high-symptom group (n = 29) and a low-symptom group (n = 69) were identified. Higher perceived stress (odds ratio [OR] = 1.28; p = 0.006), poorer spiritual well-being (OR = 0.84; p = 0.006), and lower household income (OR = 0.12; p = 0.089) were associated with being classified into the high-symptom group. Patients in the high-symptom group reported worse quality of life across all domains (p < 0.05). Prostate cancer survivors experience varying degrees of symptom severity. Understanding the symptom profiles and associated factors can inform nurses about patients in need of symptom management and targeted interventions.

Background Physicians treating similar patients in similar care-delivery contexts vary in the intensity of life-extending care provided to their patients at the end-of-life. Physician psychological propensities are an important potential determinant of this variability, but the pertinent literature has yet to be synthesized. Objective Conduct a review of qualitative studies to explicate whether and how psychological propensities could result in some physicians providing more intensive treatment than others. Methods Systematic searches were conducted in five major electronic databases—MEDLINE ALL (Ovid), Embase (Elsevier), CINAHL (EBSCO), PsycINFO (Ovid), and Cochrane CENTRAL (Wiley)—to identify eligible studies (earliest available date to August 2021). Eligibility criteria included examination of a physician psychological factor as relating to end-of-life care intensity in advanced life-limiting illness. Findings from individual studies were pooled and synthesized using thematic analysis, which identified common, prevalent themes across findings. Results The search identified 5623 references, of which 28 were included in the final synthesis. Seven psychological propensities were identified as influencing physician judgments regarding whether and when to withhold or de-escalate life-extending treatments resulting in higher treatment intensity: (1) professional identity as someone who extends lifespan, (2) mortality aversion, (3) communication avoidance, (4) conflict avoidance, (5) personal values favoring life extension, (6) decisional avoidance, and (7) over-optimism. Conclusions Psychological propensities could influence physician judgments regarding whether and when to de-escalate life-extending treatments. Future work should examine how individual and environmental factors combine to create such propensities, and how addressing these propensities could reduce physician-attributed variation in end-of-life care intensity.