Have You Read? July 2021

By: Daniel A. Shoskes, MD | Posted on: 28 Jul 2021

Tellechea L, Zuo S, Kohn JR et al: The effect of social determinants of health on overactive bladder symptom severity. J Urol 2021; 205: 1415–1420.

Overactive bladder symptoms depend on perception and reaction and as such can be influenced by many factors, including social determinants of health. In this study, the authors evaluated the association between social determinants of health and overactive bladder severity. They conducted a multicenter, cross-sectional study of patients presenting to outpatient female pelvic medicine and reconstructive surgery clinics. Surveys were administered to screen for overactive bladder and to evaluate social determinants of health. Ordinal logistic regression models were used to examine the association between overactive bladder symptom level and social determinants of health items while adjusting for age, race, body mass index, parity, history of pelvic surgery and clinical site.

A total of 256 patients with a mean±SD age of 58.6±14.2 years and body mass index of 30.4±7.5 kg/m2 were recruited over a 12-month period. The sample was 33.6% White, 32% Black and 29.3% Hispanic, with 5.1% categorized as other. A higher overactive bladder symptom level was associated with food insecurity (OR 2.51, 95% CI 1.03–6.11), financial strain (OR 1.94, 95% CI 1.06–3.53), difficulty finding or keeping employment (OR 3.14, 95% CI 1.01–9.72) and difficulty concentrating (OR 2.48, 95% CI 1.25–4.95), after adjusting for site, age, race, body mass index, parity and previous pelvic surgery.

The authors conclude that certain social determinants of health were associated with greater overactive bladder severity. Unmet social needs may impact the success of overactive bladder treatment. Urologists should consider collaborating with social work and mental health specialists to better serve patients with overactive bladder and social determinants of health needs.

Choueiri TK, Powles T, Burotto M et al: Nivolumab plus cabozantinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med 2021; 384: 829–841.

The options for systemic therapy in aggressive renal cell carcinoma continue to evolve. In this phase 3, randomized, open-label trial, the authors randomly assigned adults with previously untreated clear-cell, advanced renal-cell carcinoma to receive either nivolumab (240 mg every 2 weeks) plus cabozantinib (40 mg once daily) or sunitinib (50 mg once daily for 4 weeks of each 6-week cycle). The primary end point was progression-free survival, as determined by blinded independent central review.

Overall, 651 patients were assigned to receive nivolumab plus cabozantinib (323 patients) or sunitinib (328 patients). At a median followup of 18.1 months for overall survival, the median progression-free survival was 16.6 months (95% CI 12.5–24.9) with nivolumab plus cabozantinib and 8.3 months (95% CI 7.0–9.7) with sunitinib (HR for disease progression or death, 0.51; 95% CI 0.41–0.64; p <0.001). The probability of overall survival at 12 months was 85.7% (95% CI 81.3–89.1) with nivolumab plus cabozantinib and 75.6% (95% CI 70.5–80.0) with sunitinib (HR for death, 0.60; 98.89% CI 0.40–0.89; p=0.001). An objective response occurred in 55.7% of the patients receiving nivolumab plus cabozantinib and in 27.1% of those receiving sunitinib (p <0.001). Adverse events of any cause of grade 3 or higher occurred in 75.3% of the 320 patients receiving nivolumab plus cabozantinib and in 70.6% of the 320 patients receiving sunitinib. Overall, 19.7% of the patients in the combination group discontinued at least 1 of the trial drugs owing to adverse events, and 5.6% discontinued both. Patients reported better health-related quality of life with nivolumab plus cabozantinib than with sunitinib.

The authors conclude that nivolumab plus cabozantinib had significant benefits over sunitinib with respect to progression-free survival, overall survival, and likelihood of response in patients with previously untreated advanced renal-cell carcinoma.

Magnani CJ, Steinberg JR, Harmange CI et al: Clinical trial outcomes in urology: assessing early discontinuation, results reporting and publication in ClinicalTrials.gov registrations 2007–2019. J Urol 2021; 205: 1159–1168.

Clinical trials take great effort, money and willing participation of patients to help the greater good if not themselves. Studies that don’t complete and/or never publish their results waste these resources and violate patient trust. In this study, the authors assessed trial registrations from 2007 to 2019 on ClinicalTrials.gov and publication data from PubMed®/MEDLINE®. Associations between sponsor or subspecialty with early discontinuation were assessed using Cox proportional hazards and results reporting or publication with logistic regression at 3 years after completion. Of 8,636 trials 3,541 (41.0%) were completed and 999 (11.6%) were discontinued. Of completed trials 26.9% reported results and 21.6% were published. Sponsors included academic institutions (53.1%), industry (37.1%) and the U.S. government (9.8%). Academic-sponsored (adjusted HR 0.81, 95% CI 0.69–0.96, p=0.012) and government-sponsored trials (adjusted HR 0.62, 95% CI 0.49–0.78, p <0.001) were less likely than industry to discontinue early. Government-sponsored trials were more likely to report (adjusted OR 1.72, 95% CI 1.17–2.54, p=0.006) and publish (adjusted OR 1.89, 95% CI 1.23–2.89, p=0.004). Academic-sponsored trials were less likely to report (adjusted OR 0.65, CI 0.48–0.88, p=0.006) but more likely to publish (adjusted OR 1.72, 95% CI 1.25–2.37, p <0.001). These outcomes were similar across subspecialties. However, endourology was more likely to discontinue early (adjusted HR 2.00, 95% CI 1.53–2.95, p <0.001), general urology was more likely to report results (adjusted OR 1.54, 95% CI 1.13–2.11, p=0.006) and andrology was less likely to publish (adjusted OR 0.53, 95% CI 0.35–0.81, p=0.003).

The authors conclude that sponsor type is significantly associated with trial completion and dissemination. Government-sponsored trials had the best performance, while industry and academic-sponsored trials lagged in completion and results reporting, respectively. Subspecialty played a lesser role. Lack of dissemination remains a problem for urology trials.

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