Evaluation of Cognitive Function in Trials Testing New-Generation Hormonal Therapy in Patients with Prostate Cancer: A Systematic Review

Marandino, Laura; Vignani, Francesca; Buttigliero, Consuelo; Gamba, Teresa; Necchi, Andrea; Tucci, Marco; Maïo, Massimo Di

doi:10.3390/cancers12092568

Cited by 10 publications

(9 citation statements)

References 65 publications

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“…Previous studies failed to perform meta-analysis because cognition function change was not viewed as a frequent adverse event, and published articles usually lack useful and important relevant data. 54,55 We found these data in the EMA, the FDA, and clini cal.gov safety reports. Besides, we used network meta-analysis to compare four NHA simultaneously.…”

Section: Discussionmentioning

confidence: 82%

Risk of cognitive impairment in men with advanced prostate cancer treated with NHAs: A systematic review and network meta‐analysis

Huang

Chen

Tseng

et al. 2022

Clinical Translational Sci

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Novel hormonal agents (NHAs) have significantly improved outcomes in men with advanced prostate cancer. However, it remains unclear whether NHAs are associated with subsequent cognitive impairment. Thus, we sought to perform a network meta-analysis to compare the risk of cognitive impairment across NHA types. Databases (PubMed, Embase, Scopus, and Web of Science), trial registries (Clini caltr ial.gov), the European Medicines Agency, and the US Food and Drug Administration drug safety reports were searched from inception through July 30, 2021. Eligible studies were clinical trials evaluating the risk of cognitive impairment between NHAs and placebo/standard care. Two independent investigators extracted the data and performed quality assessments using the Cochrane Risk of Bias Tool and ROBINS-I. We estimated the risk ratios by the frequentist approach and calculated the ranking probabilities of all treatments with the surface under the cumulative ranking probabilities. The primary outcome and secondary outcome were odds ratio (OR) and incidence rate ratio of cognitive impairment, respectively. We identified 15 trials with 14,723 participants comparing HNAs with placebo/standard care. Treatments associated with cognitive impairment, from the most to the least, were enzalutamide (OR, 3.66; 95% confidence interval [CI], 2.84-4.73), apalutamide (OR, 1.76; 95% CI, 1.08-2.87), abiraterone acetate (OR, 1.64; 95% CI, 1.01-2.45), and darolutamide (OR, 1.11 95% CI, 0.51-2.39). After adjustment of treatment time duration, enzalutamide still had the highest risk of cognitive impairment with an incidence rate ratio of 2.17 (95% CI, 1.65-2.78). These findings suggest that NHAs, especially enzalutamide, may increase the risk of cognitive impairment compared with placebo/standard care.

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Section: Discussionmentioning

confidence: 82%

Risk of cognitive impairment in men with advanced prostate cancer treated with NHAs: A systematic review and network meta‐analysis

Huang

Chen

Tseng

et al. 2022

Clinical Translational Sci

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“…The effect of ARPIs on the cognitive functions of PC patients has not been adequately evaluated in the pivotal studies. 80 Apalutamide and enzalutamide, have been associated with adverse central nervous system-related events in patients with PC, including fatigue and mental impairment disorders. 81 In contrast, limited data suggest fewer drug-related cognitive effects with abiraterone compared with enzalutamide.…”

Section: Cognitive Disordersmentioning

confidence: 99%

How to Improve the Quality of Life of Patients with Prostate Cancer Treated with Hormone Therapy?

Turco¹,

Prima²,

Pisano³

et al. 2023

RRU

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Prostate cancer (PC) is a hormone-sensitive tumor. Androgen deprivation therapy (ADT) is the cornerstone of systemic therapy for patients with intermediate or high-risk localized, recurrent, and metastatic prostate cancer. Although generally well tolerated, ADT can lead to short- and long-term adverse events that can worsen the quality of life of patients with PC. In the last decade, the introduction of novel generation androgen receptor pathway inhibitors (ARPI) has resulted in an improvement in the prognosis of patients with metastatic PC when used in combination with ADT. The use of ARPI in increasingly early stages of the disease determines a longer exposure of patients to these treatments. Although ARPIs are normally well-tolerated drugs, they generally cause an increase in toxicity compared to ADT alone, being able to worsen some adverse events already induced by ADT or leading to the development of specific side effects. Although there are no specific treatments for all the adverse events induced by hormonal therapies, it is essential to know the possible toxicities induced by the different treatments and to start procedures to prevent and/or recognize and consequently treat them early in order to not compromise the quality of life of the patients with PC. The aim of this review is to describe the adverse events induced by hormonal therapies. We will first describe the side effects induced by both ADT and ARPI and then the specific adverse events of the different ARPIs. Furthermore, we will try to highlight the possible therapeutic options to prevent or mitigate the toxicity induced by hormone therapies in order to improve the quality of life of the patients with PC.

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“…Although generally well tolerated, ADT-induced hypogonadism and AR-pathway inhibitors have been linked to the development of cognitive dysfunction in men with prostate cancer, although argument for causation has been inconsistent [41][42][43]. Separate evidence suggests that testosterone may exert neuroprotective effects [44], as its depletion has been associated with learning and memory deficits [10,41,42,44,45].…”

Section: Drug Treatment and Other Factors Associated With Cognitive D...mentioning

confidence: 99%

Assessment and Management of Cognitive Function in Patients with Prostate Cancer Treated with Second-Generation Androgen Receptor Pathway Inhibitors

et al. 2022

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Preservation of cognitive function is an important outcome in oncology. Optimal patient management requires an understanding of cognitive effects of the disease and its treatment and an efficacious approach to assessment and management of cognitive dysfunction, including selection of treatments to minimize the risk of cognitive impairment. Awareness is increasing of the potentially detrimental effects of cancer-related cognitive dysfunction on functional independence and quality of life. Prostate cancer occurs most often in older men, who are more likely to develop cognitive dysfunction than younger individuals; this population may be particularly vulnerable to treatment-related cognitive disorders. Prompt identification of treatment-induced cognitive dysfunction is a crucial aspect of effective cancer management. We review the potential etiologies of cognitive decline in patients with prostate cancer, including the potential role of androgen receptor pathway inhibitors; commonly used tools for assessing cognitive function validated in metastatic castration-resistant prostate cancer and adopted in non-metastatic castration-resistant prostate cancer trials; and strategies for management of cognitive symptoms. Many methods are currently used to assess cognitive function. The prevalence and severity of cognitive dysfunction vary according to the instruments and criteria applied. Consensus on the definition of cognitive dysfunction and on the most appropriate approaches to quantify its extent and progression in patients treated for prostate cancer is lacking. Evidence-based guidance on the appropriate tools and time to assess cognitive function in patients with prostate cancer is required. Plain Language SummaryMen with prostate cancer are usually elderly and may have other health conditions. Old age, poor health, and some medications can all affect a person's ability to think clearly, make sound judgments, remember things, and learn new information. These mental difficulties can make it hard for people to do day-to-day tasks such as shopping or making a meal, looking after themselves, or taking medications correctly. People may also have problems with friendships and relationships. Therefore, before a man starts treatment for prostate cancer, he and his doctor must consider the likelihood that his mental ability might be affected by the treatment in order to choose the most suitable treatment option. Initially, the doctor can use short screening tests, such as asking the patient to remember and repeat numbers or words, draw objects, name things in a picture, or complete a survey. If these tests show that the patient might be having mental difficulties, he may be invited for additional tests with a specialist, called a neuropsychologist. A patient with, or at risk of, mental difficulties will be offered a care plan, which might include one or more of the following: selecting or switching treatments to avoid side effects; using memory aids; treatment for pain, difficulty sleeping, depression, or other problems that mi...

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Evaluation of Cognitive Function in Trials Testing New-Generation Hormonal Therapy in Patients with Prostate Cancer: A Systematic Review

Cited by 10 publications

References 65 publications

Risk of cognitive impairment in men with advanced prostate cancer treated with NHAs: A systematic review and network meta‐analysis

Risk of cognitive impairment in men with advanced prostate cancer treated with NHAs: A systematic review and network meta‐analysis

How to Improve the Quality of Life of Patients with Prostate Cancer Treated with Hormone Therapy?

Assessment and Management of Cognitive Function in Patients with Prostate Cancer Treated with Second-Generation Androgen Receptor Pathway Inhibitors

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