National Consensus on Non-metastatic Castration-Resistant Prostate Cancer: more than just a snapshot

Abstract

The landscape of castration-resistant prostate cancer (CRPC) has dramatically improved in the last few years. Still, it remains a very heterogeneous clinical setting. It ranges from patients with good performance status having an asymptomatic PSA elevation after hormone blockage failure with previous hormone-sensitive prostate cancer to those with a rapidly progressing disease and a dismal prognosis. Non-metastatic castration-resistant prostate cancer (nmCRPC-M0) is a transient stage that affects almost 10% of prostate cancer patients, with up to 60% progressing to the metastatic disease within 5 years (1). Recently 3 new androgen receptor blockers have been approved in Brazil by ANVISA for nmCRPC based on their level 1 pivotal studies-Spartan (apalutamide); Prosper (enzalutamide) and Aramis (darolutamide). These studies showed a remarkably similar result albeit targeting patients with slightly different characteristics (Table-1). Overall, the pooled analysis of the data revealed a significantly increased overall survival and improved progression-free survival due to these new agents compared with placebo. In the current edition of the IBJU, Maluf et al. describe a national consensus of experts on nmCRPC, aiming to provide data on diverse topics such as diagnosis, patient selection, management of comorbidities, treatment efficacy, side effects due to the "inexistence of a national guideline for this clinical scenario" (2). It was not stated on the paper which criteria was used for selecting the Specialists nor which Medical Societies (if any) promoted the consensus; and, there was no disclaimer of how the consensus was supported. The article brings a good review of the literature to hold up the expert's opinions. While every effort is expected from groups of experts to provide the best knowledge to diagnostic and treatments according to the most up-to-date data and international recommendations, one must not lose sight of the significant gaps and controversies that might coexist regarding clinically meaningful endpoints, financial toxicity, overtreatment, pharmacoeconomic and polypharmacy for this type of cancer patients, especially in a country as large and heterogeneous as Brazil, which may provide all available resources in one area but may lack significant basic means in several others. Thus, several important points deserve consideration. The consensus is somehow outdated; although the authors do mention data from the Aramis study, darolutamide was not included in the experts' questions and responses because it was only approved in Brazil by December 2019. The panel agreed to answer questions on the assumption of the existence of an ideal clinical scenario based on the best evidence available. Yet it was unable to reach consensus in any of the questions EDITORIAL COMMENT

Perception of castration value over cost in the metastatic prostate cancer scenario: a contemporary pharmacoeconomic perspective

“…Another subject of interest is the potential effect of drug interactions considering that many patients have comorbidities and face polypharmacy (23). In the metastatic non-curable disease scenario, the surgical castration irreversibility is not an issue, and it can save money for sequential treatments once financial burden impacts not only the individual but also the overall healthcare system.…”

Treatment Patterns Among Patients With Advanced Prostate Cancer in Brazil: An Analysis of a Private Healthcare System Database

“…Abiraterone approval preceded enzalutamide approval by 1 year, which could explain the higher use of abiraterone. ANVISA only recently approved enzalutamide for the treatment of metastatic castration-sensitive prostate cancer [ 26 ]. It is important to note that the recent approval of NHTs by the Brazilian regulatory agencies and the increasing use of these drugs in private healthcare practices will probably increase the disparities in treatment patterns between the private and public healthcare systems as the approvals by the public health system are deferred due to availability of resources.…”