Does Research from Clinical Trials in Metastatic Hormone-sensitive Prostate Cancer Treatment Translate into Access to Treatments for Patients in the "Real World"? A Systematic Review - Beyond the Abstract

Within the last decade, there have been vast changes in the approach to the management of metastatic hormone sensitive prostate cancer (mHSPC). The basis of treatment has been androgen deprivation therapy (ADT) but following several practice-changing trials there are now additional systemic treatment options available. ‘Treatment intensification’ using cytotoxic (i.e. Docetaxel) or Novel Hormonal Therapy (NHT) (i.e. Enzalutamide, Apalutamide, and Abiraterone) in combination with ADT, has demonstrated improved overall survival in mHSPC.

Despite this, early evidence suggests that not all patients eligible for these treatments are receiving them. This study aims to explore the evidence that research from clinical trials in mHSPC treatment is being translated into access to treatments for patients in clinical practice, through a systemic review of the current literature. The primary outcome of the study was to describe and analyse the utilisation rates of systemic treatment intensification in mHSPC and how these have changed over time. The secondary outcome of this analysis was to identify the determinants of variation of receipt of treatment intensification in this patient cohort.

The research cited in this review demonstrates that the utilisation rate of ‘treatment intensification’ with either docetaxel or NHT (enzalutamide, apalutamide, and abiraterone), in addition to ADT, is low (range 9.3% to 38.1%) but that NHT utilisation rates appear to have increased over time. Whilst the utilisation rates of docetaxel and NHT are low across all settings identified in this systematic review, there are patterns of underuse with certain groups of patients and in particular settings. Younger, white patients with fewer co-morbidities living in more urban settings were more likely to be prescribed treatment intensification. Patients treated in private, academic institutions by oncologists were more likely to receive docetaxel or NHT. Socio-economic status did not impact on receipt of systemic therapy.

The reasons for the underutilisation of treatment intensification for patients with primary mHSPC could include patient preference, prescribing restrictions including financial barriers or access to certain drug treatments, geographic access, educational access, and consideration of other patient determinants (e.g. patient frailty).

These results highlight the discordance between recent practice changing trials in the treatment of mHSPC and the translation of these trials into clinical practice, with low utilisation rates of treatment intensification. Implementation of the trial results will be supported by further research that can provide better understanding of how the uptake of treatment intensification can be facilitated. There is a need to change the approach to the treatment of primary mHSPC in the real world to optimise upfront systemic therapy for these patients by harnessing the practice changing results of recent trials in this setting.

Written by: Joanna Dodkins, NPCA Clinical Research Fellow, Clinical Effectiveness Unit, The Royal College of Surgeons of England, London, United Kingdom

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