Impact of next-generation hormonal agents on treatment patterns among patients with metastatic hormone-sensitive prostate cancer: a real-world study from the United States, five European countries and Japan

Abstract

Background Until five years ago, the metastatic hormone-sensitive prostate cancer (mHSPC) treatment landscape was dominated by the use of androgen deprivation therapy (ADT) alone. However, novel hormonal agents (NHAs) and chemotherapy are now approved for male patients with mHSPC. This study aimed to understand the impact NHA approvals had on mHSPC real-world treatment patterns and to identify the key factors associated with NHA or chemotherapy (± ADT) usage vs ADT alone. Methods Data were collected from the Adelphi Prostate Cancer Disease Specific Programme (DSP)™, a point-in-time survey of physicians and their consulting patients conducted in the United States (US), five European countries (France, Germany, Italy, Spain, and the United Kingdom), and Japan between January and August 2020. Data were analysed using descriptive statistics for individual countries, regions, and all countries combined. Pairwise analyses were used to further investigate differences between treatment groups at global level. Results 336 physicians provided data on 1195 mHSPC patients. Globally, at data collection, the most common mHSPC regimen initiated first was ADT alone (47%), followed by NHAs (± ADT) (31%, of which 21% was abiraterone, 8% was enzalutamide, and 2% was apalutamide) and chemotherapy (± ADT) (19%). The highest rates of ADT alone usage were observed in Japan (78%) and Italy (66%), and the lowest in Spain (34%) and in the US (36%). Our results showed that clinical decision making was driven by patient fitness, compliance, tolerance of adverse events, and balance of impact on quality of life vs overall survival. Conclusions This real-world survey offered early insights into the evolving mHSPC treatment paradigm. It showed that in 2020, ADT alone remained the most common initial mHSPC therapy, suggesting that physicians may prefer using treatments which they are familiar and have experience with, despite clinical trial evidence of improved survival with NHAs or chemotherapy (± ADT) vs ADT alone. Results also indicated that physicians prescribed specific mHSPC treatments primarily based on the following criteria: patient preference, disease burden/severity, and the performance status and comorbidities of the patient. To fully appreciate the rapidly changing mHSPC treatment landscape and monitor NHA uptake, additional real-world studies are required.

Impact of presentation timing in metastatic hormone‐sensitive prostate cancer: Characterization of patients and identification of prognostic factors

“…The fact that in our cohort, the majority of patients were mainly treated with ADT and a low percentage were actually receiving contemporary treatment could function as an independent variable, data from seven countries showed that in Japan and Italy 78% and 66%, respectively were on ADT alone 9 which is similar to our findings which were 73%.…”

“…10 In a subgroup analysis of the GETUG, | 567 documented a gradual trend toward treatment intensification, although a substantial percentage of patients still remain on exclusive hormonal treatment. 9,12 The retrospective nature of the present study, along with the sample size, distribution of patients within subgroups, and implementation of treatment intensification, could introduce biases into the reported results. This study addressed a population with ethnically distinct characteristics compared to those typically reported in the literature, exhibiting substantial differences in the risk groups that have been utilized in recent years and have been proposed as eligibility criteria for treatment intensification in realworld settings as well as in clinical trials.…”

“…This treatment pattern observed in our cohort could be explained by the fact that newer therapies targeting the androgen receptor axis have received regulatory approval relatively recently in our country, and as Leith et al pointed out, a reason why physicians prescribe more ADT, despite evidence showing improved survival with chemotherapy and therapies targeting the androgen receptor axis, is because physicians prefer using treatments with which they are familiar. 9 One of the independent factors described in our multivariate analysis was functional assessment using ECOG performance status.…”

The Role of Physician Specialty in the Underutilization of Standard-of-Care Treatment Intensification in Patients With Metastatic Castration-sensitive Prostate Cancer

“…Our results also showed that ADT + ARPI was the most prescribed regimen in LOT2 and LOT3 across all specialties, suggesting that both oncologists and urologists, constrained by concerns of perceived tolerability, lack of urgency to treat up front, access to care, costs, quality of life, or the information gap on overall survival gain and sequencing, 30 may be reserving TI for later lines. 25 Such hesitation could also stem from insufficient clinician awareness about the benefits of early TI with ARPIs and current guidelines, which state there is likely minimal added benefit of long-term NSAAs in mCSPC patients.…”

Double or Triple Trouble in Metastatic Hormone-sensitive Prostate Cancer?

“…However, the semantics of whether we should offer doublet or triplet therapy is completely lost when we consider the real-world utilisation of neither. Many patients still receive ADT alone for mHSPC [6,7], despite irrefutable high-level evidence existing for many years supporting doublet therapy with docetaxel or NHT. Multiple factors, including delayed drug regulatory approval, high treatment costs, and patient/physician preference to avoid cytotoxic therapy, probably contribute to the use of ADT monotherapy in the face of such evidence.…”