https://orcid.org/0000-0003-0176-4478
Abstract
Aim: To characterize real-world patients with metastatic hormone-sensitive prostate cancer (mHSPC) and treating physicians and evaluate treatment trends and baseline concordance versus guidelines internationally. Materials & methods: Retrospective, cross-sectional data from the Ipsos Global Oncology Monitor database 2018–2020 were used for descriptive analysis of mHSPC patients, treating physicians and treatment utilization. Results: Among the 6198 mHSPC patients from five countries, the most common treatment was either androgen deprivation therapy (ADT) monotherapy or first-generation androgen receptor inhibitor + ADT. Second-generation androgen receptor inhibitor use was only initiating but increasing over the study period. Conclusion: Despite contemporaneous guidelines recommending treatment intensification of ADT in combination with novel antihormonals or docetaxel, 76.1% of reported mHSPC patients received non–guideline-concordant care.
Plain language summary
Prostate cancer is the second most common cancer among men worldwide and a leading cause of cancer-related death globally. Metastatic hormone-sensitive prostate cancer (mHSPC) refers to the stage of prostate cancer where it has spread to other parts of the body (’metastatic’) but still responds to hormonal therapy (’hormone-sensitive’), such as androgen deprivation therapy (ADT). Treatment guidelines around the world for men with mHSPC have changed over time, but there remains a lack of understanding of how well guidelines are followed in real-world practice. Consequently, this study analyzes real-world data from five countries between 2018 and 2020 to understand treatment patterns, baseline concordance versus guidelines and potential drivers of treatment trends. The study found prevalent use of ADT monotherapy and older antihormonal agents, and only marginal but increasing use of novel antihormonals in real-world practice. These practices deviate from guidelines from the study period, which generally recommended ADT combination with either newer antihormonal agents or docetaxel for patients with mHSPC. Overall, the proportion of the 6198 patients treated with non–guideline-concordant therapies was 76.1%. Since guideline-recommended care is associated with better outcomes, this baselining finding highlights the need for appropriate treatment selection and intensification for mHSPC patients.
Tweetable abstract
New study using real-world Ipsos data found that, between 2018 and 2020, three of four men with metastatic hormone-sensitive prostate cancer in five studied countries did not receive treatment for their prostate cancer according to clinical guidelines.
Keywords: :
- androgen antagonists, therapeutic use
- antineoplastic agents, hormonal, therapeutic use
- antineoplastic combined chemotherapy protocols, therapeutic use
- guideline adherence
- health care surveys, trends
- neoplasm metastasis
- practice guidelines as topic
- practice patterns, physicians’ trends
- prostatic neoplasms, drug therapy
- prostatic neoplasms, pathology
Prostate cancer is the second most common cancer among men worldwide and is a leading cause of cancer-related mortality [Citation1]. In 2018, reported prostate cancer deaths by region were 32,686 in North America, 107,315 in Europe and 4465 in Asia [Citation2]. While androgen deprivation therapy (ADT) has been the cornerstone systemic therapy for metastatic hormone-sensitive prostate cancer (mHSPC) since the 1940s, phase III trials from recent decades have validated the superior efficacy of ADT combination therapy, with agent classes including first-generation androgen receptor inhibitors (FGARIs), taxane-based chemotherapy, androgen synthesis inhibitor (ASI), and, most recently, second-generation androgen receptor inhibitors (SGARIs) [Citation3–11]. Such evidence has led to product approvals for mHSPC and treatment guideline updates recommending ADT combination therapies as standard of care options for mHSPC. As clinical science continues to advance, most recently with demonstrated incremental survival benefit of triple versus doublet therapy combinations for mHSPC [Citation12,Citation13], and guidelines continue to evolve, it is important to investigate real-world data to determine whether patients are indeed benefiting from these gains through guideline-concordant care. To that end, we conducted a retrospective, cross-sectional analysis using the Ipsos Global Oncology Monitor database to describe demographic and clinical characteristics of mHSPC patients and treating physicians, as well as real-world treatment patterns and their baseline concordance with mHSPC treatment guidelines in five countries across three continents, during the initial treatment intensification era.
Methods
Study design & data source
This study was a retrospective real-world data analysis of mHSPC patients across five countries, namely the USA, Germany, France, China and Japan, from January 2018 through June 2020 (December 2019 for China). The study used the Ipsos Global Oncology Monitor, a comprehensive cross-sectional database of de-identified oncology patient records submitted by treating physicians. Each year, approximately 4000 oncology physicians across the globe report on over 240,000 patients seen in consultation. Participating physicians must be the primary decision-makers in drug treatment for their reported patients. Record collection is primarily done online, with some done via paper forms, with physician callbacks or emails to verify data or understand any outliers. Sample validation is conducted through market-sizing studies every 2 years to ensure sufficient sample size and representativeness vis-à-vis the wider population of relevant treating physicians. Data validation is conducted through comparison with disease and mortality data from Surveillance, Epidemiology and End Results (SEER) and the World Health Organization and through drug consumption versus company sales report matchups. The Ipsos Global Oncology Monitor is a well-established real-world evidence database under the Ipsos Oncology Centre of Expertise, with data used for publications at key conferences [Citation14,Citation15], supporting product reviews within and outside of oncology by health technology assessment agencies (e.g., the National Institute for Health and Care Excellence in the UK and Gemeinsamer Bundesausschuss [GBA; The Federal Joint Committee] in Germany) [Citation16,Citation17], informing national best-practice expert groups (e.g., Community Academic Research Education faculty in Canada) [Citation18], and earning industry recognition [Citation19]. For prostate cancer, the database contains information including patient demographics (e.g., age, race, smoking status), clinical characteristics (e.g., prostate risk, comorbidities, prostate-specific antigen testing frequency, Eastern Cooperative Oncology Group [ECOG] score) and lines of treatments received [Citation20].
Patient population
Our study analyzed mHSPC patients ≥18 years of age across five countries of interest, namely the USA, Germany, France, China and Japan, whose de-identified data were reported by sampled physicians from January 2018 to June 2020 (to December 2019 for China). Metastatic and hormone-sensitive disease was determined through a combination of two questionnaire fields on the Ipsos Global Oncology Monitor patient record form: 1) current patient status = ’Metastases’; and 2) whether the patient was considered hormone refractory/castrate resistant = ’No’. Ethics approval was not required for this study as Ipsos Global Oncology Monitor data are de-identified and anonymized and do not contain any patient-identifiable information.
Outcomes
Patient demographic characteristics including, but not limited to, age, race, smoking status and patient clinical characteristics including ECOG score, comorbidities and Gleason score were captured. Treating physician characteristics, including physician specialty and patient co-management, were also captured. Treatment patterns were analyzed for each country at the levels of guideline-relevant treatment class and treatment regimen, across the full study period and by semi/annual cohorts. The operational definition for each drug class is reported in .
Table 1. Operational definitions for drug classes.
Statistical analysis
Descriptive analyses were conducted to assess patient demographic and clinical characteristics, treating physician characteristics, and treatment patterns among mHSPC patients. For categorical (including dichotomous) variables, frequency distributions were reported as percentages. Continuous variables were summarized using mean, standard deviation, median and interquartile range. All analyses were conducted in Microsoft Excel.
Results
The study included 6198 mHSPC patients internationally (USA/3893, Germany/867, France/513, China/284 and Japan/641). Across the study countries, the reported mHSPC patients tended to be ≥70 years of age (67.4–80.3%), with prostate cancer disease that had metastasized to the bone (69.0–84.2%), was commonly asymptomatic to mildly symptomatic (38.6–50.9%), and was mostly high grade, with Gleason scores 8–10 (49.7–79.3%). These patients tended to be well-functioning, with ECOG scores 0–1 (59.2–90.6%), and had hypertension as the top-reported comorbidity (40.2–63.1%). Treating physicians in the Ipsos Global Oncology Monitor sample tended to be urologists (73.9–99.4%) in all countries except the USA, where there was a split between urologists and oncologists (42.5 vs 56.3%). Physicians typically did not co-manage their patients in all countries where data were available (61.6–86.6%; unavailable for Japan; ).
Table 2. Characteristics of mHSPC patients and mHSPC-treating physicians, by study country.
Treatment patterns differed by geography at both the class and regimen levels. The most commonly prescribed treatment class was luteinizing hormone-releasing hormone (LHRH) agonists in the Western countries in this study, the USA, Germany and France (69.4–82.6%), and FGARIs in the Eastern countries, China and Japan (70.8–74.6%; ). Correspondingly, at the treatment regimen level, the most commonly prescribed was ADT monotherapy in the Western countries (53.4–58.1%) and FGARI + ADT in the Eastern countries (54.6–67.2%; ). The next most common regimen within each country varied and was often split across more than one regimen. Remaining regimens tended to have low, single-digit utilization rates. When a SGARI was used, enzalutamide was much more common (up to 5%) than apalutamide (below 1%) across the five countries.
Note: ASI refers to abiraterone, and taxane-based chemotherapy refers to docetaxel.
*Study time frame of January 2018 through December 2019 for China versus through June 2020 for other countries due to data availability.
Source: Ipsos Global Oncology Monitor; mHSPC-treating physicians reporting on 6198 patients seen in consultation January 2018 through June 2020 (through December 2019 for China), data collected online (and/or via pen and paper). Participating physicians were primary treaters and saw a minimum number of patients per month. Data © Ipsos 2023, all rights reserved.
ASI: Androgen synthesis inhibitor; FGARI: First-generation androgen receptor inhibitor; LHRH: Luteinizing hormone-releasing hormone; SGARI: Second-generation androgen receptor inhibitor.
*Study time frame of January 2018 through December 2019 for China versus through June 2020 for other countries due to data availability.
Source: Ipsos Global Oncology Monitor; mHSPC-treating physicians reporting on 6198 patients seen in consultation January 2018 through June 2020 (through December 2019 for China), data collected online (and/or via pen and paper). Participating physicians were primary treaters and saw a minimum number of patients per month.
ADT: Androgen deprivation therapy; FGARI: First-generation androgen receptor inhibitor; SGARI: Second-generation androgen receptor inhibitor.
Data © Ipsos 2023, all rights reserved.
Treatment trends across semi/annual cohorts differed by country but generally reflected a shift toward newer-to-market agents, including SGARIs ( & ). Overall, 76.1% of the reported patients across all countries were receiving non–guideline-concordant therapies (including various monotherapy regimens and FGARI + ADT combination therapy) during the study period, with non-concordance being higher in the Eastern than the Western countries (85.9–92.2% vs 70.2–74.4%; ). In terms of future prescribing expectations among physicians from the latest semi/annual cohorts across countries, use of current regimen over the next 6 months was mostly expected to stay the same (80–95%) but to increase on net (4–17%) among those who expected change. Expectations for ADT monotherapy and for FGARIs were similar except with more tempered net increase for the former and signs of net zero or decrease for the latter, especially within the USA, where trends may emerge faster due to earlier availability of newer therapies. Although directional due to limited cohort counts, these expectations further reveal potential latency in closing the gap between clinical guidelines and practice and the need for ongoing monitoring through real-world data.
Note: ASI refers to abiraterone, and taxane-based chemotherapy refers to docetaxel.
Source: Ipsos Global Oncology Monitor; mHSPC-treating physicians reporting on 6198 patients seen in consultation January 2018 through June 2020 (through December 2019 for China), data collected online (and/or via pen and paper). Participating physicians were primary treaters and saw a minimum number of patients per month.
ASI: Androgen synthesis inhibitor; FGARI: First-generation androgen receptor inhibitor; LHRH: Luteinizing hormone-releasing hormone; SGARI: Second-generation androgen receptor inhibitor.
Data © Ipsos 2023, all rights reserved.
Source: Ipsos Global Oncology Monitor; mHSPC-treating physicians reporting on 6198 patients seen in consultation January 2018 through June 2020 (through December 2019 for China), data collected online (and/or via pen and paper). Participating physicians were primary treaters and saw a minimum number of patients per month.
ADT: Androgen deprivation therapy; FGARI: First-generation androgen receptor inhibitor; SGARI: Second-generation androgen receptor inhibitor.
Data © Ipsos 2023, all rights reserved.
Source: Ipsos Global Oncology Monitor; mHSPC-treating physicians reporting on 6198 patients seen in consultation January 2018 through June 2020 (through December 2019 for China), data collected online (and/or via pen and paper). Participating physicians were primary treaters and saw a minimum number of patients per month.
mHSPC: Metastatic hormone-sensitive prostate cancer.
Data © Ipsos 2023, all rights reserved.
USA
Among the patients reported in the USA (n = 3893), the majority were ≥70 years of age (67.4%) with metastatic disease that had spread to the bone (81.0%; ). Just under half had mildly symptomatic or symptomatic bone status (45.9%), and just over half had higher-grade prostate cancer, with Gleason scores 8–10 (54.2%). The patients were mostly well-functioning, with ECOG scores 0–1 (84.0%). The most common current comorbidity recorded was, by far, hypertension (63.1%), followed by cardiovascular disease (29.9%) and diabetes (25.8%). The patients were more commonly treated by oncologists (56.3%) than urologists (42.5%) and generally without co-management (86.6%).
In terms of treatment utilization by class, LHRH agonists (82.6%) dominated, followed by FGARIs (15.8%), ASI (15.5%), LHRH antagonists (9.2%), SGARIs (7.4%) and taxane-based chemotherapy (7.3%; ). In terms of specific regimens, ADT monotherapy (53.9%) was used for over half of reported mHSPC patients, followed by comparable rates of abiraterone + ADT (13.7%) and FGARI + ADT (13.7%), then of SGARI + ADT (5.6%), predominantly with enzalutamide (4.7%) than apalutamide (0.9%) as the SGARI, and lastly docetaxel + ADT (). Over the study period, the use of FGARIs decreased slightly, whereas the use of abiraterone and SGARIs increased slightly ( & ).
Germany
Among the reported patients in Germany (n = 867), the majority were ≥70 years of age (67.0%) and had metastatic disease that had spread to the bone (83.9%; ). Over half had either mildly symptomatic or symptomatic bone status (52.9%), and many had higher-grade cancer, with Gleason scores 8–10 (59.5%). However, the patients were still largely well-functioning, with ECOG scores 0–1 (85.2%). The most common current comorbidities recorded were hypertension (46.3%), cardiovascular disease (33.6%) and diabetes (20.8%), the same as in the USA and in France, but with a lower prevalence of hypertension. The patients were generally treated by urologists (92.7%), without co-management (82.9%).
In terms of drug class, LHRH agonists (69.4%) were most frequently used, followed distantly by LHRH antagonists (19.6%), taxane-based chemotherapy (17.0%), ASI (12.6%), FGARIs (8.05%) and SGARIs (5.4%; ). In terms of specific regimens, ADT monotherapy was most commonly used (58.1%), followed by docetaxel + ADT (11.2%), abiraterone + ADT (9.2%), FGARI + ADT (5.8%) and SGARI + ADT (3.8%), with the SGARI predominantly being enzalutamide (2.9%) rather than apalutamide (0.9%), a similar trend as in the USA (). Over the study period, use of ADT with LHRH antagonists decreased, whereas use of docetaxel, abiraterone and SGARIs increased ( & ).
France
Among reported patients in France (n = 513), the majority were ≥70 years of age (76.2%), the greatest proportion among the Western countries in the study (). Most patients had metastatic disease that had spread to the bone (83.4%) and, for many, also to distant lymph nodes (55.6%), a higher rate than in the other countries analyzed. In spite of this, just under half of these patients had any symptomatic bone status (49.1%) and Gleason scores 8–10 (49.7%), lower rates than in other countries. The patients were mostly well-functioning, with ECOG scores 0–1 (78.6%). Hypertension (61.8%), cardiovascular disease (31.0%) and diabetes (28.8%) were the topmost common comorbidities. The rate of depression (12.3%) was uniquely in the double digits for France compared with <6% for other countries. Overall, the mHSPC patients from France exhibited some differences in prostate cancer disease status and comorbidities versus those from other countries. They were mostly treated by urologists versus oncologists (73.9 vs 26.1%) and were mostly not co-managed (70.4%).
In terms of drug class, LHRH agonists (76.6%) were most frequently prescribed, followed by ASI (19.5%), taxane-based chemotherapy (14.0%), LHRH antagonists (9.7%), FGARIs (7.6%) and SGARIs (2.5%; ). In terms of specific regimens, over half of the patients were treated with ADT monotherapy (53.4%) and the rest with abiraterone + ADT (17.9%), docetaxel as either monotherapy or ADT combination therapy (7.2 vs 6.0%), FGARI + ADT (7.0%), or SGARI + ADT (1.8%) entirely with enzalutamide (). Over the study period, use of ADT with an LHRH antagonist decreased, while use of docetaxel increased consistently, as did use of SGARIs, but to a lesser extent; the use of abiraterone netted an overall increase ( & ).
China
Among the reported patients in China (n = 284), the majority were ≥70 years of age (70.1%) and had metastatic disease that had spread to the bone (84.2%; ). Just over half of patients had either mildly symptomatic or symptomatic bone status (50.4%) and had high-grade disease, with Gleason scores 8–10 (52.8%). Among all the countries analyzed, the reported patients in China tended toward worse physical functioning, with the lowest rate of ECOG scores 0–1 (59.2%) and the highest rates of ECOG score 2 (38.0%) and ECOG scores 3+ (2.8%). The most common comorbidity was hypertension (54.6%), as was the case for all study countries, but the second and third most common were, respectively, diabetes (32.0%) and cardiovascular disease (16.9%), a reverse order versus the Western countries and common to the other Eastern country, Japan. A relatively high rate of other comorbidities (23.6%) was also recorded. Patients were mostly treated by urologists (80.3%) versus oncologists (15.1%) and sometimes by ’Others’ (4.6%), a higher rate than in other countries (<2%).
In terms of drug classes used, patterns differed from Western countries in that FGARIs (74.6%) were most frequently prescribed, followed by LHRH agonists (71.8%), taxane-based chemotherapy (11.6%), ASI (9.2%) and non–taxane-based chemotherapy (3.2%; ). In terms of specific regimens, FGARIs were mostly used, as combination therapy with ADT (54.6%), then as monotherapy (15.5%), followed by ADT monotherapy (7.4%), abiraterone monotherapy (5.6%), then as combination therapy with ADT (3.5%), and lastly with docetaxel split between monotherapy (2.8%) and combination therapy with ADT (2.5%; ). Based on the patients reported in China (2018–2019), the use of docetaxel and to a lesser extent ADT with LHRH agonists decreased, whereas the use of FGARIs and abiraterone increased. The use of SGARIs was not observed, likely because these products had not yet been approved during the study period ( & ).
Japan
Among the reported patients in Japan (n = 641), a large majority were ≥70 years of age (80.3%), the highest rate among countries analyzed (). While a majority had metastatic disease that had spread to the bone (69.0%), this rate was the lowest among the countries analyzed (>80% for others). In keeping with relatively less disease spread, bone symptomaticity was also low, with nearly half of the patients being asymptomatic (48.4%). The one discrepant feature was the Gleason score, where the rate of high-grade, aggressive disease with Gleason scores 8–10 (79.3%) was the highest among all countries analyzed (others 50–60%). The reported patients in Japan had the highest rate of ECOG scores 0–1 (90.6%) in terms of physical functioning and the lowest rates of each common comorbidity, including hypertension (40.2%), diabetes (16.8%) and cardiovascular disease (12.8%). Notably, the patients in Japan had the highest rate of no comorbidities (35.1 vs other countries at <24%). Patients were nearly always managed by urologists (99.4%), with rare cases by Other specialists (0.6%). No data were available on co-management status.
The predominant drug classes used to treat the mHSPC patients in Japan were FGARIs (70.8%) and LHRH agonists (69.7%), akin to China, then followed by LHRH antagonists (25.1%), ASI (7.6%) and rarely SGARIs (0.6%; ). In terms of specific regimens, FGARI + ADT dominated (67.2%), followed distantly by abiraterone + ADT (6.6%) and SGARI + ADT (0.6%), entirely with enzalutamide (). No use of docetaxel was recorded, likely due to its lack of approval status during the study period. During this time, usage shifted from FGARIs, which showed a decrease, to abiraterone, which increased. ADT use remained high, and SGARI use remained low ( & ).
Discussion
This study aims to provide a comprehensive depiction of the mHSPC patient cohort, treatments and trends, potential drivers and concordance versus guidelines in countries across the globe, based on the Ipsos Global Oncology Monitor database. Key findings include prevalent ADT monotherapy (non-intensification) and also FGARI combination therapy (non-recommended use), thereby providing a more complete view of the scale of the practice versus guidelines gap during the pivotal period of rapid evolution (2018–2020). As such, these findings constitute a baseline where ongoing monitoring could check for narrowing of the gap. The consideration of physicians’ future prescribing expectations projecting forward from this period will help contextualize study findings within the growing body of knowledge for mHSPC.
Within a real-world setting, regulatory approvals, payer reimbursement and guideline endorsement of novel prostate cancer therapies may all impact treatment trends (). Depending on whether or not countries tend to be frontrunners in therapeutic innovation and product launches, there may or may not be a directional cascade from product approval to reimbursement to guideline endorsement, as is typical for the USA. Elsewhere, the sequence may be such that guideline update follows approval but precedes individual country reimbursement, as in Europe; precedes approval and reimbursement, as in China; or still be pending for long periods post approval and reimbursement, which may be simultaneous, as in Japan. These dynamics, along with modulators like acceptance of off-label use, fragmentation of reimbursement models, and frequency of guideline updates, together shape the different utilization patterns observed among treatment classes and across countries.
Table 3. Treatment pattern drivers in mHSPC, including regulatory approvals, reimbursement and prostate cancer treatment guidelines, by country and by product within study period.
In mHSPC, the latest clinical evidence on the superiority of triple therapy regimens comprising a combination of ADT with docetaxel and either darolutamide, as in the ARASENS randomized controlled trial, or abiraterone, as in the PEACE-1 trial [Citation12,Citation13], has garnered guideline support and, in the case of darolutamide, regulatory approval, factors that may potentially lead to increased use over time. Indeed, large-scale registries such as PIONEER in Europe and IRONMAN internationally have started tracking treatment trends in the post-2020 era [Citation21,Citation22]. Considering that guideline-concordant care is associated with increased survival [Citation23–25], it is essential to take a baseline measure of the gap between recommended and clinical practice, as is the objective of this analysis and to continue monitoring for prompt closing of the gap so that patients may maximally benefit from treatment.
The strengths of this study are founded upon the source of the data and the depth of the analysis. Real-world studies, unlike clinical trials, provide an integrative view of actual mHSPC patient care subject to forces of product approval, reimbursement and guideline recommendations. To the best of our knowledge, this study is notable for being among the few with global scope and the only to span the North American, European and Asian continents simultaneously, forming the largest such sample to date of 6198 patients. Versus two other recent studies [Citation26,Citation27], ours is additionally unique in sourcing data from Ipsos versus the Adelphi Prostate Cancer Disease Specific Programme and in comprehensively evaluating treatment pattern drivers, physician features, trends over time and differences among countries. In addition, it gauges the baseline level of non-concordance between real-world versus guideline-recommended practice and latency in gap closure to assess translation of clinical advancement to patient benefit.
The limitations of this study are typical of and inherent to retrospective real-world data collection. Since data collection for the Ipsos Global Oncology Monitor relies on physician reporting, there is a potential risk of subjectivity during clinical assessment, which may introduce a measure of patient sample heterogeneity, and a potential risk of recall bias, which may impact the trends observed. While data are collected at the individual patient level and form cohorts enabling cross-sectional analysis of pattern shifts over time periods, longitudinal trend analysis throughout time or regression analysis of which factor among product approval, reimbursement, or guidelines most affected utilization patterns would not be supportable. There was limited ability to validate whether patients may have had contraindications warranting use of non-recommended regimens, although it is unlikely for all to have qualified for this exceptional status. Data availability at the time of analysis (up to year-end 2019 for China and mid-2020 for other countries) precluded observations beyond this period, and differential data availability across markets precludes further subgroup analyses. This study was descriptive in nature and did not include pairwise comparison between countries nor analysis of subnational dynamics, as reported on previously [Citation26,Citation27].
Conclusion
To the best of our knowledge, this is the largest real-world study on mHSPC patients across major countries in North America, Europe and Asia, encompassing 6198 patients from the USA, Germany, France, China and Japan. In addition to characterizing the mHSPC patients in the Ipsos Global Oncology Monitor database, their treating physicians, and treatment patterns, our study confirmed a high baseline level of non-concordance between clinical guidelines and clinical practice for these patients during the study period and evaluated potential drivers of treatment patterns that may contribute to this gap. Despite treatment guidelines not recommending ADT monotherapy or FGARI + ADT combination therapy for treatment of mHSPC, the study found prevalent use in a real-world setting, where the former was the predominant regimen for the patients in the USA, Germany and France and the latter the predominant regimen for the patients in China and Japan, with use expected to persist or even slightly increase for ADT monotherapy for the subsequent 6 months. In terms of other treatment classes, the results of our study are largely consistent with those of multiple US studies [Citation28–31] and two global studies [Citation26,Citation27] showing single- to low double-digit use of docetaxel in the USA and higher ex-US and yet low use of SGARIs during the respective study periods, but with expected increase as SGARIs have gained approval, reimbursement and guideline endorsement on the basis of the most recent trials, such as ARASENS and PEACE-1 [Citation12,Citation13]. As guidelines continue to evolve in light of new evidence, it is essential to evaluate the speed and extent to which they are being implemented in clinical practice. This baselining study shows that during the dynamic 2018–2020 time frame, more than three in four of the mHSPC patients received treatments that were non-concordant with guidelines. Future real-world studies are needed to monitor how rapidly clinical practice catches up to guideline recommendations to help ensure that mHSPC patients derive maximal clinical benefit from the most up-to-date, evidence-based care.
Prostate cancer is the second most common cancer among men worldwide and is a leading cause of cancer-related mortality.
Global treatment guidelines for metastatic hormone-sensitive prostate cancer (mHSPC) have evolved over the years; however, little research has been done to assess how well clinical practice patterns are keeping pace with current treatment guidelines.
This study depicts global real-world mHSPC patients and treating physicians and evaluates baseline concordance between current clinical practice and treatment guidelines to identify potential opportunities to improve patient care.
Reported mHSPC patients were predominantly aged ≥70 years, had metastatic disease within the bone, and were largely well-functioning, with Eastern Cooperative Oncology Group scores 0–1.
Among all guideline-relevant therapies, patients were most frequently treated with androgen deprivation therapy (ADT) monotherapy in the USA, Germany and France and with first-generation androgen receptor inhibitors + ADT combination therapy in China and Japan. Second-generation androgen receptor inhibitor use was low but showed an increase later in the study period.
A range of factors, including drug approval, reimbursement status and country-specific clinical practice standards and treatment guidelines, can influence mHSPC treatment patterns and cause heterogeneity in these patterns across various geographies.
The prevalent use of ADT monotherapy and first-generation androgen receptor inhibitors + ADT combination therapy in real-world clinical practice deviates from treatment guidelines that generally recommend use of ADT in combination with abiraterone, enzalutamide, or apalutamide and, in select cases, docetaxel for mHSPC.
Overall, the proportion of patients treated with non–guideline-concordant therapies was 76.1% across all geographies. This highlights the need for appropriate treatment selection and intensification to conform to best practices for treating mHSPC patients.
Author contributions
PJ Goebell: conception and design, data analysis and interpretation, revision of the manuscript, final approval of manuscript, agreement to be accountable for all aspects of the work. R Raina: conception and design, collection and/or assemblage of data, data analysis and interpretation, manuscript writing, final approval of manuscript, agreement to be accountable for all aspects of the work. S Chen: conception and design, provision of study materials, data analysis and interpretation, manuscript writing, final approval of manuscript, agreement to be accountable for all aspects of the work. S Rege: conception and design, collection and/or assemblage of data, data analysis and interpretation, manuscript writing, final approval of manuscript, agreement to be accountable for all aspects of the work. R Shah: conception and design, revision of the manuscript, final approval of manuscript, agreement to be accountable for all aspects of the work. J Partridge Grossman: conception and design, data analysis and interpretation, manuscript writing, final approval of manuscript, agreement to be accountable for all aspects of the work. A Reginald Waldeck: conception and design, manuscript writing, final approval of manuscript, agreement to be accountable for all aspects of the work.
Financial disclosure
This study was funded by Bayer Healthcare Pharmaceuticals, Inc., which also supported Open Access publication. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Competing interests disclosure
PJ Goebell has a consulting/advisory relationship with Bayer; received honoraria from Astellas, AstraZeneca, Bayer, BMS, Eisai, Ipsen, Janssen, Novartis, Pfizer, Roche and Sanofi; and received support for travel expenses from Astellas, AstraZeneca, Bayer, BMS, Eisai, Ipsen, Janssen, Novartis, Pfizer, Roche and Sanofi. R Raina is an employee of OPEN Health, which received funding from Bayer Healthcare Pharmaceuticals, Inc., to support this study. S Chen is an employee of and stockholder in Bayer Healthcare Pharmaceuticals, Inc. S Rege is a former employee of OPEN Health, which received funding from Bayer Healthcare Pharmaceuticals, Inc., to support this study. R Shah is a former employee of OPEN Health, which received funding from Bayer Healthcare Pharmaceuticals, Inc., to support this study. J Partridge Grossman is an employee of and stockholder in Bayer Healthcare Pharmaceuticals, Inc. A Reginald Waldeck is an employee of and stockholder in Bayer Healthcare Pharmaceuticals, Inc. The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Writing disclosure
Editorial assistance was provided by Christina DuVernay of OPEN Health, which received support for the study from Bayer Healthcare Pharmaceuticals, Inc.
Ethical conduct of research
Ethics approval was not required for this study as Ipsos Global Oncology Monitor data are de-identified and anonymized and do not contain any patient-identifiable information.
Data availability
The data underlying this article were provided by Ipsos under data license agreement with Bayer Healthcare Pharmaceuticals, Inc. Data will be shared on request to the corresponding author, A. Reginald Waldeck, with permission of Ipsos. Ipsos Global Oncology Monitor data are copyright Ipsos 2023, all rights reserved.
Open access
This work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/4.0/
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