https://orcid.org/0009-0000-6513-5940
Abstract
Aim
This study assessed the treatment patterns, healthcare resource utilization (HRU), costs, and annual prevalence and incidence of metastatic hormone-sensitive prostate cancer (mHSPC) and nonmetastatic castration-resistant prostate cancer (nmCRPC) in China.
Methods
A retrospective study was conducted using electronic medical records (EMR) of patients with prostate cancer from three tertiary-care hospitals in China between January 2014 and March 2021. Descriptive statistics were used to analyze study outcomes.
Results
In total, 1086 patients with mHSPC and 679 patients with nmCRPC were included. From 2015 to 2020, the annual percentage of prevalent and incident cases of mHSPC decreased from 22.4% to 20.0% and 11.1% to 6.9%, respectively; for nmCRPC, these increased from 3.8% to 13.6% and 3.3% to 8.4%. Androgen-deprivation therapy and first-generation antiandrogens (bicalutamide or flutamide) were the most frequently prescribed prostate cancer–related medications at baseline and follow-up in patients with mHSPC. Bicalutamide was the most frequently prescribed prostate cancer–related medication during follow-up in patients with nmCRPC. For mHSPC, inpatient admission costs were the highest, with the median (interquartile range) costs per person-month being USD 403.00 (USD 85.50–1226.20), whereas outpatient visit costs were the highest for nmCRPC (USD 372.60 [USD 139.50–818.50]).
Limitations
EMR-based study design did not capture treatment patterns, HRU and associated costs, and healthcare encounters that occurred outside of participating hospitals, which could have led to underestimation of the true disease burden.
Conclusions
A contrasting trend of a decline in the prevalence and incidence of mHSPC and an increase in these for nmCRPC was observed between 2015 and 2020 in China. Androgen-deprivation therapy and first-generation antiandrogens were the most frequently prescribed prostate cancer–related medications. Healthcare resource utilization was driven by inpatient costs in mHSPC and outpatient costs in nmCRPC.
Introduction
Prostate cancer (PC) is the second most common malignant tumor and the fifth leading cause of cancer-related mortality in men globallyCitation1. Before PC reaches the terminal stage, it can manifest as metastatic hormone-sensitive prostate cancer (mHSPC)—defined as de novo metastasis even when the cancer is susceptible to medical or surgical castration—or nonmetastatic castration-resistant prostate cancer (nmCRPC)Citation2. In patients with nmCRPC, no metastasis is detected on conventional imaging, and prostate-specific antigen (PSA) levels rise despite castrate levels of testosteroneCitation3. Most patients with mHSPC and nmCRPC will eventually experience disease progression and display substantial morbidities, including paraneoplastic syndromes involving systemic clinical manifestationsCitation2,Citation4.
In China, the age-standardized incidence rate of PC in 2019 was 17.3 per 100,000, with the incidence increasing at a higher rate (95% increase since 1990) than the global average (13%)Citation5. The 5-year prevalence of PC in 2022 in China, as reported by the World Health Organization-International Agency for Research on Cancer (WHO-IRAC), was 2.8 per 100,000Citation6. Metastatic PC makes up 5–6% of new PC cases in Europe and the US but 54% of new PC cases in ChinaCitation7. Further information on the annual prevalence and incidence of mHSPC and nmCRPC in China is needed to investigate the current disease burden in these populations.
Surgical or medical castration (with androgen-deprivation therapy [ADT]) was the mainstay of treatment for patients with mHSPC for decades, while ADT with or without first-generation nonsteroidal antiandrogens (flutamide and bicalutamide) was used for patients with nmCRPCCitation8–11. The recent approval of androgen receptor pathway inhibitors (ARPIs) like abiraterone, apalutamide, darolutamide, and enzalutamide has expanded the array of treatments available for patients with mHSPC and nmCRPCCitation8,Citation9,Citation11. Intensification of ADT with ARPIs has been shown to improve overall survival for patients with mHSPCCitation12–16. Similarly, addition of an ARPI to ADT in patients with nmCRPC with a PSA doubling time of ≤10 months on continuous ADT led to significant improvements in metastasis-free survivalCitation17–19. With the advent of novel therapeutic agents for patients with mHSPC and nmCRPC, there is a need to assess treatment patterns and the economic impact of these agents to better align disease management in China. According to the Chinese guidelines for PC care, ADT is the primary systemic treatment for patients with advanced metastatic PC, with chemotherapy, abiraterone, enzalutamide, apalutamide, bicalutamide, or flutamide as add-on treatmentsCitation7. Apalutamide, enzalutamide, or darolutamide combined with ADT is recommended for patients with nmCRPC who are at a high risk for metastasis (PSA doubling time ≤10 months)Citation7.
In this context, the present real-world observational study estimated the annual prevalence and incidence of mHSPC and nmCRPC and assessed the treatment patterns, healthcare resource utilization (HRU), and costs associated with the management of these conditions in China. The results of this study may help address potential knowledge gaps in clinical and health economic evidence for the integration of novel treatments for mHSPC and nmCRPC in China.
Patients and methods
Study design and patient population
This was a retrospective, observational, descriptive study of patients with mHSPC and nmCRPC in China. We used electronic medical records of patients with PC from three tertiary-care hospitals in China from January 2014 to March 2021. The population of the geographical regions where these hospitals are located (site 1, Northern China, Tianjin, 13,710,000; site 2, Western China, Chongqing, 32,120,000; site 3, Southern China, Guangdong, 126,840,000) account for 12% of the total Chinese populationCitation20.
Three PC populations were identified for this study: patients with PC, patients with mHSPC, and patients with nmCRPC. Patients were ≥18 years of age and identified based on one inpatient record or two outpatient records (at least 30 days apart) of PC diagnosis. They had to have at least one clinical visit during the 6 months preceding and at least 1 day of follow-up after the PC diagnosis date. The PC diagnosis date was as per the first inpatient or outpatient record of PC diagnosis. In addition to these criteria, patients with mHSPC had a diagnosis of metastatic disease but without PSA progression or clinical diagnosis of CRPC (supplementary methods). Similarly, patients with nmCRPC were identified by PSA progression or clinical diagnosis of CRPC before developing metastatic disease (supplementary methods). The index date was the first date when a patient was identified as having mHSPC or nmCRPC. The baseline period was 6 months before and inclusive of the index date. The follow-up period started from the day following the index date until the end of the study.
Study outcomes
Study outcomes were the annual prevalence and incidence of mHSPC and nmCRPC in patients with PC, as well as baseline demographic and clinical characteristics, medication use, treatment patterns, HRU, and costs in patients with mHSPC and nmCRPC.
Annual prevalence was defined as the percentage of patients with mHSPC and nmCRPC among patients with PC in each calendar year (Formula A in supplementary methods), and annual incidence was defined as the percentage of newly diagnosed patients with mHSPC and nmCRPC among patients with PC in each calendar year (Formula B in supplementary methods). Demographic and clinical characteristics including age at the index date, ethnicity, metastases status for mHSPC, PSA test and level, Charlson Comorbidity Index, individual comorbidities, and prescriptions of PC-related medication and other potentially PC-related medications were examined at baseline. Treatment patterns included frequency of medication use, treatment duration, and treatment switch during follow-up. HRU was reported as potentially PC-related HRU (defined as HRU with a diagnosis of PC in any diagnosis position in the inpatient or outpatient setting), which included potentially PC-related inpatient admissions, length of in-hospital stays (days), surgeries, outpatient visits, emergency room visits, laboratory tests, and imaging tests. Healthcare costs were calculated for both potentially PC-related HRU and the pharmacy costs of potentially PC-related medications.
Statistical analyses
Demographic and clinical characteristics were summarized using descriptive statistics. For continuous variables, patients with missing data were excluded from the respective analyses, and for categorical variables, patients with missing data were included as a separate category. To analyze treatment patterns, the number and percentage of patients receiving specific regimens within each observed line of therapy (LOT) were estimated. A Sankey diagram was used to describe the sequence of LOTs for mHSPC. The median duration of regimens with a 95% confidence interval (CI) within each observed LOT was estimated using Kaplan–Meier methods. The potentially PC-related HRU rate was reported per patient per month with 95% CIs. The cumulative incidence risk, that is, the percentage of patients with different HRUs in the first 12 months of follow-up, was also estimated. The average length of stay per inpatient admission was summarized using mean (standard deviation [SD]) and median (interquartile range [IQR]). Potentially PC-related costs were reported as costs per patient per month for each cohort using mean (SD) and median (IQR). Costs were inflated in the most recent calendar year (i.e. the year 2021) using the healthcare-related Consumer Price Index published by the National Bureau of Statistics of China. The costs were measured in Chinese yuan (CNY) and converted to US dollars (USD) using the exchange rate of 6.4512 CNY per USDCitation21. All analyses were conducted separately in patients with mHSPC and nmCRPC.
Results
Patients
A total of 6033 patients with PC (Supplementary Figure 1), 1086 patients with mHSPC, and 679 patients with nmCRPC were identified during the study period (2014–2021) ().
Figure 1. Attrition algorithm for patients with (a) mHSPC and (b) nmCRPC. *Patients identified by definition A and definition B were not mutually exclusive. Abbreviations. mHSPC, metastatic hormone-sensitive prostate cancer; nmCRPC, nonmetastatic castration-resistant prostate cancer; PC, prostate cancer; PSA, prostate-specific antigen.
Prevalence and incidence
Between 2015 and 2020, the annual percentage of prevalent and incident cases of mHSPC decreased from 22.4% to 20.0% and 11.1% to 6.9%, respectively (). In contrast, the annual percentage of prevalent and incident cases of nmCRPC increased from 3.8% to 13.6% and 3.3% to 8.4%, respectively ().
Figure 2. Prevalence and incidence of patients with (a) mHSPC and (b) nmCRPC over the study period. Abbreviations. mHSPC, metastatic hormone-sensitive prostate cancer; nmCRPC, nonmetastatic castration-resistant prostate cancer.
Baseline characteristics
The mean age at diagnosis was 71.9 years in patients with mHSPC and 74.7 years in patients with nmCRPC (). A total of 46.9% of patients with mHSPC had a total PSA test within 14 days up to the index date, and almost all patients with nmCRPC (96.8%) underwent this test within 14 days up to the index date. The proportion of patients presenting with comorbidities was higher in the mHSPC cohort than in the nmCRPC cohort ().
Table 1. Baseline demographic and clinical characteristics.
Treatment patterns
At baseline, ADT and first-generation antiandrogens (bicalutamide or flutamide) were the most frequently prescribed PC-related medications in 44.0% and 42.3% of patients with mHSPC, respectively, and 82.6% and 71.7% of patients with nmCRPC, respectively (). During follow-up, in patients with mHSPC, ADT and first-generation antiandrogens were the most common first LOT (61.5%), and ADT with abiraterone with or without prednisone was the most common second (29.3%) and third (35%) LOT (). Similarly, in patients with nmCRPC, first-generation antiandrogens (with or without ADT) remained the most common treatment prescribed during follow-up (69.1%). The median treatment duration for bicalutamide in patients with nmCRPC was 15.8 months (95% CI: 11.6, 33.2). Regarding other potentially PC-related medications at baseline, antibacterials and opioids were the most frequently prescribed.
Figure 3. Medication use at baseline. ADT included LHRH agonist (leuprolide/Leuplin/leuprorelin, goserelin/Zoladex, triptorelin, and histrelin) and LHRH antagonist (degarelix/Gonax). Antiandrogens included bicalutamide and flutamide. Novel hormone therapy included enzalutamide and apalutamide. Abbreviations. ADT, androgen-deprivation therapy; LHRH luteinizing hormone-releasing hormone; mHSPC, metastatic hormone-sensitive prostate cancer; nmCRPC, nonmetastatic castration-resistant prostate cancer; PC prostate cancer.
Figure 4. Sankey diagram detailing changes of first line to second line of treatment in patients with mHSPC. Abbreviations. ADT, androgen-deprivation therapy; mHSPC, metastatic hormone-sensitive prostate cancer.
Docetaxel was used in 6.7% of patients with mHSPC at baseline. At follow-up, docetaxel was used in combination with the following agents in the first-line setting: ADT (1.8%), ADT + prednisone (0.8%), ADT + bicalutamide (7.1%), and ADT + bicalutamide + prednisone (3.4%).
Healthcare resource utilization
A total of 137 patients (20.2%) with nmCRPC had an inpatient admission, 630 patients (92.8%) had an outpatient visit, and 23 patients (3.4%) had an emergency room visit; the corresponding numbers for mHSPC were 894 patients (82.3%), 924 patients (85.1%), and 120 patients (11.0%). The median follow-up time from the index date was shorter in patients with nmCRPC than in patients with mHSPC (3.7 months [IQR: 1.0, 9.6] vs 11.8 months [IQR: 3.8, 24.9]) (). The median (IQR) length of stay was 6.00 days (2.00, 10.00) for patients with nmCRPC and 7.00 days (4.00, 11.00) for patients with mHSPC (). The inpatient admission, outpatient visit, and emergency room visit rates (per person-month) were 0.69 (95% CI: 0.43, 1.00), 3.96 (95% CI: 3.29, 4.72), and 0.05 (95% CI: 0.01, 0.11), respectively, for patients with nmCRPC and 0.52 (95% CI: 0.45, 0.58), 1.36 (95% CI: 1.17, 1.62), and 0.1 (95% CI: 0.04, 0.21), respectively, for patients with mHSPC. The cumulative incidence risk was higher in patients with mHSPC than in patients with nmCRPC for inpatient admissions (59.7% vs 25.6%), emergency room visits (11.1% vs 7.3%), and surgery (26.8% vs 12.9%). The HRU associated with most of the laboratory tests and imaging studies was similar for patients with mHSPC and nmCRPC.
Table 2. Potentially prostate cancer–related HRU for patients with mHSPC and nmCRPC.
Healthcare-associated costs
Among all potentially PC-related HRU costs per patient per month, inpatient admission costs were the highest (USD 402.99 [USD 85.49, 1226.24]) for patients with mHSPC, whereas outpatient visit costs were the highest (median [IQR]: USD 372.64 [USD 139.51, 818.48]) for patients with nmCRPC (). Emergency room visit costs and costs for surgery were similar between the patients with mHSPC and nmCRPC. ADT, bicalutamide, and abiraterone were the medications that incurred the highest costs in patients with mHSPC and nmCRPC.
Table 3. Potentially prostate cancer–related healthcare-associated costs for patients with mHSPC and nmCRPC.
Discussion
To our knowledge, this was the first comprehensive study that assessed the prevalence and incidence of mHSPC and nmCRPC, along with HRU and associated costs, in China.
As a result of the introduction of PSA screening, an aging population, and treatment advances, the incidence and prevalence of PC have been increasing in recent years. About 70% of patients with newly diagnosed PC in China have locally advanced or widely metastatic disease; thus, treating patients with early-stage PC may improve prognosesCitation22. A previous study in China using data from the Chinese Prostate Cancer Consortium found that about 20% of patients who were diagnosed in 2008 with PC had metastatic disease, whereas there was a decrease in the proportion of these patients through 2013, indicating a trend toward diagnosing patients at an earlier disease stage during 2008–2013Citation23. In 2015, the first consensus on PC screening and early detection was published in China, emphasizing PSA screening as a crucial recommendationCitation24. Accordingly, our study observed a decrease in the number of patients with mHSPC from 2015 to 2020, suggesting the potential impact of these early detection strategies. A model-based analysis further substantiated this observation, showing that early PSA screening could elevate the prevalence of nonmetastatic PCCitation25. Nonetheless, the current results indicate that there was still a considerable proportion of patients with metastatic disease in China between 2015 and 2020, and further research is needed to confirm this observation.
Most patient characteristics reported in this study were similar to those reported in the previous literatureCitation26, indicating a high prevalence of comorbidities, such as hypertension and type 2 diabetes mellitus, especially in patients with mHSPC. More than half of the patients with mHSPC had bone metastasis, which is in line with previous studies reporting the bone as the most common site of metastasis in patients with advanced PCCitation26.
The approval of three ARPIs—apalutamide, enzalutamide, and darolutamide—has led to the availability of new therapies for the management of patients with mHSPC and nmCRPC globallyCitation8,Citation9,Citation11. Recent guidelines recommend ARPIs in patients with nmCRPC and a PSA doubling time of ≤10 months, who are at increased risk for disease progression, in addition to continuing ADT, to delay metastasisCitation27. The 2022 Chinese guidelines for the diagnosis and treatment of PC also recommend ARPIs for the treatment of mHSPC and nmCRPCCitation7. However, the present study did not identify patients treated with second-generation ARPIs, as these were approved by the Chinese National Medical Products Administration and subsequently listed in the National Reimbursement Drug List only in 2021─2022 (whereas the study period was 2014─2021). ADT and first-generation antiandrogens (bicalutamide or flutamide) remained the most frequently prescribed PC-related medications for mHSPC and nmCRPC in China for the period 2015–2020. In a real-world study in Japan in 2019, bicalutamide and flutamide were the most commonly prescribed treatments in the first, second, and third regimens for nmCRPC, and there was a low proportion of patients with nmCRPC who received first-line abiraterone and enzalutamide (2.2% and 10.8%, respectively)Citation28. In another point-in-time survey of 336 physicians in the US, five European countries (France, Germany, Italy, Spain, and the United Kingdom), and Japan in which 1195 patients were consulted, the most common mHSPC treatment regimen that was first initiated was ADT alone (47%), followed by ARPIs with or without ADT) (31%, of which 21% was abiraterone, 8% was enzalutamide, and 2% was apalutamide) and chemotherapy with or without ADT) (19%)Citation29.
A study based on the Chinese National Health Insurance Database reported an increase in the inpatient admissions rate per patient per year from 1.5 in 2015 to 2.0 in 2017 for patients with PC. The annual direct medical costs per patient also increased from USD 2300.10 in 2015 to USD 3543.30 in 2017Citation30. In another Chinese study that combined a Web-based survey of urologists and a systematic literature review, the average annual economic burden of patients with mHSPC was estimated to be 65,203 CNYCitation31. The average total annual cost per patient with nmCRPC was estimated at 69,145 CNY, with an annual direct medical cost of 48,815 CNYCitation32. The current study estimated potentially PC-related HRU costs per person-month for patients with mHSPC and nmCRPC, which could inform HRU and costs in these patients in China and help generate clinical and health economic evidence for the integration of novel treatments for mHSPC and nmCRPC in China.
Limitations
The limitations of this study are mainly associated with the electronic medical record–based study design. The electronic medical record database of a hospital does not capture treatment patterns, HRU and associated costs, and healthcare encounters that occur outside of participating hospitals, raising the possibility of the true disease burden being underestimated. Moreover, due to the potentially incomplete capture of patients’ medical history, prevalent or incident cases or disease states may have been misclassified. Additionally, since metastatic disease was mostly diagnosed using free text and recording of metastatic disease might be incomplete or inaccurate, a small proportion of patients with metastatic disease could have been misclassified as patients without metastatic disease. There was also a considerable amount of missing data for some baseline characteristics, such as weight, height, smoking status, and oncology-related information such as tumor, lymph node, metastasis score, and Gleason score. Another limitation was the recording of only in-hospital deaths and not deaths that occurred outside the hospital setting. Moreover, lack of hospital sites from other areas of China may limit the generalizability of these results across the Chinese population. Since the three hospitals selected for this study did not use second-generation androgen receptor-targeting agents, it was not possible to collect any information about these agents or the costs associated with their use.
Conclusion
This real-world study in China showed a decline in the prevalence and incidence of mHSPC and an increase in the prevalence and incidence of nmCRPC between 2015 and 2020. The treatment patterns for mHSPC and nmCRPC were similar, with ADT and first-generation antiandrogens being the most frequently prescribed PC-related medications. HRU was driven by inpatient costs in mHSPC and outpatient costs in nmCRPC. Further real-world studies are needed to fully evaluate the rapidly changing treatment landscape for mHSPC and nmCRPC and monitor the use of ARPIs or novel hormone therapies in these patient populations.
Transparency
Declaration of financial/other relationships
YW, CL, CL, and YN received research funding from Astellas Pharma Inc. and Pfizer Inc. for this study. YL is an employee of Astellas, China; LB is an employee of Evidera, a business unit of PPD, a Thermo Fisher Scientific company, which was contracted by Astellas for the conduct of this study.
Author contributions
All the authors were involved in the conception and/or design of the work, acquisition of data, data analysis, and/or interpretation of data. All authors had access to the study results, reviewed and revised the manuscript, and approved the final draft submitted for publication.
Previous presentation
A poster presenting part of this work titled “Real-World Treatment Patterns (TxP) and Healthcare Resource Utilization (HRU) in Patients with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) and Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC) in China” was presented at ISPOR 2023, Boston, MA, USA (May 7–10, 2023).
Ethical oversight/IRB approval/patient consent
IRB approval was obtained at each participating hospital.
Supplemental Material
Download MS Word (199.4 KB)Supplemental Material
Download EPS Image (1.7 MB)Acknowledgements
The authors would like to thank Leena Patel, Chrysi Petraki, and Rucha Kurtkoti from IQVIA for medical writing and editorial support.
Data availability statement
The datasets used during this study are not publicly available due to local data access policy but may become available from the corresponding author upon reasonable request.
Additional information
Funding
References
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