Use and outcomes in men with metastatic castration-sensitive prostate cancer (mCSPC) treated with docetaxel in addition to androgen deprivation therapy (ADT): Analysis of real-world data in the United States (US).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19322-e19322
Author(s):  
Neeraj Agarwal ◽  
Suneel Mundle ◽  
Lindsay Dearden ◽  
Ravi C. Potluri ◽  
Sandhya Nair ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Androgen Deprivation Therapy ◽  
Real World ◽  
De Novo ◽  
Specific Antigen ◽  
The United States ◽  
Androgen Deprivation ◽  
Castration Resistant Prostate Cancer ◽  
The Real ◽  
The Us

e19322 Background: mCSPC patients treated with docetaxel + androgen deprivation therapy (D+ADT) demonstrate increased overall survival (OS)1,2. However, limited real-world outcome data is available for such patients. This study assesses the real-world use and outcomes with D+ADT in mCSPC in the US. Methods: Adult (≥18 years old) men with mCSPC (defined as men with metastasis at index diagnosis of prostate cancer [de novo] or those who progressed to mCSPC after prior diagnosis of localized disease) were retrospectively identified from the Optum (2007–2018) and SEER Medicare (2007–2016) databases. Men diagnosed with mCSPC in or after 2014 with exposure to docetaxel and no brain metastasis were included for analysis. Patients were characterized based on age; baseline prostate specific antigen (PSA) level; administration of ADT; prior radiotherapy (RT); prior radical prostatectomy (RP); presence of visceral disease, bone or bone + visceral metastases; and treatment duration of docetaxel. OS and time to metastatic castration-resistant prostate cancer (mCRPC) were measured. Results: Among 4959 men identified with mCSPC during or after 2014, 192 (3.8%) received D+ADT ± Bicalutamide as first line systemic therapy. Baseline characteristics are presented in the Table below. Mean ± SD duration of docetaxel exposure was 115 ± 84.2 days (median 118 days). Median OS among these men was 30.5 (28.1, 36.7) months and median time to mCRPC was 18.3 (14.5, 24.6) months. Only 9% of men received docetaxel for ≥6 cycles (180 days); median OS in these men was NR (19.1- NR) with 74% surviving at 2 years compared to 65% surviving at 2 years in those with docetaxel duration <6 cycles. Conclusions: Use of docetaxel in the real-world mCSPC patient population in the US is limited. Majority of men received less than the recommended dose of 6 cycles. OS with D+ADT in real-world patients with mCSPC appears to be lower than the OS reported in published trials. References:1) Sweeney CJ, et al. N Engl J Med. 2015;373:737–46. 2) James ND, et al. Lancet. 2016;387:1163–77. Funding: Janssen Research & Development, LLC. [Table: see text]

Trans-Pacific variation in outcomes for men treated with primary androgen deprivation therapy for localized prostate cancer.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 92-92
Author(s):  
Matthew R. Cooperberg ◽  
Shiro Hinotsu ◽  
Mikio Namiki ◽  
Peter Carroll ◽  
Hideyuki Akaza
Keyword(s):  
Prostate Cancer ◽  
Androgen Deprivation Therapy ◽  
The United States ◽  
Androgen Deprivation ◽  
Localized Prostate Cancer ◽  
Primary Androgen Deprivation Therapy ◽  
The Pacific ◽  
Treatment Type ◽  
The Us ◽  
Primary Androgen Deprivation

92 Background: Primary androgen deprivation therapy (PADT) is endorsed as an option for monotherapy for localized prostate cancer by guidelines in Asia but not in the United States (US) or Europe. PADT use is common, however, in both the US and Japan. Prior studies on either side of the Pacific have reported disparate outcomes for PADT; we aimed to explore these differences in a direct comparison study. Methods: Data were drawn from the US community-based CaPSURE registry and from J-CaP, comprising men in Japan treated with PADT. 1934 men treated with PADT were included from CaPSURE, and 16,300 treated in J-CaP. Risk adjustment was based on the validated Japan Cancer of the Prostate Risk Assessment (J-CAPRA) score. Cox proportional hazards regression was used to assess prostate cancer-specific mortality (CSM), adjusting for age, J-CAPRA, year of diagnosis, and treatment type (combined androgen blockade [CAB] vs. castration (medical or surgical) monotherapy). Results: Men treated with PADT in J-CaP were older than those in CaPSURE (mean age 75.0 vs. 72.7, p<0.001), and had higher risk disease (mean J-CAPRA score 3.0 vs. 2.1, p<0.001). They were more likely to be treated with CAB: 67.1% vs. 44.5% (p<0.001). In the Cox model, the hazard ratio (HR) for PCSM was 0.31 for J-CaP compared to CaPSURE, 95% CI 0.25–0.40. In J-CaP, CAB improved survival compared to castration alone (HR 0.81, 95% CI 0.66–1.0), but this effect was not observed in CaPSURE (HR 0.96, 95% CI 0.69–1.34). For all-cause mortality, the HR for J-CaP was 0.27 (95% CI 0.24–0.30). Conclusions: Adjusting for multiple factors including disease risk and type of androgen ablation, men treated with PADT in Japan compared to the US have more than 3-fold lower CSM and 4-fold better overall survival. CAB improved outcomes compared to castration alone in J-CaP but not in CaPSURE. These findings support existing guidelines both encouraging PADT in Asia and discouraging its use in the West. The reasons for these substantial differences likely include both genetic and dietary/environmental factors, as well as potential confounding variables such as comorbidities. Such factors may explain varying biology of prostate cancer on both sides of the Pacific.

scholarly journals Efficacy and safety of abiraterone acetate plus prednisolone in patients with early metastatic castration-resistant prostate cancer who failed first-line androgen-deprivation therapy: a single-arm, phase 4 study

2020 ◽  
Author(s):  
K Kobayashi ◽  
N Okuno ◽  
G Arai ◽  
H Nakatsu ◽  
A Maniwa ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Prostate Specific Antigen ◽  
Androgen Deprivation Therapy ◽  
Specific Antigen ◽  
Progression Free Survival ◽  
Abiraterone Acetate ◽  
Androgen Deprivation ◽  
Castration Resistant Prostate Cancer ◽  
First Line ◽  
Castration Resistant

Abstract Aim The aim was to evaluate the efficacy and safety of abiraterone acetate plus prednisolone in patients with chemotherapy-naïve early metastatic castration-resistant prostate cancer who failed first-line androgen deprivation therapy. Methods Patients with early metastatic castration-resistant prostate cancer with confirmed prostate-specific antigen progression within 1-year or prostate-specific antigen progression without having normal prostate-specific antigen level (&lt;4.0 ng/mL) during first-line androgen deprivation therapy were enrolled and administered abiraterone acetate (1000 mg) plus prednisolone (10 mg). A minimum of 48 patients were required according to Simon’s minimax design. The primary endpoint was prostate-specific antigen response rate (≥50% prostate-specific antigen decline by 12 weeks), secondary endpoints included prostate-specific antigen progression-free survival and overall survival. Safety parameters were also assessed. Results For efficacy, 49/50 patients were evaluable. Median age was 73 (range: 55–86) years. The median duration of initial androgen deprivation therapy was 32.4 (range: 13.4–84.1) weeks and 48 patients experienced prostate-specific antigen progression within 1-year after initiation of androgen deprivation therapy. prostate-specific antigen response rate was 55.1% (95% confidence interval: 40.2%–69.3%), median prostate-specific antigen–progression-free survival was 24.1 weeks, and median overall survival was 102.9 weeks (95% confidence interval: 64.86 not estimable [NE]). Most common adverse event was nasopharyngitis (15/50 patients, 30.0%). The most common ≥grade 3 adverse event was alanine aminotransferase increased (6/50 patients, 12.0%). Conclusions Abiraterone acetate plus prednisolone demonstrated a high prostate-specific antigen response rate of 55.1%, suggesting tumor growth still depends on androgen synthesis in patients with early metastatic castration-resistant prostate cancer. However, prostate-specific antigen–progression-free survival was shorter than that reported in previous studies. Considering the benefit–risk profile, abiraterone acetate plus prednisolone would be a beneficial treatment option for patients with chemotherapy-naive metastatic prostate cancer who show early castration resistance.

scholarly journals PSA Nadir and Time to PSA Nadir Following Androgen Deprivation Therapy are the Predictors for Castration-Resistant Prostate Cancer in Patients with Metastatic Prostate Cancer

2021 ◽  
Vol 1 (1) ◽  
Author(s):  
Patranuch Noppakulsatit
Keyword(s):  
Prostate Cancer ◽  
Disease Progression ◽  
Androgen Deprivation Therapy ◽  
Specific Antigen ◽  
Androgen Deprivation ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Hormone Sensitive ◽  
Psa Nadir

Purpose: To evaluate the influence of nadir prostate-specific antigen (PSA) level and time to PSA nadir following androgen deprivation therapy (ADT)on disease progression of castration-resistant prostate cancer (CRPC) in patients with metastatic, hormone-sensitive prostate cancer (mHSPC). Patients and methods: A total of 90 patients with metastatic, hormone-sensitive prostate cancer treated with androgen deprivation therapy in our hospital were included in our retrospective study. Patients’ characteristics, PSA at PADT initiation (initial PSA), PSA nadir, TTN, follow up time, CRPC event were analyzed using Kaplan-Meier analysis and Cox regression model. Results: At a median follow-up of 12 months, 57 patients (63.3%) showed disease progression of CRPC Both PSA nadir and time to PSA nadir (TTN) was independent and significant predictors of CRPC event. Patients with higher PSA nadir (≥0.2ng/dL) and shorter time to PSA nadir (TTN <6 months) had significant shorter time to CRPC. Meanwhile, the Gleason score, age and initial PSA werenot significant predictors of disease progression. In the combined analyses showed patients with higher of PSA nadir and shorter TTN had significantly higher risk for CRPC event compared to lower PSA nadir and longer TTN (HR 69.243, p-value< 0.001) Conclusion: We concluded that both higher PSA nadir and shorter time to PSA nadir are significant predictors of CRPC in patients with metastatic, hormone-sensitive prostate cancer receiving ADT.

scholarly journals Real-World Utilization of Androgen Deprivation Therapy-Intensification Among Older Canadian Men with de Novo Metastatic Prostate Cancer

2021 ◽  
Author(s):  
Christopher J D Wallis ◽  
Shawn Malone ◽  
Ilias Cagiannos ◽  
Scott C Morgan ◽  
Robert J Hamilton ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Androgen Deprivation Therapy ◽  
Real World ◽  
De Novo ◽  
Population Based ◽  
P Uptake ◽  
Abiraterone Acetate ◽  
Androgen Deprivation ◽  
Treatment Intensification ◽  
Clinical Trial Evidence

Abstract Background Despite the wealth of evidence demonstrating the efficacy of treatment intensification beyond androgen deprivation therapy (ADT) among patients with de novo metastatic castration-sensitive prostate cancer (mCSPC), little is known of its real-world utilization. This study examined the real-world uptake of ADT treatment intensification among older men in a large Canadian province. Methods We performed a retrospective population-based cohort study using province-wide linked administrative data in Ontario, Canada. Patients 66 years and older with de novo mCSPC were included and their treatment with conventional ADT-based regimens, ADT plus next-generation androgen receptor-axis-targeted therapy (ARAT), and ADT plus docetaxel were identified and stratified by time. Results From 2014 to 2019, 3556 patients were identified with de novo mCSPC. Most patients (n = 2794, 78.6%) were treated with a conventional ADT regimen while 399 (11.2%) patients received ADT intensification with docetaxel and 52 (1.5%) patients received abiraterone acetate plus prednisone (AA+P). In a time-stratified analysis of ADT intensification before and after the pivotal AA+P trial (LATITUDE), AA+P uptake increased from 0.5% to 3.0% while docetaxel use dropped from 12.0% to 10.0%. The median survival of the study population was 18 months (IQR = 10–31). Conclusion The majority of patients with de novo mCSPC are treated with ADT alone in the Canadian real-world setting, despite randomized clinical trial evidence of benefit with the use of ADT-intensified regimens. As ADT treatment intensification is substantially under-used, better understanding the barriers to treatment and targeted education to address these are needed.

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