Overall survival by race in chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) patients treated with abiraterone acetate or enzalutamide.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 212-212 ◽  
Author(s):  
Megan Ann McNamara ◽  
Daniel J. George ◽  
Krishnan Ramaswamy ◽  
Stanislav Lechpammer ◽  
Jack Mardekian ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Retrospective Study ◽  
Index Date ◽  
Abiraterone Acetate ◽  
Cox Proportional Hazards ◽  
Veterans Health ◽  
Health Administration ◽  
Castration Resistant Prostate Cancer ◽  
Kaplan Meier

212 Background: Prostate cancer (PC) is the most common malignancy among US men and the 2nd leading cause of cancer-related death. African Americans (AAs) have higher mortality from mCRPC than Whites (W). Despite this disparity, a small prior study suggested AAs may have better PSA response to abiraterone acetate (ABAC) than Ws, though radiographic progression did not differ. We evaluated overall survival (OS) in AA vs W chemotherapy-naïve (CN) mCRPC patients (Ps) treated with ABAC or enzalutamide (ENZ). Methods: This was a retrospective study that used the Veterans Health Administration (VHA) database. Male PC Ps (≥18 years) who had surgical or medical castration were identified from Apr 1, 2013 to Mar 31, 2018. The index date was the first prescription claim date for ABAC or ENZ following castration. Ps had no chemotherapy for 12 months pre-index date and had continuous VA health plan enrollment for ≥12 months pre- and post-index date. Ps were followed until death or disenrollment. Unadjusted and Kaplan-Meier survival analyses adjusted for demographic and clinical characteristics were used to calculate survival time, and multivariate Cox proportional hazards models assessed the relationship between race and OS. Results: This study included 2,123 W and 787 AA mCRPC Ps with mean ages of 74 and 71 years, respectively. The median follow‐up time was 570 days and 561 days for AA and W, respectively. AA were more prone to comorbid hypertension (77.1% vs 67.1%; p<.0001), type II diabetes (38.1% vs 29.3%; p<.0001), and liver damage or abnormality (8.8% vs 5.2%; p=0.0003) than W . From the unadjusted analysis, the median Kaplan-Meier estimated OS was 910 days for AAs and 784 days for Ws; AAs had better OS than Ws (HR=0.887; 95%CI [0.790-0.996]). From the adjusted analysis, the median Kaplan-Meier estimated OS was 918 days for AAs and 781 days for Ws; AAs still had better OS (HR=0.826; 95%CI [0.732-0.933]). Conclusions: This large retrospective study provides the first evidence that AA CN mCRPC Ps may have better OS with ABAC or ENZ than W Ps. Trials are needed to validate this finding and explore the mechanisms of racial disparities in outcomes with new hormonal therapies.

scholarly journals Survival outcomes in patients with chemotherapy-naive metastatic castration-resistant prostate cancer treated with enzalutamide or abiraterone acetate

2021 ◽  
Author(s):  
Scott T. Tagawa ◽  
Krishnan Ramaswamy ◽  
Ahong Huang ◽  
Jack Mardekian ◽  
Neil M. Schultz ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Retrospective Analysis ◽  
Index Date ◽  
Abiraterone Acetate ◽  
Cox Proportional Hazards ◽  
Veterans Health ◽  
Health Administration ◽  
Castration Resistant Prostate Cancer ◽  
Risk Of Death ◽  
Castration Resistant

Abstract Objective Evaluation of the comparative effectiveness of enzalutamide and abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) is limited to meta-analyses of randomized trials that exclude patients with significant comorbidities. We evaluated overall survival (OS) in patients with chemotherapy-naive mCRPC treated with enzalutamide or abiraterone acetate (abiraterone) in a real-world single payer setting. Methods A retrospective analysis (4/1/2014–3/31/2018) of the Veterans Health Administration (VHA) database was conducted. Patients with mCRPC had ≥1 pharmacy claim for enzalutamide or abiraterone (first claim date = index date) following disease progression on surgical/medical castration, without chemotherapy <12 months prior to index date. Patients had continuous VHA enrollment for ≥12 months pre-index date and were followed until death, disenrollment, or end of study. Kaplan–Meier analysis and multivariable Cox proportional hazards regression models examined the OS treatment effect. Results Patients with chemotherapy-naive mCRPC (N = 3174; enzalutamide, n = 1229; abiraterone, n = 1945) had mean ages of 74 and 73 years, respectively. Median follow-up was 18.27 and 19.07 months with enzalutamide and abiraterone, respectively. Enzalutamide-treated patients had longer median treatment duration than abiraterone-treated patients (9.93 vs 8.47 months, respectively, p = 0.0008). After baseline comorbidity adjustment, enzalutamide-treated patients had a 16% reduced risk of death (hazard ratio [HR] = 0.84; 95% CI, 0.76–0.94; p = 0.0012). For patients who remained on first line-therapy only, enzalutamide-treated patients had improved OS versus abiraterone-treated patients (HR = 0.71; 95% CI, 0.62–0.82). Enzalutamide-treated patients who crossed over to abiraterone had a comparable risk of death versus abiraterone-treated patients who crossed over to enzalutamide (HR = 0.91; 95% CI, 0.74–1.13). These results were confirmed by sensitivity analysis, which considered prognostic variables. Conclusions Retrospective analysis of the VHA database indicated that chemotherapy-naive patients with mCRPC initiating therapy with enzalutamide had improved survival versus abiraterone.

Association between radiographic response and overall survival in men with metastatic castration-resistant prostate cancer receiving chemotherapy.

2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 118-118
Author(s):  
G. Sonpavde ◽  
G. R. Pond ◽  
W. R. Berry ◽  
R. De Wit ◽  
M. A. Eisenberger ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Proportional Hazards ◽  
Objective Assessment ◽  
Objective Response ◽  
Cox Proportional Hazards ◽  
Phase Iii ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Kaplan Meier

118 Background: In men with metastatic castration resistant prostate cancer (CRPC),the association of measurable tumor responses with overall survival (OS) is unknown. We retrospectively evaluated the TAX327 phase III trial to study this relationship. Methods: Eligible patients for this analysis included those with WHO-defined measurable metastatic disease randomized to receive either docetaxel or mitoxantrone. OS was estimated using the Kaplan-Meier method and the prognostic relationship of WHO-defined radiologic response with OS was performed using Cox proportional hazards regression. Landmark analyses evaluated survival from baseline and 2, 3, 4 and 6 months after baseline. Results: Four hundred and twelve patients enrolled on the TAX327 trial had measurable tumors. Thirty-seven patients exhibited a complete or partial objective response (CR/PR, 9.0%), 116 had stable disease (SD, 28.2%), 99 had progressive disease (PD,24%) and 160 (38.8%) did not have a post-baseline objective assessment. Partial responders demonstrated longer median OS (29.0 months) than patients with SD (22.1 months), or those with PD (10.8 months) or those who were not assessed (12.7 months). These results remained after landmark analysis. We found a significant association between ≥30% PSA declines and radiologic response, with ≥30% PSA declines occurring in all patients with CR/PR, 79.8% of patients with SD and 34.4% with PD. Radiologic response remained a significant but modest post-treatment prognostic factor for OS after adjusting for treatment, pain-response and ≥30% PSA-decline (p=0.009). Conclusions: In men with metastatic CRPC and measurable disease receiving chemotherapy, objective tumor response was prognostic for OS, and appears to complement PSA assessment. [Table: see text]

Treatment duration and utilization patterns in metastatic castration-resistant prostate cancer patients receiving enzalutamide or abiraterone acetate.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 229-229
Author(s):  
Vahan Kassabian ◽  
Scott Flanders ◽  
Samuel Wilson ◽  
Bruce A. Brown ◽  
Yan Song ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Treatment Duration ◽  
Index Date ◽  
Abiraterone Acetate ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Kaplan Meier ◽  
Utilization Patterns ◽  
The Difference ◽  
Hormonal Therapies

229 Background: Enzalutamide (ENZA) and abiraterone acetate (ABI) are approved hormonal therapies for men with metastatic castration-resistant prostate cancer (mCRPC). This study assessed real-world treatment duration and utilization patterns in patients receiving ENZA or ABI. Methods: Adult mCRPC patients initiating ENZA or ABI before or after cytotoxic chemotherapy were identified from the Truven MarketScan® claims database (2012–2015). The index date was the first initiation of ENZA or ABI; continuous insurance enrollment for ≥6 months prior to and ≥3 months after the index date was required. Treatment discontinuation was defined as a prescription gap of ≥45 days. Median treatment duration was estimated using Kaplan–Meier method. Treatment switching was defined as starting a new mCRPC-related therapy within 30 days before to 45 days after the discontinuation date. Analyses were separately conducted for chemo-naïve and chemo-experienced patients. Results: The study included 3230 chemo-naive (ENZA 920; ABI 2310) and 692 chemo-experienced patients (ENZA 262; ABI 430). Among chemo-naive patients, ENZA cohort was older (mean age 74.5 vs 73.5; p = 0.013), with a higher proportion of comorbidities vs ABI cohort. Treatment duration was longer for ENZA cohort than ABI cohort (log-rank p = 0.008; median = ENZA 10.7 vs ABI 8.8 months). Within 1 year of initiation, 55.7% of ENZA and 60.8% of ABI cohort discontinued treatment and 22.5% and 34.7%, respectively, switched to other mCRPC therapies. Results were consistent among subgroups with specific comorbidities. Treatment duration was shorter among chemo-experienced patients than chemo-naïve; the difference between ENZA vs ABI among chemo-experienced patients was not statistically significant (log-rank p = 0.255; median = ENZA 7.5 vs ABI 7.1 months). Conclusions: Despite a more complex profile at baseline, chemo-naive mCRPC patients in the ENZA cohort had a longer treatment duration and lower proportion of switching to other prostate-cancer-directed therapies vs the ABI cohort. The difference of treatment duration between the two cohorts was not statistically significant for chemo-experienced patients.

Gaps in treatment amongst metastatic castration resistant prostate cancer (mCRPC) patients taking abiraterone acetate or enzalutamide.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 334-334
Author(s):  
Ajay Behl ◽  
Lorie Ellis ◽  
Dominic Pilon ◽  
Yongling Xiao ◽  
Patrick Lefebvre ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Index Date ◽  
Drug Dosage ◽  
Abiraterone Acetate ◽  
Data Availability ◽  
Castration Resistant Prostate Cancer ◽  
Cancer Treatments ◽  
Loss To Follow Up ◽  
Castration Resistant ◽  
Kaplan Meier

334 Background:Abiraterone acetate (ABI) and enzalutamide (ENZ) are novel oral therapies offering survival benefit to metastatic castration-resistant prostate cancer (mCRPC) patients. The efficacy of cancer treatments rely on patient consistency and adherence to recommended dosage regimens. Factors such as drug-drug interactions and intolerance or toxicities can result in patients or their providers reducing the drug dosage. This study aims to describe treatment discontinuation patterns observed for ABI and ENZ. Methods: The Truven Health MarketScan Research Databases were used to conduct a retrospective analysis of mCRPC patients initiated on ABI or ENZ (index date) between 10/01/2012 to 12/31/2014 with ≥6 months of continuous eligibility prior to index date and a PC diagnosis during the period of continuous eligibility. Patients were observed until loss to follow-up, or end of data availability. Kaplan-Meier (KM) survival curves were used to compare the rates of having a refill gap (i.e., ≥14 days, ≥30 days, or ≥60 days) in patients initiated on ABI or ENZ. Results: The table below summarizes the KM probabilities of having a refill gap among patients initiated on ABI or ENZ. Conclusions: Significantly higher rates of refill gaps ≥30 days and ≥ 60 days were observed for patients initiating ENZ as compared to ABI after 6 months of observation in this initial analysis. Additional research is needed to understand the reasons for gaps in treatment in patients treated with mCRPC therapies. [Table: see text]

Overall survival (OS) in men with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) receiving bicalutamide (BIC) followed by enzalutamide (ENZA) or abiraterone (ABI).

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 40-40
Author(s):  
Daniel J. George ◽  
Scott T. Tagawa ◽  
Stanislav Lechpammer ◽  
Dave Russell ◽  
Agnes Hong ◽  
...  
Keyword(s):  
Real World ◽  
Index Date ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Veterans Health ◽  
Health Administration ◽  
Castration Resistant Prostate Cancer ◽  
First Line ◽  
Cox Analysis ◽  
The Impact

40 Background: The objective of this study was to evaluate real-world OS in men with chemotherapy-naïve mCRPC treated with first-line ENZA or ABI or sequencing to these agents after treatment with BIC ( > 90 d). Methods: A retrospective analysis was performed using the Veterans Health Administration (VA) database. Men with mCRPC and ≥ 1 pharmacy claim for ABI or ENZA (1st claim date = index date) following surgical or medical castration and with no chemotherapy treatment 12 months pre-index date were identified from 01APR2014 to 31MAR2017. Men had continuous VA enrollment for ≥ 12 months pre- index date and were followed until death or study end. Cox proportional hazards regression models examined the impact of treatment on OS, and the impact of first using BIC ( > 90 d) vs first-line use of ABI and ENZA on OS. Adjusted Kaplan-Meier analysis was conducted to graphically describe OS. Results: This study included 1229 ENZA- and 1945 ABI-treated men with mCRPC with mean ages of 74 and 73 y, respectively. Median follow‐up was 548 and 572 d, and median OS was 892 and 786 d, respectively. ENZA and ABI were first-line treatment in 1068 and 1628 men, but BIC ( > 90 d) was first used before sequencing to ENZA or ABI in 161 and 317 men, respectively. Median duration of BIC treatment was similar in men subsequently treated with ENZA or ABI (251 v 246 d, respectively). Compared with first-line ABI, use of ABI following BIC led to shorter OS (hazard ratio [HR] = 1.30; 95% CI 1.11 -1.52). Compared with first-line ENZA, use of ENZA following BIC resulted in a nonsignificant effect on OS (HR = 0.92; 95% CI 0.72-1.19). In the Cox analysis, ENZA-treated men had longer OS compared with ABI-treated men (HR = 0.84; 95% CI 0.76-0.94). Conclusions: Use of BIC ( > 90 d) before sequencing to ENZA did not negatively effect OS, however BIC before ABI impacted OS adversely in men with chemotherapy-naïve mCRPC. There are significant differences in OS favoring ENZA compared with ABI regardless of prior BIC. Real-world observational data are nonrandomized, and markers for disease severity/volume are not available in the claims database. Further research is required to confirm these findings.

scholarly journals Oncological outcomes of metastatic castration resistant prostate cancer (mCRPC) treated with different therapies sequences after completion of docetaxel: a retrospective study in Songklanagarind Hospital

2021 ◽  
Vol 42 (2) ◽  
pp. 131-137
Author(s):  
Isaris Chaokhamin ◽  
◽  
Worapat Attawettayanon ◽  
Virote Chalieopanyarwong ◽  
Monthira Tanthanuch ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Proportional Hazards ◽  
Multivariable Analysis ◽  
Abiraterone Acetate ◽  
Cox Proportional Hazards ◽  
Castration Resistant Prostate Cancer ◽  
Oncological Outcomes ◽  
Castration Resistant ◽  
Docetaxel Chemotherapy

Objective: Many treatment options of metastatic castration-resistant prostate cancer (mCRPC) after docetaxel chemotherapy have proved efficacious in clinical trials but, to date, knowledge regarding oncological outcomes is limited. Materials and Methods: We assessed the oncological outcome of 4 drugs (abi- raterone acetate, cabazetaxel, enzalutamide and ketoconazole) in a normal clinical setting in a university-based hospital. Our cohort consisted of 69 patients with post-docetaxel mCRPC. The primary endpoint was overall survival (OS). The secondary endpoint was predicted factor associated overall survival with all sec- ond-line mCRPC treatment outcomes according to the Cox proportional hazards regression model. Results: This cohort consisted of 69 patients with progressive mCRPC after docetaxel chemotherapy. Median overall survival following treatment with abiraterone acetate and ketoconazole was 25.92 and 9.59 months respectively (p < 0.05). Overall survival rates at 1-year following abiraterone acetate, cabazetaxel, enzalutamide and ketoconazole therapy were 76.3%, 83.3%, 100% and 41.9%, respectively. Multivariable analysis found that abiraterone acetate, cabazitaxel and enzalutamide significantly improved survival in comparison to ketoconazole (p < 0.001). Conclusion: Analysis of overall survival following second-line treatment of mCRPC post docetaxel in our study statistically significantly confirmed that abiraterone acetate, cabazitaxel and enzalutamide improve overall survival in comparison to ketoconazole. The study also found that enzalutamide treatment resulted in better outcomes in comparison to the other drugs.

Bone modifying agents in veterans with castration-resistant prostate cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6582-6582
Author(s):  
Jordan Bauman ◽  
Kyle Kumbier ◽  
Jennifer A. Burns ◽  
Jordan Sparks ◽  
Phoebe A. Tsao ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Zoledronic Acid ◽  
Bone Metastases ◽  
Specific Antigen ◽  
Veterans Health ◽  
Health Administration ◽  
Castration Resistant Prostate Cancer ◽  
National Guidelines ◽  
Castration Resistant ◽  
Unit Increase

6582 Background: Skeletal related events (SREs) are a known complication for the 80% of men with metastatic prostate cancer who have bone metastases. Previous studies have demonstrated that bone modifying agents (BMAs) such as zoledronic acid and denosumab reduce SREs in men with metastatic castration-resistant prostate cancer who have bone metastases and are now recommended by national guidelines. We sought to investigate factors associated with use of BMAs in Veterans with CRPC across the Veterans Health Administration (VA). Methods: Using the VA Corporate Data Warehouse, consisting of aggregated medical record data from 130 facilities, we used an algorithm previously published to identify men with a diagnosis of castration-resistant prostate cancer (CRPC) based on rising prostate specific antigen (PSA) levels while on androgen deprivation therapy and who received systemic treatment for CRPC with one of the commonly used therapies: abiraterone, enzalutamide, docetaxel, ketoconazole between 2010 and 2017. To account for clustering among facilities, we used a multilevel multivariable logistic regression to determine the association of patient and disease-specific variables on the odds of a patient receiving a BMA after they started treatment for CRPC. Results: Of 4,998 patients with CRPC in our cohort, 2223 (44%) received either zoledronic acid or denosumab at some point after they were initiated on treatment for CRPC. After adjusting for other variables and accounting for a facility, the odds of receiving a BMA decreased by 3% for every additional year of age (odds ratio [OR] 0.97, 95% confidence interval [CI] 0.96-0.98), and decreased significantly with increasing comorbid conditions (OR 0.94, 95% CI 0.72-0.98 for Charlson Comorbidity Index [CCI] of 1; OR 0.69, 95% CI 0.59-0.81 for CCI 2+). Patients who were Black had 25% lower odds of receiving a BMA than patients who were White (OR 0.75, 95% CI 0.65-0.87). PSA at time of CRPC treatment start had a small but not significant effect on receipt of a BMA (OR 1.04, 95% CI 1.00-1.08) for every unit increase of PSA on the log scale. PSA doubling time was not associated with receipt of a BMA. The presence of a diagnosis code for bone metastases was far lower than expected in this cohort of patients with CRPC (40.7%), and thus was not included in the model. We did not expect the presence of bone metastases to vary significantly among the other independent variables. Conclusions: Despite most patients with CRPC historically having bone metastases, less than half of patients with CRPC received a BMA. Patients who are older, had more comorbidities, or were Black were less likely to receive a BMA after starting treatment for CRPC. Understanding factors that lead to different patterns of treatment can guide initiatives toward more guideline-concordant care.

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