Prostate-specific antigen response among Black and non-Black patients with advanced prostate cancer treated with apalutamide in a urology setting.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 124-124
Author(s):  
Michael Durkin ◽  
Dominic Pilon ◽  
Carmine Rossi ◽  
Ibrahim Khilfeh ◽  
Frederic Kinkead ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Prostate Specific Antigen ◽  
Clinical Data ◽  
Real World ◽  
Index Date ◽  
Specific Antigen ◽  
The United States ◽  
Median Baseline ◽  
Black Patients ◽  
Baseline Psa

124 Background: Apalutamide (APA) is approved to treat patients with non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic castration-sensitive prostate cancer (mCSPC) in the United States (US) but low enrollment of Black patients in clinical trials has led to limited clinical data about APA for this population. This study describes prostate-specific antigen (PSA) responses among Black and non-Black patients with nmCRPC or mCSPC treated with APA in a real-world community urology setting. Methods: Clinical data from 2/2018 to 3/2021 collected at 69 US urology practices were used to evaluate nmCRPC or mCSPC patients who received ≥1 APA prescription fill (index date). Baseline PSA was reported based with the most recent baseline PSA value and PSA doubling time (PSADT) in months (mo) was calculated in patients with at least 2 PSA tests before APA initiation. PSA response defined as the proportion of patients achieving either a reduction of 50% (PSA50) or 90% (PSA90) from baseline and was evaluated in patients with a PSA test result 8 weeks or later after initiating APA. Among patients with a response, the time from the index date to the response was also evaluated. Study results for Black and non-Black cohorts were summarized separately. Results: Data from 289 nmCRPC (19% Black) and 237 mCSPC (19% Black) patients were identified. Median baseline PSA, median baseline PSADT and post-index PSA responses are shown in Table. A PSA50 response was attained by numerically similar proportions of Black and non-Black patients with nmCRPC or mCSPC. A PSA90 response was observed in a numerically higher proportion of Black than non-Black nmCRPC patients. Median time to PSA50 and PSA90 was also similar between groups. Conclusions: This real-world study of nmCRPC and mCSPC patients demonstrates that PSA50 and PSA90 responses are achieved by high proportions of both Black and non-Black patients. Moreover, the PSA50 and PSA90 responses observed in this study are highly consistent with those observed in APA’s Phase 3 registrational trials for nmCRPC (SPARTAN)1 and for mCSPC (TITAN)2. References: 1Smith MR, et al. N Engl J Med. 2018;378:1408-1418. 2Chi KN, et al. N Engl J Med. 2019;381:13-24. Funding Source: Janssen Scientific Affairs, LLC.[Table: see text]

Real-world clinical resource utilization of metastatic prostate cancer patients in the United States: Results from two large claims databases.

2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 204-204
Author(s):  
M. Lafeuille ◽  
M. Senbetta ◽  
R. S. McKenzie ◽  
P. Lefebvre
Keyword(s):  
Prostate Cancer ◽  
Resource Utilization ◽  
Real World ◽  
Metastatic Prostate Cancer ◽  
Index Date ◽  
Specific Antigen ◽  
The United States ◽  
Medicare Patients ◽  
Clinical Resource ◽  
Observation Period

204 Background: In metastatic prostate cancer (MPC) patients, treatment options include hormonal therapies, chemotherapy, and radiotherapy. This study quantifies the real-world healthcare resource utilization of MPC patients. Methods: Health insurance claims from 40 self-insured companies across the US (Employer [E]; 01/1999-02/2009), and from the Medicare 5% ([M]; 1999-2008) databases were analyzed. Patients with a metastasis diagnosis (ICD-9: 196-199) following 2 prostate cancer diagnoses (ICD-9: 185, V10.46) within 365 days were identified. Patients with other malignant diagnoses at baseline, defined as 365 days prior to metastasis diagnosis (index date), were excluded. Patients were evaluated for baseline medical history and for chemotherapy, hormonal agents, radiation, and corticosteroids utilization during both baseline and observation periods. Hospitalization rates and prostate cancer-related procedures post index date were also reported. Results: The study population comprised 11,725 patients (E: 3,227; M: 8,498). Mean age (SD) was 72.8 (10.2) in Employer and 78.1 (7.7) in Medicare. Mean observation period (SD) was 803 (753) days in Employer and 9.2 (8.2) quarters in Medicare. During the baseline period, chemotherapy, hormonal agents, radiation therapy, and corticosteroids were administered to 5%, 52%, 9%, and 21% of Employer, and 2%, 45%, 8%, and 12% of Medicare patients respectively, whereas these interventions increased to 22%, 55%, 39%, and 46% for Employer, and to 21%, 50%, 33%, and 29% for Medicare during the observation period. A total of 66% Employer and 79% Medicare patients were hospitalized post index date. Most patients (E: 92%; M: 98%) had prostate cancer-related procedures, including prostate specific-antigen testing (E: 39%; M: 80%), computerized axial tomography scan (E: 72%; M: 81%), prostate biopsy (E: 47%; M: 54%), X-ray (E: 11%; M: 64%), bone scan (E: 56%; M: 60%), and magnetic resonance imaging scan (E: 35%; M: 37%). Conclusions: This observational study describes real-world utilization patterns in patients with advanced prostate cancer. [Table: see text]

Changing characteristics of patients treated with sipuleucel-T (sip-T) over time: Real-world experience from the PROCEED registry.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 320-320
Author(s):  
Andrew J. Armstrong ◽  
Celestia S. Higano ◽  
A. Oliver Sartor ◽  
Nicholas J. Vogelzang ◽  
William R. Berry ◽  
...  
Keyword(s):  
Overall Survival ◽  
Real World ◽  
African American Men ◽  
Specific Antigen ◽  
Cellular Immunotherapy ◽  
Second Line ◽  
Median Baseline ◽  
Castration Resistant ◽  
Over Time ◽  
Baseline Psa

320 Background: Sip-T is an autologous cellular immunotherapy approved by the FDA for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer. PROCEED (NCT01306890) is a phase 4 registry evaluating men receiving sip-T therapy in the US. Patient characteristics and treatment trends were assessed from 2011 to 2013, when several agents with an overall survival benefit became commercially available. Methods: For patients enrolled from 2011 to 2013, baseline patient and disease characteristics at the first sip-T infusion, trends in prior therapy, and pre–sip-T baseline prostate-specific antigen (PSA) levels were examined year over year. Results: From 2011 to 2013, 1902 patients were enrolled and received ≥ 1 sip-T infusion: 2011, n = 145; 2012, n = 967; 2013, n = 790. During this time period, enrollment of African American men nearly doubled from 6.9% to 13.4%, and central venous catheter use to facilitate sip-T infusion decreased (from 53.8% to 44.1%). Median baseline lactate dehydrogenase (LDH) levels and the number of lymph node metastases also decreased as well as median baseline PSA values (17.8 ng/mL to 11.9 ng/mL [P = 0.002]). Prior use of first-generation anti-androgens (from 73.1% to 60.5%), ketoconazole (17.2% vs. 6.3%), and estrogen (4.8% vs. 1.6%) decreased along with prior docetaxel use (19.3% vs. 7.5%). In contrast, prior investigational use of abiraterone acetate (from 3.4% to 8.9%) and enzalutamide (1.4% vs. 3.2%) increased over time. Conclusions: Over the duration of PROCEED, the decrease in baseline PSA, lower LDH, fewer nodal metastases, and decline in prior docetaxel use suggest that sip-T is being used earlier in the course of metastatic castration-resistant disease. Moreover, second-line hormonal therapy use with agents that do not improve overall survival appears to be substituted by therapies that do. This decrease in second-line hormonal therapies during PROCEED could suggest a real-world preference for earlier sip-T use. Clinical trial information: NCT01306890.

RE: THE PROSTATE SPECIFIC ANTIGEN ERA IN THE UNITED STATES IS OVER FOR PROSTATE CANCER: WHAT HAPPENED IN THE LAST 20 YEARS?

2005 ◽  
Vol 173 (6) ◽  
pp. 2205-2205 ◽  
Author(s):  
T.A. Stamey ◽  
M. Caldwell ◽  
J.E. McNeal ◽  
R. Nolley ◽  
M. Hemenez ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
United States ◽  
Prostate Specific Antigen ◽  
Specific Antigen ◽  
The United States

Cancer-Specific Mortality After Surgery or Radiation for Patients With Clinically Localized Prostate Cancer Managed During the Prostate-Specific Antigen Era

2003 ◽  
Vol 21 (11) ◽  
pp. 2163-2172 ◽  
Author(s):  
Anthony V. D’Amico ◽  
Judd Moul ◽  
Peter R. Carroll ◽  
Leon Sun ◽  
Deborah Lubeck ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Prostate Specific Antigen ◽  
Specific Antigen ◽  
Risk Groups ◽  
The United States ◽  
Localized Prostate Cancer ◽  
Institutional Setting ◽  
Psa Failure ◽  
Specific Mortality ◽  
Cancer Specific Mortality

Purpose: To determine whether pretreatment risk groups shown to predict time to prostate cancer–specific mortality (PCSM) after treatment at a single institution retained that ability in a multi-institutional setting. Patients and Methods: From 1988 to 2002, 7,316 patients treated in the United States at 44 institutions with either surgery (n = 4,946) or radiation (n = 2,370) for clinical stage T1c-2, N0 or NX, M0 prostate cancer made up the study cohort. A Cox regression analysis was performed to determine the ability of pretreatment risk groups to predict time to PCSM after treatment. The relative risk (RR) of PCSM and 95% confidence intervals (CIs) were calculated for the intermediate- and high-risk groups relative to the low-risk group. Results: Estimates of non-PCSM 8 years after prostate-specific antigen (PSA) failure were 4% v 15% (surgery versus radiation; Plog rank = .002) compared with 13% v 18% (surgery versus radiation; Plog rank = .35) for patients whose age at the time of PSA failure was less than 70 as compared with ≥ 70 years, respectively. The RR of PCSM after treatment for surgery-managed patients with high- or intermediate-risk disease was 14.2 (95% CI, 5.0 to 23.4; PCox < .0001) and 4.9 (95% CI, 1.7 to 8.1; PCox = .0037), respectively. These values were 14.3 (95% CI, 5.2 to 24.0; PCox < .0001) and 5.6 (95% CI, 2.0 to 9.3; PCox = .0012) for radiation-managed patients. Conclusion: This study provided evidence to support the prediction of time to PCSM after surgery or radiation on the basis of pretreatment risk groups for patients with clinically localized prostate cancer managed during the PSA era.

Impact of prostate specific antigen doubling time on time to metastasis and overall survival in non-metastatic castration-resistant prostate cancer patients.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 211-211
Author(s):  
Stephen J. Freedland ◽  
Krishnan Ramaswamy ◽  
Stanislav Lechpammer ◽  
Jack Mardekian ◽  
Neil M. Schultz ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Prostate Specific Antigen ◽  
Doubling Time ◽  
Index Date ◽  
Cox Regression ◽  
Specific Antigen ◽  
Prognostic Impact ◽  
Health Administration ◽  
Castration Resistant

211 Background: Prostate-Specific Antigen Doubling Time (PSADT) can help predict prostate cancer (PC) patient outcomes, particularly in hormone sensitive disease. However, PSADT has not been well validated in non-metastatic castration-resistant (nmCR) PC patients. This study examined the prognostic impact of PSADT on time to metastasis (TTM) and overall survival (OS) among nmCRPC patients in the Veterans Health Administration (VHA) database. Methods: VHA patients in this retrospective study were males with PC who had medical or surgical castration between Jan 1, 2012 and Dec 31, 2016. Patients actively receiving luteinizing hormone-releasing hormone treatment with ≥2 PSA post-castration increases were identified. The 3rd PSA value ≥25% and 2 ng/ml > the 1st PSA value was the CRPC (index) date; patients had continuous VHA enrollment for ≥12-months pre- to post-index date. Patients were followed until the earliest of death or disenrollment. PSADT was calculated as the natural log of 2 divided (Ln2) by the log slope of PSA using all PSA values after CRPC until metastases, and patients were categorized into 2-month cohorts. A demographically and clinically adjusted Cox regression model explored associations between PSADT cohorts and TTM and OS. Results: We identified 3,579 patients from which 1,389 (38.8%) progressed to mCRPC while 2,190 (61.2%) remained nmCRPC. Overall, patients averaged 73 years of age. PSADT was calculable in 2,800 patients with an average PSA value of 25.49 ng/mL. After a median follow-up of 820 days, the median PSADT was 17 months. Compared with the PSADT > 12 months cohort, PSADT ≤2, > 2 to ≤4, > 4 to ≤6, > 6 to ≤8, and > 8 to ≤10 month cohorts were associated with higher risk of metastasis (hazard ratio [HR]: 33.77, CI: 25.93-43.96; HR: 14.32, CI: 11.83-17.32; HR: 6.58, CI: 5.42-7.98, HR: 4.14, CI: 3.27-5.25; HR: 3.14, CI: 2.45-4.03, respectively) and death (HR: 12.27, CI: 9.20-16.35; HR: 5.32, CI: 4.26-6.64; HR: 3.50, CI: 2.74-4.47, HR: 2.29, CI: 1.68-3.14; HR: 1.64, CI: 1.14-2.37, respectively). Conclusions: Short PSADT strongly associated with TTM and poor OS in nmCRPC patients. Newer nmCRPC treatments are advisable for high-risk patients.

Real-world utilization of advanced therapies and racial disparity among patients with metastatic castration-sensitive prostate cancer (mCSPC): A Medicare database analysis.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5073-5073
Author(s):  
Stephen J. Freedland ◽  
Neeraj Agarwal ◽  
Krishnan Ramaswamy ◽  
Rickard Sandin ◽  
Dave Russell ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Real World ◽  
Index Date ◽  
Treatment Intensification ◽  
Black Patients ◽  
Advanced Therapies ◽  
Nationally Representative ◽  
Medicare Database ◽  
Over Time ◽  
White Patients

5073 Background: Several randomized controlled trials have shown that adding docetaxel or novel hormonal therapy (NHT) to androgen deprivation therapy (ADT) improves survival in mCSPC patients. This study aimed to evaluate the real-world utilization of advanced therapies over time and to provide data on utilization patterns among racial minorities that are often under-represented in clinical trials. Methods: This was a retrospective analysis of a Medicare database (Jan 2009-Dec 2018). Adult men with ≥1 claim for prostate cancer (PC) who initiated ADT (index date) within 90 days prior to or any time after a metastasis diagnosis were included. The first-line (1L) treatment was grouped by PC drugs prescribed within 30 days prior to and 120 days after the index date, in 4 categories: ADT alone, ADT + first-generation anti-androgen (AA; ≥90 days to avoid capturing AA for flare control), ADT + docetaxel, and ADT + NHT (abiraterone, apalutamide, and enzalutamide). The 1L treatment distributions were described over time and stratified by race. Results: A total of 35,195 patients with mCSPC were included in the study, with a mean (SD) age of 76.5 (7.9) years. 11.8% were Black, 5.3% Hispanic, and 78.5% White. 76.4% received ADT alone as 1L treatment, 14.3% ADT + AA, 4.8% ADT + docetaxel, and 4.5% ADT + NHT. While the proportion of patients treated with ADT alone and ADT + AA slowly decreased over time, the utilization of ADT + docetaxel increased since 2015 and the utilization of ADT + NHT increased since 2017 (Table). After the emergence of NHTs for treatment of mCSPC in 2017, treatment intensification with ADT + NHT was numerically lower for Black than White patients. Data from before 2017 also suggest a similar lower use of ADT + AA in Black patients (Table). Survival analysis across treatment cohorts and race are ongoing. Conclusions: In this large and nationally representative sample of mCSPC patients, less than one-third of patients received treatment intensification by 2018, possibly due to patient/disease characteristics, provider awareness or therapeutic inertia, or cost. Importantly, the data showed less frequent treatment intensification in Black vs White patients. Further study is required to elucidate underlying reasons for this disparity.[Table: see text]

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