Raadpleeg ook de lijst van niet-toxische ondersteuning specifiek bij prostaatkanker van arts-bioloog drs. Engelbert Valstar.
En als donateur kunt u ook korting krijgen bij verschillende bedrijven, waaronder bij Medpro voor o.a. prostasol een veel gebruikt natuurlijk middel bij prostaatkanker als alternatief voor hormoontherapie.
2 mei 2022: Bron: Science Direct
Patiënten met niet uitgezaaide castratieresistente prostaatkanker die werden behandeld met apalutamide in de klinische praktijk (gegevens uit 63 verschillende ziekenhuizen waar prostaatkankerpatiënten de apalutamide kregen als behandeling werden geanalyseerd), laten dezelfde goede resultaten zien op de daling van de PSA waarden als is gebleken uit klinische studies. Na 12 maanden follow-up was de PSA-respons 86,0%, 93,1% en 85,9% voor respectievelijk de totale groep van patiënten, de groep zwarte patiënten en de groep niet-zwarte patiënten.
Bovendien toonden zowel zwarte als niet-zwarte patiënten een hoge therapietrouw aan de behandeling met apalutamide. Tijdens een gemiddelde follow-upperiode van 333 dagen, 352 dagen en 326 dagen was de therapietrouw respectievelijk 93,6%, 90,1% en 94,5% voor de totale groep patiënten, en de zwarte en niet-zwarte groepen.
Dat er zo'n grote therapie trouw was heeft te maken met de acceptabele bijwerkingen van apalutamide, aldus de onderzoekers.
- De PSA-respons werd beoordeeld tijdens de follow-up periode bij patiënten met ≥ 1 PSA-meting tijdens de baselineperiode en één meting tijdens de eerste 6 maanden of eerste 12 maanden van de follow-up periode.
- Een stijgende PSA werd gedefinieerd als een huidige PSA-waarde die hoger was dan de vorige PSA-waarde.
- De PSA-respons werd gedefinieerd als een afname van ≥50% vanaf het meest recente PSA-niveau bepaald tijdens de baselineperiode (inclusief indexdatum) tot een PSA-meting tijdens de eerste 6 maanden of 12 maanden van de follow-upperiode.
- Botmetastase werd beoordeeld tijdens de gehele follow-up periode.
Table 1 Baseline characteristics of apalutamide patients
| Overall (N = 193) | Black (N = 33) | Non-Black (N = 138) | |
|---|---|---|---|
| Age group, n (%) | |||
| ≤70 y | 27 (14.0) | 8 (24.2) | 16 (11.6) |
| 71-80 y | 73 (37.8) | 9 (27.3) | 59 (42.8) |
| 81-90 y | 73 (37.8) | 12 (36.4) | 49 (35.5) |
| >90 y | 20 (10.4) | 4 (12.1) | 14 (10.1) |
| Year of CRPC diagnosis, n (%) | |||
| ≤2014 | 22 (11.4) | 5 (15.2) | 16 (11.6) |
| 2015 | 16 (8.3) | 7 (21.2) | 8 (5.8) |
| 2016 | 28 (14.5) | 5 (15.2) | 17 (12.3) |
| 2017 | 40 (20.7) | 6 (18.2) | 27 (19.6) |
| 2018 | 66 (34.2) | 6 (18.2) | 55 (39.9) |
| 2019 | 21 (10.9) | 4 (12.1) | 15 (10.9) |
| Prior use of ADT, n (%) | 190 (98.4) | 33 (100.0) | 136 (98.6) |
| Year of index date, n (%) | |||
| 2018 | 124 (64.2) | 22 (66.7) | 89 (64.5) |
| 2019 | 69 (35.8) | 11 (33.3) | 49 (35.5) |
| Reported PSA test, n (%) | 190 (98.4) | 33 (100.0) | 135 (97.8) |
| PSA level, ng/mL, mean ± SD | 7.0 ± 11.8 [3.2] | 10.5 ± 14.4 [6.4] | 5.6 ± 9.0 [2.8] |
| Number of PSA tests, mean ± SD | 3.9 ± 1.5 [4.0] | 3.7 ± 1.5 [4.0] | 3.9 ± 1.6 [4.0] |
| Number of rising PSA, mean ± SD | 1.4 ± 1.1 [1.0] | 1.3 ± 1.1 [1.0] | 1.5 ± 1.1 [1.0] |
| Time from latest baseline PSA measure to index date, days, mean ± SD | 33.3 ± 42.8 [22.0] | 35.6 ± 40.1 [24.0] | 32.9 ± 46.1 [19.0] |
| Calculated PSA doubling time, n (%) , | 90 (46.6) | 16 (48.5) | 70 (50.7) |
| PSA doubling time, months, mean ± SD | 10.8 ± 9.6 [8.5] | 10.2 ± 10.8 [7.3] | 10.1 ± 7.7 [8.4] |
| PSA doubling time ≤10 mo, n (%) | 57 (63.3) | 10 (62.5) | 46 (65.7) |
| Reported testosterone test, n (%) | 146 (75.6) | 22 (66.7) | 105 (76.1) |
| Testosterone level, ng/dL, mean ± SD | 16.3 ± 28.6 [11.0] | 15.1 ± 11.8 [12.4] | 17.3 ± 33.0 [10.3] |
| Number of testosterone tests, mean ± SD | 2.5 ± 1.6 [2.0] | 2.8 ± 1.2 [3.0] | 2.4 ± 1.7 [2.0] |
| Time from latest baseline testosterone measure to index date, days, mean ± SD | 60.1 ± 75.7 [30.5] | 52.4 ± 73.9 [23.0] | 61.2 ± 74.8 [32.0] |
| Comorbidities, n (%) | |||
| Hypertension | 43 (22.3) | 9 (27.3) | 29 (21.0) |
| Dyslipidemia or hyperlipidemia | 20 (10.4) | 2 (6.1) | 16 (11.6) |
| Diabetes | 19 (9.8) | 2 (6.1) | 15 (10.9) |
| Coronary artery disease | 6 (3.1) | 0 (0.0) | 5 (3.6) |
| Myocardial infarction | 4 (2.1) | 0 (0.0) | 4 (2.9) |
| Imaging tests | |||
| Bone scan, n (%) | 22 (11.4) | 2 (6.1) | 17 (12.3) |
| Time from index date to last scan, days, mean ± SD | 85.2 ± 72.0 [74.5] | 131.5 ± 46.0 [131.5] | 87.2 ± 75.6 [72.0] |
| CT scan, n (%) | 100 (51.8) | 20 (60.6) | 65 (47.1) |
| Time from index date to last scan, days, mean ± SD | 87.1 ± 93.7 [43.0] | 72.7 ± 69.6 [54.0] | 92.7 ± 103.4 [43.0] |
| PET scan, n (%) | 33 (17.1) | 5 (15.2) | 26 (18.8) |
| Time from index date to last scan, days, mean ± SD | 65.5 ± 69.4 [43.0] | 44.2 ± 31.3 [35.0] | 68.6 ± 73.8 [43.5] |
ADT, androgen deprivation therapy; CRPC, castration-resistant prostate cancer; CT, computed tomography; PET, positron emission tomography; PSA, prostate-specific antigen; SD, standard deviation.
In deze grafiek zijn de verschillen in respons tussden de drie groepen weergegeven:
Het volledige studierapport is gratis in te zien, klik op de titel van het abstract:
Real-World Prostate-Specific Antigen Response and Treatment Adherence of Apalutamide in Patients With Non-Metastatic Castration-Resistant Prostate Cancer
Abstract
Objective
To describe prostate-specific antigen (PSA) response and treatment adherence, overall and stratified by race, for patients with non-metastatic castration-resistant prostate cancer (nmCRPC) treated with apalutamide.
Methods
Electronic medical records representing 63 urology practices from the United States were used to conduct this study. Patients with ≥2 apalutamide prescription fills and ≥12 months of prior prostate cancer management were identified. Patients were followed from apalutamide initiation until a switch to another antineoplastic treatment, death, or end of data availability (October 4, 2019). PSA response (≥50% decline from baseline PSA) and apalutamide adherence rates are described for the overall nmCRPC population treated and also stratified by race (Black and non-Black cohorts).
Results
Overall, 193 patients with nmCRPC were initiated on apalutamide. Thirty-three patients were Black (17.1%), 138 were non-Black (71.5%), and the remaining had an unknown racial background. The mean baseline PSA level for the overall, Black, and non-Black cohorts, was 7.0 ng/mL, 10.5 ng/mL, and 5.6 ng/mL, respectively. At 12 months of follow-up, PSA response was 86.0%, 93.1%, and 85.9% for the overall, Black, and non-Black cohorts, respectively. During a mean follow-up period of 333 days, 352 days, and 326 days, adherence was 93.6%, 90.1%, and 94.5% for the overall, Black and non-Black cohorts, respectively.
Conclusion
This real-world study of patients with nmCRPC initiated on apalutamide showed that PSA response was robust and consistent with clinical trial data. Moreover, both Black and non-Black patients demonstrated high treatment adherence.
Prostate cancer (PC) is the most prevalent cancer among men and it is the second most common cause of death in men in the United States (US).
,
Although 1 man in 8 will be diagnosed with PC during their lifetime,
Black men have a 70% higher incidence rate than white men.
,
,
Historically androgen deprivation therapy (ADT) has been the standard of care for patients with PC, however, over time most men become resistant to the treatment and develop castration-resistant prostate cancer (CRPC).
Within the last decade, new treatments for CRPC have been investigated for patients in the metastatic state,
,
although prior to advancing to metastatic disease, PC progresses to non-metastatic CRPC (nmCRPC). Apalutamide, a next-generation androgen signaling inhibitor, has been studied in the phase III randomized, placebo-controlled SPARTAN trial in patients with nmCRPC who were at a high risk of developing metastasis.
Based on that study, which demonstrated that metastasis-free survival and time to progression of symptoms were significantly longer for patients treated with apalutamide vs placebo, apalutamide was approved by the US Food and Drug Administration for treatment of nmCRPC in February 2018.
,
,
Given the recent approval of apalutamide, research regarding its clinical benefits in real-world practice is limited.
Additionally, the benefits of apalutamide stratified by race is unknown. Considering some studies suggesting that there are potentially different characteristics of PC and molecular responses based on race, there is an impetus to further examine this possibility.
,
To help address this knowledge gap, this study was conducted to describe the real-world prostate-specific antigen (PSA) response, treatment patterns, and adherence in men with nmCRPC, stratified by race (ie, Black vs non-Black) across urology practices in the US.
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Cancer Facts & Figures for African Americans 2016-2018.American Cancer Society, Atlanta2016
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Enzalutamide in metastatic prostate cancer before chemotherapy.N Engl J Med. 2014; 371: 424-433
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Apalutamide for the treatment of prostate cancer.Expert Rev Anticancer Ther. 2018; 18: 823-836
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FDA approves apalutamide for metastatic castration-sensitive prostate cancer [press release]. 2019.
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Prostate-specific antigen response in black and white patients treated with abiraterone acetate for metastatic castrate-resistant prostate cancer.Urol Oncol. 2017; 35: 418-424
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Medication adherence, treatment patterns, and dose reduction in patients with metastatic castration-resistant prostate cancer receiving abiraterone acetate or enzalutamide.Am Health Drug Benefits. 2017; 10: 296-303
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Adherence patterns for abiraterone acetate and concomitant prednisone use in patients with prostate cancer.J Manag Care Spec Pharm. 2014; 20: 477-484
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Article Info
Publication History
Published online: March 19, 2022
Accepted: February 15, 2022
Received: October 18, 2021
Publication stage
In Press Journal Pre-ProofFootnotes
Financial Disclosure: B. Lowentritt, G. Brown, K. Kernen, P. Sieber, and N. Shore have received financial support from Janssen Scientific Affairs, LLC. D. Pilon, G. Germain, C. Rossi, and P. Lefebvre are employees of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC. L. Ellis is an employee of Janssen Scientific Affairs, LLC. Medical writing assistance was provided by Gloria DeWalt, an employee of Analysis Group, Inc.; financial support for this assistance was provided by Janssen Scientific Affairs, LLC.
Funding Source: This work was supported by Janssen Scientific Affairs, LLC. The study sponsor was involved in the study design, composition and editing of the article.
Identification
Copyright
© 2022 The Authors. Published by Elsevier Inc.
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