Adherence Measures for Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Abiraterone Acetate plus Prednisone: Results of a Prospective, Cluster-Randomized Trial
Residual androgen production causes tumor progression in metastatic, castration-resistant prostate cancer (mCRPC) patients. Abiraterone acetate (AA), a prodrug of abiraterone, is an oral CYP-17 inhibitor that blocks androgen production. It was hypothesized that adherence-enhancing measures (AEM) mig...
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| Format: | Article |
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MDPI AG
2020-09-01
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| Series: | Cancers |
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| Online Access: | https://www.mdpi.com/2072-6694/12/9/2550 |
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| author | Henrik Suttmann Jochen Gleissner Andreas Huebner Tim Mathes Werner Baurecht Katrin Krützfeldt Hussein Sweiti Susan Feyerabend |
| author_facet | Henrik Suttmann Jochen Gleissner Andreas Huebner Tim Mathes Werner Baurecht Katrin Krützfeldt Hussein Sweiti Susan Feyerabend |
| author_sort | Henrik Suttmann |
| collection | DOAJ |
| description | Residual androgen production causes tumor progression in metastatic, castration-resistant prostate cancer (mCRPC) patients. Abiraterone acetate (AA), a prodrug of abiraterone, is an oral CYP-17 inhibitor that blocks androgen production. It was hypothesized that adherence-enhancing measures (AEM) might be beneficial for mCRPC patients receiving abiraterone acetate plus prednisone (AA + P). This multicenter, prospective, 2-arm trial allocated mCRPC patients who were progressive after docetaxel-based chemotherapy or asymptomatic/mildly symptomatic after failure of an androgen deprivation therapy to Arm A (with AEM) or Arm B (without AEM) by center-based cluster-randomization. The primary objective was to assess the influence of AEM on discontinuation rates and medication adherence in mCRPC patients treated with AA + P. A total of 360 patients were allocated to Arm A, and 315 patients to Arm B. At month 3, the rate of treatment discontinuation, not due to disease progression or the start of new cancer therapy, was low in both arms (A: 9.0% vs. B: 7.3%, OR = 1.230). Few patients had a medium/low Morisky Medication Adherence Scale (MMAS-4) score (A: 6.4% vs. B: 9.1%, OR = 0.685). The results obtained did not suggest any clear adherence difference between Arm A and Arm B. In patients with mCRPC taking AA + P medication, adherence seemed to be generally high. |
| first_indexed | 2024-03-10T16:29:44Z |
| format | Article |
| id | doaj.art-7cd9d8094a814db4b8fca49d11af364f |
| institution | Directory Open Access Journal |
| issn | 2072-6694 |
| language | English |
| last_indexed | 2024-03-10T16:29:44Z |
| publishDate | 2020-09-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Cancers |
| spelling | doaj.art-7cd9d8094a814db4b8fca49d11af364f2023-11-20T12:55:15ZengMDPI AGCancers2072-66942020-09-01129255010.3390/cancers12092550Adherence Measures for Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Abiraterone Acetate plus Prednisone: Results of a Prospective, Cluster-Randomized TrialHenrik Suttmann0Jochen Gleissner1Andreas Huebner2Tim Mathes3Werner Baurecht4Katrin Krützfeldt5Hussein Sweiti6Susan Feyerabend7Private Practice, Urologikum Hamburg, 22399 Hamburg, GermanyPrivate Practice, MVZ-DGU-Die GesundheitsUnion GmbH, 42103 Wuppertal, GermanyPrivate Practice, Center for Oncology and Urology, 18107 Rostock, GermanyInstitut für Forschung in der Operativen Medizin, University Witten/Herdecke, 51109 Cologne, GermanyBiometrics, Acromion GmbH, 50226 Frechen, GermanyMedical Affairs, Janssen-Cilag GmbH, 41470 Neuss, GermanyClinical Development, Janssen Research and Development LLC, Pennsylvania, PA 19477, USAPrivate Practice Studienpraxis Urologie, 72622 Nürtingen, GermanyResidual androgen production causes tumor progression in metastatic, castration-resistant prostate cancer (mCRPC) patients. Abiraterone acetate (AA), a prodrug of abiraterone, is an oral CYP-17 inhibitor that blocks androgen production. It was hypothesized that adherence-enhancing measures (AEM) might be beneficial for mCRPC patients receiving abiraterone acetate plus prednisone (AA + P). This multicenter, prospective, 2-arm trial allocated mCRPC patients who were progressive after docetaxel-based chemotherapy or asymptomatic/mildly symptomatic after failure of an androgen deprivation therapy to Arm A (with AEM) or Arm B (without AEM) by center-based cluster-randomization. The primary objective was to assess the influence of AEM on discontinuation rates and medication adherence in mCRPC patients treated with AA + P. A total of 360 patients were allocated to Arm A, and 315 patients to Arm B. At month 3, the rate of treatment discontinuation, not due to disease progression or the start of new cancer therapy, was low in both arms (A: 9.0% vs. B: 7.3%, OR = 1.230). Few patients had a medium/low Morisky Medication Adherence Scale (MMAS-4) score (A: 6.4% vs. B: 9.1%, OR = 0.685). The results obtained did not suggest any clear adherence difference between Arm A and Arm B. In patients with mCRPC taking AA + P medication, adherence seemed to be generally high.https://www.mdpi.com/2072-6694/12/9/2550metastatic castration-resistant prostate cancerabiraterone acetateadherencediscontinuationMMAS-4quality of life |
| spellingShingle | Henrik Suttmann Jochen Gleissner Andreas Huebner Tim Mathes Werner Baurecht Katrin Krützfeldt Hussein Sweiti Susan Feyerabend Adherence Measures for Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Abiraterone Acetate plus Prednisone: Results of a Prospective, Cluster-Randomized Trial Cancers metastatic castration-resistant prostate cancer abiraterone acetate adherence discontinuation MMAS-4 quality of life |
| title | Adherence Measures for Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Abiraterone Acetate plus Prednisone: Results of a Prospective, Cluster-Randomized Trial |
| title_full | Adherence Measures for Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Abiraterone Acetate plus Prednisone: Results of a Prospective, Cluster-Randomized Trial |
| title_fullStr | Adherence Measures for Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Abiraterone Acetate plus Prednisone: Results of a Prospective, Cluster-Randomized Trial |
| title_full_unstemmed | Adherence Measures for Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Abiraterone Acetate plus Prednisone: Results of a Prospective, Cluster-Randomized Trial |
| title_short | Adherence Measures for Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Abiraterone Acetate plus Prednisone: Results of a Prospective, Cluster-Randomized Trial |
| title_sort | adherence measures for patients with metastatic castration resistant prostate cancer treated with abiraterone acetate plus prednisone results of a prospective cluster randomized trial |
| topic | metastatic castration-resistant prostate cancer abiraterone acetate adherence discontinuation MMAS-4 quality of life |
| url | https://www.mdpi.com/2072-6694/12/9/2550 |
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