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Adherence Measures for Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Abiraterone Acetate plus Prednisone: Results of a Prospective, Cluster-Randomized Trial.

ABSTRACT: 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.

SUBMITTER: Suttmann H

PROVIDER: S-EPMC7564106 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Adherence Measures for Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Abiraterone Acetate plus Prednisone: Results of a Prospective, Cluster-Randomized Trial.

Suttmann Henrik H Gleissner Jochen J Huebner Andreas A Mathes Tim T Baurecht Werner W Krützfeldt Katrin K Sweiti Hussein H Feyerabend Susan S

Cancers 20200908 9

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-bas ...[more]

PMID: 32911627

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Project description:IntroductionProstate cancer (PC) is the second leading cause of cancer death among US men and accounts for considerable healthcare expenditures. We evaluated economic outcomes in men with chemotherapy-naïve metastatic castration-resistant PC (mCRPC) treated with enzalutamide or abiraterone acetate plus prednisone (abiraterone).MethodsWe performed a retrospective analysis on 3174 men (18 years or older) utilizing the Veterans Health Administration (VHA) database from 1 April 2014 to 31 March 2018. Men with mCRPC were included if they had at least one pharmacy claim for enzalutamide or abiraterone (first claim date = index date) following surgical or medical castration, had no chemotherapy treatment within 12 months prior to the index date, and had continuous VHA enrollment for at least 12 months pre- and post-index date. Men were followed until death, disenrollment, or end of study and were 1:1 propensity score matched (PSM). All-cause and PC-related resource use and costs per patient per month (PPPM) in the 12 months post index were compared between matched cohorts.ResultsWe identified 1229 men with mCRPC prescribed enzalutamide and 1945 prescribed abiraterone with mean ages of 74 and 73 years, respectively. After PSM, each cohort had 1160 patients. The enzalutamide cohort had fewer all-cause (2.51 vs 2.86; p < 0.0001) and PC-related outpatient visits (0.86 vs 1.03; p < 0.0001), with corresponding lower all-cause ($2588 vs $3115; p < 0.0001) and PC-related ($1356 vs $1775; p < 0.0001) PPPM outpatient costs compared with the abiraterone cohort. All-cause total costs (medical and pharmacy) PPPM ($8085 vs $9092; p = 0.0002) and PC-related total costs PPPM ($6321 vs $7280; p < 0.0001) were significantly lower in the enzalutamide cohort compared with the abiraterone cohort.ConclusionsEnzalutamide-treated men with chemotherapy-naïve mCRPC had significantly lower resource utilization and healthcare costs compared with abiraterone-treated men.

Project description:BackgroundAbiraterone acetate plus prednisone with androgen deprivation therapy is a standard treatment option for patients with high-risk metastatic castration-sensitive prostate cancer (mCSPC). However, no data are available on the optimal subsequent treatment option in patients treated with abiraterone acetate plus prednisone for high-risk mCSPC.ObjectiveWe aimed to compare the clinical outcomes of subsequent therapy after discontinuation of abiraterone acetate plus prednisone in patients with high-risk mCSPC.MethodsOverall survival and time to treatment failure from initiation of subsequent therapies were estimated by applying a marginal structural Cox proportional hazards model using inverse probability of treatment weighting with a change of time scale to time on treatment.ResultsA total of 217 patients received subsequent therapies: 127 received chemotherapy, 49 received non-chemotherapy, and 41 received other treatments. For overall survival, when adjusted with the marginal structural Cox proportional hazards model using inverse probability of treatment weighting, the hazard ratio was 1.212 (95% confidence interval [CI] 0.742-1.979) for chemotherapy versus non-chemotherapy, 0.534 (95% CI 0.267-1.066) for non-chemotherapy versus other treatments, and 0.635 (95% CI 0.317-1.271) for chemotherapy versus other treatments. For time to treatment failure, the hazard ratio was 1.287 (95% CI 0.832-1.989) for chemotherapy versus non-chemotherapy, 0.785 (95% CI 0.486-1.269) for non-chemotherapy versus other treatments, and 0.898 (95% CI 0.612-1.318) for chemotherapy versus other treatments.ConclusionsNo differences were observed between the treatment effects of chemotherapy and non-chemotherapy in patients with high-risk mCSPC after abiraterone acetate plus prednisone. These findings suggest that life-extending subsequent therapy after abiraterone acetate plus prednisone for mCSPC should be chosen at the physician's discretion and patient's preference.Clinical trial registrationClinicalTrials.gov, NCT01715285, registered 26 October, 2012.

Dataset Information

Adherence Measures for Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Abiraterone Acetate plus Prednisone: Results of a Prospective, Cluster-Randomized Trial.

Publications

Adherence Measures for Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Abiraterone Acetate plus Prednisone: Results of a Prospective, Cluster-Randomized Trial.

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