Adherence enhancing program for patients with metastatic, castration-resistant prostate carcinoma treated with abiraterone acetate plus prednisone: A cluster randomized trial

Autor: Jochen Gleissner, Susan Feyerabend, Andreas Hübner, Katrin Krützfeldt, Tim Mathes, Henrik Suttmann, Hussein Sweiti, Werner Baurecht
Rok vydání: 2019
Předmět:
Zdroj: Journal of Clinical Oncology. 37:e16520-e16520
ISSN: 1527-7755
0732-183X
DOI: 10.1200/jco.2019.37.15_suppl.e16520
Popis: e16520 Background: Abiraterone acetate plus prednisone (AA+P) is an effective treatment for patients (pts) with metastatic, castration-resistant prostate carcinoma (mCRPC). Adherence is an important factor for the success of AA+P treatment. Research has shown that adherence in pts taking oral anti-cancer agents is often lower than required. The objective of this cluster randomized trial (CRT) was to assess the influence of an adherence enhancing program (AP) for AA+P in pts with mCRPC. Methods: This was a pragmatic parallel CRT of pts with mCRPC performed under real-world conditions. The study sites were randomly assigned to AP or no-AP (1:1) using a computer generated random schedule. The AP consisted of an educational video and reminder telephone calls. The primary endpoint was “rate of therapy discontinuation after 3 months for reasons other than disease progression or start of a new cancer therapy” (discontinuation). A secondary outcome was medication adherence (Morisky Scale; MMAS-4). Results: In the final intention-to-treat analysis, 47 sites comprising 360 men were allocated to AP and 40 sites comprising 315 men to no-AP. Baseline characteristics and results for each group are presented in the table. The odds ratio (OR) for discontinuation, adjusted for baseline adherence was 1.16 (95%CI: 0.63 to 2.11) and 1.21 (95%CI: 0.74 to 1.97) for 3 and 6 months, respectively. The OR for medium/low medication adherence, adjusted for baseline adherence, was 0.56 (95%CI: 0.26 to 1.21) and 0.84 (95%CI: 0.36 to 1.97) for 3 and 6 months, respectively. Conclusions: The rate of treatment discontinuation in the first 3 and 6 months was low and similar in both study arms. Medication adherence at baseline was generally high, but with some difference between both arms. The adjusted OR for medication adherence at 3 and 6 months revealed a trend towards a slower drop in medication adherence for the AP arm, compared to the no-AP arm, but with a wide confidence interval. Table Clinical trial information: 284. [Table: see text]
Databáze: OpenAIRE
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