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. 2016 May 17:5:653.
doi: 10.1186/s40064-016-2280-8. eCollection 2016.

The AVOCAT study: Bicalutamide monotherapy versus combined bicalutamide plus dutasteride therapy for patients with locally advanced or metastatic carcinoma of the prostate-a long-term follow-up comparison and quality of life analysis

Siebren Dijkstra  1 , Wim P J Witjes  1 , Erik P M Roos  2 , Peter L M Vijverberg  3 , Arno D H Geboers  4 , Jos L Bruins  5 , Geert A H J Smits  6 , Henk Vergunst  7 , Peter F A Mulders  1
Affiliations

The AVOCAT study: Bicalutamide monotherapy versus combined bicalutamide plus dutasteride therapy for patients with locally advanced or metastatic carcinoma of the prostate-a long-term follow-up comparison and quality of life analysis

Siebren Dijkstra et al. Springerplus. .

Abstract

Purpose: Compare the efficacy and tolerability of dutasteride in combination with bicalutamide to bicalutamide monotherapy in the treatment of locally advanced and metastatic prostate cancer (PCa).

Methods: One-hundred-fifty PCa patients with locally advanced or metastatic disease were prospectively enrolled and randomly assigned to receive either bicalutamide monotherapy 150 mg once daily (79 patients) or bicalutamide 150 mg plus dutasteride 0.5 mg once daily (71 patients). Treatment response was assessed by serum PSA level measurement, and standard procedures for diagnosis of clinical progression were used during follow-up. Patient-reported quality of life (QoL) was assessed using validated questionnaires (EORTC QLQ-C30 and QLQ-PR25).

Results: At 3 years follow-up, PSA progression was found in 52 patients [65.8 %; 95 % confidence interval (CI) 55.4-76.3] in the monotherapy group compared to 38 patients (53.5 %; 95 % CI 41.9-65.1) in the combined therapy group (p = 0.134). At the time of analysis 37 men (46.8 %; 95 % CI 35.8-57.8) in the monotherapy group had died versus 30 men (42.3 %; 95 % CI 30.8-53.7) in the combined therapy group. Median survival time was 5.4 and 5.8 years, respectively (p = 0.694). There was no statistically significant difference in the presentation frequency of adverse events between groups (p = 0.683). QoL was good and comparable between the two groups.

Conclusions: Both therapies were well tolerated with a good QoL. However, despite a trend toward higher efficacy of the combined therapy, progression-free survival and overall survival was not significantly different between the groups. Further research on this therapy should be performed.

Keywords: 5α-Reductase inhibitor; Bicalutamide; Dutasteride; Overall survival; PSA progression; Prostate cancer.

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Figures

Fig. 1
Fig. 1
Kaplan-Meier estimates of overall survival (a) and biochemical progression-free survival (b) in the bicalutamide group and the bicalutamide plus dutasteride group
Fig. 2
Fig. 2
Quality of life outcome in both groups on five functional scales (physical, emotional, social, sexual functioning and general quality of life) and six symptom scales (nausea, pain, urinary, bowel and treatment related symptoms) at screening, 3, 6 and 12 months of treatment. A high score for general quality of life or a functional scale reflects a high QoL or a high level of functioning, whereas a high score for a symptoms scale implies a high level of symptoms
See this image and copyright information in PMC

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