Background: AA+P has been proven to improve QoL in men with mCRPC in randomized controlled trials (RCTs). Real-world data on factors that may influence QoL in this patient population is limited. An objective of this study was to assess factors that may influence QoL in men with mCRPC treated with AA+P.
Methods: This was a prospective cohort study performed under real-world conditions in Germany. We performed a multivariate analysis of covariance to assess the influence of several baseline characteristics and adherence measures on change from baseline in QoL at 3 and 6 months after initiating treatment. QoL was measured with FACT-P (score range 0 to 156, higher values indicate higher QoL). The analyzed baseline characteristics were age, education, comorbidity, co-medications, previous chemotherapy and adherence.
Results: The change from baseline analysis for patients who completed the FACT-P questionnaire showed a slight increase in QoL after 3 months (mean change from baseline [MCB] = 3.5) as well as 6 months (MCB = 3.6). At 3 months, MCB in QoL was higher in patients without comorbidities (adjusted mean difference of MCB 6.60, standard deviation 3.66, p=0.003). At 6 months, MCB in QoL was higher for patients who had not received prior chemotherapy (adjusted mean difference of MCB 8.20, standard deviation 3.73, p=0.030). For the remaining factors, statistical uncertainty was high, and the effect was weak.
Table 1 shows the baseline characteristics.
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Baseline characteristics
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Age (mean ± standard deviation)
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74.7 (7.7)
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Living alone
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89 (13%)
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Education (high)
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159 (68%)
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Alcohol consumption (yes)
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172 (25.5%)
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Post chemotherapy (yes)
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203 (30%)
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Morsiky Adherence Scale (high)
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523 (77.5%)
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Charlson Score (0)
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243 (36.0%)
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Conclusion: Our real-world study indicates that in the first six months after starting treatment, QoL is stable in men with mCRPC treated with AA+P. This finding is concordant with data from RCTs, which showed that treatment with AA+P significantly delayed HRQoL deterioration. Furthermore, no prior chemotherapy and the absence of comorbidities appear to have a positive impact on the stability of QoL.
