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QUALITY OF LIFE AND FATIGUE DECREASE WITH THE INITIATION OF ANDROGEN RECEPTOR SIGNALING INHIBITORS FOR THE TREATMENT OF ADVANCED PROSTATE CANCER

Abstract

BACKGROUND: Quality of life (QoL) is a key patient reported outcome that can be tracked during prostate cancer (PC) treatment and in response to interventions. It is well-established testosterone suppression for localize PC adversely impacts QoL, although far less is known during advanced disease. Cross-sectional studies suggest that men with metastatic PC being treated with androgen receptor signaling inhibitors (ARSI) have lower QoL. However, the rate of change in QoL remains unclear and to what extent of the decline is due to ARSI treatment. This 12-week observational pilot study aimed to determine longitudinal changes in QoL following the initiation of ARSI treatment. Changes in fatigue, depression and anxiety were also examined. METHODS: Men with advanced PC (n=6, 70±9 y, 30.1±3.5 kg/m2 BMI) initiating ARSI completed testing at baseline and after 12 weeks of follow up. The majority (66.7%) of men were diagnosed with castration-sensitive metastatic PC. QoL was the primary outcome and was assessed using the functional assessment of cancer treatment-prostate (FACT-P). The minimal clinically important change (MCID) for FACT-P is 6-10 points. Fatigue was assessed using the Functional Assessment of Chronic Illness Therapy (FACIT-F), with a MCID of 3 points. Depression and anxiety were assessed using the Hospital Anxiety and Depression Score (HADS). Mean differences (MD) were calculated as 12-week follow-up - baseline and effect sizes are presented as Cohen’s D (d). RESULTS: QoL from baseline to 12-weeks revealed worsening change that approached significance (MD= -11.8, 95% CI -21.0, -2.5, d=1.01; p= 0.056) but exceeded the MCID. There was a non-significant decrease (worsening) for fatigue (MD=-4.0, 95% CI -8.0, 0.1, d=0.779; p=0.115) that also exceeded the MCID. Fatigue and QoL also revealed a strong correlation (r=0.732, p=0.007). There were no changes in anxiety and depression scores (MD=1.2, 95% CI -0.6, 3.0, d=0.523; p=0.256). CONCLUSIONS: In support of cross-sectional studies, these preliminary results suggest that 12 weeks of ARSI lead to clinically important decreases with large effect sizes in both QoL and fatigue during advanced PC treatment. Interventions that can minimize fatigue may lead to improvements in QoL. Longer follow up studies (i.e., 24 weeks) and larger sample sizes are required to confirm these initial findings.

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