Men were randomly assigned to ADT+ D (six cycles) or to ADT alone. QOL was assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P), FACT-Taxane, Functional Assessment of Chronic Illness Therapy-Fatigue, and the Brief Pain Inventory at baseline and at 3, 6, 9, and 12 months. The Wilcoxon signed rank test was used to examine changes over time. Mixed-effect models compared the QOL between arms at each time point.
Seven hundred ninety men were randomly assigned (ADT+D [n = 397] and ADT[ n = 393]) and completed FACT-P (90% at baseline, 86% at 3 months, 83% at 6 months, 78% at 9 months, and 77% at 12 months). ADT+D patients reported a statistically significant decline in FACT-P at 3 months (P < .001) but FACT-P did not differ significantly between baseline and 12 months (P = .38). ADT+D FACT-P scores were significantly lower at 3 months (P = .02) but significantly higher at 12 months (P = .04) when compared with ADT FACT-P scores. Differences did not exceed the minimal clinically important difference at any time point. ADT+D patients reported significantly lower Functional Assessment of Chronic Illness Therapy-Fatigue scores at 3 months than did ADT patients (P < .001). Over time, both arms reported significantly poorer FACT-Taxane scores (P < .001) when compared with baseline. Brief Pain Inventory scores were similar between arms.
Although ADT+D was associated with statistically worse QOL at 3 months, QOL was better at 12 months for ADT+D patients than for ADT patients. Both arms reported a similar minimally changed QOL over time, suggesting that ADT+D is not associated with a greater long-term negative impact on QOL.
DOI: 10.1200/JCO.2017.75.3335 Journal of Clinical Oncology - published online before print March 9, 2018
Alicia K. Morgans, Yu-Hui Chen, Christopher J. Sweeney, David F. Jarrard, Elizabeth R. Plimack, Benjamin A. Gartrell, Michael A. Carducci, Maha Hussain, Jorge A. Garcia, David Cella, Robert S. DiPaola, and Linda J. Patrick-Miller
Alicia K. Morgans, Maha Hussain, and David Cella, Northwestern University Feinberg School of Medicine, Chicago, IL; Yu-Hui Chen and Christopher J. Sweeney, Dana Farber Cancer Institute, Boston, MA; David F. Jarrard, University of Wisconsin Hospital and Clinics, Madison, WI; Elizabeth R. Plimack, Fox Chase Cancer Center, Philadelphia, PA; Elizabeth R. Plimack and Benjamin A. Gartrell, Montefiore Medical Center, Bronx, NY; Michael A. Carducci, Johns Hopkins University, Baltimore, MD; Jorge A. Garcia, Cleveland Clinic, Cleveland, OH; Robert S. DiPaola, University of Kentucky College of Medicine, Lexington, KY; and Linda J. Patrick-Miller, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ.
Quality of life (QOL) analysis from CHAARTED: Chemohormonal androgen ablation randomized trial in prostate cancer (E3805)