Quality of Life During Treatment With Chemohormonal Therapy: Analysis of E3805 Chemohormonal Androgen Ablation Randomized Trial in Prostate Cancer
Chemohormonal therapy with docetaxel and androgen deprivation therapy (ADT+D) for metastatic hormone-sensitive prostate cancer improves overall survival as compared with androgen deprivation therapy (ADT) alone. We compared the quality of life (QOL) between patients with metastatic hormone-sensitive prostate cancer who were treated with ADT+D and those who were treated with ADT alone.
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.
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Supported by the National Cancer Institute of the National Institutes of Health under the following award numbers: CA180820, CA180794, CA180888, CA180847, CA180867, CA180799, [CA189859], CA180802, and CA180853. Also sponsored by Sanofi via a grant to Eastern Cooperative Oncology Group-American College of Radiology Imaging Network.
Clinical trial information: NCT00309985
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Morgans, Alicia K.; Chen, Yu-Hui; Sweeney, Christopher J.; Jarrard, David F.; Plimack, Elizabeth R.; Gartrell, Benjamin A.; Carducci, Michael A.; Hussain, Maha; Garcia, Jorge A.; Cella, David; DiPaola, Robert S.; and Patrick-Miller, Linda J., "Quality of Life During Treatment With Chemohormonal Therapy: Analysis of E3805 Chemohormonal Androgen Ablation Randomized Trial in Prostate Cancer" (2018). Internal Medicine Faculty Publications. 138.
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Published in Journal of Clinical Oncology, v. 36, no. 11, p. 1088-1095.
© 2018 by American Society of Clinical Oncology
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