Quality of Life During Treatment With Chemohormonal Therapy: Analysis of E3805 Chemohormonal Androgen Ablation Randomized Trial in Prostate Cancer

Abstract

Purpose 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. Methods 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. Results 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. Conclusion 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.

Trial registration: ClinicalTrials.gov NCT00309985.

Figures

Fig 1.

Comparison of Functional Assessment of Cancer Therapy-Prostate (FACT-P) scores over time between the docetaxel and androgen deprivation therapy (ADT+D) and androgen deprivation therapy (ADT) arms, including (A) FACT-P scores for the entire population; (B) FACT-P scores for high-volume patients; and (C) FACT-P scores for low-volume patients. Clinically meaningful change on the FACT-P total score was considered a change of 6 to10 points.

Fig 2.

Treatment-associated and disease-associated symptoms over time between the docetaxel and androgen deprivation therapy (ADT+D) and androgen deprivation therapy (ADT) arms, including(A) the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane) subscale; (B) the FACIT-Fatigue subscale; (C) the Brief Pain Inventory (BPI) pain subscale; and (D) the BPI interference subscale.

Fig A1.

CONSORT diagram. ADT+D, docetaxel and androgen deprivation therapy; ADT, androgen deprivation therapy.