Linda Patrick-Miller, Ph.D, presented the quality of life analysis from the CHAARTED trial (Chemohormonal androgen ablation randomized trial in prostate cancer (E3805)) including men with metastatic hormone sensitive prostate cancer. A secondary endpoint of the study was to determine whether an increase in disease control with androgen deprivation therapy (ADT) plus docetaxel was associated with a change in quality of life. The study included patient reported outcomes on overall quality of life, disease related symptoms, and treatment related symptoms.
The CHAARTED trial was a prospective, randomized study that included men with hormone sensitive metastatic prostate cancer who had received <120 days of ADT prior to enrollment. Men were randomized to receive ADT alone or ADT plus docetaxel. For the quality of life analysis, these populations completed patient reported outcomes surveys at baseline, 3, 6, and 12 months. The primary endpoint in this analysis was change in overall quality of life from baseline to 12 weeks, determined using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) measure of general and disease-specific quality of life. A secondary analysis was a comparison between treatment arms at each time point. Additional secondary analyses included scores on FACT-taxane and FACIT-F(atigue) measures, as well as Brief Pain Inventory (BPI) scores. All analyses were based on intention to treat, and mixed effects models were used.
As was previously reported, 790 men enrolled in the study, and the two treatment arms were well balanced. Response to the quality of life survey measures was similar between arms and high, with 90% response rate at 3 months and 69% response rate at 12 months. At the 12 week timepoint, quality of life in the ADT plus docetaxel group was significantly poorer than in the ADT alone arm (estimated difference between groups -3.06, p=0.02). By 6 months, quality of life was equivalent between groups, and by 12 months, quality of life was significantly improved in the ADT plus docetaxel group as compared to ADT alone (estimated difference between groups 2.85, p=0.04). Secondary analyses of FACIT-F similarly demonstrated poorer scores for ADT plus docetaxel at 12 weeks compared with ADT alone, but similar scores at 12 months. FACT-taxane scores were lower at all time points for the ADT plus docetaxel arm than the ADT alone arm. Pain was equivalent between groups at all time points, and emotional well-being was superior at all time points for the ADT plus docetaxel group.
Ultimately the authors conclude that there is a temporary decrease in overall quality of life in patients treated with ADT plus docetaxel, this resolved by the 6 month time point. Additionally, although patients treated with ADT plus docetaxel had a poorer overall quality of life at 12 weeks, they reported a significantly better quality of life by 12 months. Given this, patients can be counseled that the decline in quality of life that occurs in the first few months of treatment reverses, and patients receiving docetaxel may experience improved quality of life by 12 months as compared to men receiving ADT alone.
Written by: Alicia Morgans, MD.
Alicia K. Morgans: Biography
Dr. Morgans is an Assistant Professor of Medicine in the Division of Hematology/Oncology. She specializes in the treatment of genitourinary malignancies, including cancers of the prostate, bladder, testis (germ cell) and penis. She received a bachelor's degree with honors in biology before going to medical school at the University of Pennsylvania School of Medicine. She then went on to complete a residency in internal medicine at the Hospital of the University of Pennsylvania in Philadelphia. Dr. Morgans completed a fellowship in Hematology/Oncology at Harvard's Dana Farber Cancer Institute and Massachusetts General Hospital Cancer Center in Boston, before moving to Nashville as an Assistant Professor in Medicine.
Dr. Morgans is a specialist in genitourinary malignancies, with special interest in advanced prostate cancer. Her research investigates the side effects of cancer treatment (including the prevention, diagnosis of, and treatment of these effects) and treatment decision-making among men with advanced prostate cancer. She also has an interest in supporting clinical research of novel treatments for genitourinary malignancies. Dr. Morgans is a member of the American Society of Clinical Oncology and the Eastern Cooperative Oncology Group.
M.D., University of Pennsylvania School of Medicine, 2006
Residency, Internal Medicine, Hospital of the University of Pennsylvania, 2009
Fellowship, Dana Farber/Harvard Cancer Center/Massachusetts General Hospital, 2012