J E Fowler1. 1. Division of Urology, University of Mississippi School of Medicine, Jackson, Mississippi, USA.
Abstract
OBJECTIVES: To assess patient-reported general satisfaction, effect on daily activities, and effect on health-related quality of life of a 12-month leuprolide implant for prostate cancer. METHODS: A total of 80 men with prostate cancer participated in an open-label Phase III study of the Viadur leuprolide implant. One implant was inserted in each patient at enrollment and was removed after 52 weeks. At 24 and 52 weeks after implantation, patients were asked to complete a questionnaire about their experience with the implant, and at 0, 12, 24, 36, and 52 weeks after implantation, the patients were asked to complete the Medical Outcome Study Short Form-36 health-related quality-of-life instrument. RESULTS: The surveys about the patients' experience with the implant were completed by 70 subjects, and two or more SF-36 questionnaires were completed by 72 patients. At weeks 24 and 52 after implantation, greater than 90% of patients were extremely satisfied or satisfied with the overall treatment, found the implant convenient, forgot about the implant most of the time or were occasionally aware of the implant, and found the implant very comfortable or somewhat comfortable. No meaningful change was found in the summary scores of the mental and physical aspects of the SF-36 assessments during treatment. Of 73 men who were eligible for reimplantation after the 12-month study period, 70 (96%) elected to undergo reimplantation. CONCLUSIONS: In this study, patients found the Viadur 12-month leuprolide implant convenient, and the implant did not affect their health-related quality of life.
OBJECTIVES: To assess patient-reported general satisfaction, effect on daily activities, and effect on health-related quality of life of a 12-month leuprolide implant for prostate cancer. METHODS: A total of 80 men with prostate cancer participated in an open-label Phase III study of the Viadur leuprolide implant. One implant was inserted in each patient at enrollment and was removed after 52 weeks. At 24 and 52 weeks after implantation, patients were asked to complete a questionnaire about their experience with the implant, and at 0, 12, 24, 36, and 52 weeks after implantation, the patients were asked to complete the Medical Outcome Study Short Form-36 health-related quality-of-life instrument. RESULTS: The surveys about the patients' experience with the implant were completed by 70 subjects, and two or more SF-36 questionnaires were completed by 72 patients. At weeks 24 and 52 after implantation, greater than 90% of patients were extremely satisfied or satisfied with the overall treatment, found the implant convenient, forgot about the implant most of the time or were occasionally aware of the implant, and found the implant very comfortable or somewhat comfortable. No meaningful change was found in the summary scores of the mental and physical aspects of the SF-36 assessments during treatment. Of 73 men who were eligible for reimplantation after the 12-month study period, 70 (96%) elected to undergo reimplantation. CONCLUSIONS: In this study, patients found the Viadur 12-month leuprolide implant convenient, and the implant did not affect their health-related quality of life.