PURPOSE: We have used responses to questionnaires included in the CS21 degarelix trial and published mapping algorithms to address the paucity of evidence for health-related quality of life (HRQL) for patients with advanced hormone-dependent prostate cancer treated with degarelix.
MATERIALS AND METHODS: HRQL of 610 patients enrolled in the CS21 trial was measured using the Short-form 12-item questionnaire (SF-12) and the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30). Based on the responses to these questionnaires, we estimated patient utility using four published mapping algorithms. Utility was tested for relationships with aspects of symptom and side-effect burden that may be affected by treatment with degarelix: prostate-specific antigen (PSA) progression and adverse events.
RESULTS: The average utility for patients not experiencing PSA progression or an adverse event was 0.742, similar to previously published utilities for non-progressed prostate cancer states. PSA progression was associated with a utility decrement ranging between 0.062 and 0.134, depending on the mapping algorithm used. Of the adverse events considered in the analysis, musculoskeletal events were associated with the greatest effects on patient utility, with a decrement ranging between 0.029 and 0.086. The four mapping algorithms used generated similar utility estimates, although values derived from the SF-12 were consistently lower than those derived from the EORTC QLQ-C30.
CONCLUSIONS: PSA progression status and the incidence of treatment- and disease-related adverse events result in significant decrements to patient HRQL. By slowing PSA progression, degarelix may improve patient utility and the HRQL burden.
Lee D, Nielsen SK, van Keep M, Andersson F, Greene D. Are you the author?
BresMed, North Church House, 84 Queen Street, Sheffield, S1 2DW, UK; BresMed, Het Nieuwe Kantoor, Weg der Verenigde Naties 1, 3527KT Utrecht, The Netherlands; Ferring International PharmaScience Center, Kay Fiskers Plads 11, DK-2300 Copenhagen S, Denmark; Center for Medical Technology Assessment (CMT), Linköping University, SE-581 83 Linköping, Sweden; Sunderland Royal Hospital, Kayll Road, Sunderland, SR4 7TP, UK.
Reference: J Urol. 2014 Sep 25. pii: S0022-5347(14)04572-8.