Objective: Progression of hormone-refractory prostate cancer (HRPC) is associated with skeletal complications and bone pain, which contribute to deterioration in quality of life (QOL). The effects of new HRPC therapies on patients' QOL need to be studied. Patient-based assessments that help quantify the risk-benefit profile of HRPC therapies are warranted. This review summarizes the known QOL literature and estimates the potential effect of atrasentan, a novel, selective endothelin A receptor antagonist (SERA), on the QOL of HRPC patients.
Methods: Published studies were identified through a structured, detailed literature review. Clinical studies that report QOL data were reviewed, along with recent QOL data from atrasentan studies.
Results: HRPC studies have begun to use QOL assessments as primary endpoints, but different assessments and therapies are not comparable. Very few data integrate QOL with clinical endpoints. Atrasentan clinical trials demonstrated a statistically significant difference in the prostate cancer-specific QOL in favor of atrasentan (p=.032) and an increased quality-adjusted time to progression in men with HRPC.
Conclusions: Atrasentan provides QOL benefits relevant to HRPC. The quality-adjusted analyses applied in the atrasentan studies have begun to lay the foundation for interpreting clinical endpoints in conjunction with QOL. These analyses will facilitate better QOL comparisons within studies and across trials. Further evaluation of atrasentan in HRPC is warranted.