The American Society of Clinical Oncologists (ASCO) has started their annual conference in Chicago. I am anticipating a number of interesting and important abstracts that will be directly relevant to those of us with advanced prostate cancer.

Among the first release of information comes an announcement from Medivation Inc. and Astellas Pharma Inc. who have announced quality of life (QOL) data for their enzalutamide (MDV3100) AFFIRM Trial. Health Related QOL was a secondary endpoint in the study.

These new data (Abstract #4519) was presented by Johann de Bono, MBChB, FRCP, MSc, PhD, of The Institute of Cancer Research and Royal Marsden Hospital, London, and co-principal investigator of the AFFIRM trial.

Professor de Bono reported that treatment with enzalutamide resulted in reported significantly better response rate in health-related QOL as compared to placebo (43.2 percent vs. 18.3 percent; p < 0.0001), as measured by the Functional Assessment of Cancer Therapy - Prostate (FACT-P) questionnaire. The measure, FACT-P is a validated instrument comprising 27 core items to assess patient function (e.g., level of energy, ability to cope with illness, level of pain, ability to work, and amount of support from family/friends). Patients were defined as having a health-related QOL response using the standard definition of 10 point or greater improvement in their overall score. In the AFFIRM trial, the median time to occurrence of the first skeletal-related event in enzalutamide treated patients was 16.7 months as compared to placebo (13.6 months, p=0.0001, HR=0.688). A skeletal-related event was defined as a pathologic bone fracture, change of anti-cancer therapy to treat bone pain, spinal cord compression, or surgery or radiation therapy to bone. Professor de Bono reported that, "In this enzalutamide demonstrated an improvement in quality of life measures and time to first skeletal-related event.” He went on to say that "The success of this trial could give doctors a new therapy option for men with advanced prostate cancer." Enzalutamide is an oral, once-daily investigational agent that is an androgen receptor signaling inhibitor. Enzalutamide inhibits androgen receptor signaling in three distinct ways: it inhibits 1) testosterone binding to androgen receptors; 2) nuclear translocation of androgen receptors; and 3) DNA binding and activation by androgen receptors. Joel T Nowak, M.A., M.S.W.