Patients may place a higher importance on quality of life than length of life. Treatment decisions require understanding of individual patient values and preferences.
—Ethan Basch, MD, MSc, and colleagues
The ASCO Clinical Practice Guidelines Committee and the Cancer Care Ontario (CCO) program in evidence-based care have released a clinical practice guideline on systemic therapy in men with metastatic castration-resistant prostate cancer. The guideline was published in the Journal of Clinical Oncology.1
The guideline is the result of efforts of a multidisciplinary ASCO/CCO expert panel, which developed evidence-based recommendations through a systematic review of the literature guided by the question: “Which systemic therapies improve outcomes in men with metastatic [castration-resistant prostate cancer]?” The evidentiary basis of the guideline consists of 26 randomized controlled trials identified through a 2012 CCO systematic review2 and an updated literature search through June 2014.
The panel was chaired by Ethan Basch, MD, MSc, Director of the Cancer Outcomes Research Program and Associate Professor of Medicine and Public Health at the Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill.
In brief, the guideline recommends that androgen deprivation be continued indefinitely. Systemic therapy that should be offered includes abiraterone acetate (Zytiga)/prednisone, enzalutamide (Xtandi), and radium-223 (Xofigo) for men with predominantly bone metastases, with docetaxel/prednisone also being offered accompanied by discussion of toxicity risk. Sipuleucel-T (Provenge) may be offered to asymptomatic/minimally symptomatic men, with an understanding that quality-of-life outcomes data are not available. Cabazitaxel (Jevtana) may be offered to patients experiencing disease progression on docetaxel, with an understanding that quality-of-life benefits are not shown and high levels of toxicities have been reported.
Mitoxantrone can be offered accompanied by discussion of limited clinical benefit and toxicity risk, and ketoconazole or antiandrogens (eg, bicalutamide, flutamide, and nilutamide [Nilandron]) may be offered, accompanied by discussion of unknown clinical benefit amidst known toxicities. Bevacizumab (Avastin), estramustine (Emcyt), and sunitinib (Sutent) should not be used.
There is insufficient evidence to identify optimal sequences or combinations of therapies. Palliative care should be offered to all patients.
Individual recommendations are summarized below.
Therapies in Addition to Androgen-Deprivation Therapy
Therapy with survival and quality-of-life benefits
Therapy with survival benefit and unclear quality-of-life benefit
Therapy with quality-of-life benefit without demonstrated survival benefit
Therapy with biologic activity and unknown survival or quality-of-life benefit
Therapy with no demonstrated survival or quality-of-life benefit
Palliative Care Services
Disclosure: For full disclosures of the guideline authors, visit jco.ascopubs.org.
1. Basch E, Loblaw DA, Oliver, TK, et al: Systemic therapy in men with metastatic castration-resistant prostate cancer: American Society of Clinical Oncology and Cancer Care Ontario Clinical Practice Guideline. J Clin Oncol. September 8, 2014 (early release online).
2. Loblaw DA, Walker-Dilks C, Winquist E, et al: Systemic therapy in men with metastatic castration-resistant prostate cancer: A systematic review. Clin Oncol (R Coll Radiol) 25:406-430, 2013.
See commentary by Maha Hussain, MD, FACP, here.
We are witnessing unprecedented progress in the development of therapy for patients with metastatic castration-resistant prostate cancer. The U.S. Food and Drug Administration (FDA) has issued 13 approvals since 1996 for agents that have demonstrated an impact on overall survival, pain, or...