New Practice Guideline for Systemic Therapy in Men with Metastatic Prostate Cancer

Anew guideline for systemic therapy in men with metastatic castration-resistant prostate cancer (mCRPC) is based on a literature review of recent publications and outlines the survival and quality-of-life benefits/toxicity effects of each recommendation (Basch E, et al. J Clin Oncol. 2014 Sept 8. Epub ahead of print).

Jointly issued by the American Society of Clinical Oncology (ASCO) and Cancer Care Ontario (CCO), the new guideline considers new systemic therapies for mCRPC, including abiraterone acetate (Zytiga), enzalutamide (Xtandi), and radium-223 (Xofigo).

“Something different about this guideline is that quality of life and toxicity have been elevated in the recommendations themselves—the patient experience is prioritized,” said lead investigator Ethan Basch, MD, MSc, Co-Chair of the ASCO/CCO Expert Panel that developed the guideline, and Associate Professor of Medicine and Public Health, University of North Carolina at Chapel Hill. “In addition, the strength of the evidence and the strength of the recommendations are transparent.”

The new document builds on previous guidelines and a review of 25 new randomized controlled trials. According to the new recommendations:

  • Continuous androgen-deprivation therapy (ADT) via medication or surgery should be continued indefinitely, even if other therapies are added (benefit: moderate; harm: moderate; evidence: weak; recommendation: moderate)
  • Abiraterone acetate + prednisone, radium-223 in men with primarily bone metastases, or enzalutamide should be used in addition to ADT (all—benefit: moderate; harm: low; evidence: strong; recommendation: strong)
  • Docetaxel (Taxotere) + prednisone also should be used in addition to ADT (benefit: moderate; harm: moderate; evidence: strong; recommendation: moderate)
  • Other therapies to consider:
    • Sipuleucel-T (Provenge) in asymp­tomatic or in minimally symptomatic men
    • Cabazitaxel (Jevtana) and prednisone in men whose disease has progressed with docetaxel
    • Mitoxantrone (Novantrone) + prednisone
    • Antiandrogens, such as bicalu­tamide (Casodex), flu­tamide (Eulexin), or nilutamide (Nilandron)
    • Ketoconazole
    • Low-dose corticosteroid monotherapy
  • Bevacizumab (Avastin), estramustine (Emcyt), and sunitinib (Sutent) should not be used, because they do not increase survival or improve quality of life
  • Palliative care should be offered to all patients receiving any treatment, particularly those with symptoms or quality-of-life reduction.

“Our recommendation of early initiation of palliative care—which is distinct from end-of-life care—is an important part of the guideline,” Dr Basch said. “Palliative care is now looked at as beneficial and appropriate across this population, including for patients who may have a long time to live with metastatic cancer. Survival time with metastatic prostate cancer has increased with the availability of new drugs, and now it is recognized that we have to focus on support of the patients and their families and caregivers.”

He noted that cost and cost-effectiveness were not taken into consideration in the recommendations, although cost was included
in a table in the guideline and in the discussion. Dr Basch said it is important to have more postmarketing data to continue to ascertain the rate of serious adverse events in clinical practice. The team also did not recommend particular sequences or drug combinations, because of an insufficient evidence base for that, he said.

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