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New ASCO/CCO mCRPC Treatment Guideline Incorporates Latest Approved Drugs

Beth Fand Incollingo @fandincollingo
Published: Monday, Sep 08, 2014

Dr. Ethan Basch

Ethan Basch, MD

A guideline for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) has been issued by the American Society of Clinical Oncology (ASCO) and Cancer Care Ontario (CCO). The guideline is the first released by the groups on the topic of mCRPC since 2007, and incorporates information about 6 recently approved drugs that have significantly changed the therapeutic landscape for these patients.

The guideline recommends indefinite androgen deprivation therapy (ADT), as well as newer systemic therapies that can be given concurrently with that treatment. The document addresses survival, quality-of-life benefits, and side effects for each of these new drugs, and also touches on cost considerations.

“We have seen unprecedented progress against advanced prostate cancer recently, with six new treatments approved in the last couple of years,” said co-chair of the multidisciplinary ASCO/CCO Expert Panel that developed the guideline Ethan Basch, MD, the director of the Cancer Outcomes Research Program at the University of North Carolina Lineberger Comprehensive Cancer Center. “There are a lot of nuances about treatment selection in terms of disease stage and what prior therapies the patient received. We hope this guideline will help doctors and patients make informed treatment decisions.”

The guideline recommends, with moderate strength, that ADT be used indefinitely in these patients. In discussing specific newer drugs to complement ADT, the document strongly recommends abiraterone (given with prednisone), enzalutamide, and radium-223 as treatments that improve survival and quality of life and have a favorable benefit/harm balance. Survival and quality of life are also improved with docetaxel plus prednisone, but a moderate toxicity risk is associated with the treatment; hence, the moderate strength of the recommendation to prescribe it. The guideline gives a weak recommendation to the use of sipuleucel-T in asymptomatic and minimally symptomatic patients, saying it offers improved survival, an unclear effect on quality of life, and low toxicity.

“In the context of incurable metastatic cancer, it is the opinion of the panel that the goal of treatment is to provide the best possible quality of life for as long as possible,” the guideline states. “Over the past decade, multiple therapies have become available for metastatic CRPC that provide overall survival benefit (although generally modest and measured in months), as well as quality of life and pain benefits, demonstrated through well-designed phase III trials. In the contemporary selection of treatments, attention should be given to clinically meaningful benefit, risk of harm, quality of evidence, and cost when assisting patients with treatment decisions.”

Key guideline recommendations state that physicians should:

  • Keep patients with mCRPC on ADT (pharmaceutical or surgical) indefinitely. (recommendation level: moderate)
  • Offer abiraterone/prednisone, enzalutamide, or radium-223 (for men whose cancer has spread predominantly to the bones) in addition to ADT, as all three treatments are associated with improved survival, quality of life, and favorable balance of benefits and harms. (recommendation level: strong)
  • If considering chemotherapy, offer docetaxel/prednisone, but discuss side-effect risks. (recommendation level: moderate)
  • If a patient’s disease worsens despite treatment with docetaxel, consider offering cabazitaxel plus prednisone, but discuss side-effect risks. (recommendation level: moderate) 
  • Consider offering sipuleucel-T to men who have no symptoms or minimal symptoms. (recommendation level: weak)
  • Consider offering mitoxantrone plus prednisone, accompanied by a discussion of limited clinical benefit and side-effect risk. (recommendation level: weak)
  • Consider offering ketoconazole or antiandrogens (bicalutamide, flutamide, nilutamide), accompanied by a discussion of limited clinical benefit. (recommendation level: weak)
  • Consider offering low-dose corticosteroid monotherapy as a second-line hormonal therapy. (recommendation level: weak)
  • Offer palliative care early to all patients. (recommendation level: strong)
  • Never offer bevacizumab, estramustine, or sunitinib. (recommendation level: strong)
Although insufficient clinical evidence was available to recommend the optimal sequence in which treatments should be given, ongoing clinical trials are exploring this question, as well as potential benefits of combining various treatments. 

The guideline builds upon prior recommendations from ASCO and CCO that were based on a systematic review of 28 randomized clinical trials published between 1979 and 2004. Those recommendations were released by CCO in 2006 and endorsed by ASCO in 2007.

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