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Impact of Abiraterone Evident in New AUA Guidelines for mCRPC

Ben Leach
Published: Thursday, Aug 15, 2013
Dr. Adam S. Kibel
Adam S. Kibel, MD

Chief, Urologic Surgery
Brigham and Women’s Hospital
Professor of Surgery
Harvard Medical School
Dana-Farber Cancer Institute
Boston, MA

Dana-Farber Cancer Institute
Amid a flurry of new drug approvals in recent years, the American Urological Association (AUA) has issued its first set of guidelines for the management of patients with metastatic castration-resistant prostate cancer (mCRPC). The guidelines, presented during the 2013 AUA Annual Meeting in San Diego, California, in May, incorporate an extensive role for abiraterone acetate (Zytiga) at several stages of the disease.

Abiraterone is part of a class of newer agents called androgen synthesis inhibitors that are designed to target androgen receptors to block the signaling pathways associated with prostate cancer. In 2011, the FDA approved abiraterone in combination with prednisone for patients with mCRPC who had previously received docetaxel. In 2012, that approval was expanded to include patients with mCRPC who have not yet received chemotherapy.

“These trials showed a definitive survival advantage,” said Adam S. Kibel, MD, disease center leader of Urology at Dana-Farber Cancer Institute in Boston, Massachusetts. “Patients didn’t just show a quality of life improvement. Patients lived longer.”

Kibel served as vice chair on a panel for the AUA that developed the guidelines for mCRPC patients. While abiraterone appears to help many patients with mCRPC, the guidelines make it clear that the drug may not be appropriate to use in all cases.

The AUA’s board of directors approved the recommendations in April, before the FDA granted clearance for radium Ra 223 dichloride (Xofigo). As a result, the agent is not mentioned in the guidelines, although it may be in the future, according to a notice attached to the document.

The guidelines discuss treatment options for six different index patients that take into consideration symptoms, performance status, metastases, and whether docetaxel was administered (Table).

Table. Patient Categories for mCRPC Guidelines1

Index Patient 1—Asymptomatic nonmetastatic CRPC
  • Rising prostate-specific antigen (PSA) despite medical or surgical castration
  • No radiologic evidence of metastatic prostate cancer
  • Castrate levels of testosterone (<50 ng/mL)
Index Patient 2—Asymptomatic or minimally symptomatic mCRPC without prior docetaxel chemotherapy
  • Rising PSA in the setting of castrate levels of testosterone
  • Documented metastatic disease on radiographic imaging
  • No regular narcotics for pain relief for symptoms attributable to metastases
Index Patient 3—Symptomatic mCRPC with good performance status and
no prior docetaxel chemotherapy
  • Rising PSA in the setting of castrate levels of testosterone
  • Documented symptomatic metastatic disease on radiographic imaging
  • Regular narcotics for pain relief for symptoms attributable to metastases
Index Patient 4—Symptomatic mCRPC with poor performance status and
no prior docetaxel chemotherapy
  • Performance status Eastern Cooperative Oncology Group (ECOG) 3-4
Index Patient 5—Symptomatic mCRPC with good performance status and prior docetaxel chemotherapy
  • Castration-resistant disease based on serologic progression
  • Excellent ECOG performance status
Index Patient 6—Symptomatic mCRPC with poor performance status and prior docetaxel chemotherapy
  • ECOG performance status 3-4



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