ASCO 2017: Assessment of quality of life, cognitive function and depression in a randomized phase II study of abiraterone acetate (ABI) plus prednisone (P) vs enzalutamide (ENZA) for metastatic castrate-resistant prostate cancer (mCRPC)

Chicago, IL (UroToday.com) As enzalutamide (Enza) and abiraterone (Abi) have become mainstays of therapy for patients with metastatic castration-resistant prostate cancer (mCRPC), a difficult clinical question has always been how to sequence these medications. In this randomized phase II clinical study, the goal is to evaluate the clinical efficacy and side effects of sequencing these two medications.

In this study, a FACT-P quality of life (QOL) questionnaire, patient health questionnaire (PHQ-9) and Montreal Cognitive Assessment (MoCA) were completed throughout the study. The primary outcome was the proportion of patients with a clinically significant change in FACT-P (10 points total FACT-P score, 3 points FACT-P subscales), worsening of PHQ-9 depression symptom severity (none = 0-4, mild = 5-9, moderate = 10-14, moderate-severe = 15-19, severe ≥20) and decline in MoCA cognitive impairment level (normal = 27-30, mild = 18-26, moderate = 10-17, severe ˂ 10) at week 12 was compared between study arms.

Of the 202 patients included in the phase II study, there were 145 and 142 patients with baseline and 12-week assessments; baseline scores were similar in both arms.

Over the course of treatment, the median total FACT-P score improved in the Abi arm, but there was no change in the Enza arm. At 12 and 24 weeks, the median total FACT-P scores were significantly higher in the Abi arm as opposed to the Enza arm. On subscale analysis, Enza was associated with a higher rate of worsening in the physical well-being (PWB) subscale, consistent with known fatigue for patients taking Enza, and a higher rate of worsening depression severity in the Enza arm, although worsening to a moderate-severe/severe level occurred in only 2 patients. A higher proportion of patients had a MoCa cognitive impairment in the Enza arm.

Overall, these preliminary results suggest that, all things being equal, Abi has a higher QOL impact on patients than Enza, and Enza should potentially be reserved for patients failing Abi. However, the final oncologic results regarding sequencing may affect this recommendation.

Presented By: Daniel Khalaf, MD

Co-Authors: Katherine Sunderland, Bernhard J. Eigl, Daygen L. Finch, Conrad D. Oja, Joanna Vergidis, Sunil Parimi, Muhammad Zulfiqar, Martin Gleave, Kim N. Chi

Institution(s): BC Cancer Agency, Vancouver, BC, Canada; British Columbia Cancer Agency, Southern Interior Centre, Kelowna, BC, Canada; British Columbia Cancer Agency, Fraser Valley Centre, Vancouver, BC, Canada; British Columbia Cancer Agency, Vancouver Island Centre, Victoria, BC, Canada; British Columbia Cancer Agency, Vancouver Centre, Vancouver, BC, Canada; BC Cancer Agency, Abbotsford, BC, Canada; Vancouver Prostate Centre, University of British Columbia, Vancouver, BC, Canada; British Columbia Cancer Agency, Vancouver, BC, Canada

Written By: Thenappan Chandrasekar, MD, Clinical Fellow, University of Toronto, Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Twitter: @tchandra_uromd

at the 2017 ASCO Annual Meeting - June 2 - 6, 2017 – Chicago, Illinois, USA
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