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