Geoffrey Gotto1, Darrel E Drachenberg2, Joseph Chin3, Richard Casey4, Vincent Fradet5, Robert Sabbagh6, Bobby Shayegan7, Ricardo A Rendon8, Brita Danielson9, Fernandes Camacho10, Anousheh Zardan11, Richard Plante11, Huong Hew11, Katherine Chan11, Andrew Feifer12. 1. University of Calgary, Calgary, AB, Canada. 2. University of Manitoba, Winnipeg, MB, Canada. 3. London Health Sciences Centre-Victoria Hospital, London, ON, Canada. 4. The Fe/Male Health Centres, Oakville, ON, Canada. 5. Hotel Dieu du Québec (CHUQ), Quebec City, QC, Canada. 6. CIUSSE-CHUS - Université de Sherbrooke, Sherbrooke, QC, Canada. 7. McMaster University, Hamilton, ON, Canada. 8. Dalhousie University, Halifax, NS, Canada. 9. University of Alberta, Edmonton, AB, Canada. 10. Damos Inc, Toronto, ON, Canada. 11. Janssen Inc., Toronto, ON, Canada. 12. Trillium Health Partners, Toronto, ON, Canada.
Abstract
INTRODUCTION: Abiraterone acetate plus prednisone (AA+P) has shown to significantly improve survival. COSMiC, a Canadian Observational Study in Metastatic Cancer of the Prostate, set out to prospectively amass real-world data on metastatic castrate-resistant prostate cancer (mCRPC) patients managed with AA+P in Canada. Here, we report their patient-reported outcomes (PROs). METHODS: After a median followup of 67.1 weeks, 254 patients were enrolled across 39 sites. Functional Assessment of Cancer Therapy-Prostate (FACT-P), Montreal Cognitive Assessment (MoCA), Brief Pain Inventory-Short form (BPI-SF), Brief Fatigue Inventory (BFI), and Current Health Satisfaction in Prostate Cancer (CHS-PCa) were evaluated at baseline, as well as at weeks 12, 24, 48, and 72 after AA+P initiation. Descriptive analysis was used with continuous variables. Changes from baseline were summarized using mean (standard deviation [SD]). RESULTS: At a median age of 76.6 (8.94), baseline FACT-P total score was 111.3 (19.56) with no significant change in their functional status observed from baseline over time. The median baseline MoCA score was 25.2 (4.52), yet subsequent assessments showed an absence of cognitive decline while under treatment. Similarly, no meaningful changes were detected in BPI, BFI, and CHS-PCa during the 72-week study period, thus suggesting that patients' PROs were well-maintained throughout AA+P treatment. Prostate-specific antigen (PSA) response with >50% decline was 66.4%. Safety profile was consistent with the known side effect of AA+P. CONCLUSIONS: COSMiC represents the largest Canadian mCRPC cohort treated with AA+P with real-world, prospective evaluation of PROs. This data demonstrated the maintenance in quality of life and cognitive status over the course of the study and underscores the importance of PRO use in this complex patient population.
INTRODUCTION:Abiraterone acetate plus prednisone (AA+P) has shown to significantly improve survival. COSMiC, a Canadian Observational Study in Metastatic Cancer of the Prostate, set out to prospectively amass real-world data on metastatic castrate-resistant prostate cancer (mCRPC) patients managed with AA+P in Canada. Here, we report their patient-reported outcomes (PROs). METHODS: After a median followup of 67.1 weeks, 254 patients were enrolled across 39 sites. Functional Assessment of Cancer Therapy-Prostate (FACT-P), Montreal Cognitive Assessment (MoCA), Brief Pain Inventory-Short form (BPI-SF), Brief Fatigue Inventory (BFI), and Current Health Satisfaction in Prostate Cancer (CHS-PCa) were evaluated at baseline, as well as at weeks 12, 24, 48, and 72 after AA+P initiation. Descriptive analysis was used with continuous variables. Changes from baseline were summarized using mean (standard deviation [SD]). RESULTS: At a median age of 76.6 (8.94), baseline FACT-P total score was 111.3 (19.56) with no significant change in their functional status observed from baseline over time. The median baseline MoCA score was 25.2 (4.52), yet subsequent assessments showed an absence of cognitive decline while under treatment. Similarly, no meaningful changes were detected in BPI, BFI, and CHS-PCa during the 72-week study period, thus suggesting that patients' PROs were well-maintained throughout AA+P treatment. Prostate-specific antigen (PSA) response with >50% decline was 66.4%. Safety profile was consistent with the known side effect of AA+P. CONCLUSIONS: COSMiC represents the largest Canadian mCRPC cohort treated with AA+P with real-world, prospective evaluation of PROs. This data demonstrated the maintenance in quality of life and cognitive status over the course of the study and underscores the importance of PRO use in this complex patient population.
Authors: Christopher J D Wallis; Shawn Malone; Ilias Cagiannos; Scott C Morgan; Robert J Hamilton; Naveen S Basappa; Cristiano Ferrario; Geoffrey T Gotto; Ricardo Fernandes; Tamim Niazi; Krista L Noonan; Fred Saad; Sebastien J Hotte; Huong Hew; Katherine F Y Chan; Laura Park Wyllie; Bobby Shayegan Journal: JNCI Cancer Spectr Date: 2021-10-01
Authors: G Procopio; V E Chiuri; M Giordano; A R Alitto; R Maisano; R Bordonaro; S Cinieri; S Rossetti; S De Placido; M Airoldi; L Galli; D Gasparro; G M Ludovico; P F Guglielmini; C Carella; P Nova; M Aglietta; L Schips; P Beccaglia; A Sciarra; L Livi; D Santini Journal: ESMO Open Date: 2022-04-08
Authors: Malgorzata K Nowakowska; Xiudong Lei; Mackenzie R Wehner; Paul G Corn; Sharon H Giordano; Kevin T Nead Journal: JAMA Netw Open Date: 2021-12-01
Authors: Shabbir M H Alibhai; Henriette Breunis; Gregory Feng; Narhari Timilshina; Aaron Hansen; Padraig Warde; Richard Gregg; Anthony Joshua; Neil Fleshner; George Tomlinson; Urban Emmenegger Journal: JAMA Netw Open Date: 2021-07-01