OUTCOMES MANAGEMENT IN A REAL WORLD EVIDENCE CONTEXT. THE CASE OF ABIRATERONE AND ENZALUTAMIDE IN THE TREATMENT OF METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
Author(s)
Cardoso P1, Santos C2, Costa F2, Gonçalves FR3
1Luz Saúde, Lisboa, 14, Portugal, 2Luz Saúde, Lisboa, Portugal, 3Luz Saúde and Faculty Medicine University of Porto, Lisboa, Portugal
Presentation Documents
OBJECTIVES: We discuss an outcomes management methodology, supporting the follow-up of patients. This involves, namely, (a) measuring relevant baseline traits and (b) outcomes such as: overall survival, treatment duration, patient reported outcomes and adverse events. This research empirically reports the case of patients with metastatic castration resistance cancer, using Abiraterone (A) or Enzulatamide (E), as per recommendations of ESMO and NCCN. METHODS: the dataset includes all appropriate patients undergoing treatment with A or E, from 2012 to 2019. Data is collected in a hospital-based, EHR of Luz Saúde, Portugal. Includes age, staging, ECOG, Gleason, histology, duration treatment and survival. Statistical analysis uses SPSS V23.0 for the overall survival analysis with Kaplan Meyer Curves. QoL data at Luz Saúde is captured with the use of EPIC26 for prostate cancer. RESULTS: This population had a median age at diagnosis of 69 years old and, comparing for survival, both present similar OS (Abiraterone 16,7 months vs Enzalutamide 17,2 months, p>0,05), but the median duration of treatment was higher in the A group (6,5 months vs 4,3 months). Higher discontinuation due to adverse events in E group. Regarding the QoL analysis, an initial decrease in post-intervention but a significant progressive improvement over the long-term, in measures such as: urinary incontinence , urinary irritative/obstructive, bowel, sexual. CONCLUSIONS: We aimed and achieved variability and facial validity of the results. This will reinforce the capabilities of the proposed methodology for doing proper follow up and discrimination among the findings. As a result, by showing that we can captures the distinctive clinical benefits of A and E , and that PROs can be systematically collected for more than 2 years per living patient, we can now incorporate these findings in clinical discussions, risk sharing agreements or policy level arguments.
Conference/Value in Health Info
2019-11, ISPOR Europe 2019, Copenhagen, Denmark
Code
PCN51
Topic
Clinical Outcomes, Methodological & Statistical Research, Patient-Centered Research
Topic Subcategory
Clinical Outcomes Assessment, Clinician Reported Outcomes, Patient-reported Outcomes & Quality of Life Outcomes, PRO & Related Methods
Disease
Oncology