Abstract 1376P
Background
Pain is an important dimension of quality-of-life in patients with metastatic castrate-sensitive prostate cancer (mCSPC). However, it is unclear if dynamic change in pain over time can predict for overall survival (OS) or time to radiographic progression (TTRP) in these patients.
Methods
This is an exploratory analysis of LATITUDE, in which men with de novo mCSPC were randomized to receive either ADT plus abiraterone versus ADT alone. Information was collected on patient-reported worst pain score (WPS) from the Brief Pain Inventory-Short Form. We applied separate univariate joint models to determine the association of dynamic changes in WPS with OS and TTRP, respectively. For the time-to-event submodel, a Cox proportional hazard regression model was constructed. For the longitudinal submodel, a linear mixed effect model was built. The two submodels were linked through a random effect. The joint models were fitted with the use of Markov chain Monte Carlo algorithms.
Results
Overall, 1125 patients with at least 3 pain score measurements were eligible. Patients were initially stratified into two categories based on presence of baseline pain. Median OS for patients with and without any pain at baseline was 35.7 and 41.1 months and median TTRP was 31.8 and 23.1 months, respectively. On Cox multivariable regression, 1 unit higher baseline WPS was associated with inferior OS (hazard ratio [HR]: 1.05 [95%confidence interval [CI]: 1.02-1.09]; time dependent area under curve [tAUC] 0.64) and inferior TTRP (HR: 1.05 [1.01-1.08]; tAUC 0.64). On independent joint modeling, a dynamic increase in the current value of WPS by 1-unit was associated with inferior OS (HR: 1.32 [1.26-1.38]; tAUC 0.74) and TTRP (HR: 1.32 [1.26-1.38]; tAUC 0.70).
Conclusions
The above findings highlight the potential dynamic interplay between patient-reported pain with OS and TTRP in mCSPC. Compared to baseline pain, such dynamic assessment of pain was found to have superior predictive ability as denoted by superior tAUC. Dynamic evaluation of pain score has the potential to tailor subsequent treatment based on response to initial therapy beyond its role as a very important dimension of quality-of-life.
Clinical trial identification
NCT01715285.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
C. Wallis: Financial Interests, Other, Honoraria: Knight Therapeutics, Haymarket Media; Financial Interests, Other, Consulting fees: J&J; Financial Interests, Other, Personal Fees: SESEN Bio. S.C. Morgan: Financial Interests, Other, Personal fees: Astellas, Bayer, Janssen, TerSera. A.U. Kishan: Financial Interests, Other, Personal Fees and Research Support: ViewRay; Financial Interests, Other, Personal fees: Varian, Intelligent automation. D.E. Spratt: Financial Interests, Other, Personal fees: Blue Earth, Janssen, AstraZeneca, Boston Scientific, GammaTile, Varian. F. Saad: Financial Interests, Personal, Advisory Board: Astellas, Bayer, BMS, Janssen, Sanofi, Pfizer, Myovant, Novartis; Financial Interests, Institutional, Invited Speaker: Novartis, Astellas, Bayer, Janssen, Sanofi, BMS, Amgen, Pfizer. S. Malone: Financial Interests, Other, Honoraria: Astellas, Bayer, Janssen, Sanofi; Financial Interests, Other, Travel and Accomodation: TerSera, Sanofi. All other authors have declared no conflicts of interest.