Observational Health Data Analysis of the Cardiovascular Adverse Events of Systemic Treatment in Patients with Metastatic Hormone-sensitive Prostate Cancer: Big Data Analytics Using the PIONEER Platform.
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Rajwa Pawel, Borkowetz Angelika, Abbott Thomas, Alberti Andrea, Beyer Katharina, Bjartell Anders, Brash James T, Chilelli Andrew, Davies Eleanor, Meulder Bertrand De, Fazekas Tamas, Golozar Asieh, Hijazy Ayman, Josefsson Andreas, Kasivisvanathan Veeru, Kolde Raivo, Kotik Daniel, Leapman Michael S, Miszczyk Marcin, Nicoletti Rossella, Prinsen Peter, Remmers Sebastiaan, Ribal Maria J, Rivas Juan Gómez, Rodriguez-Sanchez Lara, Roobol Monique J, Smith Emma, Snijder Robert, Steinbeisser Carl, Stroomberg Hein V, Gandaglia Giorgio, Cornford Philip, Evans-Axelsson Susan, N'Dow James, Willemse Peter-Paul M, PIONEER Consortium
Аннотация
METHODS: Leveraging PIONEER's Big Data platform, with databases standardised using the Observational Medical Outcomes Partnership model, we defined cohorts and calculated the incidence rates of AEs per 1000 person-years. The time to first event was assessed via a Kaplan-Meier analysis, and the mean cumulative function (MCF) was estimated for recurrent events. Analyses were stratified by therapy and database.
KEY FINDINGS AND LIMITATIONS: We included 90 087 mHSPC patients from five databases, treated with androgen deprivation therapy (ADT) + androgen receptor pathway inhibitor (ARPI) + docetaxel (DOC) (n = 3743), ADT + ARPI (n = 13 588), ADT + DOC (n = 16 287), or ADT alone (n = 56 469). The distribution of age (63.5-73.7 yr) and comorbidities varied between databases (eg, for hypertension 22-79%). Diabetes was reported in up to 33%, heart failure in 17%, obesity in 25%, and kidney impairment in 26% of men. The highest incidence rates of AEs were as follows: 115 cases (ADT) for acute cardiac events, 403 (ADT + ARPI) for cerebral events, 214 (ADT + ARPI) for thromboembolism, 34 (ADT) for chronic heart failure, and 143 (ADT + ARPI + DOC) for hypertension. The 3-yr acute cardiac event-free survival rate ranged from 79% to 97%, and the 3-yr MCF for acute cardiac events was up to 0.33. Limitations include the retrospective nature and a lack of AE grading.
CONCLUSIONS AND CLINICAL IMPLICATIONS: Our study highlights important heterogeneity in real-world, observational mHSPC data. The included patients demonstrated a substantial comorbidity burden, often exceeding that reported in clinical trials, alongside a high rate of cardiovascular AEs.