Impact of Abiraterone Acetate plus Prednisone or Enzalutamide on Patient-reported Outcomes in Patients with Metastatic Castration-resistant Prostate Cancer: Final 12-mo Analysis from the Observational AQUARiUS Study

Thiery‐Vuillemin, Antoine; Poulsen, Mads Hvid; Lagneau, É.; Ploussard, Guillaume; Birtle, Alison; Dourthe, Louis Marie; Beal-Ardisson, Dominique; Pintus, Elias; Trepiakas, Redas; Lefresne, Florence; Lukáč, Martin; Sanden, Suzy Van; Pissart, Geneviève; Reid, Alison

doi:10.1016/j.eururo.2019.09.019

Cited by 51 publications

(49 citation statements)

References 18 publications

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“…HRQL benefits for patients with mCRPC are important, as several studies have suggested that PROs significantly impact clinical outcomes. 29 For example, in the COU-AA-302 trial, for patients with chemotherapy-naive mCRPC receiving abiraterone plus prednisone, worsening of PROs was associated with a greater risk of radiographic progression. 30 A limitation of the current analysis is that the number of patients and HRQL assessments decrease over time, which reduces the statistical power of the HRQL analysis in later cycles.…”

Section: Discussionmentioning

confidence: 99%

“…38 Regarding fatigue, in the AQUARiUS study, fatigue outcomes were more favorable in chemotherapynaive patients with mCRPC who received abiraterone compared with enzalutamide. 39 In STAMPEDE, a multi-arm, multi-stage trial, that in part investigated docetaxel and abiraterone in patients with metastatic hormone-sensitive prostate cancer, HRQL was higher among patients who received abiraterone compared with docetaxel in the first 2 years of treatment, although this difference did not meet the predefined clinically meaningful threshold. 40 Direct comparison of patients who received docetaxel or abiraterone in STAMPEDE showed no evidence of a difference in OS.…”

Section: Discussionmentioning

confidence: 99%

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An analysis of health-related quality of life in the phase III PROSELICA and FIRSTANA studies assessing cabazitaxel in patients with metastatic castration-resistant prostate cancer

et al. 2021

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Background: Men with metastatic castration-resistant prostate cancer (mCRPC) are living longer, therefore optimizing health-related quality of life (HRQL), as well as survival outcomes, is important for optimal patient care. The aim of this study was to assess the HRQL in patients with mCRPC receiving docetaxel or cabazitaxel. Patients and methods: PROSELICA (NCT01308580) assessed the non-inferiority of cabazitaxel 20 mg/m 2 (C20) versus 25 mg/m 2 (C25) in patients with mCRPC after docetaxel. FIRSTANA (NCT01308567) assessed the superiority of C25 or C20 versus docetaxel 75 mg/m 2 (D75) in patients with chemotherapy-naive mCRPC. HRQL and pain were analyzed using protocol-defined, prospectively collected, Functional Assessment of Cancer TherapydProstate (FACT-P) and McGill-Melzack questionnaires. Analyses included definitive improvements in HRQL, maintained or improved HRQL, and HRQL over time. Results: In total, 2131 patients were evaluable for HRQL across the two studies. In PROSELICA, 38.8% and 40.5% of patients receiving C20 and C25, respectively, had definitive FACT-P total score (TS) improvements. In FIRSTANA, 43.4%, 49.7%, and 44.9% of patients receiving D75, C20, and C25, respectively, had definitive FACT-P TS improvements. In both trials, definitive improvements started after cycle 1 and were maintained for the majority of subsequent treatment cycles. More than two-thirds of patients maintained or improved their FACT-P TS. Conclusions: In PROSELICA and FIRSTANA, >40% of the 2131 evaluable patients with mCRPC had definitive FACT-P TS improvements; improvements occurred early and were maintained. More than 75% of patients maintained or improved their FACT-P TS.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

An analysis of health-related quality of life in the phase III PROSELICA and FIRSTANA studies assessing cabazitaxel in patients with metastatic castration-resistant prostate cancer

et al. 2021

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“…Although not randomized, another couple of studies, both conducted in the mCRPC setting, the observational AQUARiUS trial and the phase IV, real-world REAAcT, are worthy of being discussed [ 39 , 40 , 41 ]. AQUARiUS was designed to describe the impact of abiraterone acetate and enzalutamide on PROs [ 39 , 40 ]. Patients were assessed for a 12-month period from treatment start with the FACT-Cog and EORTC QLQ-C30.…”

Section: Trials Testing Both Abiraterone and Enzalutamidementioning

confidence: 99%

Evaluation of Cognitive Function in Trials Testing New-Generation Hormonal Therapy in Patients with Prostate Cancer: A Systematic Review

Marandino

Vignani

Buttigliero

et al. 2020

Cancers

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In patients with prostate cancer, earlier use and longer duration of new-generation hormonal therapy (NGHT), added to androgen deprivation therapy, requires careful evaluation of cognitive function. The aim of this systematic review is to describe the evidence about cognitive function in all the randomized trials (RCTs) testing NGHT (abiraterone, enzalutamide, apalutamide, darolutamide). We assessed the availability of both investigator-assessed cognitive impairment and disorders and patient-reported evaluation of cognitive function. Nineteen RCTs (17,617 patients) were included. The investigator-based evaluation of cognitive impairment was available in seven RCTs (36.8%). In total, 19/19 RCTs (100%) included patient-reported outcomes (PROs) collection, but PRO tools adopted allowed evaluation of cognitive function in two RCTs (10.5%). Among them, PRO-based cognitive function results were presented only in one RCT (5.3%): in ENZAMET, mean changes from baseline were worse with enzalutamide than with placebo, but deterioration-free survival favored enzalutamide. Despite cognitive deterioration could be relevant, clinical development of NGHT has not included a systematic evaluation of cognitive function. Assessment by investigators is at risk of underreporting, and commonly used PROs do not allow proper cognitive function analysis. Furthermore, the methodology of analysis can jeopardize the interpretation of results. Although direct comparisons are scanty, there could be differences between different NGHTs.

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“…The AQUARIUS study was a prospective, 12-months, observational study in patients with mCRPC from Denmark, France, and the United Kingdom. The study suggested an advantage of abiraterone acetate plus prednisone over enzalutamide with regard to fatigue and cognitive function ( Thiery-Vuillemin et al, 2020 ). A meta-analysis by Khalaf et al (2019) demonstrated differential adverse effects profile in patients with mCRPC who were treated with abiraterone or enzalutamide.…”

Section: Introductionmentioning

confidence: 99%

Treatment-Emergent Co-Morbidities and Survival in Patients With Metastatic Castration-Resistant Prostate Cancer Receiving Abiraterone or Enzalutamide

et al. 2021

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Secondary hormone therapy, abiraterone and enzalutamide, has improved outcomes for metastatic castration-resistant prostate cancer (mCRPC) and prolonged patients’ lives significantly. Various studies have compared the cancer-related outcomes, adverse effects, and drug-induced comorbidities in patients with mCRPC who are treated with abiraterone or enzalutamide. However, few studies have explored associations between survival and comorbidities or comprehensive analyzed newly developed comorbidities during and after secondary hormone therapy. We attempted to clarify whether the Charlson comorbidity index (CCI) overall or itemized is predictive for overall survival, and we compared newly developed comorbidities between abiraterone and enzalutamide groups. We extracted data about expenses and comorbidities for patients who have mCRPC, received abiraterone and enzalutamide and met pre-examination operation criteria between September 2016 and December 2017 from the Taiwan National Health Insurance database. A total of 1153 patients with mCRPC who received abiraterone (n = 782) or enzalutamide (n = 371) with or without previous chemotherapy were included. We used the propensity score to match confounding factors, including age, pre-existing comorbidities, and precipitating factors for comorbidity (e.g., hypertension, hyperlipidemia), to eliminate selection bias in the comparison of newly developed comorbidities. Cox regression analysis was used for overall survival. We found that enzalutamide is superior to abiraterone with regard to overall survival. Our study revealed that there is no statistically significant difference in development of new comorbidities between abiraterone and enzalutamide group. Moreover, the CCI score, rather than any single item of the CCI, was a statistically significant predictor for overall survival.

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Impact of Abiraterone Acetate plus Prednisone or Enzalutamide on Patient-reported Outcomes in Patients with Metastatic Castration-resistant Prostate Cancer: Final 12-mo Analysis from the Observational AQUARiUS Study

Cited by 51 publications

References 18 publications

An analysis of health-related quality of life in the phase III PROSELICA and FIRSTANA studies assessing cabazitaxel in patients with metastatic castration-resistant prostate cancer

An analysis of health-related quality of life in the phase III PROSELICA and FIRSTANA studies assessing cabazitaxel in patients with metastatic castration-resistant prostate cancer

Evaluation of Cognitive Function in Trials Testing New-Generation Hormonal Therapy in Patients with Prostate Cancer: A Systematic Review

Treatment-Emergent Co-Morbidities and Survival in Patients With Metastatic Castration-Resistant Prostate Cancer Receiving Abiraterone or Enzalutamide

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