Abstract 4574
Background
Three recent RCT (Spartan, Prosper and Aramis) have demonstrated improved metastasis-free survival with new ARi Apalutamide (A), Enzalutamide (E) and Darolutamide (D), respectively, vs placebo (pl) in nmCRPC. We conducted a meta-analysis of RCT to evaluate the safety of ARi.
Methods
Random-effects meta-analysis was performed to describe pooled odds ratio (OR) vs pl and presence of heterogeneity in the effect among RCT. Network meta-analysis was performed to describe OR of indirect comparisons.
Results
4104 patients were included in safety analysis. Many adverse events (AEs) (falls, fractures, fatigue, nausea, diarrhea, hypertension, rash) showed a significant difference in the incidence in patients receiving pl, mostly higher in the Spartan trial. The use of ARi was associated with an higher risk of developing selected AEs compared to pl: serious AEs (OR 1.28, 95%CI 1.10-1.50); falls (OR 1.81, 95%CI 1.40-2.34); fractures (OR 1.58, 95%CI 1.11-2.23); fatigue (all grades OR 2.00, 95%CI 1.68-2.39; severe OR 2.21, 95%CI 1.06-4.60); rash (OR 4.90, 95%CI 3.24-7.41); diarrhea (OR 1.24, 95%CI 1.00-1.54); hypertension (all grades OR 1.55, 95%CI 1.25-1.92; severe OR 1.44, 95%CI 1.08-1.92); dizziness (OR 1.67, 95%CI 1.26-2.21), mental impairment (OR 1.73, 95%CI 1.13-2.66). Significant heterogeneity in the effect among ARi was found for falls (D better than E: OR 0.29, 95%CI 0.14-0-60; D better than A: OR 0.48, 95%CI 0.25-0.91); fatigue all grades (D better than E: OR 0.59, 95%CI 0.39-0.88; A better than E: OR 0.61, 95%CI 0.44-0.84) and severe (D Better than E: OR 0.10, 95%CI 0.02-0.60); hypertension (D better than E: OR 0.51, 95%CI 0.27-0.98; A better than E: OR 0.53, 95%CI 0.31-0.92); mental impairment (D better than E: OR 0.15, 95%CI 0.04-0.58; D better than A: OR 0.24, 95%CI 0.06-0.90). No significant heterogeneity was found for other AEs.
Conclusions
With the limitations of the network meta-analysis, our findings suggest that the use of ARi in nmCRPC is associated with a statistically significant increased risk of developing selected AEs according to the type of agent used. Potential specific toxicities should be considered before starting ARi in nmCRPC.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
A. Altavilla: Travel / Accommodation / Expenses: Pfizer; Travel / Accommodation / Expenses: Janssen. M. Di Maio: Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Merck Sharp & Dohme; Honoraria (self): Roche; Honoraria (self): AstraZeneca; Honoraria (self): Janssen; Honoraria (self): Takeda; Research grant / Funding (institution): Tesaro. M. Tucci: Honoraria (self): Astellas; Honoraria (self): Janssen; Honoraria (self): Bayer; Honoraria (self): Sanofi. U. De Giorgi: Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): roche; Advisory / Consultancy, Research grant / Funding (institution): Sanofi; Advisory / Consultancy: Astellas; Advisory / Consultancy: Bayer; Advisory / Consultancy, Travel / Accommodation / Expenses: Bristol Meyer Squibb; Advisory / Consultancy, Travel / Accommodation / Expenses: Ipsen; Advisory / Consultancy, Travel / Accommodation / Expenses: Janssen; Advisory / Consultancy: Merck; Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer. All other authors have declared no conflicts of interest.
Resources from the same session
5579 - Quality of informed consent in clinical trials patients
Presenter: Gianluca Catania
Session: Poster Display session 3
Resources:
Abstract
5147 - Patient's rights: Where do we stand?
Presenter: Maja Kozuh
Session: Poster Display session 3
Resources:
Abstract
1279 - The oncology nurse coordinator’s role in a digestive oncology department: Impact on patient and hospital
Presenter: Fouad Awada
Session: Poster Display session 3
Resources:
Abstract
1670 - Nursing model for a breast cancer unit at the Catalan Institute of Oncology
Presenter: Ana Rodriguez-ortega
Session: Poster Display session 3
Resources:
Abstract
3936 - Role of cancer nurse in the prevention and control of acute deterioration for oncohematologic patient
Presenter: Raquel Azor Portolés
Session: Poster Display session 3
Resources:
Abstract
2789 - Standardized nursing care in the department of radiotherapy of a network of cancer centres
Presenter: José Delgado
Session: Poster Display session 3
Resources:
Abstract
4482 - Exploring anxiety, depression and quality of life of ambulatory cancer patients during chemotherapy.
Presenter: Theodoula Adamakidou
Session: Poster Display session 3
Resources:
Abstract
3075 - Implementing a Cancer Survivorship Program for Individuals with Recurrent Breast Cancer
Presenter: Darcy Burbage
Session: Poster Display session 3
Resources:
Abstract
3869 - The perceptions of parents/guardians regarding their child/adolescent’s experience of reflexology or non-specific foot massage The perceptions of parents/guardians regarding their child/adolescents experience of reflexology or non-specific foot massage
Presenter: Patricia Fox
Session: Poster Display session 3
Resources:
Abstract
4064 - Quality of life in survivors of adult haematological malignancies
Presenter: Anita Immanuel
Session: Poster Display session 3
Resources:
Abstract