^

Association details:

Biomarker:
No biomarker
Direction:
Sensitive

Evidence:

Evidence Level:
Sensitive: A1 - Approval
Title:
apalutamide (Erleada®) is not recommended for use within NHSScotland
Published date:
12/04/2020
Excerpt:
"CONTRADICTING EVIDENCE: apalutamide (Erleada®) is not recommended for use within NHSScotland....in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy."
Evidence Level:
Sensitive: A1 - Approval
Excerpt:
Erleada is indicated:...in adult men for the treatment of non metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease...in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).
Evidence Level:
Sensitive: A1 - Approval
Source:
Excerpt:
ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with...metastatic castration-sensitive prostate cancer….non-metastatic castration-resistant prostate cancer.
Evidence Level:
Sensitive: A2 - Guideline
Source:
Excerpt:
Apalutamide [ESMO-MCBS v1.1 score: 3], darolutamide [ESMO-MCBS v1.1 score: 3] or enzalutamide [ESMOMCBS v1.1 score: 3] should be considered as options for men with M0 (on bone scan and CT) CRPC and a high risk of disease progression [I, B].
Evidence Level:
Sensitive: A2 - Guideline
Source:
Excerpt:
Apalutamide is a category 1 option for patients with M1 castration-naive prostrate cancer.
Evidence Level:
Sensitive: B - Late Trials
New
Title:
Apalutamide in Patients With Metastatic Castration-Sensitive Prostate Cancer: Final Survival Analysis of the Randomized, Double-Blind, Phase III TITAN Study
Published date:
04/29/2021
Excerpt:
Compared with placebo, apalutamide plus ADT significantly reduced the risk of death by 35%...and by 48% after adjustment for crossover....The final analysis of TITAN confirmed that, despite crossover, apalutamide plus ADT improved OS, delayed castration resistance...
DOI:
10.1200/JCO.20.03488
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:
632P - Health-related quality of life (HRQoL) at final analysis of the SPARTAN study of apalutamide (APA) vs placebo (PBO) in patients (pts) with non-metastatic castration-resistant prostate cancer (nmCRPC) receiving androgen deprivation therapy (ADT)
Published date:
09/14/2020
Excerpt:
HRQoL was assessed using Functional Assessment of Cancer Therapy-Prostate (FACT-P) and EQ-5D-3L at baseline….Pts were minimally symptomatic, with good HRQoL at baseline...The APA group generally maintained favorable scores for FACT-P (total and subscales) and EQ-5D-3L, while PBO group scores tended to decline over time....Longer term SPARTAN data confirmed APA + ADT improved MFS and OS in pts with nmCRPC while preserving HRQoL, whereas HRQoL of pts receiving PBO + ADT declined after ∼1 y.
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:
Apalutamide and Overall Survival in Prostate Cancer
Published date:
09/06/2020
Excerpt:
Median OS was markedly longer with apalutamide versus placebo, reaching prespecified statistical significance (73.9 vs 59.9 mo, hazard ratio [HR]: 0.78 [95% confidence interval {CI}, 0.64-0.96]; p=0.016).
DOI:
10.1016/j.eururo.2020.08.011
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:
Efficacy and safety of apalutamide in Japanese patients with nonmetastatic castration-resistant prostate cancer: a subgroup analysis of a randomized, double-blind, placebo-controlled, Phase-3 study
Published date:
05/28/2020
Excerpt:
In the Japanese subpopulation, treatment with apalutamide with ADT resulted in favorable efficacy outcomes with comparable benefit-risk profile to the global population with nm-CRPC who are at high-risk of developing metastases.
Secondary therapy:
Hormone Therapy
DOI:
10.1016/j.prnil.2020.05.002
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