2911 - Health-Related Quality of Life (HRQoL) After Progressive Disease (PD) in SPARTAN: a Phase 3 Trial of Apalutamide (APA) Versus Placebo (PBO) in Men with Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC)

Background

Compared with PBO, APA prolongs the median metastasis-free survival (MFS) by > 2 y (HR = 0.30; 95% CI, 0.24-0.36), and provids a 55% reduction in the risk of symptomatic progression (Sx PD) (HR = 0.45; 95% CI, 0.32-0.63) in patients (pts) with nmCRPC (SPARTAN study, Smith MR, et al. NEJM 2018), with no decline in HRQoL in either treatment group up to the time of developing distant metastases (Mets). Here, we report pt HRQoL following PD.

Methods

1207 pts (median age, both arms: 74 y) with nmCRPC were randomized 2:1 to APA (240 mg QD) or PBO. ADT was continued in all pts. HRQoL was assessed using the pt-reported outcome (PRO) questionnaire Functional Assessment of Cancer Therapy-Prostate (FACT-P). Following development of Mets, pts in the 2 arms received similar treatments, and PROs were collected at 4, 8, and 12 mo. Sx PD was defined as 1) development of a skeletal-related event; 2) initiation of new systemic anticancer treatment due to pain progression or worsening of disease-related symptoms; or 3) development of clinically significant symptoms due to loco-regional tumor progression requiring surgery or radiation. Descriptive statistics were performed for all FACT-P subscales.

Results

Group mean PRO scores after PD were available from 341 pts and from 60 pts after Sx PD (Table). These PRO scores were similar for APA vs PBO up to 12 mo after PD. While APA delayed time to Sx PD, once Sx PD was reached there were similar numeric decreases from baseline across FACT-P subdomains up to 12 mo after Sx PD.Table: 804P

PRO group mean scores

^aIncludes pts with and without subsequent approved treatment for metastatic CRPC. SE, standard error.

Conclusions

Relative to PBO, pts treated with APA had a longer MFS, with no decline in HRQoL through the time of Mets, and similar HRQoL after Mets. Sx PD was delayed with APA vs PBO and was associated with a decline in HRQoL in both groups. Thus, HRQoL decline for pts treated with APA was delayed because of a longer time to Sx PD.

Clinical trial identification

NCT01946204.

Legal entity responsible for the study

Janssen Research & Development.

Funding

Janssen Research & Development.

Editorial Acknowledgement

This study was funded by Janssen Research & Development. Writing assistance was provided by Ann Tighe, PhD, of PAREXEL, and was funded by Janssen Global Services, LLC.

Disclosure

D. Cella: Consultant: AbbVie, Astellas, Bayer, Bristol-Myers Squibb, Daiichi Sankyo, Inc, Evidera, GlaxoSmithKline, Helsinn, Ipsen, Janssen Research & Development, Novartis; President: FACIT.org. F. Saad: Grants, Personal fees, Non-financial support: Janssen, Astellas, Sanofi, Bayer. B.A. Hadaschik: Grants: German Cancer Aid, German Research Foundation, Profound Medical; Grants Janssen, Uromed; Personal fees: Janssen, Astellas, Bayer, Uromed; Non-financial support: Janssen, Astellas, Bayer. J.N. Graff: Grants: Janssen, Sanofi, Astellas, Merck Bristol-Myers Squibb; Personal fees: Janssen, Sanofi, Astellas, Bayer, Dendreon. H. Uemura: Personal fees: Janssen, Astellas, Takeda, Sanofi, Bayer, and Astra-Zeneca. S. Oudard: Personal fees: Janssen, Sanofi, Astellas, Bayer, Merck. S. Hudgens: Consulting fees: Janssen. K. McQuarrie, M.K. Yu, A. Lopez-Gitlitz, B. Rooney: Employee: Janssen Research & Development; Stock owner: Johnson & Johnson. M. Morris: Consulting fees: Janssen. M.R. Smith: Grants: Janssen; Personal fees: Janssen, Astellas, Bayer. All other authors have declared no conflicts of interest.