Abstract 632P
Background
The phase III SPARTAN study evaluated APA vs PBO in pts with nmCRPC who had prostate-specific antigen doubling time of ≤ 10 mo and were receiving ongoing ADT. At primary analysis, APA significantly improved metastasis-free survival and extended time to metastasis, progression-free survival, and time to symptomatic progression vs PBO (Smith NEJM 2018) while preserving HRQoL (Saad Lancet Oncol 2018). At final analysis, APA significantly improved overall survival and time to chemotherapy vs PBO (Small ASCO 2020). We evaluated HRQoL in SPARTAN after longer follow-up.
Methods
1207 nmCRPC pts were randomized 2:1 to APA (240 mg QD) or PBO. HRQoL was assessed using Functional Assessment of Cancer Therapy-Prostate (FACT-P) and EQ-5D-3L at baseline and Day 1 of: cycle 1 (pre-dose), cycles 2-6, every 2 cycles from 7 to 13, and every 4 cycles thereafter during treatment, end of treatment, and every 4 months post progression for up to 1 year. Each cycle was 28 d. Descriptive statistics and least squares mean changes from baseline using mixed model for repeated measures (LSM-MMRM) are reported. No adjustment for multiplicity was made.
Results
With 52 mo follow-up, median treatment durations were 32.9 mo (APA) and 11.5 mo (PBO). Pts were minimally symptomatic, with good HRQoL at baseline. At each cycle, > 90% of pts in each group completed questionnaires. Per LSM-MMRM, change in FACT-P total score from baseline to cycles 21 and 25 significantly favored APA vs PBO (p = 0.0138 and 0.0009, respectively). 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 (separation between APA and PBO started at cycles 11-15 and was more pronounced by cycles 21-25). Of note, responses to individual items on FACT-P indicated most pts were “not at all bothered” by side effects and bother did not increase over time with APA or PBO.
Conclusions
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.
Clinical trial identification
NCT01946204.
Editorial acknowledgement
Tamara Fink, PhD, of Parexel International provided editorial assistance for this abstract.
Legal entity responsible for the study
Janssen Research & Development.
Funding
Janssen Research & Development.
Disclosure
S. Oudard: Honoraria (self), Advisory/Consultancy: Astellas; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bayer; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Eisai; Research grant/Funding (self): Ipsen; Honoraria (self), Advisory/Consultancy: Janssen; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Merck Sharp & Dohme; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Sanofi. B.A. Hadaschik: Honoraria (self), Advisory/Consultancy: ABX; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Astellas; Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy: Bayer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Bristol-Myers Squibb; Research grant/Funding (self): German Cancer Aid; Research grant/Funding (self): German Research Foundation; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Janssen; Honoraria (self), Advisory/Consultancy: Lightpoint Medical; Honoraria (self), Advisory/Consultancy: Pfizer. F. Saad: Honoraria (self): AbbVie; Honoraria (self): Amgen; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Astellas; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca/MedImmune; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Bayer; Research grant/Funding (institution): Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Janssen; Research grant/Funding (institution): Pfizer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Sanofi. D. Cella: Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): Amgen; Honoraria (self), Research grant/Funding (institution): Astellas; Research grant/Funding (institution): AstraZeneca; Honoraria (self), Research grant/Funding (institution): Bristol-Myers Squibb; Research grant/Funding (institution): Clovis; Officer/Board of Directors: FACIT.org; Honoraria (self), Research grant/Funding (institution): GlaxoSmithKline; Research grant/Funding (institution): Janssen; Honoraria (self), Research grant/Funding (institution): Novartis; Honoraria (self), Research grant/Funding (institution): Pfizer. E. Basch: Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: CareVive Systems; Advisory/Consultancy: Dana-Farber Cancer Institute; Officer/Board of Directors: Journal of the American Medical Association; Advisory/Consultancy: Memorial Sloan Kettering Cancer Centers; Advisory/Consultancy: Research Triangle Institute; Advisory/Consultancy: Sivan Healthcare. P.N. Mainwaring: Honoraria (self), Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Astellas; Honoraria (self), Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Ipsen; Honoraria (self), Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Janssen; Honoraria (self), Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Medivation; Research grant/Funding (self): Merck KGaA; Honoraria (self), Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Merck Sharp & Dohme; Honoraria (self), Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche/Genentech; Shareholder/Stockholder/Stock options: Xing Technologies. J.N. Graff: Honoraria (self), Research grant/Funding (institution): Astellas; Honoraria (self), Travel/Accommodation/Expenses: Bayer; Research grant/Funding (institution): Bristol-Myers Squibb; Travel/Accommodation/Expenses: Clovis Oncology; Advisory/Consultancy: Exelixis; Honoraria (self), Research grant/Funding (institution): Janssen; Honoraria (self), Research grant/Funding (institution): Medivation; Research grant/Funding (institution), Travel/Accommodation/Expenses: Merck Sharp & Dohme; Licensing/Royalties: Oncoresponse: Exceptional Responders; Research grant/Funding (institution), Travel/Accommodation/Expenses: Sanofi. S. Dibaj: Full/Part-time employment: Janssen; Shareholder/Stockholder/Stock options: Johnson & Johnson. S. Li: Full/Part-time employment: Janssen; Shareholder/Stockholder/Stock options: Johnson & Johnson. S.D. Brookman-May: Full/Part-time employment: Janssen; Shareholder/Stockholder/Stock options: Johnson & Johnson. P. De Porre: Full/Part-time employment: Janssen; Shareholder/Stockholder/Stock options: Johnson & Johnson. J.J. Trudeau: Full/Part-time employment: Janssen; Shareholder/Stockholder/Stock options: Johnson & Johnson. E.J. Small: Advisory/Consultancy, Shareholder/Stockholder/Stock options: Fortis; Shareholder/Stockholder/Stock options: Harpoon Therapeutics; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Janssen; Research grant/Funding (self): Merck Sharp & Dohme. M.R. Smith: Advisory/Consultancy, Travel/Accommodation/Expenses: Amgen; Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Bayer; Research grant/Funding (self): Gilead; Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Janssen; Advisory/Consultancy, Travel/Accommodation/Expenses: Lilly; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pfizer.