221P - Patient-reported sexual and urinary function in nonmetastatic castration-resistant prostate cancer (nmCRPC) when treated with apalutamide (APA) vs placebo (PBO) and ongoing androgen deprivation therapy (ADT) in SPARTAN

Background

SPARTAN is a phase III trial that evaluated the efficacy of APA vs PBO in pts with nmCRPC with a prostate-specific antigen doubling time of ≤ 10 mo. 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 MR, et al. N Engl J Med. 2018) while preserving health-related quality of life (Saad F, et al. Lancet Oncol. 2018). At final analysis, APA significantly improved overall survival and time to chemotherapy vs PBO (Small ASCO 2020). We evaluated sexual and urinary function in SPARTAN.

Methods

A total of 1207 pts were randomized 2:1 to APA (240 mg once daily) or PBO. Sexual and urinary function HRQoL was assessed using Functional Assessment of Cancer Therapy-Prostate (FACT-P) response items collected at baseline and Day 1 of: cycle 1 (pre-dose), cycles 2-6, every 2 cycles from 7 to 13, every 4 treatment cycles thereafter, end of treatment, and every 4 months post progression for up to 1 year. Each cycle was 28 d. Descriptive statistics are reported. At each cycle, the number of patients with stable and improved FACT-P scores were summed; mean percentage (range) for APA and PBO were calculated separately.

Results

Median follow-up was 52 mo; median treatment durations were 32.9 mo (APA) and 11.5 mo (PBO). At each cycle, > 90% of all eligible pts completed the questionnaire. Patients receiving APA generally reported stable or improved sexual and urinary function over time during treatment (table). Compared with PBO, a slightly larger proportion of APA-treated patients maintained erectile and urinary functioning compared with baseline or showed improvement over time.

Conclusions

Health-related quality of life data from SPARTAN indicate that baseline sexual and urinary function in pts with nmCRPC is preserved during APA + ADT therapy. Table: 221P

^aBaseline data for GS7 and BL5 includes “a little bit,” “somewhat,” “quite a bit,” or “very much”; baseline data for P7, BL2, and P8 includes “not at all.”

Clinical trial identification

SPARTAN: NCT01946204.

Editorial acknowledgement

William Turner, PhD Parexel International.

Legal entity responsible for the study

Janssen Research and Development.

Funding

Janssen Research and Development.

Disclosure

H. Uemura: Honoraria (self), Advisory/Consultancy: Astellas; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Bayer; Advisory/Consultancy, Research grant/Funding (institution): Chugai; Honoraria (self), Research grant/Funding (institution): FRI-Toyama chem; Honoraria (self), Advisory/Consultancy, Leadership role, Travel/Accommodation/Expenses: Janssen; Honoraria (self), Research grant/Funding (institution): Kyowa-Kirin; Honoraria (self), Research grant/Funding (institution): Sanofi; Research grant/Funding (institution): Taiho; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Takeda. 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; 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 Center; Advisory/Consultancy: Research Triangle Institute; Advisory/Consultancy: Sivan Healthcare. 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: JohnsonJohnson. P. De Porre: Full/Part-time employment: Janssen; Shareholder/Stockholder/Stock options: JohnsonJohnson. K. Bevans: Full/Part-time employment: Janssen; Shareholder/Stockholder/Stock options: JohnsonJohnson. J. Trudeau: Full/Part-time employment: Janssen; Shareholder/Stockholder/Stock options: Johnson & Johnson. 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. 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. All other authors have declared no conflicts of interest.