Abstract 221P
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
Fact-P item | Favorable responses at baseline,a % | Mean % stable or improved (range across cycles) | ||
APA + ADT | PBO + ADT | APA + ADT | PBO + ADT | |
GS7: I am satisfied with my sex life | 19 | 23 | 43 (41-46) | 46 (44-48) |
BL5: I am able to have and keep an erection | 15 | 14 | 86 (84-88) | 82 (76-88) |
P7: I have difficulty urinating | 61 | 61 | 83 (79-87) | 77 (70-84) |
BL2: I urinate more frequently than usual | 27 | 26 | 74 (70-78) | 71 (65-77) |
P8: My problems with urinating limit my activities | 60 | 60 | 78 (73-81) | 75 (68-85) |
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.
Resources from the same session
67TiP - HER2CLIMB-02: A randomized, double-blind, phase III study of tucatinib or placebo with T-DM1 for unresectable locally-advanced or metastatic HER2+ breast cancer
Presenter: Norikazu Masuda
Session: e-Poster Display Session
68TiP - KEYLYNK-009: A phase II/III, open-label, randomized study of pembrolizumab (pembro) + olaparib (ola) vs pembro + chemotherapy after induction with first-line (1L) pembro + chemo in patients (pts) with locally recurrent inoperable or metastatic TNBC
Presenter: Shigehira Saji
Session: e-Poster Display Session
69TiP - MADELINE Asia: A mobile app-based prospective observational study of patient reported outcomes in advanced breast cancer in Asia
Presenter: Anna Tai
Session: e-Poster Display Session
113TiP - Prospective observational study monitoring circulating tumour DNA in resectable colorectal cancer patients undergoing radical surgery: GALAXY study in CIRCULATE-Japan
Presenter: Hiroki Yukami
Session: e-Poster Display Session
195TiP - GLOW: Phase III study of first-line zolbetuximab + CAPOX versus placebo + CAPOX in Claudin18.2⁺/HER2⁻ advanced/metastatic gastric or gastroesophageal junction adenocarcinoma (G/GEJ)
Presenter: Rui-Hua Xu
Session: e-Poster Display Session
196TiP - Perioperative sintilimab in combination with concurrent chemoradiotherapy for patients with locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma
Presenter: Jia Wei
Session: e-Poster Display Session
197TiP - A randomized, double-blind, phase III study of pembrolizumab plus chemotherapy as first-line therapy in patients with HER2-negative, advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: KEYNOTE-859
Presenter: Shukui Qin
Session: e-Poster Display Session
198TiP - SPOTLIGHT: Phase III study of zolbetuximab + mFOLFOX6 versus placebo + mFOLFOX6 in first-line Claudin18.2⁺/HER2⁻ advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (G/GEJ)
Presenter: Kohei Shitara
Session: e-Poster Display Session
233TiP - Pembrolizumab (pembro) or placebo added to docetaxel and prednisone/prednisolone for metastatic castration-resistant prostate cancer (mCRPC) previously treated with next-generation hormonal agents (NHAs): KEYNOTE-921 phase III study
Presenter: Daniel Petrylak
Session: e-Poster Display Session
254TiP - ENGOT-cx11/KEYNOTE-A18: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab With Chemoradiotherapy in Patients With High-Risk Locally Advanced Cervical Cancer
Presenter: Domenica Lorusso
Session: e-Poster Display Session