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
372P - Treatment patterns and outcomes in stage III non-small cell lung cancer (NSCLC): Real-world experience in Singapore from the KINDLE study
Presenter: Ross A. Soo
Session: e-Poster Display Session
373P - Chromatin accessibility reveals potential prognostic value of the peak set associated with smoking history in patients with lung adenocarcinoma
Presenter: Jianlian Deng
Session: e-Poster Display Session
384P - BLU-945, a highly potent and selective 4th generation EGFR TKI for the treatment of EGFR T790M/C797S resistant NSCLC
Presenter: Stefanie Schalm
Session: e-Poster Display Session
385P - Patient reported outcomes (PROs) analysis for patients with ROS1 fusion-positive (ROS1+) non-small cell lung cancer (NSCLC) receiving entrectinib in the global phase II STARTRK-2 study
Presenter: Fabrice Barlesi
Session: e-Poster Display Session
386P - A single-arm phase Ib study of autologous cytokine-induced killer (CIK) cell immunotherapy in combination with sintilimab plus chemotherapy in patients with advanced non-small cell lung cancer (NSCLC)
Presenter: LI Zhou
Session: e-Poster Display Session
387P - Phase Ib study of savolitinib ± osimertinib in Japanese patients (pts) with advanced solid malignancies & EGFRm NSCLC: TATTON part C
Presenter: Tomonori Hirashima
Session: e-Poster Display Session
388P - Biosimilar TAB008 compared with bevacizumab in advanced non-squamous, non-small cell, EGFR wildtype lung cancer patients
Presenter: Zhen Zhou
Session: e-Poster Display Session
389P - Updated analysis from the KEYNOTE-042 China study: 1L pembrolizumab (pembro) vs chemotherapy (chemo) in Chinese patients (pts) with advanced NSCLC with PD-L1 TPS ≥1%
Presenter: Yi-Long Wu
Session: e-Poster Display Session
391P - Economic impact of next-generation sequencing (NGS) versus single-gene testing modalities to detect genomic alterations (GAs) in metastatic non-small cell lung cancer (mNSCLC) in Asia
Presenter: Herbert Loong
Session: e-Poster Display Session
392P - Clinical data from the real world: Efficacy analysis of ceritinib (450mg) in ALK-positive non-small cell lung cancer patients with brain metastases in China
Presenter: Zhixin Qiu
Session: e-Poster Display Session