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Found 2 Presentations For Request "Abs: 632P"
632P - Health-related quality of life (HRQoL) at final analysis of the SPARTAN study of apalutamide (APA) vs placebo (PBO) in patients (pts) with non-metastatic castration-resistant prostate cancer (nmCRPC) receiving androgen deprivation therapy (ADT)
- Stephane Oudard (Paris, France)
Abstract
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
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:
1165P - Subgroup analysis by Ki-67 and primary tumour origins of the randomized, placebo-controlled phase III study of surufatinib in advanced well-differentiated extrapancreatic neuroendocrine tumours (SANET-ep)
- Zhiwei Zhou (Guangzhou, China)
Abstract
Background
Surufatinib, a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptors (1,2,3), fibroblast growth factor receptor 1 and colony stimulating factor 1 receptor, has demonstrated superior efficacy in extrapancreatic neuroendocrine tumors (NETs) in a phase III study (SANET-ep, ESMO 2019 Abs. LBA76). The proliferation marker Ki-67 and primary tumor origins are the major prognostic factors in NETs.
Methods
The post-hoc efficacy analysis of surufatinib versus placebo was conducted by Ki-67 subcategory (<3%, 3-10%, >10%) and primary tumor origins (foregut, midgut, hindgut, others or unknown) in patients (pts) with advanced well-differentiated (grade 1 or 2) extrapancreatic NETs. The primary endpoint (progression-free survival [PFS]) and secondary endpoint (objective response rate [ORR]) both by investigator assessment (RECIST1.1) were analyzed.
Results
Median PFS was significantly prolonged with surufatinib compared to placebo in subgroups of Ki-67 3-10% (7.6 vs 4.6 months [mo], hazard ratio [HR] 0.47,
Conclusions
Surufatinib demonstrated clinically significant benefits for pts with advanced well-differentiated extrapancreatic NETs compared to placebo. Results of this exploratory analysis were consistent with those reported for the SANET-ep primary analysis, and improved outcomes were observed across major subgroups.
Clinical trial identification
NCT02588170.
Legal entity responsible for the study
Hutchison MediPharma Limited.
Funding
Hutchison MediPharma Limited.
Disclosure
J. Li, J. He: Full/Part-time employment: Hutchison MediPharma Limited. W. Su: Shareholder/Stockholder/Stock options, Full/Part-time employment: Hutchison MediPharma Limited. All other authors have declared no conflicts of interest.