Abstract 2134
Background
Androgen deprivation therapy (ADT) for prostate cancer (PC) increases fracture risk. In non-cancer populations, FRAX, a fracture risk assessment tool, is used routinely to calculate 10-year probability of major osteoporotic fracture (MOF; spine/hip/forearm/humeral fractures) and hip fracture alone to determine the need for bone density (BMD) assessment and/or treatment. We calculated FRAX using risk factors at entry to the large STAMPEDE PC study.
Methods
STAMPEDE includes men with newly diagnosed metastatic/high risk non-metastatic PC about to commence ADT, randomised to add or substitute other therapies. Our pre-planned analysis included 6379 men, 86% of enrolment at the time of analysis (2018) for whom FRAX clinical risk factors (excluding femoral neck BMD) were collected prospectively. Secondary osteoporosis in FRAX was set to ‘yes’ for all, as they were about to receive ADT. Glucocorticoid use was set to ‘yes’ for men allocated to abiraterone due to potentially long concomitant use, but not for those allocated shorter treatment with docetaxel.
Results
Baseline characteristics for this largest dataset of its kind, are shown below. The mean (SD) baseline FRAX 10-year probability was 3.06(2.96)% for hip fracture and 8.70(4.02)% for MOF. Risk increased with increased age at entry, eg MOF probability at age 50-54 years was 4.9% rising to 11.3% in those aged 75 years or older. Using UK National Osteoporosis Guideline Thresholds, 2221 (34.8%) men were classified as high/intermediate risk (meriting BMD scan).The need for BMD assessment varied across planned treatment arms (18.4% in men receiving ADT only to 80.0% in men also planned to receive abiraterone).Table:
857P
Characteristic | |
---|---|
Randomisation years | 2006- 2018 |
Age (y) | 67.4±7.2 |
Height (cm) | 174.7±6.9 |
Weight (kg) | 85.6±14.8 |
BMI (kg/m2) | 28.0±4.5 |
Prevalence of FRAX risk factors (%) Previous fracture after age 50yr | 6.1 |
Glucocorticoid use (≥4 mo) | 27.4 |
Parental hip fracture | 7.7 |
Rheumatoid arthritis | 2.4 |
Alcohol (≥3 units daily) | 15.5 |
Current smoking | 11.5 |
Conclusions
FRAX fracture risk assessment in men starting ADT suggests 1 in 3 require BMD assessment to decide on the need for bone protection. Planned treatment in addition to ADT, rather than age, was the main determinant for consideration of bone health.
Clinical trial identification
2004-000193-31.
Editorial acknowledgement
Legal entity responsible for the study
University of Sheffield.
Funding
University of Sheffield.
Disclosure
J.E. Brown: Honoraria (self), Research grant / Funding (institution): Amgen; Honoraria (self), Research grant / Funding (institution): Novartis; Honoraria (self), Research grant / Funding (institution): Bayer; Honoraria (self): BMS; Honoraria (self): Daiichi-Sankyo; Honoraria (self): Ipsen; Honoraria (self): Sandoz; Honoraria (self): Merck Sharpe Dome. All other authors have declared no conflicts of interest.
Resources from the same session
5043 - Comprehensive results of a Phase Ib study with a HER2/neu B-cell peptide vaccine administered with cisplatin and 5-fluorouracil or capecitabine chemotherapy show safety, immunogenicity and clinical response in patients with HER2/Neu overexpressing advanced gastric cancer
Presenter: Ursula Wiedermann
Session: Poster Display session 3
Resources:
Abstract
4506 - Single intravenous preoperative administration of the oncolytic virus Pexa-Vec to prime anti-tumor immunity
Presenter: Adel Samson
Session: Poster Display session 3
Resources:
Abstract
1631 - Randomized phase 2 clinical trial of NY-ESO-1 protein vaccine combined with cholesteryl pullulan (CHP-NY-ESO-1) in resected esophageal cancer patients
Presenter: Shinichi Kageyama
Session: Poster Display session 3
Resources:
Abstract
4244 - T cell repertoire sequencing reveals dynamics of response to dendritic cell vaccine plus dasatinib for checkpoint blockade resistant metastatic melanoma
Presenter: Luca Quagliata
Session: Poster Display session 3
Resources:
Abstract
5791 - Ixovex, a novel oncolytic E1B-mutated adenovirus
Presenter: Mohiemen Anwar
Session: Poster Display session 3
Resources:
Abstract
4170 - Anti-CSPG4 DNA vaccination as a promising strategy for the treatment of CSPG4+ tumors: a comparative oncology trial
Presenter: Federica Riccardo
Session: Poster Display session 3
Resources:
Abstract
5780 - Antitumor activity, immunogenicity and safety of a novel PD-1 vaccine in combination with two chimeric HER-2 peptide vaccine in syngeneic Balb/c, C57Bl/6 models and in beagle dogs
Presenter: Pravin Kaumaya
Session: Poster Display session 3
Resources:
Abstract
5860 - Maternal immunization against ALK as a weapon to fight neuroblastoma
Presenter: Giuseppina Barutello
Session: Poster Display session 3
Resources:
Abstract
4720 - Phase 1 study evaluating safety, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of ABBV-428, first-in-class mesothelin (MSLN)-CD40 bispecific, in patients (pts) with advanced solid tumors
Presenter: Jason Luke
Session: Poster Display session 3
Resources:
Abstract
5717 - Anti-PD-L1/IL-15 fusion protein generates robust adaptive immune gene signatures in tumors leading to tumor inhibition and memory responses
Presenter: Stella Martomo
Session: Poster Display session 3
Resources:
Abstract