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
4692 - Immune cell biomarkers on neo-adjuvant chemo-immunotherapy treatment for resectable stage IIIA NSCLC patients
Presenter: Raquel Laza-Briviesca
Session: Poster Display session 3
Resources:
Abstract
1707 - Clinical utility of precision immunoprofiling and monitoring of the tumor microenvironment using flow cytometry and CyTOF in patients with advanced NSCLC treated with atezolizumab: results from a phase II study for biomarker analysis (EPOC1702)
Presenter: Keisuke Kirita
Session: Poster Display session 3
Resources:
Abstract
3594 - Tumor mutation burden (TMB), PD-L1, IFN-γ signaling identify subgroups of patients (pts) who benefit from durvalumab (D, anti-PDL1) or D and tremelimumab (T, anti-CTLA4) treatment in urothelial bladder cancer (UC)
Presenter: Christophe Massard
Session: Poster Display session 3
Resources:
Abstract
744 - The decrease of TMB, TNB and HLA expression are the Mechanism of Drug Resistance of NSCLC to immunosuppressive PD-1/PD-l1.
Presenter: Sheng Yu
Session: Poster Display session 3
Resources:
Abstract
2350 - Eosinophilia during treatment of immune checkpoint inhibitors (ICIs) predicts succeeding onset of immune-related adverse events (irAEs)
Presenter: Rika Kizawa
Session: Poster Display session 3
Resources:
Abstract
5930 - A transcriptomic immunologic signature predicts favorable outcome in neoadjuvant chemotherapy treated triple negative breast tumors.
Presenter: Javier Pérez-peña
Session: Poster Display session 3
Resources:
Abstract
6127 - Alterations of TMB and TCR repertoires during Chemotherapy in East Asian lung cancer patients without TKI-related driver gene mutations
Presenter: Lele Song
Session: Poster Display session 3
Resources:
Abstract
1310 - Association of SCFA in gut microbiome and clinical response in solid cancer patients treated with andi-PD-1 antibody.
Presenter: Motoo Nomura
Session: Poster Display session 3
Resources:
Abstract
2286 - Extracellular matrix and tissue derived metabolites in a liquid biopsy identifies endotypes of metastatic melanoma patients with differential response to immune checkpoint inhibitor treatment
Presenter: Nicholas Willumsen
Session: Poster Display session 3
Resources:
Abstract
4107 - Pathologic scoring of pre-treatment H&E biopsies predicts overall survival in patients with metastatic clear cell renal cell carcinoma receiving nivolumab monotherapy
Presenter: Julie Stein
Session: Poster Display session 3
Resources:
Abstract