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SREs in metastatic prostate cancer

F Saad, C Ivanescu, D Phung, Y Loriot, S Abhyankar, T M Beer, B Tombal, S Holmstrom
BACKGROUND: We investigated the impact of skeletal-related events (SREs) on health-related quality of life (HRQoL) in patients with metastatic castration-resistant prostate cancer (mCRPC) in phase III trials of enzalutamide versus placebo. METHODS: Patients with mCRPC experiencing at least one SRE during AFFIRM and PREVAIL were assessed for trajectory-adjusted mean change in HRQoL by first SRE using Functional Assessment of Cancer Therapy-Prostate (FACT-P; AFFIRM, three domains, and PREVAIL, nine domains) and EQ-5D (PREVAIL) instruments...
January 3, 2017: Prostate Cancer and Prostatic Diseases
Zachary Klaassen, Lauren E Howard, Amanda de Hoedt, Christopher L Amling, William J Aronson, Matthew R Cooperberg, Christopher J Kane, Martha K Terris, Stephen J Freedland
BACKGROUND: Skeletal-related events (SREs) are common complications of bone metastatic castration-resistant prostate cancer (mCRPC). To the authors' knowledge, there are limited data regarding which factors predict SREs. The authors identified risk factors for SREs in men with bone mCRPC using characteristics commonly available in the medical record. METHODS: Data from 454 patients with nonmetastatic CRPC were identified from 2 Veteran Affairs Medical Centers from 2000 through 2013...
December 27, 2016: Cancer
Arif Hussain, Abdalla Aly, C Daniel Mullins, Yi Qian, Jorge Arellano, Eberechukwu Onukwugha
The purpose of this study was to estimate the risk of developing skeletal-related events (SREs) based on site of metastasis at diagnosis and identify other predictors of developing SREs among metastatic prostate cancer patients. We conducted a retrospective cohort study using linked SEER (Surveillance, Epidemiology, and End Results) and Medicare data and identified men over the age of 65 with incident metastatic prostate cancer diagnosed during 2005-2009. SREs included radiation (RAD), pathological fractures (PF), bone surgery (BS), and spinal cord compression (SCC)...
November 2016: Cancer Medicine
Avin Yaldo, Lonnie Wen, Augustina Ogbonnaya, Adriana Valderrama, Jonathan Kish, Michael Eaddy, Charles Kreilick, Krishna Tangirala, Katarzyna Shields
PURPOSE: The development of skeletal-related events (SREs) (pathologic fracture, need for surgery and/or radiation to bone, spinal cord compression, and hypercalcemia of malignancy) in metastatic prostate cancer (MPC) is associated with worsened pain and compromised quality of life. Opioids are frequently used throughout the course of SRE treatment. This study describes the treatment patterns and incremental use of opioids in MPC patients diagnosed with SREs. METHODS: PC patients with bone metastases newly diagnosed with an SRE between January 1, 2005, and September 30, 2014, were identified using MarketScan Commercial and Medicare databases...
August 2016: Clinical Therapeutics
Nicholas James, Sarah Pirrie, Ann Pope, Darren Barton, Lazaros Andronis, Ilias Goranitis, Stuart Collins, Duncan McLaren, Joe O'Sullivan, Chris Parker, Emilio Porfiri, John Staffurth, Andrew Stanley, James Wylie, Sharon Beesley, Alison Birtle, Janet Brown, Prabir Chakraborti, Martin Russell, Lucinda Billingham
BACKGROUND: Bony metastatic castration-refractory prostate cancer is associated with a poor prognosis and high morbidity. TRAPEZE was a two-by-two factorial randomised controlled trial of zoledronic acid (ZA) and strontium-89 (Sr-89), each combined with docetaxel. All have palliative benefits, are used to control bone symptoms and are used with docetaxel to prolong survival. ZA, approved on the basis of reducing skeletal-related events (SREs), is commonly combined with docetaxel in practice, although evidence of efficacy and cost-effectiveness is lacking...
July 2016: Health Technology Assessment: HTA
L E Howard, A M De Hoedt, W J Aronson, C J Kane, C L Amling, M R Cooperberg, M K Terris, C H Divers, A Valderrama, S J Freedland
BACKGROUND: Skeletal-related events (SREs) including pathologic fracture, spinal cord compression, radiation to bone and surgery to bone, are common in men with bone metastatic castration-resistant prostate cancer (mCRPC). Men with mCRPC are at high risk of death. Whether SREs predict mortality is unclear. We tested the association between SREs and overall survival (OS) in a multiethnic cohort with bone mCRPC, controlling for key covariates unavailable in claims data such as bone pain, number of bone metastases and PSA doubling time (PSADT)...
December 2016: Prostate Cancer and Prostatic Diseases
Yunpeng Yang, Yuxiang Ma, Jin Sheng, Yan Huang, Yuanyuan Zhao, Wenfeng Fang, Shaodong Hong, Ying Tian, Cong Xue, Li Zhang
BACKGROUND: Bone metastases are common in patients with advanced cancer. Bisphosphonates (BPs) could prevent or delay the development of skeleton-related events (SREs). The present study aimed to identify the clinical features of and treatment strategies for Chinese patients with bone metastases. METHODS: Consecutive cancer patients who had bone metastases and received BP treatment were enrolled. A questionnaire was developed to collect the patients' clinical data, as well as information on the diagnosis and management of bone metastases...
April 25, 2016: Chinese Journal of Cancer
Joelle El-Amm, Jeanny B Aragon-Ching
Skeletal involvement in metastatic castrate-resistant prostate cancer (mCRPC) is common and results in significant morbidity and mortality. The interaction of prostate cancer with the bone microenvironment contributes to progression of cancer in the bone leading to skeletal-related events (SREs). Studies aimed at targeting the bone have been carried out over the recent years. Bisphosphonates are synthetic pyrophosphate analogs first investigated for their role in SRE prevention with zoledronic acid as the main bisphosphonate that is approved by the US Food and Drug Administration for retardation of skeletal events in men with metastatic prostate cancer...
2016: Clinical Medicine Insights. Oncology
Jean A McDougall, Aasthaa Bansal, Bernardo H L Goulart, Jeannine S McCune, Andy Karnopp, Catherine Fedorenko, Stuart Greenlee, Adriana Valderrama, Sean D Sullivan, Scott D Ramsey
BACKGROUND: Approximately 40% of men diagnosed with metastatic prostate cancer experience one or more skeletal-related events (SREs), defined as a pathological fracture, spinal cord compression, or surgery or radiotherapy to the bone. Accurate assessment of their effect on survival, health care resource utilization (HCRU), and cost may elucidate the value of interventions to prevent SREs. MATERIALS AND METHODS: Men older than age 65 years with prostate cancer and bone metastasis diagnosed between 2004 and 2009 were identified from linked Surveillance Epidemiology and End Results-Medicare records...
March 2016: Oncologist
Yuka Kinoshita, Makoto Arai, Nobuaki Ito, Yuichi Takashi, Noriko Makita, Masaomi Nangaku, Yusuke Shinoda, Seiji Fukumoto
Metastatic bone disease is one of the most common complications of advanced cancers. Pathological fractures, spinal cord compression, and radiotherapy or surgery to the bone are collectively called skeletal-related events (SREs), which cause severe pain, increase hospitalization rates, and impair the quality of life (QOL) of patients with bone metastases. The receptor activator of nuclear factor-kB ligand (RANKL)/RANK pathway is critical in the progression of bone metastases. Previous studies have demonstrated that an anti-RANKL antibody (denosumab) was superior to zoledronic acid in prolonging time to first SRE in patients with bone metastases from prostate and breast cancers...
May 31, 2016: Endocrine Journal
Nicholas D James, Sarah J Pirrie, Ann M Pope, Darren Barton, Lazaros Andronis, Ilias Goranitis, Stuart Collins, Adam Daunton, Duncan McLaren, Joe O'Sullivan, Christopher Parker, Emilio Porfiri, John Staffurth, Andrew Stanley, James Wylie, Sharon Beesley, Alison Birtle, Janet Brown, Prabir Chakraborti, Syed Hussain, Martin Russell, Lucinda J Billingham
IMPORTANCE: Bony metastatic castrate-refractory prostate cancer (CRPC) has a poor prognosis and high morbidity. Zoledronic acid (ZA) is commonly combined with docetaxel in practice but lacks evidence that combining is effective, and strontium-89 (Sr89) is generally used palliatively in patients unfit for chemotherapy. Phase 2 analysis of the TRAPEZE trial confirmed combining the agents was safe and feasible, and the objectives of phase 3 include assessment of the treatments on survival...
April 2016: JAMA Oncology
Louise Perrault, Vincent Fradet, Véronique Lauzon, Jacques LeLorier, Dominic Mitchell, Mohdhar Habib
INTRODUCTION: Metastasis of prostate cancer (PC) to bone (metastatic bone disease, MBD) increases morbidity, but Canadian data are lacking on the associated healthcare resource utilization (HCRU) and costs. We quantified MBD-related HCRU and associated costs in this population, and assessed skeletal-related events (SREs), such as pathologic fracture, spinal cord compression, bone radiotherapy, and bone surgery. METHODS: We conducted a retrospective, population-based cohort study using the Québec health insurance agency database...
September 2015: Canadian Urological Association Journal, Journal de L'Association des Urologues du Canada
Mitsuru Futakuchi, Katsumi Fukamachi, Masumi Suzui
Bone is the most common target organ of metastasis of prostate and breast cancers. This produces considerable morbidity due to skeletal-related events, SREs, including bone pain, hypercalcemia, pathologic fracture, and compression of the spinal cord. The mechanism of bone metastasis is complex and involves cooperative reciprocal interaction among tumor cells, osteoblasts, osteoclasts, and the mineralized bone matrix. The interaction between the metastatic tumor and bone stromal cells has been commonly referred to as the "vicious cycle"...
April 1, 2016: Advanced Drug Delivery Reviews
Cynthia Campbell-Baird, Stacey Harrelson, Georgette Frey, Arun Balakumaran
Antiresorptive therapies are used for the prevention of skeletal-related events (SREs) associated with metastatic bone disease related to breast cancer, prostate cancer, and other solid tumors. This review highlights the central role of nurses in supporting and educating advanced cancer patients regarding the consequences of bone metastases and SREs, including therapy management options. Contemporary clinical journals reporting evidence-based studies were reviewed. SREs associated with bone metastases can significantly impact the quality of life of advanced cancer patients...
December 2015: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
Abdalla Aly, Eberechukwu Onukwugha, Corinne Woods, C Daniel Mullins, Young Kwok, Yi Qian, Jorge Arellano, Arun Balakumaran, Arif Hussain
BACKGROUND: Skeletal related events (SREs) are common in men with metastatic prostate cancer (mPC). Various methods have been used to identify SREs from claims data. The objective of this study was to provide a framework for measuring SREs from claims and compare SRE prevalence and cumulative incidence estimates based on alternative approaches in men with mPC. METHODS: Several claims-based approaches for identifying SREs were developed and applied to data for men aged [greater than or equal to] 66 years newly diagnosed with mPC between 2000 and 2009 in the SEER-Medicare datasets and followed through 2010 or until censoring...
2015: BMC Medical Research Methodology
Benjamin A Gartrell, Robert Coleman, Eleni Efstathiou, Karim Fizazi, Christopher J Logothetis, Matthew R Smith, Guru Sonpavde, Oliver Sartor, Fred Saad
CONTEXT: Skeletal involvement is common in metastatic prostate cancer (PCa) and is associated with skeletal-related events (SREs). The interaction of PCa with the bone microenvironment contributes to self-perpetuating progression of cancer in bone. Bone-targeted agents (BTAs) are available for use in metastatic castration-resistant prostate cancer (mCRPC). OBJECTIVE: To review the biology of bone metastases in PCa and to review the clinical trial data for BTAs in PCa...
November 2015: European Urology
Jean-Jacques Body, Sandra Casimiro, Luís Costa
Bone metastases develop in most patients with metastatic castration-resistant prostate cancer (mCRPC). They affect the structural integrity of bone, manifesting as pain and skeletal-related events (SREs), and are the primary cause of patient disability, reduced quality of life (QOL) and death. Understanding the pathophysiology of bone metastases resulted in the development of agents that improve clinical outcome, suggesting that managing both the systemic disease and associated bone events is important. Historically, the treatment of CRPC bone metastases with early radiopharmaceuticals and external beam radiation therapy was largely supportive; however, now, zoledronic acid and denosumab are integral to the therapeutic strategy for mCRPC...
June 2015: Nature Reviews. Urology
Jinani Jayasekera, Eberechukwu Onukwugha, Kaloyan Bikov, Arif Hussain
Prostate cancer (PCa) outcomes vary widely among African American (AA) and non-Hispanic White (NHW) men. The authors investigated racial variation in the incidence of skeletal-related events (SREs) and SRE-related healthcare costs among AA and NHW men, a topic that has received limited attention in the literature. AA and NHW men diagnosed with metastatic PCa were identified from the linked Surveillance, Epidemiology and End Results-Medicare dataset. The sample included 6455 men with metastatic PCa, including 5420 NHW men and 1035 AA men...
June 2015: Expert Review of Pharmacoeconomics & Outcomes Research
Tilman Todenhöfer, Arnulf Stenzl, Lorenz C Hofbauer, Tilman D Rachner
Maintaining bone health remains a clinical challenge in patients with prostate cancer (PC) who are at risk of developing metastatic bone disease and increased bone loss due to hormone ablation therapy. In patients with cancer-treatment induced bone loss (CTIBL), antiresorptive agents have been shown to improve bone mineral density (BMD) and to reduce the risk of fractures. For patients with bone metastases, both zoledronic acid and denosumab delay skeletal related events (SREs) in the castration resistant stage of disease...
2015: International Journal of Endocrinology
M R Smith, R E Coleman, L Klotz, K Pittman, P Milecki, S Ng, K N Chi, A Balakumaran, R Wei, H Wang, A Braun, K Fizazi
BACKGROUND: In a phase III trial in patients with castration-resistant prostate cancer (CRPC) and bone metastases, denosumab was superior to zoledronic acid in reducing skeletal-related events (SREs; radiation to bone, pathologic fracture, surgery to bone, or spinal cord compression). This study reassessed the efficacy of denosumab using symptomatic skeletal events (SSEs) as a prespecified exploratory end point. PATIENTS AND METHODS: Patients with CRPC, no previous bisphosphonate exposure, and radiographic evidence of bone metastasis were randomized to subcutaneous denosumab 120 mg plus i...
February 2015: Annals of Oncology: Official Journal of the European Society for Medical Oncology
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