J.J. Body

Abstract P3-07-45: Bone turnover marker levels and clinical outcomes in patients with breast cancer and bone metastases treated with bone antiresorptive therapies

INTRODUCTION AND OBJECTIVES : Patients with advanced breast cancer (BC) and metastatic bone disease typically have elevated serum levels of bone turnover markers (BTMs). Potent antiresorptive agents, such as denosumab and zoledronic acid, can significantly reduce BTM levels (Stopeck et al. J Clin Oncol 2010). Prior studies have provided evidence that higher BTM baseline levels may be associated with worse clinical outcomes (Ali et al. Ann Oncol 2004). In this analysis, we assessed the association between BTM levels after treatment with antiresorptive agents and overall survival (OS), disease progression (DP) and disease progression in the bone (DPB) in patients with advanced BC and bone metastases. METHODS : This post-hoc analysis included data from patients with BC and bone metastases enrolled in an international, blinded phase 3 trial who were randomized to receive either denosumab (120 mg SC) or zoledronic acid (4 mg IV, adjusted for creatinine clearance). The BTMs urinary N-telopeptide (uNTx) and bone-specific alkaline phosphatase (BSAP) were measured at study entry and at study month 3. The clinical outcomes of OS, DP, and DPB were compared in patients with BTMs above or below median levels at month 3 of antiresorptive therapy. These covariate analyses were based on Cox models stratified by treatment, prior SRE before month 3, prior bisphosphonate use, chemotherapy at randomization, and region (Japan or other countries). RESULTS : A total of 1705 patients were measured for uNTx serum levels, with 895 patients ≥ and 810 2 bone metastases, the correlation between elevated BTMs and reduced OS and greater risk of DP and DPB was maintained. CONCLUSIONS : Patients with BTM levels ≥ median at month 3 of antiresorptive therapy had generally worse clinical outcomes than patients whose BTM levels were Citation Format: Lipton A, Stopeck A, Body J-J, Von Moos R, De Boer R, Paiva Gadelha Guimaraes A, Tonkin K, Fujiwara Y, Zhu L, Warner D. Bone turnover marker levels and clinical outcomes in patients with breast cancer and bone metastases treated with bone antiresorptive therapies. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P3-07-45.

Bone Pain And Bone Targeting Agent (Bta) Treatment Pattern In Patients With Bone Metastases (Bms) From Prostate Cancer (Pc) In Real World Setting In Europe.

Objectives: To examine bone pain and BTA utilization in patients with BMs from PC in real-world setting in Europe. Methods: This study was conducted using the Adelphi Prostate Cancer Disease Specific Programme (DSP) 2015 database, a multi-country cross-sectional survey of 241 oncologists and 103 urologists in 6 European countries (UK, Germany, France, Italy, Spain, and Belgium). Patients’ current pain state, current analgesic use, BTA treatment, and reasons for BTA treatment data were extracted from the patient record forms (PRFs) completed by the physicians. Results: A total of 3608 PRFs were collected including 1931 on PC patients with BMs. At the time of survey (an average of 15.2 months from BMs diagnosis), 41% patients experienced mild pain; and 29% had moderate/severe bone pain. The majority of the patients (96%) with pain took analgesics to manage pain, including 29% (n=387) patients who were treated with strong opioids (e.g. morphine, oxycodone etc.). Of these patients, 73% (284/387) still had moderate/severe pain. Among the patients with BMs, 74% (n=1437) were treated with a BTA, and BTA treatment occurred within 3 months of BMs diagnosis in 72% (n=1036) of them. Reasons for BTA treatment initiation within 3 months of BMs were “bone pain” (40%), “high risk of bone complications” (29%), “number of BMs” (11%), “location of BMs” (8%) and “prior history of bone complications” (5%). Reasons for not treating patients with BTA were “recent diagnosis” (36%), “low bone complication risk” (22%), and “focus on treating primary tumor” (8%). Conclusions: Bone pain is the major symptom encountered by patients with BMs from PC. The majority of these patients treated with strong opioids still experienced moderate/severe bone pain. Approximately three quarters of patients with BMs received BTAs; primary treatment goals were reductions of the risk of bone complications and associated bone pain.