Abstract
Purpose
Three bone-targeted agents (BTAs) are approved in the USA for prevention of bone complications among solid tumor patients with bone metastases: two intravenous bisphosphonates (IV BP) (pamidronate and zoledronic acid), and one subcutaneous receptor activator of nuclear factor-kappaB (RANK) ligand inhibitor (denosumab). Using electronic medical record data from outpatient community and hospital-affiliated oncology clinics, we examined the characteristics of patients who initiated treatment with a BTA in 2011 and followed them for a maximum of 12 months.
Methods
Adult patients with bone metastasis secondary to solid tumors newly treated with a BTA during 2011 were identified from the Oncology Services Comprehensive Electronic Records (OSCER) database. We examined patient characteristics at BTA initiation, treatment patterns, and compliance during a 12-month period. Sensitivity analyses were performed in a subgroup of patients who had confirmed 12 months of follow-up data.
Results
Denosumab patients (N = 1,594) were older (65 % ≥65 years vs. 60 % ≥65 years), further along in their disease progression (time since bone metastasis diagnosis: 16 % ≥2 years vs. 10 % ≥2 years), less likely to switch BTA (overall: 6 vs. 14 %; subgroup: 8 vs. 19 %), and more compliant with treatment (overall: median doses of 7 vs. 4; subgroup: 11 vs. 8) compared to IV BP patients (N = 1,975). Findings were consistent across gender, age, tumor type, naïve, and transition strata.
Conclusions
Patients receiving denosumab and IV BPs may differ. Despite higher age and more advanced disease, patients treated with denosumab are more likely to stay on treatment and have better compliance.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Coleman RE (2006) Clinical features of metastatic bone disease and risk of skeletal morbidity. Clin Cancer Res 12(20 Pt 2):6243s–6249s. doi:10.1158/1078-0432.CCR-06-0931
Coleman RE (1997) Skeletal complications of malignancy. Cancer 80(8 Suppl):1588–1594
Paes FM, Ernani V, Hosein P, Serafini AN (2011) Radiopharmaceuticals: when and how to use them to treat metastatic bone pain. J Support Oncol 9(6):197–205. doi:10.1016/j.suponc.2011.06.004
Lipton A, Theriault RL, Hortobagyi GN, Simeone J, Knight RD, Mellars K, Reitsma DJ, Heffernan M, Seaman JJ (2000) Pamidronate prevents skeletal complications and is effective palliative treatment in women with breast carcinoma and osteolytic bone metastases: long term follow-up of two randomized, placebo-controlled trials. Cancer 88(5):1082–1090
Saad F, McKiernan J, Eastham J (2006) Rationale for zoledronic acid therapy in men with hormone-sensitive prostate cancer with or without bone metastasis. Urol Oncol 24(1):4–12. doi:10.1016/j.urolonc.2005.06.020
Rosen LS, Gordon D, Tchekmedyian NS, Yanagihara R, Hirsh V, Krzakowski M, Pawlicki M, De Souza P, Zheng M, Urbanowitz G, Reitsma D, Seaman J (2004) Long-term efficacy and safety of zoledronic acid in the treatment of skeletal metastases in patients with nonsmall cell lung carcinoma and other solid tumors: a randomized, Phase III, double-blind, placebo-controlled trial. Cancer 100(12):2613–2621. doi:10.1002/cncr.20308
Norgaard M, Jensen AO, Jacobsen JB, Cetin K, Fryzek JP, Sorensen HT (2010) Skeletal related events, bone metastasis and survival of prostate cancer: a population based cohort study in Denmark (1999 to 2007). J Urol 184(1):162–167. doi:10.1016/j.juro.2010.03.034
Yong M, Jensen AO, Jacobsen JB, Norgaard M, Fryzek JP, Sorensen HT (2011) Survival in breast cancer patients with bone metastases and skeletal-related events: a population-based cohort study in Denmark (1999–2007). Breast Cancer Res Treat 129(2):495–503. doi:10.1007/s10549-011-1475-5
Schulman KL, Kohles J (2007) Economic burden of metastatic bone disease in the U.S. Cancer 109(11):2334–2342. doi:10.1002/cncr.22678
Weinfurt KPCL, Li Y, Timbie JW, Glendenning GA, Schulman KA (2004) Health-related quality of life among patients with breast cancer receiving Zometa or pamidronate disodium for metastatic bone lesions. Med Care 42:164–175
von Moos R, Sternberg C, Body JJ, Bokemeyer C (2013) Reducing the burden of bone metastases: current concepts and treatment options. Support Care Cancer 21(6):1773–1783. doi:10.1007/s00520-013-1755-1
Berenson JR, Lichtenstein A, Porter L, Dimopoulos MA, Bordoni R, George S, Lipton A, Keller A, Ballester O, Kovacs M, Blacklock H, Bell R, Simeone JF, Reitsma DJ, Heffernan M, Seaman J, Knight RD (1998) Long-term pamidronate treatment of advanced multiple myeloma patients reduces skeletal events. Myeloma Aredia Study Group. J Clin Oncol 16(2):593–602
Lipton A, Small E, Saad F, Gleason D, Gordon D, Smith M, Rosen L, Kowalski MO, Reitsma D, Seaman J (2002) The new bisphosphonate, Zometa (zoledronic acid), decreases skeletal complications in both osteolytic and osteoblastic lesions: a comparison to pamidronate. Cancer Investig 20(Suppl 2):45–54
Stopeck AT, Lipton A, Body JJ, Steger GG, Tonkin K, de Boer RH, Lichinitser M, Fujiwara Y, Yardley DA, Viniegra M, Fan M, Jiang Q, Dansey R, Jun S, Braun A (2010) Denosumab compared with zoledronic acid for the treatment of bone metastases in patients with advanced breast cancer: a randomized, double-blind study. J Clin Oncol 28(35):5132–5139. doi:10.1200/JCO.2010.29.7101
Lau EC, Mowat FS, Kelsh MA, Legg JC, Engel-Nitz NM, Watson HN, Collins HL, Nordyke RJ, Whyte JL (2011) Use of electronic medical records (EMR) for oncology outcomes research: assessing the comparability of EMR information to patient registry and health claims data. Clin Epidemiol 3:259–272. doi:10.2147/CLEP.S23690
de Borja MT, Chow E, Bovett G, Davis L, Gillies C (2004) The correlation among patients and health care professionals in assessing functional status using the karnofsky and eastern cooperative oncology group performance status scales. Support Cancer Ther 2(1):59–63. doi:10.3816/SCT.2004.n.024
Jensen PB, Jensen LJ, Brunak S (2012) Mining electronic health records: towards better research applications and clinical care. Nat Rev Genet 13(6):395–405. doi:10.1038/nrg3208
Saad F, Gleason DM, Murray R, Tchekmedyian S, Venner P, Lacombe L, Chin JL, Vinholes JJ, Goas JA, Chen B (2002) A randomized, placebo-controlled trial of zoledronic acid in patients with hormone-refractory metastatic prostate carcinoma. J Natl Cancer Inst 94(19):1458–1468
Mortimer JE, Pal SK (2010) Safety considerations for use of bone-targeted agents in patients with cancer. Semin Oncol 37(Suppl 1):S66–S72. doi:10.1053/j.seminoncol.2010.06.006
Cleeland CS, Body JJ, Stopeck A, von Moos R, Fallowfield L, Mathias SD, Patrick DL, Clemons M, Tonkin K, Masuda N, Lipton A, de Boer R, Salvagni S, Oliveira CT, Qian Y, Jiang Q, Dansey R, Braun A, Chung K (2013) Pain outcomes in patients with advanced breast cancer and bone metastases: results from a randomized, double-blind study of denosumab and zoledronic acid. Cancer 119(4):832–838. doi:10.1002/cncr.27789
Vadhan-Raj S, von Moos R, Fallowfield LJ, Patrick DL, Goldwasser F, Cleeland CS, Henry DH, Novello S, Hungria V, Qian Y, Feng A, Yeh H, Chung K (2012) Clinical benefit in patients with metastatic bone disease: results of a phase 3 study of denosumab versus zoledronic acid. Ann Oncol 23(12):3045–3051. doi:10.1093/annonc/mds175
Matza LS CZ, Chung K, et al (2012) Health state perferences associated with subcutaneous injections and intravenous infusions for treatment of bone metastases. Presented at: Annual Congress of the American Society of Clinical Oncology, Chicago, Illinois, US, 1-5 June
Arellano J, Mohamed AF, Hauber B, Collins H, Hechmati G, Gatta F, Qian Y (2013) Physicians’ preferences for bone metastases treatments in the US. European ISPOR Annual Meeting
Qian Y, Mohamed AF, Hauber B, Collins H, Hechmati G, Gatta F, Arellano J (2013) Patients’ and caregivers’ preferences for bone metastases (BM) treatments in the US. European ISPOR Annual Meeting
Fizazi K, Carducci M, Smith M, Damiao R, Brown J, Karsh L, Milecki P, Shore N, Rader M, Wang H, Jiang Q, Tadros S, Dansey R, Goessl C (2011) Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study. Lancet 377(9768):813–822. doi:10.1016/S0140-6736(10)62344-6
Henry DH, Costa L, Goldwasser F, Hirsh V, Hungria V, Prausova J, Scagliotti GV, Sleeboom H, Spencer A, Vadhan-Raj S, von Moos R, Willenbacher W, Woll PJ, Wang J, Jiang Q, Jun S, Dansey R, Yeh H (2011) Randomized, double-blind study of denosumab versus zoledronic acid in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. J Clin Oncol 29(9):1125–1132. doi:10.1200/JCO.2010.31.3304
Hatoum HT, Lin SJ, Smith MR, Barghout V, Lipton A (2008) Zoledronic acid and skeletal complications in patients with solid tumors and bone metastases: analysis of a national medical claims database. Cancer 113(6):1438–1445. doi:10.1002/cncr.23775
Acknowledgments
The authors wish to thank David C. Hallett, University of Toronto, for editorial support for manuscript submission to journal.
Conflict of interest
This work was funded by Amgen, Inc. R. Hernandez, J. Arellano, and A. Liede are employees and stockholders of Amgen, Inc. K. Chen was an employee of Amgen, Inc. at the time of initial manuscript submission.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Hernandez, R.K., Quigley, J., Pirolli, M. et al. Patients with bone metastases from solid tumors initiating treatment with a bone-targeted agent in 2011: a descriptive analysis using oncology clinic data in the US. Support Care Cancer 22, 2697–2705 (2014). https://doi.org/10.1007/s00520-014-2251-y
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00520-014-2251-y