The Effectiveness of Zoledronic Acid and Ibandronic Acid in Delaying Skeletal-Related Events in Multiple Myeloma in Indonesia

https://doi.org/10.22146/jmpf.55943

Nutrisia Aquariushinta Sayuti(1), Tri Murti Andayani(2*), Dwi Endarti(3), Kartika Widayati(4)

(1) 1) Doctoral Program, Faculty of Pharmacy, Universitas Gadjah Mada, Yogyakarta 3) Indonesian Herbal Medicine Department, Health Polytechnic of Surakarta, Ministry of Health Indonesia
(2) Doctoral Program, Faculty of Pharmacy, Universitas Gadjah Mada, Yogyakarta
(3) Doctoral Program, Faculty of Pharmacy, Universitas Gadjah Mada, Yogyakarta
(4) Division of Hematology and Medical Oncology, Department of Internal Medicine, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/Dr. Sardjito Hospital, Yogyakarta
(*) Corresponding Author

Abstract


Zoledronic acid and ibandronic acid are listed in the Indonesian national formulary to prevent skeletal-related events (SRE) in patients diagnosed with bone metastasis in multiple myeloma (MM), with limited evidence to compare their effectiveness. This study aimed to investigate the effectiveness and safety of zoledronic acid and ibandronic acid in delaying SRE. The method was the retrospective, with data obtained from the multicenter study for MM patients with bone metastasis (aged over 18 years), based on medical records between January 2016 and December 2018. Patients were assigned to zoledronic acid and ibandronic acid groups. The clinical outcome was the next SRE which consists of vertebral/bone fracture, spinal cord compression leading to the need for surgery or radiation, and adverse event (AE) due to 2 years of drugs usage. Result of this research was made up of a total of seventy (70) patients with  40  in the zoledronic acid group, and 30 in ibandronic acid. At median treatment duration of 8 months (range: 2 – 24 month), SRE incident in zoledronic acid and ibandronic acid were 20.0 % and 23.3 % respectively. Furthermore, their mean SRE free survival times were 21 months [95% confidence interval (CI) 19 - 23 months], and 19 months [95% CI, 16 – 22 months], respectively. Also, their time intervals were not significantly different (p>0.05). The osteonecrosis of the jaw (ONJ) was AE which occurred more in zoledronic acid than ibandronic acid. The conclusion was zoledronic acid tends to delay SRE time compared to ibandronic acid, although more ONJ occur.


Keywords


Multiple myeloma; zoledronic acid; ibandronic acid; SRE; safety

Full Text:

PDF


References

  1. Tan D, Lee J, Chen W, et al. Recent advances in the management of multiple myeloma: clinical impact based on resourcestratification. Consensus statement of the Asian Myeloma Network at the 16th international myeloma workshop. Leukemia & Lymphoma. Published online 2018.
  2. Dewi M. Sebaran Kanker di Indonesia, Riset Kesehatan Dasar 2007. Indones J Cancer. 2017;11(1):1–8.
  3. Tadjoedin H, Reksodiputro A, Toruan T, et al. Multiple myeloma in Indonesia. Indones J Cancer. 2011;5(2):76-81.
  4. Wu S, Dahut W, Gulley J. The use of bisphosphonates in cancer patients. Acta Oncol. 2007;46:581-591.
  5. Palmieri C, Fullarton J, Brown J. Comparative efficacy of Bisphosphonates in metastatic breast and prostate cancer and multiple myeloma: A Mixed-treatment meta-analysis. Clin Cancer Res. 2013;19(24):OF1-OF10.
  6. De Cock E, Hutton J, Canney P, et al. Cost-effectiveness of oral ibandronate compared with intravenous (i.v.) zoledronic acid or i.v. generic pamidronate in breast cancer patients with metastatic bone disease undergoing i.v. chemotherapy. Support Care Cancer. 2005;13:975-986.
  7. Machado M, Cruz L, Tannus G, Fonseca M. Efficacy of Clodronate, Pamidronate, and Zoledronate in Reducing Morbidity and Mortality in Cancer Patients With Bone Metastasis: A Meta-Analysis of Randomized Clinical Trials. Clin Ther. 2009;31(5):962-979.
  8. NCCN. Multiple Myeloma (NCCN Guideline for patients). Published online 2018.
  9. Kemenkes RI. Keputusan Menteri Kesehatan Republik Indonesia Nomor HK.02.02 / MENKES / 137 / 2016 tentang Perubahan atas Keputusan Menteri Kesehatan No. HK.02.02 / MENKES / 523 / 2015 Tentang Formularium Nasional. Published online 2016.
  10. Mhaskar R, Redzepovic J, Wheatley K, Clark O, Miladinovic B, Glasmacher A. Bisphosphonates in multiple myeloma (Review). Cochrane Database Syst Rev. 2010;(3).
  11. Gabbert T, Hoffmeister B, Felsenberg D. Risk factors influencing the duration of treatment with bisphosphonates until occurrence of an osteonecrosis of the jaw in 963 cancer patients. J Cancer Res Clin. 2014;141:749-758. doi:10.1007/s00432-014-1853-6
  12. Weide R, Koppler H, Antras L, et al. Renal toxicity in patients with multiple myeloma receiving zoledronic acid vs. ibandronate: A retrospective medical records review. J Cancer Res Ther. 2010;6(1):31-35.
  13. Menssen HD, Sakalová A, Fontana A, et al. Effects of Long-Term Intravenous Ibandronate Therapy on Skeletal-Related Events, Survival, and Bone Resorption Markers in Patients With Advanced Multiple Myeloma. J Clin Oncol. 2002;20(9):2353-2359. doi:10.1200/JCO.2002.02.032
  14. Aviles A, Neri N, Huerta-Guzman J, Nambo MJ. Randomized clinical trial of zoledronic acid in multiple myeloma patients undergoing high-dose chemotherapy and stem-cell transplantation. Curr Oncol 2013;20(1). doi:10.3747/co.20.1055
  15. Chadha V. Sample size determination in health studies. NTI Bulletin. 2006;42(3 & 4):55-65.
  16. World Health Organization. Global Health Observatory. Published online 2018. Accessed September 1, 2019. https://gco.iarc.fr/databases.php
  17. Pozzi S, Raje N. The Role of Bisphosphonates in Multiple Myeloma: Mechanisms, Side Effects, and the Future. Oncologist. 2011;16(5):651-662. doi:10.1634/theoncologist.2010-0225

18. Union for International Cancer Control. Bisphosphonate theraphy (2016 Review of cancer medicines on the WHO list of essential medicines). Published online 2016.

19. Terpos E, Viniou N, de la fuente J, et al. Pamidronate is superior to ibandronate in decreasing bone resorption interleukin-6 and b 2-microglobulin in multiple myeloma. Eur J Haematol. 2003;70:34-42.

20. Garcia-Sanz R, Oriol A, Moreno MJ, et al. Zoledronic acid as compared with observation in multiple myeloma patients at biochemical relapse: results of the randomized AZABACHE Spanish trial. Haematologica. 2015;100(9):1207-1213. doi:10.3324/haematol.2015.128439

21. Henry DH, Costa L, Goldwasser F, et al. 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. 2011;29(9):1125-1132. doi:10.1200/JCO.2010.31.3304

22. Morgan GJ, Davies FE, Gregory WM, et al. First-line treatment with zoledronic acid as compared with clodronic acid in multiple myeloma (MRC Myeloma IX): a randomised controlled trial. Lancet. 2010;376(9757):1989-1999. doi:10.1016/S0140-6736(10)62051-X

23. Geng C-J, Liang Q, Zhong J-H, et al. Ibandronate to treat skeletal-related events and bone pain in metastatic bone disease or multiple myeloma: a meta-analysis of randomised clinical trials. BMJ open. 2015;5(6):e007258.



DOI: https://doi.org/10.22146/jmpf.55943

Article Metrics

Abstract views : 2405 | views : 3271

Refbacks

  • There are currently no refbacks.


Copyright (c) 2020 JURNAL MANAJEMEN DAN PELAYANAN FARMASI (Journal of Management and Pharmacy Practice)

Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

©Jurnal Manajemen dan Pelayanan Farmasi
Faculty of Pharmacy
Universitas Gadjah Mada
Creative Commons License
View My Stats