Difference between revisions of "Zoledronic acid (Zometa)"

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===[[Breast cancer]]===
 
===[[Breast cancer]]===
 
*'''Amgen 20050136:''' 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. 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. 2010 Dec 10;28(35):5132-9. Epub 2010 Nov 8. [https://doi.org/10.1200/jco.2010.29.7101 link to original article] [https://pubmed.ncbi.nlm.nih.gov/21060033/ PubMed] [https://clinicaltrials.gov/study/NCT00321464 NCT00321464]
 
*'''Amgen 20050136:''' 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. 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. 2010 Dec 10;28(35):5132-9. Epub 2010 Nov 8. [https://doi.org/10.1200/jco.2010.29.7101 link to original article] [https://pubmed.ncbi.nlm.nih.gov/21060033/ PubMed] [https://clinicaltrials.gov/study/NCT00321464 NCT00321464]
 +
*'''CALGB 70604:''' Himelstein AL, Foster JC, Khatcheressian JL, Roberts JD, Seisler DK, Novotny PJ, Qin R, Go RS, Grubbs SS, O'Connor T, Velasco MR Jr, Weckstein D, O'Mara A, Loprinzi CL, Shapiro CL. Effect of Longer-Interval vs Standard Dosing of Zoledronic Acid on Skeletal Events in Patients With Bone Metastases: A Randomized Clinical Trial. JAMA. 2017 Jan 3;317(1):48-58. [https://doi.org/10.1001/jama.2016.19425 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc5321662/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28030702/ PubMed] [https://clinicaltrials.gov/study/NCT00869206 NCT00869206]
  
 
===[[Multiple myeloma]]===
 
===[[Multiple myeloma]]===
 
* '''MRC Myeloma IX:''' Morgan GJ, Davies FE, Gregory WM, Cocks K, Bell SE, Szubert AJ, Navarro-Coy N, Drayson MT, Owen RG, Feyler S, Ashcroft AJ, Ross F, Byrne J, Roddie H, Rudin C, Cook G, Jackson GH, Child JA; National Cancer Research Institute Haematological Oncology Clinical Study Group. First-line treatment with zoledronic acid as compared with clodronic acid in multiple myeloma (MRC Myeloma IX): a randomised controlled trial. Lancet. 2010 Dec 11;376(9757):1989-99. Epub 2010 Dec 3. [https://doi.org/10.1016/S0140-6736(10)62051-X link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3639680/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/21131037/ PubMed]
 
* '''MRC Myeloma IX:''' Morgan GJ, Davies FE, Gregory WM, Cocks K, Bell SE, Szubert AJ, Navarro-Coy N, Drayson MT, Owen RG, Feyler S, Ashcroft AJ, Ross F, Byrne J, Roddie H, Rudin C, Cook G, Jackson GH, Child JA; National Cancer Research Institute Haematological Oncology Clinical Study Group. First-line treatment with zoledronic acid as compared with clodronic acid in multiple myeloma (MRC Myeloma IX): a randomised controlled trial. Lancet. 2010 Dec 11;376(9757):1989-99. Epub 2010 Dec 3. [https://doi.org/10.1016/S0140-6736(10)62051-X link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3639680/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/21131037/ PubMed]
 +
*'''CALGB 70604:''' Himelstein AL, Foster JC, Khatcheressian JL, Roberts JD, Seisler DK, Novotny PJ, Qin R, Go RS, Grubbs SS, O'Connor T, Velasco MR Jr, Weckstein D, O'Mara A, Loprinzi CL, Shapiro CL. Effect of Longer-Interval vs Standard Dosing of Zoledronic Acid on Skeletal Events in Patients With Bone Metastases: A Randomized Clinical Trial. JAMA. 2017 Jan 3;317(1):48-58. [https://doi.org/10.1001/jama.2016.19425 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc5321662/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28030702/ PubMed] [https://clinicaltrials.gov/study/NCT00869206 NCT00869206]
  
 
===[[Prostate cancer]]===
 
===[[Prostate cancer]]===
 
*'''Amgen 20050103:''' Fizazi K, Carducci M, Smith M, Damião R, Brown J, Karsh L, Milecki P, Shore N, Rader M, Wang H, Jiang Q, Tadros S, Dansey R, Goessl C. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study. Lancet. 2011 Mar 5;377(9768):813-22. Epub 2011 Feb 25. [https://doi.org/10.1016/S0140-6736(10)62344-6 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3090685/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/21353695/ PubMed] [https://clinicaltrials.gov/study/NCT00321620 NCT00321620]
 
*'''Amgen 20050103:''' Fizazi K, Carducci M, Smith M, Damião R, Brown J, Karsh L, Milecki P, Shore N, Rader M, Wang H, Jiang Q, Tadros S, Dansey R, Goessl C. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study. Lancet. 2011 Mar 5;377(9768):813-22. Epub 2011 Feb 25. [https://doi.org/10.1016/S0140-6736(10)62344-6 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3090685/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/21353695/ PubMed] [https://clinicaltrials.gov/study/NCT00321620 NCT00321620]
 +
*'''CALGB 70604:''' Himelstein AL, Foster JC, Khatcheressian JL, Roberts JD, Seisler DK, Novotny PJ, Qin R, Go RS, Grubbs SS, O'Connor T, Velasco MR Jr, Weckstein D, O'Mara A, Loprinzi CL, Shapiro CL. Effect of Longer-Interval vs Standard Dosing of Zoledronic Acid on Skeletal Events in Patients With Bone Metastases: A Randomized Clinical Trial. JAMA. 2017 Jan 3;317(1):48-58. [https://doi.org/10.1001/jama.2016.19425 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc5321662/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28030702/ PubMed] [https://clinicaltrials.gov/study/NCT00869206 NCT00869206]
  
 
==Dosing==
 
==Dosing==

Revision as of 20:41, 28 May 2024

General information

Class/mechanism: Bisphosphonate, inhibits osteoclast activity and bone resorption/turnover, induces osteoclast apoptosis, and inhibits skeletal calcium release by tumor stimulatory factors.[1][2][3]
Route: IV
Extravasation: no information

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Disease-specific information

For now this will be a gathering point for RCTs examining the use of this agent, which does not have clear antineoplastic properties; in the future this information may be moved to separate page(s).

  • Amgen 20050244: 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. 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 Mar 20;29(9):1125-32. Epub 2011 Feb 22. link to original article PubMed NCT00330759

Breast cancer

  • Amgen 20050136: 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. 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. 2010 Dec 10;28(35):5132-9. Epub 2010 Nov 8. link to original article PubMed NCT00321464
  • CALGB 70604: Himelstein AL, Foster JC, Khatcheressian JL, Roberts JD, Seisler DK, Novotny PJ, Qin R, Go RS, Grubbs SS, O'Connor T, Velasco MR Jr, Weckstein D, O'Mara A, Loprinzi CL, Shapiro CL. Effect of Longer-Interval vs Standard Dosing of Zoledronic Acid on Skeletal Events in Patients With Bone Metastases: A Randomized Clinical Trial. JAMA. 2017 Jan 3;317(1):48-58. link to original article link to PMC article PubMed NCT00869206

Multiple myeloma

  • MRC Myeloma IX: Morgan GJ, Davies FE, Gregory WM, Cocks K, Bell SE, Szubert AJ, Navarro-Coy N, Drayson MT, Owen RG, Feyler S, Ashcroft AJ, Ross F, Byrne J, Roddie H, Rudin C, Cook G, Jackson GH, Child JA; National Cancer Research Institute Haematological Oncology Clinical Study Group. First-line treatment with zoledronic acid as compared with clodronic acid in multiple myeloma (MRC Myeloma IX): a randomised controlled trial. Lancet. 2010 Dec 11;376(9757):1989-99. Epub 2010 Dec 3. link to original article link to PMC article PubMed
  • CALGB 70604: Himelstein AL, Foster JC, Khatcheressian JL, Roberts JD, Seisler DK, Novotny PJ, Qin R, Go RS, Grubbs SS, O'Connor T, Velasco MR Jr, Weckstein D, O'Mara A, Loprinzi CL, Shapiro CL. Effect of Longer-Interval vs Standard Dosing of Zoledronic Acid on Skeletal Events in Patients With Bone Metastases: A Randomized Clinical Trial. JAMA. 2017 Jan 3;317(1):48-58. link to original article link to PMC article PubMed NCT00869206

Prostate cancer

  • Amgen 20050103: Fizazi K, Carducci M, Smith M, Damião R, Brown J, Karsh L, Milecki P, Shore N, Rader M, Wang H, Jiang Q, Tadros S, Dansey R, Goessl C. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study. Lancet. 2011 Mar 5;377(9768):813-22. Epub 2011 Feb 25. link to original article link to PMC article PubMed NCT00321620
  • CALGB 70604: Himelstein AL, Foster JC, Khatcheressian JL, Roberts JD, Seisler DK, Novotny PJ, Qin R, Go RS, Grubbs SS, O'Connor T, Velasco MR Jr, Weckstein D, O'Mara A, Loprinzi CL, Shapiro CL. Effect of Longer-Interval vs Standard Dosing of Zoledronic Acid on Skeletal Events in Patients With Bone Metastases: A Randomized Clinical Trial. JAMA. 2017 Jan 3;317(1):48-58. link to original article link to PMC article PubMed NCT00869206

Dosing

  • CALGB 70604 results, published as abstract only, demonstrate non-inferiority of 3-month dosing vs. monthly dosing.[4]
  • OPTIMIZE-2 demonstrated non-inferiority between every 4 week and every 12 week dosing in metastatic breast cancer.[5]

Patient drug information

Management checklist

  • Basic metabolic panel (BMP) including creatinine and calcium, albumin (to calculate corrected calcium), phosphorus, vitamin D 25, bone density, calcium & vitamin D supplementation, dental exam/dental health

Also known as

  • Generic names: acido zoledronico, zoledronate
  • Brand names: Aclasta, Blaztere, Cytozol, Reclast, Servycal, Zobone, Zoldonat, Zomera, Zometa, Zyfoss

References

  1. ↑ 1.0 1.1 1.2 Zoledronic acid (Zometa) package insert
  2. ↑ Zoledronic acid (Zometa) package insert (locally hosted backup)
  3. ↑ Zometa manufacturer's site
  4. ↑ Himelstein, Andrew Louis, Qin, Rui, Novotny, Paul J., Seisler, Drew K., Khatcheressian, James L., Roberts, John D., Grubbs, Stephen S., O'Connor, Tracey, Weckstein, Douglas, Loprinzi, Charles L., Shapiro, Charles L. CALGB 70604 (Alliance): A randomized phase III study of standard dosing vs. longer interval dosing of zoledronic acid in metastatic cancer. J Clin Oncol (Meeting Abstracts) 2015 33: 9501 link to abstract
  5. ↑ Hortobagyi GN, Van Poznak C, Harker WG, Gradishar WJ, Chew H, Dakhil SR, Haley BB, Sauter N, Mohanlal R, Zheng M, Lipton A. Continued Treatment Effect of Zoledronic Acid Dosing Every 12 vs 4 Weeks in Women With Breast Cancer Metastatic to Bone: The OPTIMIZE-2 Randomized Clinical Trial. JAMA Oncol. 2017 Jul 1;3(7):906-912. link to original article PubMed
  6. ↑ Zoledronic acid (Zometa) patient drug information (Chemocare)
  7. ↑ Zoledronic acid (Zometa) patient drug information (UpToDate)
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