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Renal safety of 1-hour pamidronate infusion for breast cancer and multiple myeloma patients: comparison between clinical trials and population-based database
Mário L de Lemos, MSc (Clin Pharm), PharmD, MSc (Oncol)
Provincial Drug Information Co-ordinator, Provincial Systemic Therapy Program, British Columbia Cancer Agency, 600 West 10th Avenue, Vancouver, BC, V5Z 4E6, Canada; mdelemos{at}bccancer.bc.ca
Suzanne C Taylor, BSc (Pharm), PharmD, BCPS, FCSHP
Jeff B Barnett, BSc (Pharm), FCSHP
Francis Hu, BSc (Pharm), MBA
Provincial Systemic Therapy Program, British Columbia Cancer Agency, Vancouver, BC, Canada
Adeera Levin, MD, FRCPC
British Columbia Provincial Renal Agency, Vancouver, BC, Canada
Veronika Moravan, MSc
Population and Preventive Oncology, British Columbia Cancer Agency, Vancouver, BC, Canada
Susan E O'Reilly, MB, FRCPC
Provincial Systemic Therapy Program, British Columbia Cancer Agency, Vancouver, BC, Canada
Purpose. The American Society of Clinical Oncology recommends infusion of pamidronate over 2 hours to avoid renal deterioration, although there are data to suggest that 1-hour infusions may be safe.
Methods, Prevalence of renal deterioration with 1-hour pamidronate infusions from a population database was compared to renal deterioration with 2-hour pamidronate infusions, in randomised, controlled, trials. A cost-minimisation analysis, comparing the 1-and 2-hour pamidronate infusions, and the 15-minute infusion of zoledronic acid, was performed with a sensitivity analysis that varied the opportunity cost of time in the treatment room.
Results. Renal deterioration occurred in 7.7% of 169 patients with multiple myeloma and metastatic breast cancer. There is no evidence that this differs from the 10% reported in randomised, controlled, trials (one-tailed binomial test, P=0.3874). A subgroup analysis showed that renal deterioration occurred in 15 and 1.1% of patients with multiple myeloma and metastatic breast cancer, respectively. The median increase in serum creatinine was 13 and 7% in the multiple myeloma and breast cancer groups, respectively. The respective costs/dose (drug/ labour/supplies) of pamidronate and zoledronic acid are $325 and $610. Cost neutrality occurs if the opportunity cost of chair time is $6.33/ minute for pamidronate 1-hour versus zoledronic acid, and $2.71/minute for pamidronate 2-hour versus zoledronic acid. If a median $4/minute is used, the respective costs of pamidronate 1-hour, 2-hour, and zoledronic acid infusions are $685, $925, and $790/cycle.
Conclusions. Prevalence of renal deterioration with 1-hour pamidronate infusions from a population database was not significantly different to 2-hour pamidronate infusions in clinical trials. Our findings suggest further support for the safety of 1-hour pamidronate infusions. Pamidronate via 1-hour infusion is less expensive than zoledronic acid.
Key Words: biphosphonates • breast cancer • multiple myeloma • pamidronate • renal toxicity
References
- Berenson JR, Hillner BE, Kyle RA, et al. American Society of Clinical Oncology Clinical Practice Guidelines: the role of bisphosphonates in multiple myeloma . J Clin Oncol 2002; 20: 3719–3736 .[Abstract/Free Full Text]
- Hillner BE, Ingle JN, Chlebowski RT, et al. American Society of Clinical Oncology 2003 update on the role of biphosphonates and bone health issues in women with breast cancer . J Clin Oncol 2003; 21: 4042–4057 .[Abstract/Free Full Text]
- Adami S, Zamberlan N. Adverse effects of biphosphonates: a comparative review . Drug Safety 1996; 14: 158–170 .[Medline]
[Order article via Infotrieve]
- Buysschaert M, Cosyns JP, Barreto L, et al. Pamidronateinduced tubulointerstitial nephritis with Fanconi syndrome in a patient with primary hyperparathyroidism . Nephrol Dial Transplant 2003; 18: 826–829 .[Free Full Text]
- Banerjee D, Asif A, Striker L, et al. Short-term, high-dose pamidronate-induced acute tubular necrosis: the postulated mechanisms of bisphosphonate nephrotoxicity . Am J Kidney Dis 2003; 41: E18–E18 .[CrossRef][Medline]
[Order article via Infotrieve]
- Markowitz GS, Appel GB, Fine PL, et al. Collapsing focal segmental glomerulosclerosis following treatment with high-dose pamidronate . J Am Soc Nephrol 2001; 12: 1164–1172 .[Abstract/Free Full Text]
- Desikan R, Veksler Y, Raza S, et al. Nephrotic proteinuria associated with high-dose pamidronate in multiple myeloma . Br J Haematol 2002; 119: 496–499 .[CrossRef][Medline]
[Order article via Infotrieve]
- Markowitz GS, Fine PL, D'Agati VD. Nephrotic syndrome after treatment with pamidronate . Am J Kidney Dis 2002; 39: 1118–1122 .[CrossRef][Medline]
[Order article via Infotrieve]
- Rosen LS, Gordon D, Kaminski M, et al. Zoledronic acid versus pamidronate in the treatment of skeletal metastases in patients with breast cancer or osteolytic lesions of multiple myeloma: a phase III, double-blind, comparative trial . Cancer J 2001; 7: 377–387 .[Medline]
[Order article via Infotrieve]
- Berenson JR, Rosen LS, Howell A, et al. Zoledronic acid reduces skeletal-related events in patients with osteolytic metastases . Cancer 2001; 91: 1191–1200 .[CrossRef][Medline]
[Order article via Infotrieve]
- Vilimovskij A, Thuerlimann B, Berenson JR, et al. Renal safety and tolerability of 90 mg of aredia (pamidronate) administered as an intravenous 1 hour infusion: preliminary results . Proc Am Soc Clin Oncol 1999; 18: 576a-576a (abstract 2223).
- Tyrrell CJ, Collinson M, Madsen EL, et al. Intravenous pamidronate: infusion rate and safety . Ann Oncol 1994; 5: S27–S29 .[Abstract/Free Full Text]
- Tyrrell CJ. Role of pamidronate in the management of bone metastases from breast cancer: results of a non-comparative multicenter phase II trial. Aredia Multinational Co-operative Group . Ann Oncol 1994; 5: S37–S40 .[Abstract/Free Full Text]
- Van Poznak CH, Ben-Porat L, Panageas K, et al. Renal safety of 1 hour infusion rate of pamidronate in patients (pts) with metastatic breast cancer . Proc Am Soc Clin Oncol 2002; 21: (abstract 208).
- Janssen van Doorn K, Neyns B, Van der Niepen P, et al. Pamidronate-related nephrotoxicity (tubulointerstitial nephritis) in a patient with osteolytic bone metastases . Nephron 2001; 89: 467–468 .[CrossRef][Medline]
[Order article via Infotrieve]
- Lockridge L, Papac RJ, Perazella MA. Pamidronate-associated nephrotoxicity in a patient with Langerhans's histiocytosis . Am J Kidney Dis 2002; 40: E2-E2 .[CrossRef][Medline]
[Order article via Infotrieve]
- DesHarnais Castel L, Bajwa K, Markle JP, et al. A microcosting analysis of zoledronic acid and pamidronate therapy in patients with metastatic bone disease . Support Care Cancer 2001; 9: 545–551 .[CrossRef][Medline]
[Order article via Infotrieve]
- Dranitsaris G, Castel LD, Baladi JF, et al. Zoledronic acid versus pamidronate as palliative therapy in cancer patients: a Canadian time and motion analysis . J Oncol Pharm Pract 2001; 7: 27–33 .[Abstract/Free Full Text]
- Rosen LS, Gordon D, Tchekmedyian NS, et al. Long-term efficacy and safety of zoledronic acid in the treatment of skeletal metastases in patients with non-small cell lung carcinoma and other solid tumors: a randomized, Phase III, double-blind, placebo-controlled trial . Cancer 2004; 100: 2613–2621 .[CrossRef][Medline]
[Order article via Infotrieve]
- Rosen LS, Gordon D, Tchekmedyian S, et al. Zoledronic acid versus placebo in the treatment of skeletal metastases in patients with lung cancer and other solid tumors: a phase III, double-blind, randomized trial - the Zoledronic Acid Lung Cancer and Other Solid Tumors Study Group . J Clin Oncol 2003; 21: 3150–3157 .[Abstract/Free Full Text]
- Cancer Therapy Evaluation Program. Common terminology criteria for adverse events (CTCAE), version 3.0. National Cancer Institute , 2003.
- Rosen LS, Gordon D, Kaminski M, et al. Long-term efficacy and safety of zoledronic acid compared with pamidronate disodium in the treatment of skeletal complications in patients with advanced multiple myeloma or breast carcinoma: a randomized, double-blind, multicenter, comparative trial . Cancer 2003; 98: 1735–1744 .[CrossRef][Medline]
[Order article via Infotrieve]
- Berry DC, Knapp PR, Raynor T. Is 15 per cent very common? Informing people about the risks of medication side effects . Int J Pharm Pract 2002; 10: 145–151 .
- Berry DC, Raynor DK, Knapp P, et al. Patients' understanding of risk associated with medication use: impact of European Commission guidelines and other risk scales . Drug Safety 2003; 26: 1–11 .[CrossRef][Medline]
[Order article via Infotrieve]
- Jones B, Jarvis P, Lewis JA, et al. Trials to assess equivalence: the importance of rigorous methods . Br Med J 1996; 313: 36–39 .[Free Full Text]
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). ICH E 9. Statistical principles for clinical trials. European Agency for the Evaluation of Medicinal Products , 1998.
- Taylor SCM, Uyeno KT, O'Reilly SE, et al. Development of a systemic therapy costing model in a provincial oncology center . Eur J Cancer 2000; 36: S26–S26 (abstract).
- Taylor SCM, Chow L. Development of a pharmacoeconomics service in a provincial oncology program . Eur J Cancer 1997; 33: S31–S31 (abstract).[Medline]
[Order article via Infotrieve]
- Taylor SCM, Chow L. Development of a pharmacoeconomics service in a provincial oncology program . J Oncol Pharm Pract 1997; 3: 40–40 (abstract).
- Rosen LS, Gordon DH, Dugan W Jr, et al. Zoledronic acid is superior to pamidronate for the treatment of bone metastases in breast carcinoma patients with at least one osteolytic lesion . Cancer 2004; 100: 36–43 .[CrossRef][Medline]
[Order article via Infotrieve]
- Ford JM, Flesch G, Leyvraz S, et al. In Bijvoet OLM, Lipton A eds. Influence of infusion rate on the pharmacokinetics of intravenous pamidronate (APD) in patients with bone metastases . Presented at the Fifteenth International Cancer Congress, Hamburg, Germany, August 1990. Hogrefe & Huber, 1990: 11–17 .
- Millward MJ, Simmons D, Procter M, et al. Comparison of 1-hour vs. 2-hour infusions of disodium pamidronate (APD) in breast cancer with bone metastases (abstract) . Br J Cancer 1990; 62: 521–522 .
- Conte PF, Latreille J, Mauriac L, et al. Delay in progression of bone metastases in breast cancer patients treated with intravenous pamidronate: results from a multinational randomized controlled trial. The Aredia Multinational Co-operative Group . J Clin Oncol 1996; 14: 2552–2559 .[Abstract]
- Berenson JR, Lichtenstein A, Porter L, et al. Efficacy of pamidronate in reducing skeletal events in patients with advanced multiple myeloma. Myeloma Aredia Study Group [see comments] . New Engl J Med 1996; 334: 488–493 .[Abstract/Free Full Text]
- McKee M, Britton A, Black N, et al. Methods in health services research.Interpreting the evidence: choosing between randomised and non-randomised studies . Br Med J 1999; 319: 312–315 .[Free Full Text]
- MacMahon S, Collins R. Reliable assessment of the effects of treatment on mortality and major morbidity, II: observational studies . Lancet 2001; 357: 455–462 .[CrossRef][Medline]
[Order article via Infotrieve]
- Vandenbroucke JP. When are observational studies as credible as randomised trials? Lancet 2004; 363: 1728–1731 .[CrossRef][Medline]
[Order article via Infotrieve]
- Knudsen LM, Hjorth M, Hippe E. Renal failure in multiple myeloma: reversibility and impact on the prognosis. Nordic Myeloma Study Group . Eur J Haematol 2000; 65: 175–181 .[CrossRef][Medline]
[Order article via Infotrieve]
- Lipton A, Zheng M, Seaman J. Zoledronic acid delays the onset of skeletal-related events and progression of skeletal disease in patients with advanced renal cell carcinoma . Cancer 2003; 98: 962–969 .[CrossRef][Medline]
[Order article via Infotrieve]
- Saad F, Gleason DM, Murray R, et al. A randomized, placebo-controlled trial of zoledronic acid in patients with hormone-refractory metastatic prostate carcinoma . J Natl Cancer Inst 2002; 94: 1458–1468 .[Abstract/Free Full Text]
- Bamias A, Kastritis E, Bamia C, et al. Osteonecrosis of the jaw in cancer after treatment with bisphosphonates: incidence and risk factors . J Clin Oncol 2005; 23: 8580–8587 .[Abstract/Free Full Text]
- Migliorati CA, Siegel MA, Elting LS, et al. Bisphosphonateassociated osteonecrosis: a long-term complication of bisphosphonate treatment .[see comment]. Lancet Oncol 2006; 7: 508–514 .[CrossRef][Medline]
[Order article via Infotrieve]
Journal of Oncology Pharmacy Practice, Vol. 12, No. 4,
193-199 (2006)
DOI: 10.1177/1078155206073520
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