Efficacy and safety of intravenous bisphosphonates for patients with breast cancer metastatic to bone: A review of randomized, double-blind, phase III trials

Clinical Breast Cancer

Volumn 6, Issue 2, 2005, Pages 125-131

  Gordon, David H ^a  

^a Developmental Therapeutics Committee and Co Chair of the Genitourinary Committee   (United States)

Author keywords

Ibandronate; Pamidronate; Skeletal related events; Zoledronic acid

Indexed keywords

BISPHOSPHONIC ACID DERIVATIVE; CYTOTOXIC AGENT; MEGESTROL ACETATE; NITROGEN; PAMIDRONIC ACID; PLACEBO; TAMOXIFEN; ZOLEDRONIC ACID;

ANEMIA; ANOREXIA; ARTHRALGIA; BONE DISEASE; BONE METASTASIS; BONE PAIN; BREAST CANCER; CLINICAL TRIAL; DRUG CHOICE; DRUG EFFICACY; DRUG INDUCED DISEASE; DRUG INFUSION; DRUG SAFETY; FEMALE; FLU LIKE SYNDROME; HUMAN; HYPERPHOSPHATEMIA; INFUSION REACTION; KIDNEY FAILURE; LEUKOPENIA; MORBIDITY; MYALGIA; NAUSEA; OSTEOLYSIS; PATIENT CARE; PHASE 3 CLINICAL TRIAL; REVIEW; RISK REDUCTION; STATISTICAL ANALYSIS; THROMBOCYTOPENIA; VOMITING;

EID: 22144499565     PISSN: 15268209     EISSN: None     Source Type: Journal    
DOI: 10.3816/CBC.2005.n.014     Document Type: Review

References (27)

1. Jemal A, Murray T, Ward A, et al. Cancer statistics, 2005. CA Cancer J Clin 2005; 51:10-30.
2. Coleman RE, Rubens RD. The clinical course of bone metastases from breast cancer. Br J Cancer 1987; 55:61-66.
3. Coleman RE. Metastatic bone disease: clinical features, pathophysiology and treatment strategies. Cancer Treat Rev 2001; 27:165-176.
4. Hortobagyi GN, Theriault RL, Lipton A, et al. Long-term prevention of skeletal complications of metastatic breast cancer with pamidronate. Protocol 19 Aredia Breast Cancer Study Group. J Clin Oncol 1998; 16:2038-2044.
5. Theriault RL, Lipton A, Hortobagyi GN, et al. Pamidronate reduces skeletal morbidity in women with advanced breast cancer and lytic bone lesions: a randomized, placebo-controlled trial. Protocol 19 Aredia Breast Cancer Study Group. J Clin Oncol 1999; 17:846-854.
6. Hortobagyi GN, Theriault RL, Porter L, et al. Efficacy of pamidronate in reducing skeletal complications in patients with breast cancer and lytic bone metastases. Protocol 19 Aredia Breast Cancer Study Group. N Engl J Med 1996; 335:1785-1791.
7. Hillner BE, Ingle JN, Berenson JR, et al. American society of Clinical Oncology guideline on the role of bisphosphonates in breast cancer. American Society of Clinical Oncology Bisphosphonates Expert Panel. J Clin Oncol 2000; 18:1378-1391.
8. Hilner BE, Ingle JN, Chlebowski RT, et al. American Society of Clinical Oncology 2003 update on the role of bisphosphonates and bone health issues in women with breast cancer. J Clin Oncol 2003; 21:4042-4057.
9. Center for Drug Evaluation and Research. Food and Drug Administration [Web Site]. Available at: http://www.fda.gov/cder/foi/nda/98/20036s015_Aredia.htm. Accessed March 5, 2004.
10. Lipton A, Theriault RL, Hortobagyi GN, et al. 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 2000; 88:1082-1090.
11. Coleman RE. Efficacy of zoledronic acid and pamidronate in breast cancer patients: a comparative analysis of randomized phase III trials: Am J Clin Oncol 2002; 25(6 suppl 1):S25-S31.
12. Green JR, Muller K, Jaeggi KA. Preclinical pharmacology of CGP 42′446, a new, potent, heterocyclic bisphosphonate compound. J Bone Miner Res 1994; 9:745-751.
13. 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.
14. 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.
15. 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.
16. Williams G, Pazdur R, Temple R. Assessing tumor-related signs and symptoms to support cancer drug approval. J Biopharm Stat 2004; 14:5-21.
17. Major PP, Cook RJ, Chen BL, et al. Survival-adjusted multiple event analysis of skeletal complications from bone metastases: a comprehensive analysis of treatment benefit. Presented at: IV International Conference on Cancer-Induced Bone Diseases; December 7-9, 2003. San Antonio, TX.
18. Major P, Lortholary A, Hon J, et al. Zoledronic acid is superior to pamidronate in the treatment of hypercalcemia of malignancy: a pooled analysis of two randomized, controlled clinical trials. J Clin Oncol 2001; 19:558-567.
19. 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.
20. Rosen LS, Coleman RE, Gordon D, et al. Zoledronic acid is superior to pamidronate in patients with breast cancer and bone metastases. Presented at: St. Gallen Oncology Conferences: Primary Therapy of Early Breast Cancer 8th International Conference; March 12-15, 2003; St. Gallen, Switzerland.
21. Coleman RE. Skeletal complications of malignancy. Cancer 1997; 80(8 suppl): 1588-94.
22. Dunford JE, Thompson K, Coxon FP et al. Structure-activity relationships for inhibition of farnesyl diphosphate synthase in vitro and inhibition of bone resorption in vivo by nitrogen-containing bisphosphonates. J Pharmacol Exp Ther 2001; 296:235-242.
23. Muhlbauer RC, Bauss F, Schenk R, et al. BM 21.0955, a potent new bisphosphonate to inhibit bone resorption. J Bone Miner Res 1991; 6:1003-1011.
24. Tripathy D, Body JJ, Diel I, et al. Oral daily ibandronate: efficacy in reducing skeletal complications in patients with metastatic bone disease from breast cancer. Proc Am Soc Clin Oncol 2003; 22:46 (Abstract #185).
25. Body JJ, Diel IJ, Lichinitser MR, et al. Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases. Ann Oncol 2003; 14:1399-1405.
26. Joshua DE, Chern B, Dalley D, et al. Resource use by zoledronic acid or pamidronate infusions in multiple myeloma and cancer. Blood 2002; 100(suppl):496b (Abstract #5571).
27. 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.