Clinical efficacy and safety of zoledronic acid in prostate and breast cancer

Expert Review of Anticancer Therapy

Volumn 9, Issue 9, 2009, Pages 1211-1218

  Doggrell, Sheila A ^a  

^a QUEENSLAND UNIVERSITY OF TECHNOLOGY   (Australia)

Author keywords

Bisphosphonates; Bone metastases; Breast cancer; Clinical trials; Efficacy; Osteoporosis; Prostate cancer; Zoledronic acid

Indexed keywords

ALENDRONIC ACID; ANASTROZOLE; ANTIANDROGEN; ANTINEOPLASTIC AGENT; AROMATASE INHIBITOR; BISPHOSPHONIC ACID DERIVATIVE; CALCIUM; CLODRONIC ACID; DENOSUMAB; DOCETAXEL; DOXORUBICIN; GONADORELIN AGONIST; GOSERELIN; LETROZOLE; PAMIDRONIC ACID; PLACEBO; VITAMIN D; ZOLEDRONIC ACID;

ANDROGEN DEPRIVATION THERAPY; ANEMIA; ANTIANGIOGENIC ACTIVITY; ANTINEOPLASTIC ACTIVITY; ARTHRALGIA; BACKACHE; BONE DENSITY; BONE METASTASIS; BONE NECROSIS; BREAST CANCER; CANCER HORMONE THERAPY; CANCER RADIOTHERAPY; CLINICAL TRIAL; DOSE RESPONSE; DRUG DOSE COMPARISON; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FEVER; DRUG MEGADOSE; DRUG POTENTIATION; DRUG SAFETY; DRUG TOLERABILITY; EYE INFLAMMATION; FATIGUE; FLU LIKE SYNDROME; HUMAN; KIDNEY DYSFUNCTION; LEG EDEMA; MYALGIA; NAUSEA; NEPHROTOXICITY; NONHUMAN; ORCHIECTOMY; ORTHOPEDIC SURGERY; OSTEOLYSIS; OSTEOPOROSIS; PATIENT COMPLIANCE; PRIMARY PREVENTION; PROSTATE CANCER; RECOMMENDED DRUG DOSE; REVIEW; SECONDARY OSTEOPOROSIS; UNSPECIFIED SIDE EFFECT; VOMITING;

ANIMALS; BONE DENSITY; BONE DENSITY CONSERVATION AGENTS; BONE NEOPLASMS; BREAST NEOPLASMS; CLINICAL TRIALS AS TOPIC; DIPHOSPHONATES; FEMALE; HUMANS; IMIDAZOLES; MALE; PROSTATIC NEOPLASMS;

EID: 70350633932     PISSN: 14737140     EISSN: 17448328     Source Type: Journal    
DOI: 10.1586/ERA.09.95     Document Type: Review

References (61)

1. Mangiapane S, Hoer A, Gothe H, Bargout V, Haeussler B. Higher persistency with i.v. bisphosphonates in patients with bone metastases. J. Clin. Oncol. ASCO Annual Meeting Proceedings (Post-Meeting Edition) 24, 18S, 18623 (2006).
2. Black DM, Delmas PD, Eastell R et al. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N. Engl. J. Med. 356, 1809-1822 (2007).
3. Lyles KW, Colón-Emetic CS, Magaziner JS et al. Zoledronic acid and clinical fractures and mortality after hip fracture. N. Engl. J. Med. 357, 1799 - 1809 (2007).
4. Smith MR. Treatment-related osteoporosis in men with prostate cancer. Clin. Cancer Res. 12(20 Suppl.) S6315-S6319 (2006).
5. Smith MR, Eastham J, Gleason DM et al. Randomized controlled trial of zoledronic acid to prevent bone loss in men receiving androgen deprivation therapy for nonmetastatic prostate cancer. J. Urol. 169, 2008-2012 (2003). •• Showed that zoledronic acid decreased the loss of bone mineral density in men with hormone-sensitive prostate cancer being treated with androgen deprivation therapy. (Pubitemid 36576705)
6. Ryan CW, Huo D, Demers LM, Beer TM, Lacerna LV. Zoledronic acid initiated during the first year of androgen deprivation therapy increases bone mineral density in patients with prostate cancer. J. Urol. 176, 972-978 (2006). (Pubitemid 44142571)
7. Michaelson MD, Kaufman DS, Lee H et al. Randomized controlled trial of annual zoledronic acid to prevent gonadotropin-releasing hormone agonist-induced bone loss in men with prostate cancer. J. Clin. Oncol. 25, 1038-1042 (2007). (Pubitemid 46596753)
8. Polascik TJ, Given RW, Metzger C et al. Open-label trial evaluating the safety and efficacy of zoledronic acid in preventing bone loss in patients with hormone-sensitive prostate cancer and bone metastases. Urology 66, 1054-1059 (2005). (Pubitemid 41587160)
9. 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. 94, 1458-1468 (2002). •• Shows that zoledronic acid decreases skeletal-related events in bone metastases associated with prostate cancer.
10. Weinfurt KP, Anstrom KJ, Castel LD, Schulman KA, Saad F. Effect of zoledronic acid on pain associated with bone metastasis in patients with prostate cancer. Ann. Oncol. 17, 986-989 (2006). (Pubitemid 43097349)
11. Saad F, Gleason DM, Murray R et al. Long-term efficacy of zoledronic acid for the prevention of skeletal complications in patients with metastatic hormone-refractory prostate cancer. J. Natl Cancer Inst. 96, 879-882 (2004). (Pubitemid 38365413)
12. Fulfaro F, Leto G, Badalamenti G et al. The use of zoledronic acid in patients with bone metastases from prostate carcinoma: effect on analgesic response and bone metabolism biomarkers. J. Chemother. 17, 555-559 (2005). (Pubitemid 41695604)
13. Jakesz R, Jonat W, Gnant M et al. Switching of postmenopausal women with endocrine responsive early breast cancer to anastrozole after 2 years' adjuvant tamoxifen: combined results of ABCSG trial 8 and ARNO 95 trial. Lancet 366, 455-462 (2005). (Pubitemid 41111693)
14. Brufsky A, Harker WG, Beck JT et al. Zoledronic acid inhibits adjuvant letrozole-induced bone loss in postmenopausal women with early breast cancer. J. Clin. Oncol. 25, 829-836 (2007). • Important clinical trial showing that zoledronic acid inhibits the bone mineral density loss with the aromatase inhibitor letrozole in postmenopausal women with hormone-sensitive breast cancer. (Pubitemid 350002883)
15. Bundred NJ, Campbell ID, Davidson N et al. Effective inhibition of aromatase inhibitor-associated bone loss by zoledronic acid in postmenopausal women with early breast cancer receiving adjuvant letrozole - ZO-FAST Study results. Cancer 112, 1001-1010 (2008). (Pubitemid 351304583)
16. Brufsky A, Bundred N, Coleman R et al. Integrated analysis of zoledronic acid for prevention of aromatase inhibitor-associated bone loss in postmenopausal women with early breast cancer receiving adjuvant letrozole. Oncologists 13, 503-514 (2008). (Pubitemid 351304583)
17. Brufsky AM, Bosserman LD, Caradonna RR et al. Zoledronic acid effectively prevents aromatase inhibitor-associated bone loss in postmenopausal women with early breast cancer receiving adjuvant letrozole: Z-FAST study 36-month follow-up results. Clin. Breast Cancer 9, 77-85 (2009).
18. Grant MFX, Mlineritsch B, Luschin-Ebengreuth G et al. Zoledronic acid prevents cancer treatment-induced bone loss in premenopausal women receiving adjuvant therapy for hormone-responsive breast cancer: a report from the Austrian Breast and Colorectal Cancer Study Group. J. Clin. Oncol. 25, 820-828 (2007). • Important trial showing that zoledronic acid prevented the bone loss associated with hormonal deprivation therapy in premenopausal women with breast cancer. (Pubitemid 350002882)
19. Grant MFX, Mlineritsch B, Luschin-Ebengreuth G et al. Adjuvant endocrine therapy plus zoledronic acid in premenopausal women with early-stage breast cancer: 6-year follow-up of the ABCSG-12 bone-mineral density substudy. Lancet Oncol. 9, 840-849 (2008).
20. Grant M, Mineritsch B, Schippinger W et al. Endocrine therapy plus zoledronic acid in premenopausal breast cancer. N. Engl. J. Med. 360, 679-691. •• Demonstrates that zoledronic acid has anticancer activity in premenopausal women with breast cancer.
21. Kohno N, Aogi K, Minami H et al. Zoledronic acid significantly reduces skeletal complications compared with placebo in Japanese women with bone metastases from breast cancer: a randomized, placebo-controlled trial. J. Clin. Oncol. 23, 3314-3321 (2005). • Important trial showing that zoledronic acid reduced skeletal-related events in bone metastases associated with breast cancer. (Pubitemid 46243475)
22. Wardley A, Davidson N, Barrett-Lee P et al. Zoledronic acid significantly improves pain scores and quality of life in breast cancer patients with bone metastases: a randomised, crossover study of community vs hospital bisphosphonate administration. Br. J. Cancer 92, 1869-1876 (2005).
23. Carteni G, Bordonaro R, Giotta F et al. Efficacy and safety of zoledronic acid in patients with breast cancer metastatic to bone: a multicenter clinical trial. Oncologist 11, 841-848 (2006). (Pubitemid 44157572)
24. Body JJ, Bartl R, Burckhardt P et al. Current use of bisphosphonates in oncology. International Bone and Cancer Study Group. J. Clin. Oncol. 16, 3890-3899 (1998).
25. Rosen LS, Gordon DH, Dugan W 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 100, 36-43 (2004).
26. Clemons MJ, Dranitsaris G, Ooi WS et al. Phase II trial evaluation the palliative benefit of second-line zoledronic acid in breast cancer patients with either a skeletal-related event or progressive bone metastases despite firstline bisphosphonate therapy. J. Clin. Oncol. 24, 4895-4900.
27. Pavlakis N, Schmidt R, Stockler M. Bisphosphonates for breast cancer. Cochrane Database Syst. Rev. 20, CD003474 (2005).
28. Tranveryanon T, Stiff PJ. Management of the adverse effects associated with intravenous bisphosphonates. Ann. Oncol. 17, 897-907 (2006).
29. Bujanda DA, Sarmiento UB, Suárez MAC, Morales JA. Assessment of renal toxicity and osteonecrosis of the jaws in patients receiving zoledronic acid for bone metastasis. Ann. Oncol. 18, 556-560 (2007).
30. Maclean C, Newberry S, Maglioned M et al. Systematic review: comparative effectiveness of treatments to prevent fractures in men and women with low bone density or osteoporosis. Ann. Intern. Med. 148, 197-213 (2008). (Pubitemid 351665507)
31. Oh WK, Proctor K, Nakabayashi M et al. The risk of renal impairment in hormone-refractory prostate cancer patients with bone metastases treated with zoledronic acid. Cancer 109, 1090-1096 (2007). (Pubitemid 46435387)
32. Migliorati CA, Schubert MM, Peterson DE, Seneda LM. Bisphosphonate- associated osteonecrosis of mandibular and maxillary bone: an emerging oral complication of supportive cancer therapy. Cancer 104, 83-93 (2005).
33. Merigo E, Manfredi M, Meleti M et al. Bone necrosis of the jaws associated with bisphosphonate treatment: a report of twenty-nine cases. Acta Biomed. 77, 109-117 (2006). (Pubitemid 44884943)
34. Hoff AO, Toth BB, Altundag K et al. Frequency and risk factors associated with osteonecrosis of the jaw in cancer patients treated with intravenous bisphosphonates. J. Bone Miner. Res. 23, 826-838 (2008). (Pubitemid 351768801)
35. Olson KB, Hellie CM, Pienta KJ. Osteonecrosis of jaw in patients with hormone-refractory prostate cancer treated with zoledronic acid. Urology 66, 658 (2005).
36. García Sáenz JA, López Tarruella S, García Paredes B et al. Osteonecrosis of the jaw as an adverse bisphosphonates event: three cases of bone metastatic prostate cancer patients treated with zoledronic acid. Med. Oral Patol. Oral Cir. Bucal 12, E351-E356 (2007).
37. Ortega C, Montemurro F, Faggiuolo R et al. Osteonecrosis of the jaw in prostate cancer patients with bone metastases treated with zoledronate: a retrospective analysis. Acta Oncol. 46, 664-668 (2007). (Pubitemid 46911907)
38. Benderson D, Karakunnel J, Kathuria S, Badros A. Scleritis complication zoledronic acid infusion. Clin. Lymphoma Myeloma 7, 145-147 (2006). (Pubitemid 44596598)
39. Phillips PM, Newman SA. Orbital inflammatory disease after intravenous infusion of zoledronate for treatment of metastatic renal cell carcinoma. Arch. Ophthalmol. 126, 137-139 (2008).
40. Kilickap S, Ozdamar Y, Altundag MK, Disdar O. A case report: zoledronic acid-induced anterior uveitis. Med. Oncol. 25, 238-240 (2008).
41. Vogel CL, Yanagihara RH, Wood AJ et al. Safety and pain palliation of zoledronic acid in patients with breast cancer, prostate cancer, or multiple myeloma who previously received bisphosphonate therapy. Oncologist 9, 687-695 (2004).
42. Ripamonti C, Fagnoni E, Campa T et al. Decreases in pain at rest and movementrelated pain during zoledronic acid treatment in patients with bone metastases due to breast or prostate cancer: a pilot study. Support. Care Cancer 15, 1177-1184 (2007). (Pubitemid 47459863)
43. Kretzschmar A, Wiege T, Al-Batran SE et al. Rapid and sustained influence of intravenous zoledronic acid on course of pain and analgesics consumption in patients with cancer with bone metastases: a multicenter open-label study over 1 year. Support. Cancer Ther. 4, 203-210 (2007). (Pubitemid 47606346)
44. Saad F. New research findings on zoledronic acid: survival, pain, and anti-tumour effects. Cancer Treat. Res. 34, 183-192 (2008).
45. Lipton A. Emerging role of bisphosphonates in the clinic - antitumor activity and prevention of metastasis in bone. Cancer Treat. Rev. 34, S25-S30 (2008).
46. Daubiné F, Le Gall C, Gasser J, Green J, Clézardin P. Antitumor effects of clinical dosing regimens of bisphosphonates in experimental breast cancer bone metastasis. J. Natl Cancer Inst. 99, 322-330 (2007). (Pubitemid 47073494)
47. Ottewell PD, Mönkkönen H, Jones M et al. Antitumour effects of doxorubicin followed by zoledronic acid in a mouse model of breast cancer. J. Natl Cancer Inst. 100, 1167-1178 (2008).
48. Brubaker KD, Brown LG, Vessella RL, Corey E. Administration of zoledronic acid enhances the effects of docetaxel on growth of prostate cancer in the bone environment. BMC Cancer 6, 15 (2006). (Pubitemid 43193496)
49. Vordos D, Paule B, Vacherot F et al. Docetaxel and zoledronic acid in patients with metastatic hormone-refractory prostate cancer. BJU Int. 94, 524-527 (2004). (Pubitemid 39256473)
50. Corso A, Varettoni M, Zappasodi P et al. A different schedule of zoledronic acid can reduce the risk of the osteonecrosis of the jaw in patients with multiple myeloma. Leukemia 21, 1545-1548 (2007). (Pubitemid 46965296)
51. Dimopoulos MA, Kastritis E, Bamia C et al. Reduction of osteonecrosis of the jaw (ONJ) after implantation of preventive measures in patients with multiple myeloma treated with zoledronic acid. Ann. Oncol. 20(1), 117-120 (2009).
52. Ripamonti CI, Maniezzo M, Campa T et al. Decreased occurrence of osteonecrosis of the jaw after implementation of dental preventive measures in solid tumour patients with bone metastases treated with bisphosphonates. The experience of the National Cancer Institute of Milan. Ann. Oncol. 20(1), 137-145 (2009).
53. Khan AA, Sándor GK, Dore E et al. Canadian consensus practice guidelines for bisphosphonate associated osteonecrosis of the jaw. J. Rheumatol. 35, 1391-1397 (2008). (Pubitemid 352000790)
54. Christodoulou C, Pervena A, Klouvas G et al. Combination of bisphosphonates and antiangiogenic factors induce osteonecrosis of the jaw more frequently than bisphosphonates alone. Oncology 76, 209-211 (2009).
55. Lipton A, Steger GG, Figueroa J et al. Randomized active-controlled Phase II study of denosumab efficacy and safety in patients with breast cancer-related bone metastases. J. Clin. Oncol. 25, 4431-4437 (2007). (Pubitemid 350013849)
56. Lipton A, Steger GG, Figueroa J et al. Extended efficacy and safety of denosumab in breast cancer patients with bone metastases not receiving prior bisphosphonate therapy. Clin. Cancer Res. 14, 6690-6696 (2008).
57. Zometa® (zoledronic acid) injection prescribing information www.pharma.us.novartis.com/product/pi/pdf/Zometa.pdf
58. Three trials support evidence of Zometa® anticancer benefit in pre- and postmenopausal women with early-stage breast cancer www.medicalnewstoday. com/articles/121720.php (Accessed 20 May 2009)
59. A trial to see if zoledronic acid can help chemotherapy work better before surgery for breast cancer (ANZAC) www.cancerhelp.org.uk/trials/trials/ trial.asp?freetextsearch=bisphosphonate&searchtype=&trial= 18954&trialno=11273&spage=1&objective=0&cancer=0&stage= 0&phase=0&treatment=0&location=0 (Accessed 20 May 2009)
60. Efficacy and safety of zoledronic acid (every 4 weeks vs every 12 weeks) in patients with documented bone metastases from bone cancer www.clinicaltrials.gov/ct2/show/NCT00320710?term=zoledronic+cancer&rank=13 (Accessed 12 November 2008)
61. Double-blind study of denosumab compared with zoledronic acid in the treatment of bone metastases in men with hormone-refractory prostate cancer www.clinicaltrials.gov/ct2/show/NCT00321620?term=prostate+cancer+zoledronic& rank=11 (Accessed 20 May 2009)