© 2002 by Oxford University Press
Journal of the National Cancer Institute, Vol. 94, No. 19, 1458-1468,
October 2, 2002
© 2002 Oxford University Press
ARTICLE |
A Randomized, Placebo-Controlled Trial of Zoledronic Acid in Patients With Hormone-Refractory Metastatic Prostate Carcinoma
For the Zoledronic Acid Prostate Cancer Study Group
Affiliations of authors: F. Saad, Centre Hospitalier de l'Université de Montréal, Hôpital Notre-Dame, Montréal, Quebec, Canada; D. M. Gleason, Advanced Clinical Therapeutics, Tucson, AZ; R. Murray, Division of Hematology and Medical Oncology, Peter MacCallum Cancer Institute, East Melbourne, Victoria, Australia; S. Tchekmedyian, Pacific Shores Medical Group, Long Beach, CA; P. Venner, Cross Cancer Center, Edmonton, Alberta, Canada; L. Lacombe, CHUQ-Hôtel-Dieu de Quebec, Quebec, Quebec, Canada; J. L. Chin, London Health Sciences Centre, London, Ontario, Canada; J. J. Vinholes, Irmandade de Santa Casa de Misericordia de Porto Alegre, Rio Grande do Sul, Brazil; J. A. Goas, B. Chen, Novartis Pharmaceuticals Corporation, East Hanover, NJ.
Correspondence to: Fred Saad, M.D., Uro-Oncology Clinic, Centre Hospitalier de l'Université de Montréal, Hôpital Notre-Dame, 1560 Rue Sherbrooke East, Montréal, Quebec, Canada H2L 4M1 (e-mail: fred.saad{at}ssss.gouv.qc.ca).
Background: Bone metastases are a common cause of morbidity in patients with prostate carcinoma. We studied the effect of a new bisphosphonate, zoledronic acid, which blocks bone destruction, on skeletal complications in prostate cancer patients with bone metastases. Methods: Patients with hormone-refractory prostate cancer and a history of bone metastases were randomly assigned to a double-blind treatment regimen of intravenous zoledronic acid at 4 mg (N = 214), zoledronic acid at 8 mg (subsequently reduced to 4 mg; 8/4) (N = 221), or placebo (N = 208) every 3 weeks for 15 months. Proportions of patients with skeletal-related events, time to the first skeletal-related event, skeletal morbidity rate, pain and analgesic scores, disease progression, and safety were assessed. All statistical tests were two-sided. Results: Approximately 38% of patients who received zoledronic acid at 4 mg, 28% who received zoledronic acid at 8/4 mg, and 31% who received placebo completed the study. A greater proportion of patients who received placebo had skeletal-related events than those who received zoledronic acid at 4 mg (44.2% versus 33.2%; difference = –11.0%, 95% confidence interval [CI] = –20.3% to –1.8%; P = .021) or those who received zoledronic acid at 8/4 mg (38.5%; difference versus placebo = –5.8%, 95% CI = –15.1% to 3.6%; P = .222). Median time to first skeletal-related event was 321 days for patients who received placebo, was not reached for patients who received zoledronic acid at 4 mg (P = .011 versus placebo), and was 363 days for those who received zoledronic acid at 8/4 mg (P = .491 versus placebo). Compared with urinary markers in patients who received placebo, urinary markers of bone resorption were statistically significantly decreased in patients who received zoledronic acid at either dose (P = .001). Pain and analgesic scores increased more in patients who received placebo than in patients who received zoledronic acid, but there were no differences in disease progression, performance status, or quality-of-life scores among the groups. Zoledronic acid at 4 mg given as a 15-minute infusion was well tolerated, but the 8-mg dose was associated with renal function deterioration. Conclusion: Zoledronic acid at 4 mg reduced skeletal-related events in prostate cancer patients with bone metastases.
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- Re: A Randomized, Placebo-Controlled Trial of Zoledronic Acid in Patients With Hormone-Refractory Metastatic Prostate Carcinoma
- Eric Winquist and Scott Berry
J Natl Cancer Inst 2004 96: 1183.[Extract] [Full Text] [PDF]
- RESPONSE: Re: A Randomized, Placebo-Controlled Trial of Zoledronic Acid in Patients With Hormone-Refractory Metastatic Prostate Carcinoma
- Fred Saad
J Natl Cancer Inst 2004 96: 1183-1184.[Extract] [Full Text] [PDF]
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J. E. Brown, R. J. Cook, P. Major, A. Lipton, F. Saad, M. Smith, K.-A. Lee, M. Zheng, Y.-J. Hei, and R. E. Coleman Bone Turnover Markers as Predictors of Skeletal Complications in Prostate Cancer, Lung Cancer, and Other Solid Tumors J Natl Cancer Inst, January 5, 2005; 97(1): 59 - 69. [Abstract] [Full Text] [PDF]
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T. Tanvetyanon Re: Long-Term Efficacy of Zoledronic Acid for the Prevention of Skeletal Complications in Patients with Metastatic Hormone-Refractory Prostate Cancer J Natl Cancer Inst, January 5, 2005; 97(1): 70 - 70. [Full Text] [PDF]
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J. R. Berenson Recommendations for Zoledronic Acid Treatment of Patients with Bone Metastases Oncologist, January 1, 2005; 10(1): 52 - 62. [Abstract] [Full Text] [PDF]
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J. Berenson and R. Hirschberg In Response to Diel I, Bergner R. Letter to the Editor of The Oncologist Re: Safety and Convenience of a 15-Minute Infusion of Zoledronic Acid Oncologist, January 1, 2005; 10(1): 84 - 87. [Full Text] [PDF]
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F. Joly and I. F. Tannock Chemotherapy for patients with hormone-refractory prostate cancer Ann. Onc., November 1, 2004; 15(11): 1582 - 1584. [Full Text] [PDF]
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C. L. Vogel, R. H. Yanagihara, A. J. Wood, F. M. Schnell, C. Henderson, B. H. Kaplan, M. H. Purdy, R. Orlowski, J. L. Decker, L. Lacerna, 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, November 1, 2004; 9(6): 687 - 695. [Abstract] [Full Text] [PDF]
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 I. F. Tannock, R. de Wit, W. R. Berry, J. Horti, A. Pluzanska, K. N. Chi, S. Oudard, C. Theodore, N. D. James, I. Turesson, et al. Docetaxel plus Prednisone or Mitoxantrone plus Prednisone for Advanced Prostate Cancer N. Engl. J. Med., October 7, 2004; 351(15): 1502 - 1512. [Abstract] [Full Text] [PDF]
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C. C. Parker Re: Long-Term Efficacy of Zoledronic Acid for the Prevention of Skeletal Complications in Patients With Metastatic Hormone-Refractory Prostate Cancer J Natl Cancer Inst, October 6, 2004; 96(19): 1480 - 1480. [Full Text] [PDF]
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A. Lipton, A. Colombo-Berra, R. M. Bukowski, L. Rosen, M. Zheng, and G. Urbanowitz Skeletal Complications in Patients with Bone Metastases from Renal Cell Carcinoma and Therapeutic Benefits of Zoledronic Acid Clin. Cancer Res., September 15, 2004; 10(18): 6397S - 6403S. [Abstract] [Full Text] [PDF]
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I. Mancini, J.-C. Dumon, and J.-J. Body Efficacy and Safety of Ibandronate in the Treatment of Opioid-Resistant Bone Pain Associated With Metastatic Bone Disease: A Pilot Study J. Clin. Oncol., September 1, 2004; 22(17): 3587 - 3592. [Abstract] [Full Text] [PDF]
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D. Lussier, A. G. Huskey, and R. K. Portenoy Adjuvant Analgesics in Cancer Pain Management Oncologist, September 1, 2004; 9(5): 571 - 591. [Abstract] [Full Text] [PDF]
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R. E. Coleman Bisphosphonates: Clinical Experience Oncologist, September 1, 2004; 9(suppl_4): 14 - 27. [Abstract] [Full Text] [PDF]
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P. Conte and V. Guarneri Safety of Intravenous and Oral Bisphosphonates and Compliance With Dosing Regimens Oncologist, September 1, 2004; 9(suppl_4): 28 - 37. [Abstract] [Full Text] [PDF]
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E. Winquist and S. Berry Re: A Randomized, Placebo-Controlled Trial of Zoledronic Acid in Patients With Hormone-Refractory Metastatic Prostate Carcinoma J Natl Cancer Inst, August 4, 2004; 96(15): 1183 - 1183. [Full Text] [PDF]
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F. Saad RESPONSE: Re: A Randomized, Placebo-Controlled Trial of Zoledronic Acid in Patients With Hormone-Refractory Metastatic Prostate Carcinoma J Natl Cancer Inst, August 4, 2004; 96(15): 1183 - 1184. [Full Text] [PDF]
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 N. Pandit-Taskar, M. Batraki, and C. R. Divgi Radiopharmaceutical Therapy for Palliation of Bone Pain from Osseous Metastases J. Nucl. Med., August 1, 2004; 45(8): 1358 - 1365. [Abstract] [Full Text] [PDF]
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F. Saad, D. M. Gleason, R. Murray, S. Tchekmedyian, P. Venner, L. Lacombe, J. L. Chin, J. J. Vinholes, J. A. Goas, and M. Zheng Long-Term Efficacy of Zoledronic Acid for the Prevention of Skeletal Complications in Patients With Metastatic Hormone-Refractory Prostate Cancer J Natl Cancer Inst, June 2, 2004; 96(11): 879 - 882. [Abstract] [Full Text] [PDF]
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J. Berenson and R. Hirschberg Safety and Convenience of a 15-Minute Infusion of Zoledronic Acid Oncologist, June 1, 2004; 9(3): 319 - 329. [Abstract] [Full Text] [PDF]
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D. Tripathy, M. Lichinitzer, A. Lazarev, S. A. MacLachlan, J. Apffelstaedt, M. Budde, and B. Bergstrom Oral ibandronate for the treatment of metastatic bone disease in breast cancer: efficacy and safety results from a randomized, double-blind, placebo-controlled trial Ann. Onc., May 1, 2004; 15(5): 743 - 750. [Abstract] [Full Text] [PDF]
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M. D. Michaelson, R. M. Marujo, and M. R. Smith Contribution of Androgen Deprivation Therapy to Elevated Osteoclast Activity in Men with Metastatic Prostate Cancer Clin. Cancer Res., April 15, 2004; 10(8): 2705 - 2708. [Abstract] [Full Text] [PDF]
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 T. Tanvetyanon and A. M Choudhury Hypocalcemia and Azotemia Associated with Zoledronic Acid and Interferon Alfa Ann. Pharmacother., March 1, 2004; 38(3): 418 - 421. [Abstract] [Full Text] [PDF]
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E. J. Small, M. R. Smith, J. J. Seaman, S. Petrone, and M. O. Kowalski Combined Analysis of Two Multicenter, Randomized, Placebo-Controlled Studies of Pamidronate Disodium for the Palliation of Bone Pain in Men With Metastatic Prostate Cancer J. Clin. Oncol., December 1, 2003; 21(23): 4277 - 4284. [Abstract] [Full Text] [PDF]
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W. K. Kelly and G. Steineck Bisphosphonates for Men With Prostate Cancer: Sifting Through the Rubble J. Clin. Oncol., December 1, 2003; 21(23): 4261 - 4262. [Full Text] [PDF]
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D. Santini, U. Vespasiani Gentilucci, B. Vincenzi, A. Picardi, F. Vasaturo, A. La Cesa, N. Onori, S. Scarpa, and G. Tonini The antineoplastic role of bisphosphonates: from basic research to clinical evidence Ann. Onc., October 1, 2003; 14(10): 1468 - 1476. [Abstract] [Full Text] [PDF]
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 G. R. Mundy Endothelin-1 and osteoblastic metastasis PNAS, September 16, 2003; 100(19): 10588 - 10589. [Full Text] [PDF]
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