A randomized, placebo-controlled trial of zoledronic acid in patients with hormone-refractory metastatic prostate carcinoma

Journal of the National Cancer Institute

Volumn 94, Issue 19, 2002, Pages 1458-1468

  Saad, Fred ^a   Gleason, Donald M ^a   Murray, Robin ^a   Tchekmedyian, Simon ^a   Venner, Peter ^a   Lacombe, Louis ^a   Chin, Joseph L ^a   Vinholes, Jeferson J ^a   Goas, J Allen ^a   Chen, Bee ^a  

^a NOTRE DAME HOSPITAL   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ANALGESIC AGENT; ANTIDEPRESSANT AGENT; BIOLOGICAL MARKER; BISPHOSPHONIC ACID DERIVATIVE; CREATININE; DEOXYPYRIDINOLINE; NARCOTIC AGENT; PLACEBO; PYRIDINOLINE; TRANQUILIZER; ZOLEDRONIC ACID;

ADULT; AGED; ANOREXIA; ARTICLE; BONE DESTRUCTION; BONE DISEASE; BONE METASTASIS; BONE PAIN; CLINICAL TRIAL; CONTROLLED STUDY; DEATH; DISEASE COURSE; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG INFUSION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEVER; FRACTURE; GASTROINTESTINAL DISEASE; HEMATOLOGIC DISEASE; HUMAN; INHIBITION KINETICS; KIDNEY DISEASE; MAJOR CLINICAL STUDY; MALE; MORBIDITY; MUSCLE WEAKNESS; NAUSEA AND VOMITING; OSTEOLYSIS; PAIN ASSESSMENT; PRIORITY JOURNAL; PROSTATE CARCINOMA; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SPINAL CORD COMPRESSION; TIME; URINALYSIS; VERTIGO;

ADENOCARCINOMA; AGED; ANTINEOPLASTIC AGENTS; BIOLOGICAL MARKERS; BONE DENSITY; BONE NEOPLASMS; BONE RESORPTION; DIPHOSPHONATES; DISEASE PROGRESSION; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; HUMAN; IMIDAZOLES; INFUSIONS, INTRAVENOUS; MALE; NEOPLASMS, HORMONE-DEPENDENT; PROSTATIC NEOPLASMS; QUALITY OF LIFE; SUPPORT, NON-U.S. GOV'T; TREATMENT OUTCOME;

EID: 0037009822     PISSN: 00278874     EISSN: None     Source Type: Journal    
DOI: 10.1093/jnci/94.19.1458     Document Type: Article

References (49)

1. Parkin DM, Laara E, Muir CS. Estimates of the worldwide frequency of sixteen major cancers in 1980. Int J Cancer 1988;41:184-97.
2. Parker SL, Tong T, Bolden S, Wingo PA. Cancer statistics, 1996. CA Cancer J Clin 1996;46:5-27.
3. Carlin BI, Andriole GL. The natural history, skeletal complications, and management of bone metastases in patients with prostate carcinoma. Cancer 2000;88:2989-94.
4. Pentyala SN, Lee J, Hsieh K, Waltzer WC, Trocchia A, Musacchia L, et al. Prostate cancer: a comprehensive review. Med Oncol 2000;17:85-105.
5. Townsend MF, Sanders WH, Northway RO, Graham SD Jr. Bone fractures associated with luteinizing hormone-releasing hormone agonists used in the treatment of prostate carcinoma. Cancer 1997;79:545-50.
6. Collinson MP, Tyrell CJ, Hutton C. Osteoporosis occurring in two patients receiving LHRH analogs for carcinoma of the prostate [letter]. Calcif Tissue Int 1994;54:327-8.
7. Daniell HW. Osteoporosis after orchiectomy for prostate cancer. J Urol 1997;157:439-44.
8. Clarke NW, McClure J, George NJ. The effects of orchiectomy on skeletal metabolism in metastatic prostate cancer. Scand J Urol Nephrol 1993;27:475-83.
9. Scher HI, Chung LW. Bone metastases: improving the therapeutic index. Semin Oncol 1994;21:630-56.
10. Berruti A, Dogliotti L, Bitossi R, Fasolis G, Gorzegno G, Bellina M, et al. Incidence of skeletal complications in patients with bone metastatic prostate cancer and hormone refractory disease: predictive role of bone resorption and formation markers evaluated at baseline. J Urol 2000;164:1248-53.
11. Hamdy NA, Papapoulos SE. The palliative management of skeletal metastases in prostate cancer: use of bone-seeking radionuclides and bisphosphonates. Semin Nucl Med 2001;31:62-8.
12. Kuban DA, Delbridge T, el-Mahdi AM, Schellhammer PF. Half-body irradiation for treatment of widely metastatic carcinoma of the prostate. J Urol 1989;141:572-4.
13. Clarke NW, McClure J, George NJ. Morphometric evidence for bone resorption and replacement in prostate cancer. Br J Urol 1991;68:74-80.
14. Garnero P, Buchs N, Zekri J, Rizzoli R, Coleman RE, Delmas PD. Markers of bone turnover for the management of patients with bone metastases from prostate cancer. Br J Cancer 2000;82:858-64.
15. Costa L, Demers L, Oliveira A, Schaller J, Costa E, Moura M, et al. Biochemical evaluation of different x-ray patterns of bone metastases: a prospective study [abstract]. Proc ASCO 2001;20:429a.
16. Berenson JR, Lichtenstein A, Porter L, Dimopoulos MA, Bordoni R, George S, et al. Efficacy of pamidronate in reducing skeletal events in patients with advanced multiple myeloma. Myeloma Aredia Study Group. N Engl J Med 1996;334:488-93.
17. Hortobagyi GN, Theriault RL, Porter L, Blayney D, Lipton A, Sinoff C, et al. Efficacy of pamidronate in reducing skeletal complications in patients with breast cancer and lyric bone metastases. Protocol 19 Aredia Breast Cancer Study Group. N Engl J Med 1996;335:1785-91.
18. Lipton A, Small E, Saad F, Gleason D, Gordon D, Smith M, et al. The new bisphosphonate, Zometa® (zoledronic acid) decreases skeletal complications in both lytic and blastic lesions: a comparison to pamidronate [abstract 34]. Cancer Invest 2001;20:45-7.
19. Dearnaley DP, Sydes MR, on behalf of the MRC Pr05 Collaborators. Preliminary evidence that oral clodronate delays symptomatic progression of bone metastases from prostate cancer: first results of the MRC Pr05 Trial [abstract]. Proc ASCO 2001;20:174a.
20. Berenson JR, Vescio R, Henick K, Nishikubo C, Rettig M, Swift RA, et al. A phase I, open label, dose ranging trial of intravenous bolus zoledronic acid, a novel bisphosphonate, in cancer patients with metastatic bone disease. Cancer 2001;91:144-54.
21. Berenson JR, Vescio RA, Rosen LS, VonTeichert JM, Woo M, Swift R, et al. A phase I, dose-ranging trial of monthly infusions of zoledronic acid for the treatment of osteolytic bone metastases. Clin Cancer Res 2001;7:478-85.
22. Rosen LS, Gordon D, Antonio BS, Kaminski M, Howell A, Belch A, 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;7:377-87.
23. Beahrs OH, Henson DE, Hutter RV, Myers MH, editors. Manual for staging of cancer. 3rd ed. Philadelphia (PA): J.B. Lippincott; 1988.
24. Murphy GP, Slack NH. Response criteria for the prostate of the USA National Prostate Cancer Project. Prostate 1980;1:375-82.
25. Hayward JL, Carbone PP, Heuson JC, Kumaoka S; Segaloff A, Rubens RD. Assessment of response to therapy in advanced breast cancer: a project of the Programme on Clinical Oncology of the International Union against Cancer, Geneva, Switzerland. Cancer 1977;39:1289-94.
26. Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singapore 1994;23:129-38.
27. Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, et al. The Functional Assessment of Cancer Therapy Scale: development and validation of the general measure. J Clin Oncol 1993; 11:570-9.
28. EuroQol Group. EuroQol: a new facility for the measurement of health-related quality of life. Health Policy 1990;16:199-208.
29. Tong D, Gillick L, Hendrickson FR. The palliation of symptomatic osseous metastases: final results of the Study by the Radiation Therapy Oncology Group. Cancer 1982;50:893-9.
30. Landis RJ, Heyman ER, Koch GG. Average partial association in three-way contingency tables: a review and discussion of alternative tests. Int Stat Rev 1978;46:237-54.
31. Kalbfleisch JD, Prentice RL. The statistical analysis of failure time data. New York (NY): John Wiley and Sons, Inc.; 1980. p. 16-9.
32. Munro BH, Page EB. Statistical methods for health care research. 2nd ed. Philadelphia (PA): J.B. Lippincott; 1993.
33. SAS/STAT® user's guide, version 6. Vol 1. 4th ed. Cary (NC): SAS Institute Inc.; 1989. p. 872-5.
34. Oh WK. Chemotherapy for patients with advanced prostate carcinoma. Cancer 2000;88:3015-21.
35. Coleman RE, Seaman JJ. The role of zoledronic acid in cancer: clinical studies in the treatment and prevention of bone metastases. Semin Oncol 2001;28:11-6.
36. Smith MR, McGovern FJ, Zietman AL, Fallon MA, Hayden DL, Schoenfeld DA, et al. Pamidronate to prevent bone loss during androgen-deprivation therapy for prostate cancer. N Engl J Med 2001;345:948-55.
37. Orwoll E, Ettinger M, Weiss S, Miller P, Kendler D, Graham J, et al. Alendronate for the treatment of osteoporosis in men. N Engl J Med 2000;343:604-10.
38. Percival RC, Urwin GH, Harris S, Yates AJ, Williams JL, Beneton M, et al. Biochemical and histological evidence that carcinoma of the prostate is associated with increased bone resorption. Eur J Surg Oncol 1987;13:41-9.
39. Clarke NW, McClure J, George NJ. Disodium pamidronate identifies differential osteoclastic bone resorption in metastatic prostate cancer. Br J Urol 1992;69:64-70.
40. Ikeda I, Miura T, Kondo I. Pyridinium cross-links as urinary markers of bone metastases in patients with prostate cancer. Br J Urol 1996;77:102-6.
41. Adami S, Salvagno G, Guarrera G, Bianchi G, Dorizzi R, Rosini S, et al. Dichloromethylene-diphosphonate in patients with prostatic carcinoma metastatic to the skeleton. J Urol 1985;134:1152-4.
42. Carey PO, Lippert MC. Treatment of painful prostatic bone metastases with oral etidronate disodium. Urology 1988;32:403-7.
43. Adami S, Mian M. Clodronate therapy of metastatic bone disease in patients with prostatic carcinoma. Recent Results Cancer Res 1989;116:67-72.
44. Elomaa I, Kylmala T, Tammela T, Viitanen J, Ottelin J, Ruutu M, et al. Effect of oral clodronate on bone pain: a controlled study in patients with metastatic prostate cancer. Int Urol Nephrol 1992;24:159-66.
45. Pelger RC, Hamdy NA, Zwinderman AH, Lycklama AA, Nijeholt A, Papapoulos SE. Effects of the bisphosphonate olpadronate in patients with carcinoma of the prostate metastatic to the skeleton. Bone 1998;22:403-8.
46. Smith JA Jr. Palliation of painful bone metastases from prostate cancer using sodium etidronate: results of a randomized, prospective, double-blind, placebo-controlled study. J Urol 1989;141:85-7.
47. Strang P, Nilsson S, Brandstedt S, Sehlin J, Borghede G, Varenhorst E, et al. The analgesic efficacy of clodronate compared with placebo in patients with painful bone metastases from prostatic cancer. Anticancer Res 1997; 17:4717-21.
48. Kylmala T, Taube T, Tammela TL, Risteli L, Risteli J, Elomaa I. Concomitant i.v. and oral clodronate in the relief of bone pain-a double-blind, placebo-controlled study in patients with prostate cancer. Br J Cancer 1997;76:939-42.
49. Adami S, Zamberlan N. Adverse effects of bisphosphonates. A comparative review. Drug Saf 1996;14:158-70.