Combined analysis of two multicenter, randomized, placebo-controlled studies of pamidronate disodium for the palliation of bone pain in men with metastatic prostate cancer

Journal of Clinical Oncology

Volumn 21, Issue 23, 2003, Pages 4277-4284

  Small, Eric J ^a   Smith, Matthew R ^a   Seaman, John J ^a   Petrone, Stephanie ^a   Kowalski, Mildred Ortu ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

ANALGESIC AGENT; PAMIDRONIC ACID; PLACEBO; ANTINEOPLASTIC AGENT; BISPHOSPHONIC ACID DERIVATIVE;

ARTICLE; BONE METASTASIS; BONE PAIN; CANCER GROWTH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; HUMAN; LABORATORY TEST; MALE; MULTICENTER STUDY; OSTEOLYSIS; PAIN ASSESSMENT; PALLIATIVE THERAPY; PRIORITY JOURNAL; PROSTATE CANCER; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; TREATMENT RESPONSE; ADULT; AGED; BONE TUMOR; COMPARATIVE STUDY; METASTASIS; MIDDLE AGED; PAIN; PATHOLOGY; PHASE 3 CLINICAL TRIAL; PROSTATE TUMOR; RETROSPECTIVE STUDY;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; BONE NEOPLASMS; DIPHOSPHONATES; DOUBLE-BLIND METHOD; HUMANS; MALE; MIDDLE AGED; PAIN; PALLIATIVE CARE; PLACEBOS; PROSTATIC NEOPLASMS; RETROSPECTIVE STUDIES; TREATMENT OUTCOME;

EID: 0642337996     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2003.05.147     Document Type: Article

References (51)

1. Jemal A, Thomas A, Murray T, et al: Cancer statistics, 2002. CA Cancer J Clin 52:23-47, 2002
2. Carlin BI, Andriole GL: The natural history, skeletal complications, and management of bone metastases in patients with prostate carcinoma. Cancer 88:2989-2994, 2000 (suppl)
3. Pentyala SN, Lee J, Hsieh K, et al: Prostate cancer: A comprehensive review. Med Oncol 17:85-105, 2000
4. Coleman RE: Skeletal complications of malignancy. Cancer 80:1588-1594, 1997 (suppl)
5. Mercadante S, Casuccio A, Pumo S, et al: Opioid responsiveness-primary diagnosis relationship in advanced cancer patients followed at home. J Pain Symptom Manage 20:27-34, 2000
6. Tennvall J, Darte L, Lundgren R, et al: Palliation of multiple bone metastases from prostatic carcinoma with strontium-89. Acta Oncol 27:365-369, 1988
7. Correns HJ, Mebel M, Buchali K, et al: 89Strontium therapy of bone metastases of carcinoma of the prostatic gland. Eur J Nucl Med 4:33-35, 1979
8. 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. N Engl J Med 334:488-493, 1996
9. Berenson JR, Lichtenstein A, Porter L, et al: Long-term pamidronate treatment of advanced multiple myeloma patients reduces skeletal events: Myeloma Aredia Study Group. J Clin Oncol 16:593-602, 1998
10. 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
11. Drake WM, Kendler DL, Brown JP: Consensus statement on the modern therapy of Paget's disease of bone from a Western Osteoporosis Alliance symposium: Biannual Foothills Meeting on Osteoporosis, Calgary, Alberta, Canada, September 9-10, 2000. Clin Ther 23:620-626, 2001
12. 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 335:1785-1791, 1996
13. 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 16:2038-2044, 1998
14. 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 88:1082-1090, 2000
15. Mundy GR, Wilkinson R, Heath DA: Comparative study of available medical therapy for hypercalcemia of malignancy. Am J Med 74:421-432, 1983
16. 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 19:558-567, 2001
17. Nussbaum SR, Younger J, VandePol CJ, et al: Single-dose intravenous therapy with pamidronate for the treatment of hypercalcemia of malignancy: comparison of 30-, 60-, and 90-mg dosages. Am J Med 95:297-304, 1993
18. 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 18 Aredia Breast Cancer Study Group. J Clin Oncol 17:846-854, 1999
19. Marquardt H, Lioubin MN, Ikeda T: Complete amino acid sequence of human transforming growth factor type beta 2. J Biol Chem 262:12127-12131, 1987
20. Mayahara H, Ito T, Nagai H, et al: In vivo stimulation of endosteal bone formation by basic fibroblast growth factor in rats. Growth Factors 9:73-80, 1993
21. Dunstan CR, Boyce R, Boyce BF, et al: Systemic administration of acidic fibroblast growth factor (FGF-1) prevents bone loss and increases new bone formation in ovariectomized rats. J Bone Miner Res 14:953-959, 1999
22. Izbicka E, Dunstan C, Esparza J, et al: Human amniotic tumor that induces new bone formation in vivo produces growth-regulatory activity in vitro for osteoblasts identified as an extended form of basic fibroblast growth factor. Cancer Res 56:633-636, 1996
23. Berruti A, Dogliotti L, Tucci M, et al: Metabolic bone disease induced by prostate cancer: rationale for the use of bisphosphonates. J Urol 166:2023-2031, 2001
24. Clarke NW, McClure J, George NJ: Morphometric evidence for bone resorption and replacement in prostate cancer. Br J Urol 68:74-80, 1991
25. Clarke NW, McClure J, George NJ: Disodium pamidronate identifies differential osteoclastic bone resorption in metastatic prostate cancer. Br J Urol 69:64-70, 1992
26. Garnero P, Buchs N, Zekri J, et al: Markers of bone turnover for the management of patients with bone metastases from prostate cancer. Br J Cancer 82:858-864, 2000
27. Percival RC, Urwin GH, Harris S, et al: Biochemical and histological evidence that carcinoma of the prostate is associated with increased bone resorption. Eur J Surg Oncol 13:41-49, 1987
28. Taube T, Kylmala T, Lamberg-Allardt C, et al: The effect of clodronate on bone in metastatic prostate cancer: Histomorphometric report of a double-blind randomised placebo-controlled study. Eur J Cancer 30:751-758, 1994 (abstr)
29. Clarke NW, Holbrook IB, McClure J, et al: Osteoclast inhibition by pamidronate in metastatic prostate cancer: A preliminary study. Br J Cancer 63:420-423, 1991
30. Adami S, Salvagno G, Guarrera G, et al: Dichloromethylene-diphosphonate in patients with prostatic carcinoma metastatic to the skeleton. J Urol 134:1152-1154, 1985
31. Adami S: Bisphosphonates in prostate carcinoma. Cancer 80:1674-1679, 1997
32. Carey PO, Lippert MC: Treatment of painful prostatic bone metastases with oral etidronate disodium. Urology 32:403-407, 1988
33. Cresswell SM, English PJ, Hall RR, et al: Pain relief and quality-of-life assessment following intravenous and oral clodronate in hormone-escaped metastatic prostate cancer. Br J Urol 76:360-365, 1995
34. Kylmala T, Tammela TL, Lindholm TS, et al: The effect of combined intravenous and oral clodronate treatment on bone pain in patients with metastatic prostate cancer. Ann Chir Gynaecol 83:316-319, 1994
35. Pelger RC, Hamdy NA, Zwinderman AH, et al: Effects of the bisphosphonate olpadronate in patients with carcinoma of the prostate metastatic to the skeleton. Bone 22:403-408, 1998
36. Elomaa I, Kylmala T, Tammela T, et al: Effect of oral clodronate on bone pain: A controlled study in patients with metastatic prostatic cancer. Int Urol Nephrol 24:159-166, 1992
37. 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 141:85-87, 1989
38. Strang P, Nilsson S, Brandstedt S, et al: The analgesic efficacy of clodronate compared with placebo in patients with painful bone metastases from prostatic cancer. Anticancer Res 17:4717-4721, 1997
39. Kylmala T, Taube T, Tammela TL, et al: 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 76:939-942, 1997
40. Lipton A, Small E, Saad F, et al: The new bisphosphonate ZOMETA® (zoledronic acid) decreases skeletal complications in both lytic and blastic lesions: A comparison to pamidronate. Cancer Invest 20:45-47, 2001 (suppl 20; abstr)
41. Lipton A, Glover D, Harvey H, et al: Pamidronate in the treatment of bone metastases: Results of 2 dose-ranging trials in patients with breast or prostate cancer. Ann Oncol 5:S31-S35, 1994
42. Cleeland CS, Ryan KM: Pain assessment: Global use of the Brief Pain Inventory. Ann Acad Med Singapore 23:129-138, 1994
43. McCormack A, Hunter-Smith D, Piotrowski ZH, et al: Analgesic use in home hospice cancer patients. J Fam Pract 34:160-164, 1992
44. Foley KM, Inturrisi CE: Analgesic drug therapy in cancer pain: Principles and practice. Med Clin North Am 71:207-232, 1987
45. Lyles KW, Lammers JE, Shipp KM, et al: Functional and mobility impairments associated with Paget's disease of bone. J Am Geriatr Soc 43:502-506, 1995
46. Cleeland CS, Gonin R, Hatfield AK, et al: Pain and its treatment in outpatients with metastatic cancer. N Engl J Med 330:592-6, 1994
47. Russell RGG, Rogers MJ: Bisphosphonates: From the laboratory to the clinic and back again. Bone 25:97-106, 1999
48. Cook RJ, Major P: Methodology for treatment evaluation in patients with cancer metastatic to bone. J Natl Cancer Inst 93:534-538, 2001
49. 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 18:1378-1391, 2000
50. 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
51. Green JR, Müller K, Jaeggi KA: Preclinical pharmacology of CGP 42′446, a new, potent, heterocyclic bisphosphonate compound. J Bone Miner Res 9:745-751, 1994