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

Volumn 98, Issue 8, 2003, Pages 1735-1744

  Rosen, Lee S ^a   Gordon, David ^b   Kaminski, Mary ^c   Howell, Anthony ^d   Belch, Andrew ^e   Mackey, John ^e   Apffelstaedt, Justus ^f   Hussein, Mohamad A ^g   Coleman, Robert E ^h   Reitsma, Dirk J ⁱ   Chen, Bee Lian ⁱ   Seaman, John J ⁱ  

^a Cancer Institute Medical Group   (United States)

^b Division of Hematology and Medical Oncology   (United States)

^c American Medical Research Institute   (United States)

^d CHRISTIE HOSPITAL   (United Kingdom)

^e UNIVERSITY OF ALBERTA   (Canada)

^f STELLENBOSCH UNIVERSITY   (South Africa)

^g LERNER RESEARCH INSTITUTE   (United States)

^h WESTON PARK HOSPITAL   (United Kingdom)

ⁱ NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Breast neoplasms; Fractures; Hypercalcemia; Multiple myeloma; Osteolysis; Spinal cord compression; Spontaneous

Indexed keywords

ANTINEOPLASTIC AGENT; CALCIUM; HORMONE DERIVATIVE; PAMIDRONIC ACID; VITAMIN D; ZOLEDRONIC ACID;

ABDOMINAL PAIN; ADVANCED CANCER; ALOPECIA; ANEMIA; ANOREXIA; ARTHRALGIA; ARTICLE; BACKACHE; BONE LESION; BONE METASTASIS; BONE PAIN; BREAST CARCINOMA; CANCER RADIOTHERAPY; CANCER SURGERY; CHEMOTHERAPY INDUCED EMESIS; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; CYTOPENIA; DEPRESSION; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG INFUSION; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; ELECTROLYTE DISTURBANCE; EYE DISEASE; FATIGUE; FEVER; FOLLOW UP; HEADACHE; HORMONAL THERAPY; HUMAN; HYPERCALCEMIA; HYPERCALCEMIA OF MALIGNANCY; INFECTION; INJECTION SITE; INSOMNIA; LIMB PAIN; MAJOR CLINICAL STUDY; MORBIDITY; MULTICENTER STUDY; MULTIPLE MYELOMA; MUSCLE WEAKNESS; MYALGIA; NAUSEA; NEUTROPENIA; PARESTHESIA; PATHOLOGIC FRACTURE; PERIPHERAL EDEMA; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK FACTOR; SPINAL CORD COMPRESSION; STATISTICAL ANALYSIS; TREATMENT OUTCOME; VERTIGO; WEIGHT REDUCTION;

BONE DISEASES; BONE NEOPLASMS; BREAST NEOPLASMS; DIPHOSPHONATES; DOUBLE-BLIND METHOD; HUMANS; IMIDAZOLES; MIDDLE AGED; MULTIPLE MYELOMA;

EID: 10744233021     PISSN: 0008543X     EISSN: None     Source Type: Journal    
DOI: 10.1002/cncr.11701     Document Type: Article

References (29)

1. Parkin DM, Pisani P, Ferlay J. Global cancer statistics. CA Cancer J Clin. 1999;49:33-64.
2. Greenlee RT, Hill-Harmon MB, Murray T, Thun M. Cancer statistics, 2001. CA Cancer J Clin. 2001;51:15-36.
3. Coleman RE. Skeletal complications of malignancy. Cancer. 1997;80(8 Suppl):1588-1594.
4. Kyle RA. Multiple myeloma: review of 869 cases. Mayo Clin Proc. 1975;50:29-40.
5. Mercadante S. Malignant bone pain: pathophysiology and treatment. Pain. 1997;69:1-18.
6. Harrington KD. Orthopedic surgical management of skeletal complications of malignancy. Cancer. 1997;80:1614-1627.
7. Manglani HH, Marco RA, Picciolo A, Healey JH. Orthopedic emergencies in cancer patients. Semin Oncol. 2000;27:299-310.
8. Eke N. Symptomatic spinal cord involvement in prostate cancer. Cent Afr J Med. 2001;47:49-53.
9. Hussein MA. Nontraditional cytotoxic therapies for relapsed/refractory multiple myeloma. Oncologist. 2002;7(Suppl 1):20-29.
10. Ries LAG, Eisner MP, Kosary CL, et al., editors. SEER cancer statistics review, 1973-1999. Bethesda: National Cancer Institute, 2001.
11. Domchek SM, Younger J, Finkelstein DM, Seiden MV. Predictors of skeletal complications in patients with metastatic breast carcinoma. Cancer. 2000;89:363-368.
12. 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.
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. 1998;16:2038-2044.
14. 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. 1999;17:846-854.
15. 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. 1998;16:593-602.
16. 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. 1996;334:488-493.
17. 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.
18. Maxwell C, Swift R, Goode M, Doane L, Rogers M. Advances in supportive care of patients with cancer and bone metastases: nursing implications of zoledronic acid. Clin J Oncol Nurse. 2003;7:403-410.
19. Major PP, Coleman RE. Zoledronic acid in the treatment of hypercalcemia of malignancy: results of the international clinical development program. Semin Oncol. 2001;28:17-24.
20. 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.
21. 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.
22. Rosen L, Gordon D, Tchekmedyian S, et al. Zoledronic acid (Zol) significantly reduces skeletal-related events (SREs) in patients with bone metastases from solid tumors [abstract]. Proc Am Soc Clin Oncol. 2002;21:295a.
23. 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.
24. 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.
25. Andersen PK, Gill RD. Cox's regression model for counting processes: a large sample study. Ann Stat. 1982;10:1100-1120.
26. George ED, Sadovsky R. Multiple myeloma: recognition and management. Am Fam Physician. 1999;59:1885-1894.
27. Kanis JA, McCloskey EV. Bisphosphonates in multiple myeloma. Cancer. 2000;88(12 Suppl):3022-3032.
28. Major PP, Cook R. Efficacy of bisphosphonates in the management of skeletal complications of bone metastases and selection of clinical endpoints. Am J Clin Oncol. 2002;25(Suppl 1):S10-S18.
29. DesHarnais Castel L, Bajwa K, Markle JP, Timbie JW, Zacker C, Schulman KA. A microcosting analysis of zoledronic acid and pamidronate therapy in patients with metastatic bone disease. Support Care Cancer. 2001;9:545-551.