Reduction in bone relapse and improved survival with oral clodronate for adjuvant treatment of operable breast cancer [ISRCTN83688026]

Breast Cancer Research

Volumn 8, Issue 2, 2006, Pages

  Powles, Trevor ^a   Paterson, Alexander ^b   McCloskey, Eugene ^c   Schein, Phil ^d   Scheffler, Bobbi ^e   Tidy, Alwynne ^f   Ashley, Sue ^f   Smith, Ian ^f   Ottestad, Lars ^g   Kanis, John ^c  

^a Parkside Oncology Clinic   (United Kingdom)

^b TOM BAKER CANCER CENTRE   (Canada)

^c UNIVERSITY OF SHEFFIELD   (United Kingdom)

^d UNIVERSITY OF OXFORD   (United Kingdom)

^e Scheffler Group   (United States)

^f ROYAL MARSDEN HOSPITAL   (United Kingdom)

^g Radium Hospital   (Norway)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; BISPHOSPHONIC ACID DERIVATIVE; CLODRONIC ACID; PLACEBO; TAMOXIFEN; BONE DENSITY CONSERVATION AGENT;

ABDOMINAL PAIN; ADULT; ANALYSIS OF VARIANCE; ARTICLE; BONE METASTASIS; BONE NECROSIS; BONE RADIOGRAPHY; BONE SCINTISCANNING; BREAST CANCER; BREAST SURGERY; CANCER ADJUVANT THERAPY; CANCER HORMONE THERAPY; CANCER STAGING; CANCER SURVIVAL; CLINICAL TRIAL; COMPUTER ASSISTED TOMOGRAPHY; CONFIDENCE INTERVAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE FREE SURVIVAL; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ESOPHAGUS PERFORATION; ESOPHAGUS ULCER; FEMALE; FOLLOW UP; GASTROINTESTINAL SYMPTOM; HUMAN; LOG RANK TEST; MAJOR CLINICAL STUDY; MULTICENTER STUDY; NAUSEA; NUCLEAR MAGNETIC RESONANCE IMAGING; OSTEOLYSIS; OVERALL SURVIVAL; RANDOMIZED CONTROLLED TRIAL; RISK REDUCTION; STATISTICAL SIGNIFICANCE; STOMATITIS; TREATMENT OUTCOME; TREATMENT RESPONSE; VOMITING; ADJUVANT CHEMOTHERAPY; BONE DISEASES; BONE NEOPLASMS; BREAST NEOPLASMS; COMPARATIVE STUDY; MIDDLE AGED; MORTALITY; PATHOLOGY; RANDOMIZATION; RECURRENT DISEASE; SECONDARY; SURVIVAL;

BONE DENSITY CONSERVATION AGENTS; BONE DISEASES; BONE NEOPLASMS; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; CLODRONIC ACID; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MIDDLE AGED; NEOPLASM STAGING; PLACEBOS; RANDOM ALLOCATION; RECURRENCE; SURVIVAL ANALYSIS;

EID: 33744828376     PISSN: 1465542X     EISSN: 1465542X     Source Type: Journal    
DOI: 10.1186/bcr1384     Document Type: Article

References (21)

1. Early Breast Cancer Trialists' Collaborative Group: Tamoxifen for early breast cancer: an overview of the randomized trials. Lancet 1998, 351:1451-1467.
2. Early Breast Cancer Trialists' Collaborative Group: Polychemotherapy for early breast cancer: an overview of the randomized trials. Lancet 1998, 352:930-942.
3. Coleman RF, Smith P, Rubens D: Clinical course and prognostic factors following bone recurrence from breast cancer. Br J Cancer 1998, 77:336-340.
4. Goldhirsch A, Gelber RD, Price KN, Castiglione M, Coates AS, Rudenstam CM, Collins J, Lindtner J, Hacking A, Marini G, et al.: Effect of systemic adjuvant treatment on first sites of breast cancer relapse. Lancet 1994, 343:377-381.
5. Powles TJ, Clark SA, Easty DM, Easty GC, Neville AM: The inhibition by aspirin and indomethacin of osteolytic tumor deposits and hypercalcaemia in rats with Walker tumor, and its possible application in human breast cancer. Br J Cancer 1973, 28:316-321.
6. Galasko CS: Mechanisms of bone destruction in the development of skeletal metastases. Nature 1976, 263:507-508.
7. Diel IJ: Bisphosphonates in the prevention of bone metastases: current evidence. Semin Oncol 2001, 28(4 suppl 11):75-80.
8. Neville-Webbe HL, Holen I, Coleman RF: The anti-tumor activity of bisphosphonates. Cancer Treat Rev 2002, 28:305-319.
9. Padalecki SS, Guise TA: Actions of bisphosphonates in animal models of breast cancer. Breast Cancer Res 2002, 4:35-41.
10. Fleisch H: Bisphosphonates. Pharmacology and use in the treatment of tumour-induced hypercalcaemic and metastatic bone disease. Drugs 1991, 42:919-944.
11. Mundy G: Preclinical models of bone metastases. Semin Oncol 2001, 28:2-8.
12. Paterson AH, Powles TJ, Kanis JA, McCloskey E, Hanson J, Ashley S: Double-blind controlled trial of oral clodronate in patients with bone metastases from breast cancer. J Clin Oncol 1993, 11:59-65.
13. Hortobagyi GN, Theriault RL, Lipton A, Porter L, Blayney D, Sinoff C, Wheeler H, Simeone JF, Seaman JJ, Knight RD, 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, Leff R, Gluck S, Stewart JF, Costello S, Kennedy I, Simeone J, Seaman JJ, 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. Body JJ, Diel IJ, Lichinitzer M, Lazarev A, Pecherstorfer M, Bell R, Tripathy D, Bergstrom B: Oral ibandronate reduces the risk of skeletal complications in breast cancer patients with metastatic bone disease: results from two randomized, placebo-controlled phase III trials". Br J Cancer 2004, 90:1133-1137.
16. Kanis JA, Powles T, Paterson AH, McCloskey EV, Ashley S: Clodronate decreases the frequency of skeletal metastases in women with breast cancer. Bone 1996, 19:663-667.
17. Diel IJ, Solomayer EF, Costa SD, Gollan C, Goerner R, Wallwiener D, Kaufmann M, Bastert G: Reduction in new metastases in breast cancer with adjuvant clodronate treatment. N Engl J Med 1998, 339:357-363.
18. Powles T, Paterson S, Kanis JA, McCloskey E, Ashley S, Tidy A, Rosenqvist K, Smith I, Ottestad L, Legault S, et al.: Randomized, placebo-controlled trial of clodronate in patients with primary operable breast cancer. J Clin Oncol 2002, 20:3219-3224.
19. Atula S, Powles T, Paterson A, McCloskey E, Nevalainen J, Kanis J: Extended safety profile of oral clodronate after long-term use in primary breast cancer patients. Drug Safety 2003, 26:661-671.
20. Ruggiero SL, Bhoomi M, Rosenberg TJ, Engroff SL: Osteonecrosis of the jaws associated with the use of bisphosphonates: a review of 63 cases. J Oral Maxillofac Surg 2004, 62:527-534.
21. Saarto T, Vehmanen C, Blomqvist, Elomaa I: Ten-year follow-up of a randomized controlled trial of adjuvant clodronate treatment in node-positive breast cancer patients. Proc Am Soc Clin Oncol 2004, 23:8.