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Volumn 15, Issue 5, 2004, Pages 743-750

Oral ibandronate for the treatment of metastatic bone disease in breast cancer: Efficacy and safety results from a randomized, double-blind, placebo-controlled trial

(80)  Tripathy, Debu a   Lichinitzer, M b   Lazarev, A c   MacLachlan, S A d   Apffelstaedt, J e   Budde, M f   Bergstrom, B f   Abdi, E g   Abramson, N h   Baker, T M i   Kirkegaard, L W i   Schmidt, J R i   Bell, D j   Bell, R k   Belt, R J l   Bernstein, J I m   Just, R G m   Burningham, R A n   Trafficante, B n   Caggiano, V o   more..


Author keywords

[No Author keywords available]

Indexed keywords

BISPHOSPHONIC ACID DERIVATIVE; CYTOTOXIC AGENT; IBANDRONIC ACID; NARCOTIC ANALGESIC AGENT; PLACEBO;

EID: 2642518197     PISSN: 09237534     EISSN: None     Source Type: Journal    
DOI: 10.1093/annonc/mdh173     Document Type: Article
Times cited : (86)

References (37)
  • 2
    • 0038413465 scopus 로고    scopus 로고
    • SEER Cancer Statistics Review, 1975-2000
    • Bethesda, MD: National Cancer Institute
    • Ries LAG, Eisner MP, Kosary CL et al. SEER Cancer Statistics Review, 1975-2000. Bethesda, MD: National Cancer Institute 2003; http://seer.cancer.gov/csr/1975_2000
    • (2003)
    • Ries, L.A.G.1    Eisner, M.P.2    Kosary, C.L.3
  • 3
    • 0023137823 scopus 로고
    • The clinical course of bone metastases from breast cancer
    • Coleman RE, Rubens RD. The clinical course of bone metastases from breast cancer. Br J Cancer 1987; 55: 61-66.
    • (1987) Br. J. Cancer , vol.55 , pp. 61-66
    • Coleman, R.E.1    Rubens, R.D.2
  • 4
    • 0032406920 scopus 로고    scopus 로고
    • The role of bisphosphonates in the treatment of painful metastatic bone disease: A review of phase III trials
    • Fulfaro F, Casuccio A, Ticozzi C, Ripamonti C. The role of bisphosphonates in the treatment of painful metastatic bone disease: a review of phase III trials. Pain 1998; 78: 157-169.
    • (1998) Pain , vol.78 , pp. 157-169
    • Fulfaro, F.1    Casuccio, A.2    Ticozzi, C.3    Ripamonti, C.4
  • 5
    • 0034062815 scopus 로고    scopus 로고
    • American Society of Clinical Oncology guideline on the role of bisphosphonates in breast cancer. American Society of Clinical Oncology Bisphosphonates Expert Panel
    • 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 2000; 18: 1378-1391.
    • (2000) J. Clin. Oncol. , vol.18 , pp. 1378-1391
    • Hillner, B.E.1    Ingle, J.N.2    Berenson, J.R.3
  • 6
    • 0037828618 scopus 로고    scopus 로고
    • Bone metastases in breast cancer
    • Lipton A. Bone metastases in breast cancer. Curr Treat Options Oncol 2003; 4: 151-158.
    • (2003) Curr. Treat. Options Oncol. , vol.4 , pp. 151-158
    • Lipton, A.1
  • 8
    • 0033429593 scopus 로고    scopus 로고
    • Efficacy of pamidronate in breast cancer with bone metastases: A randomized, double-blind placebo-controlled multicenter study
    • Hultborn R, Gundersen S, Ryden S et al. Efficacy of pamidronate in breast cancer with bone metastases: a randomized, double-blind placebo-controlled multicenter study. Anticancer Res 1999; 19: 3383-3392.
    • (1999) Anticancer Res. , vol.19 , pp. 3383-3392
    • Hultborn, R.1    Gundersen, S.2    Ryden, S.3
  • 9
    • 7144223389 scopus 로고    scopus 로고
    • Long-term prevention of skeletal complications of metastatic breast cancer with pamidronate
    • Protocol 19 Aredia Breast Cancer Study Group
    • 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.
    • (1998) J. Clin. Oncol. , vol.16 , pp. 2038-2044
    • Hortobagyi, G.N.1    Theriault, R.L.2    Lipton, A.3
  • 10
    • 0035463593 scopus 로고    scopus 로고
    • 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
    • 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 2001; 7: 377-387.
    • (2001) Cancer , vol.7 , pp. 377-387
    • Rosen, L.S.1    Gordon, D.2    Kaminski, M.3
  • 11
    • 0037009822 scopus 로고    scopus 로고
    • A randomised, placebo-controlled trial of zoledronic acid in patients with hormone-refractory metastatic prostate carcinoma
    • Saad F, Gleason DM, Murray R et al. A randomised, placebo-controlled trial of zoledronic acid in patients with hormone-refractory metastatic prostate carcinoma. J Natl Cancer Inst 2002; 94: 1458-1468.
    • (2002) J. Natl. Cancer Inst. , vol.94 , pp. 1458-1468
    • Saad, F.1    Gleason, D.M.2    Murray, R.3
  • 12
    • 0001941381 scopus 로고    scopus 로고
    • Bone metastases
    • Klastersky J, Schimpff SC, Senn HJ (eds): 2nd edition. New York, USA: Marcel Dekker
    • Body JJ. Bone metastases. In Klastersky J, Schimpff SC, Senn HJ (eds): Handbook of Supportive Care in Cancer, 2nd edition. New York, USA: Marcel Dekker 1999; 453-481.
    • (1999) Handbook of Supportive Care in Cancer , pp. 453-481
    • Body, J.J.1
  • 13
    • 0025740255 scopus 로고
    • Tolerability and safety of clodronate therapy in bone diseases
    • Mian M, Beghe F, Caprio A et al. Tolerability and safety of clodronate therapy in bone diseases. Int J Clin Pharmacol Res 1991; 11: 107-114.
    • (1991) Int. J. Clin. Pharmacol. Res. , vol.11 , pp. 107-114
    • Mian, M.1    Beghe, F.2    Caprio, A.3
  • 14
    • 0032871110 scopus 로고    scopus 로고
    • Clodronate. A review of its use in breast cancer
    • Hurst M, Noble S. Clodronate. A review of its use in breast cancer. Drugs Aging 1999; 15: 143-167.
    • (1999) Drugs Aging , vol.15 , pp. 143-167
    • Hurst, M.1    Noble, S.2
  • 15
    • 0032798648 scopus 로고    scopus 로고
    • Oral clodronate in breast cancer patients with bone metastases: A randomized study
    • Kristensen B, Ejlertsen B, Groenvold M et al. Oral clodronate in breast cancer patients with bone metastases: a randomized study. J Intern Med 1999; 246: 67-74.
    • (1999) J. Intern. Med. , vol.246 , pp. 67-74
    • Kristensen, B.1    Ejlertsen, B.2    Groenvold, M.3
  • 16
    • 0034852609 scopus 로고    scopus 로고
    • Dosing regimens and main adverse events of bisphosphonates
    • Body JJ. Dosing regimens and main adverse events of bisphosphonates. Semin Oncol 2001; 28 (Suppl 11): 49-53.
    • (2001) Semin. Oncol. , vol.28 , Issue.SUPPL. 11 , pp. 49-53
    • Body, J.J.1
  • 17
    • 0036682211 scopus 로고    scopus 로고
    • Randomized, placebo-controlled trial of clodronate in patients with primary operable breast cancer
    • Powles T, Paterson S, Kanis JA et al. Randomized, placebo-controlled trial of clodronate in patients with primary operable breast cancer. J Clin Oncol 2002; 20: 3219-3224.
    • (2002) J. Clin. Oncol. , vol.20 , pp. 3219-3224
    • Powles, T.1    Paterson, S.2    Kanis, J.A.3
  • 18
    • 0028202499 scopus 로고
    • Preclinical pharmacology of CGP 42′446, a new, potent, heterocyclic bisphosphonate compound
    • 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.
    • (1994) J. Bone Miner. Res. , vol.9 , pp. 745-751
    • Green, J.R.1    Muller, K.2    Jaeggi, K.A.3
  • 19
    • 0029166436 scopus 로고
    • Effect of oral clodronate on metastatic bone pain: A double-blind, placebo-controlled study
    • Robertson AG, Reed NS, Ralston SH. Effect of oral clodronate on metastatic bone pain: a double-blind, placebo-controlled study. J Clin Oncol 1995; 13: 2427-2430.
    • (1995) J. Clin. Oncol. , vol.13 , pp. 2427-2430
    • Robertson, A.G.1    Reed, N.S.2    Ralston, S.H.3
  • 20
    • 0027531814 scopus 로고
    • Double-blind controlled trial of oral clodronate in patients with bone metastases from breast cancer
    • Paterson AH, Powles TJ, Kanis JA et al. Double-blind controlled trial of oral clodronate in patients with bone metastases from breast cancer. J Clin Oncol 1993; 11: 59-65.
    • (1993) J. Clin. Oncol. , vol.11 , pp. 59-65
    • Paterson, A.H.1    Powles, T.J.2    Kanis, J.A.3
  • 21
    • 17144447171 scopus 로고    scopus 로고
    • Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases
    • Body JJ, Diel IJ, Lichinitser MR et al. Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases. Ann Oncol 2003; 14: 1399-405.
    • (2003) Ann. Oncol. , vol.14 , pp. 1399-1405
    • Body, J.J.1    Diel, I.J.2    Lichinitser, M.R.3
  • 22
    • 0027252910 scopus 로고
    • The assessment of vertebrate deformity: A method for use in population studies and clinical trials
    • McCloskey EV, Spector TD, Eyres KS et al. The assessment of vertebrate deformity: a method for use in population studies and clinical trials. Osteoporosis Int 1993; 3: 138-147.
    • (1993) Osteoporosis Int. , vol.3 , pp. 138-147
    • McCloskey, E.V.1    Spector, T.D.2    Eyres, K.S.3
  • 23
    • 0141611394 scopus 로고    scopus 로고
    • Morbidity measures in the presence of recurrent composite endpoints
    • Scott M et al. Morbidity measures in the presence of recurrent composite endpoints. Pharmaceutical Statistics 2003; 2: 39-49.
    • (2003) Pharmaceutical Statistics , vol.2 , pp. 39-49
    • Scott, M.1
  • 24
    • 22544445770 scopus 로고    scopus 로고
    • Intravenous and oral ibandronate alleviates pain in patients with skeletal metastases from breast cancer
    • Tripathy D, Body J-J, Diel IJ, Bergstrom B. Intravenous and oral ibandronate alleviates pain in patients with skeletal metastases from breast cancer. Breast Cancer Res Treat 2003; 82 (Suppl 1): S69.
    • (2003) Breast Cancer Res. Treat. , vol.82 , Issue.SUPPL. 1
    • Tripathy, D.1    Body, J.-J.2    Diel, I.J.3    Bergstrom, B.4
  • 26
    • 0002670673 scopus 로고
    • Assessment of response to treatment
    • Rubens RD, Forgelman I (eds): New York, NY: Springer
    • Coleman RE. Assessment of response to treatment. In Rubens RD, Forgelman I (eds): Bone Metastases: Diagnosis and Treatment. New York, NY: Springer 1991; 99-120.
    • (1991) Bone Metastases: Diagnosis and Treatment , pp. 99-120
    • Coleman, R.E.1
  • 27
    • 0000941980 scopus 로고
    • A distribution-free k-sample test against ordered alternatives
    • Jonckheere AR. A distribution-free k-sample test against ordered alternatives. Biometrika 1954; 41: 133-145.
    • (1954) Biometrika , vol.41 , pp. 133-145
    • Jonckheere, A.R.1
  • 28
    • 0000061572 scopus 로고
    • The asymptotic normality and consistency of Kendall's s test against trend, when ties are present in one ranking
    • Terpstra TJ. The asymptotic normality and consistency of Kendall's s test against trend, when ties are present in one ranking. Indag Math 1952; 14: 327-333.
    • (1952) Indag Math. , vol.14 , pp. 327-333
    • Terpstra, T.J.1
  • 29
    • 0037594450 scopus 로고    scopus 로고
    • Zoledronic acid (4 mg) significantly reduces the relative risk of developing skeletal-related events compared with pamidronate (90 mg) in patients with breast cancer and bone metastasis
    • (Abstr 355)
    • Coleman RE, Rosen LS, Gordon D et al. Zoledronic acid (4 mg) significantly reduces the relative risk of developing skeletal-related events compared with pamidronate (90 mg) in patients with breast cancer and bone metastasis. Breast Cancer Res Treat 2002; 76 (Suppl 1): S95 (Abstr 355).
    • (2002) Breast Cancer Res. Treat. , vol.76 , Issue.SUPPL. 1
    • Coleman, R.E.1    Rosen, L.S.2    Gordon, D.3
  • 30
    • 0030955855 scopus 로고    scopus 로고
    • A randomized, controlled trial of intravenous clodronate in patients with metastatic bone disease and pain
    • Ernst DS, Brasher P, Hagen N et al. A randomized, controlled trial of intravenous clodronate in patients with metastatic bone disease and pain. J Pain Symptom Manage 1997; 13: 319-326.
    • (1997) J. Pain Symptom Manage , vol.13 , pp. 319-326
    • Ernst, D.S.1    Brasher, P.2    Hagen, N.3
  • 31
    • 0034885581 scopus 로고    scopus 로고
    • The clinical and cost considerations of bisphosphonates in preventing bone complications in patients with metastatic breast cancer or multiple myeloma
    • McCloskey EV, Guest JF, Kanis JA. The clinical and cost considerations of bisphosphonates in preventing bone complications in patients with metastatic breast cancer or multiple myeloma. Drugs 2001; 61: 1253-1274.
    • (2001) Drugs , vol.61 , pp. 1253-1274
    • McCloskey, E.V.1    Guest, J.F.2    Kanis, J.A.3
  • 32
    • 2642566241 scopus 로고    scopus 로고
    • Aredia: FDA Medical Review: CDER, Application number: 020927, 020036/S015/S016. Posted 19 July (22 September 1998 approval)
    • Aredia: FDA Medical Review: CDER, Application number: 020927, 020036/S015/S016. Posted 19 July 2000 (22 September 1998 approval).
    • (2000)
  • 33
    • 2442470201 scopus 로고    scopus 로고
    • Oral daily ibandronate: Efficacy in reducing skeletal complications in patients with metastatic bone disease from breast cancer
    • The Bondronat Study Group. (Abstr 185)
    • Tripathy D, Body JJ, Diel I, Bergstrom B. Oral daily ibandronate: efficacy in reducing skeletal complications in patients with metastatic bone disease from breast cancer. The Bondronat Study Group. Proc Am Soc Clin Oncol 2003; 22: 46 (Abstr 185).
    • (2003) Proc. Am. Soc. Clin. Oncol. , vol.22 , pp. 46
    • Tripathy, D.1    Body, J.J.2    Diel, I.3    Bergstrom, B.4
  • 34
    • 0346021648 scopus 로고    scopus 로고
    • Risk reductions in metastatic breast cancer: Multivariate Poisson regression analyses of oral and intravenous ibandronate
    • The Bondronat Study Group. (Abstr 184)
    • Body JJ, Kanis J, Diel I, Bergstrom B. Risk reductions in metastatic breast cancer: multivariate Poisson regression analyses of oral and intravenous ibandronate. The Bondronat Study Group. Proc Am Soc Clin Oncol 2003; 22: 46 (Abstr 184).
    • (2003) Proc. Am. Soc. Clin. Oncol. , vol.22 , pp. 46
    • Body, J.J.1    Kanis, J.2    Diel, I.3    Bergstrom, B.4
  • 35
    • 0032956195 scopus 로고    scopus 로고
    • Double-blind, randomised, placebo-controlled, dose-finding study of oral ibandronate in patients with metastatic bone disease
    • Coleman RE, Purohit OP, Black C et al. Double-blind, randomised, placebo-controlled, dose-finding study of oral ibandronate in patients with metastatic bone disease. Ann Oncol 1999; 10: 311-316.
    • (1999) Ann. Oncol. , vol.10 , pp. 311-316
    • Coleman, R.E.1    Purohit, O.P.2    Black, C.3
  • 36
    • 0034846708 scopus 로고    scopus 로고
    • Pharmacoeconomic issues in bisphosphonate treatment of metastatic bone disease
    • Hilner BE. Pharmacoeconomic issues in bisphosphonate treatment of metastatic bone disease. Semin Oncol 2001; 28: 64-68.
    • (2001) Semin. Oncol. , vol.28 , pp. 64-68
    • Hilner, B.E.1
  • 37
    • 0034810866 scopus 로고    scopus 로고
    • A microcosting analysis of zoledronic acid and pamidronate therapy in patients with metastatic bone disease
    • DesHarnais Castel L, Bajwa K, Markle JP et al. A microcosting analysis of zoledronic acid and pamidronate therapy in patients with metastatic bone disease. Support Care Cancer 2001; 9: 545-551.
    • (2001) Support Care Cancer , vol.9 , pp. 545-551
    • DesHarnais Castel, L.1    Bajwa, K.2    Markle, J.P.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.