Long-term safety of monthly zoledronic acid therapy beyond 1year in patients with advanced cancer involving bone (LoTESS): A multicentre prospective phase 4 study

被引：9

作者：

Khalafallah, A. A. ^{[1
,2
]}

Slancar, M. ^{[3
]}

Cosolo, W. ^{[4
]}

Abdi, E. ^{[5
]}

Chern, B. ^{[6
]}

Woodfield, R. J. ^{[7
]}

Copeman, M. C. ^{[8
]}

机构：

[1] Launceston Gen Hosp, Med, Launceston, Tas, Australia

[2] Univ Tasmania, Menzies Res Inst, Fac Hlth Sci, Launceston, Tas, Australia

[3] Haematol & Oncol Clin Australia Southport, Southport, Qld, Australia

[4] John Fawkner Canc Trial Ctr, Coburg, Vic, Australia

[5] Griffith Univ, Tweed Hosp, Tweed Heads, NSW, Australia

[6] Redcliffe Hosp, Redcliffe, Qld, Australia

[7] Novartis Pharmaceut Australia Pty Ltd, N Ryde, NSW, Australia

[8] Manly Hosp, Manly, NSW, Australia

来源：

EUROPEAN JOURNAL OF CANCER CARE | 2018年 / 27卷 / 02期

关键词：

bone metastasis; long-term safety; osteonecrosis of the jaw; renal impairment; zoledronic acid; PLACEBO-CONTROLLED TRIAL; REFRACTORY PROSTATE-CANCER; MULTIPLE-MYELOMA; BREAST-CANCER; SKELETAL COMPLICATIONS; RISK-FACTORS; BISPHOSPHONATE THERAPY; PREVENTIVE MEASURES; AMERICAN-SOCIETY; JAW ONJ;

D O I：

10.1111/ecc.12638

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 [肿瘤学];

摘要：

Malignant bone disease can cause significant morbidity. Monthly zoledronic acid (ZOL) reduces skeletal complications; however, limited data are available regarding long-term safety. We aimed to assess efficacy and safety of ZOL beyond 1year of treatment. We prospectively evaluated 73 patients; breast cancer (n=29), castrate-resistant prostate cancer (n=13), multiple myeloma (n=31) from 2006 to 2008 in 19 cancer centres. All patients were diagnosed with bone disease and had completed 1-2years of monthly ZOL (4mg) and received a further 1-2years of therapy following contemporary guidelines for managing risks of osteonecrosis of the jaw (ONJ) and renal toxicity. Overall rates of skeletal-related events (SREs), renal impairment and ONJ were assessed. Over the additional 1year of treatment, only 5.5% (n=4) of patients developed a new SRE. The overall Kaplan-Meier estimate for SRE incidence after 48weeks on study was 6.75% (95 CI: 2.5-17.3). Although 51% of patients reported serious adverse events, only two cases were suspected as ZOL related. No patients had confirmed ONJ. The observed incidence of new renal impairment was 11% (none due to ZOL). Our study confirms the benefit over risk of continuing monthly ZOL for at least 2years in patients with advanced cancer involving bone.

引用

页数：9

共 26 条

[1]

Osteonecrosis of the jaw in cancer after treatment with bisphosphonates: Incidence and risk factors [J].

Bamias, A ;

Kastritis, E ;

Bamia, C ;

Moulopoulos, LA ;

Melakopoulos, L ;

Bozas, G ;

Koutsoukou, V ;

Gika, D ;

Anagnostopoulos, A ;

Papadimitriou, C ;

Terpos, E ;

Dimopoulos, MA .

JOURNAL OF CLINICAL ONCOLOGY, 2005, 23 (34) :8580-8587

[2]

Recommendations for zoledronic acid treatment of patients with bone metastases [J].

Berenson, JR .

ONCOLOGIST, 2005, 10 (01) :52-62

[3]

Practice guidelines of the use of bisphosphonates in solid tumours with bone metastases and in multiple myeloma [J].

Brantus, J. -F. ;

Roemer-Becuwe, C. ;

Cony-Makhoul, P. ;

Salino, S. ;

Fontana, A. ;

Debourdea, P. ;

Thomas, T. ;

Guastalla, J. -P. ;

Ghesquieres, H. ;

Sebban, C. ;

Pavic, M. ;

Collet, P. ;

Larbre, J. -P. ;

Martinon, S. ;

Brocard, F. ;

Bodard, A. -G. ;

Blanc, G. ;

Balestriere, V. ;

Favier, B. ;

Farsi, F. ;

Krakowski, I. ;

Biron, P. .

REVUE DE MEDECINE INTERNE, 2011, 32 (08) :494-505

[4]

SEOM guidelines for the treatment of bone metastases from solid tumours [J].

Cassinello Espinosa, Javier ;

del Alba Baamonde, Aranzazu Gonzalez ;

Rivera Herrero, Fernando ;

Holgado Martin, Esther .

CLINICAL & TRANSLATIONAL ONCOLOGY, 2012, 14 (07) :505-511

[5]

Extended Use of Intravenous Bisphosphonate Therapy for the Prevention of Skeletal Complications in Patients with Cancer [J].

Crawford, Brooke S. ;

McNulty, Robert M. ;

Kraut, Eric H. ;

Turowski, Robert C. .

CANCER INVESTIGATION, 2009, 27 (10) :984-988

[6]

Adjuvant therapy with oral sodium clodronate in locally advanced and metastatic prostate cancer: long-term overall survival results from the MRC PR04 and PR05 randomised controlled trials [J].

Dearnaley, David P. ;

Mason, Malcolm D. ;

Parmar, Mahesh K. B. ;

Sanders, Karen ;

Sydes, Matthew R. .

LANCET ONCOLOGY, 2009, 10 (09) :872-876

[7]

Reduction of osteonecrosis of the jaw (ONJ) after implementation of preventive measures in patients with multiple myeloma treated with zoledronic acid [J].

Dimopoulos, M. A. ;

Kastritis, E. ;

Bamia, C. ;

Melakopoulos, I. ;

Gika, D. ;

Roussou, M. ;

Migkou, M. ;

Eleftherakis-Papaiakovou, E. ;

Christoulas, D. ;

Terpos, E. ;

Bamias, A. .

ANNALS OF ONCOLOGY, 2009, 20 (01) :117-120

[8]

Durie BGM, 2005, NEW ENGL J MED, V353, P99

[9]

Adjuvant endocrine therapy plus zoledronic acid in premenopausal women with early-stage breast cancer: 62-month follow-up from the ABCSG-12 randomised trial [J].

Gnant, Michael ;

Mlineritsch, Brigitte ;

Stoeger, Herbert ;

Luschin-Ebengreuth, Gero ;

Heck, Dietmar ;

Menzel, Christian ;

Jakesz, Raimund ;

Seifert, Michael ;

Hubalek, Michael ;

Pristauz, Gunda ;

Bauernhofer, Thomas ;

Eidtmann, Holger ;

Eiermann, Wolfgang ;

Steger, Guenther ;

Kwasny, Werner ;

Dubsky, Peter ;

Hochreiner, Gerhard ;

Forsthuber, Ernst-Pius ;

Fesl, Christian ;

Greil, Richard .

LANCET ONCOLOGY, 2011, 12 (07) :631-641

[10]

American society of clinical oncology 2003 update on the role of bisphosphonates and bone health issues in women with breast cancer [J].

Hillner, BE ;

Ingle, JN ;

Chlebowski, RT ;

Gralow, J ;

Yee, GC ;

Janjan, NA ;

Cauley, JA ;

Blumenstein, BA ;

Albain, KS ;

Lipton, A ;

Brown, S .

JOURNAL OF CLINICAL ONCOLOGY, 2003, 21 (21) :4042-4057

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