Adjuvant zoledronic acid in patients with early breast cancer: Final efficacy analysis of the AZURE (BIG 01/04) randomised open-label phase 3 trial

The Lancet Oncology

Volumn 15, Issue 9, 2014, Pages 997-1006

  Coleman, Robert ^a   Cameron, David ^b   Dodwell, David ^c   Bell, Richard ^e   Wilson, Caroline ^a   Rathbone, Emma ^a,c   Keane, Maccon ^f   Gil, Miguel ^g   Burkinshaw, Roger ^a   Grieve, Robert ^h   Barrett Lee, Peter ⁱ   Ritchie, Diana ^j   Liversedge, Victoria ^d   Hinsley, Samantha ^d   Marshall, Helen ^d  

^a UNIVERSITY OF SHEFFIELD   (United Kingdom)

^b UNIVERSITY OF EDINBURGH   (United Kingdom)

^c UNIVERSITY OF LEEDS   (United Kingdom)

^d UNIVERSITY OF LEEDS   (United Kingdom)

^e Andrew Love Cancer Centre   (Australia)

^f UNIVERSITY HOSPITAL GALWAY   (Ireland)

^g CATALAN INSTITUTE OF ONCOLOGY   (Spain)

^h UNIVERSITY HOSPITALS COVENTRY AND WARWICKSHIRE NHS TRUST   (United Kingdom)

ⁱ VELINDRE CANCER CENTRE   (United Kingdom)

^j BEATSON WEST OF SCOTLAND CANCER CENTRE   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTHRACYCLINE DERIVATIVE; CALCIUM; ESTROGEN RECEPTOR; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; TAXANE DERIVATIVE; TRASTUZUMAB; VITAMIN D; ZOLEDRONIC ACID; ANTINEOPLASTIC AGENT; BISPHOSPHONIC ACID DERIVATIVE; BONE DENSITY CONSERVATION AGENT; IMIDAZOLE DERIVATIVE;

ADJUVANT THERAPY; ADULT; ARTICLE; AXILLARY LYMPH NODE; BONE METASTASIS; BREAST CANCER; CANCER RECURRENCE; CANCER STAGING; CLIMACTERIUM; CONTROLLED STUDY; DISEASE FREE SURVIVAL; DRUG EFFICACY; DRUG USE; DRUG WITHDRAWAL; EARLY CANCER; FEMALE; FOLLOW UP; HIGH RISK PATIENT; HUMAN; JAW OSTEONECROSIS; MAJOR CLINICAL STUDY; MENOPAUSE; MONOTHERAPY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PREMENOPAUSE; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SYSTEMIC THERAPY; TREATMENT DURATION; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT; ADJUVANT CHEMOTHERAPY; AGED; BREAST NEOPLASMS; CLINICAL TRIAL; CONFIDENCE INTERVAL; DOSE RESPONSE; DRUG ADMINISTRATION; EARLY DIAGNOSIS; INTERNATIONAL COOPERATION; INTRAVENOUS DRUG ADMINISTRATION; KAPLAN MEIER METHOD; MIDDLE AGED; MORTALITY; PATHOLOGY; SURVIVAL RATE; TUMOR INVASION; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BONE DENSITY CONSERVATION AGENTS; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; CONFIDENCE INTERVALS; DIPHOSPHONATES; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; EARLY DETECTION OF CANCER; FEMALE; FOLLOW-UP STUDIES; HUMANS; IMIDAZOLES; INFUSIONS, INTRAVENOUS; INTERNATIONAL COOPERATION; KAPLAN-MEIER ESTIMATE; MIDDLE AGED; NEOPLASM INVASIVENESS; NEOPLASM STAGING; PROSPECTIVE STUDIES; SURVIVAL RATE; TREATMENT OUTCOME;

EID: 84905007644     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(14)70302-X     Document Type: Article

References (23)

1. Kaplan RN, Rafii S, Lyden D Preparing the 'soil': the premetastatic niche. Cancer Res 2006, 66:11089-11093.
2. Weilbaecher KN, Guise TA, McCauley LK Cancer to bone: a fatal attraction. Nat Rev Cancer 2011, 11:411-425.
3. Roodman GD Mechanisms of bone metastasis. N Engl J Med 2004, 350:1655-1664.
4. Coleman R, Gnant M, Morgan G, Clezardin P Effects of bone-targeted agents on cancer progression and mortality. J Natl Cancer Inst 2012, 104:1059-1067.
5. Coleman RE, Marshall H, Cameron D, et al. Breast cancer adjuvant therapy with zoledronic acid. N Engl J Med 2011, 365:1396-1405. on behalf of the AZURE investigators.
6. Coleman RE, de Boer R, Eidtmann H, et al. Zoledronic acid (zoledronate) for postmenopausal women with early breast cancer receiving adjuvant letrozole (ZO-fast study): final 60-month results. Ann Oncol 2013, 24:398-405.
7. Paterson AHG, Anderson SJ, Lembersky BC, et al. Oral clodronate for adjuvant treatment of operable breast cancer (National Surgical Adjuvant Breast and Bowel Project protocol B-34): a multicentre, placebo-controlled, randomised trial. Lancet Oncol 2012, 13:734-742.
8. Gnant M, Mlineritsch B, Schippinger W, et al. Endocrine therapy plus zoledronic acid in premenopausal breast cancer. N Engl J Med 2009, 360:679-691.
9. Marx RE Pamidronate (Aredia) and zoledronate (Zometa) induced avascular necrosis of the jaws: a growing epidemic. J Oral Maxillofac Surg 2003, 61:1115-1117.
10. Khosla S, Burr D, Cauley J, et al. American Society for Bone and Mineral Research. Bisphosphonate-associated osteonecrosis of the jaw: report of a task force of the American Society for Bone and Mineral Research. J Bone Miner Res 2007, 22:1479-1491.
11. Manual for Clinical Research in Breast Cancer 2004, European Organization for Research and Treatment of Cancer (EORTC), Greenwich Medical Media, London. 5th edn.
12. McCloskey E, Paterson A, Kanis J, Tähtelä R, Powles T Effect of oral clodronate on bone mass, bone turnover and subsequent metastases in women with primary breast cancer. Eur J Cancer 2010, 46:558-565.
13. Hudis CA, Barlow WE, Constantino JP, et al. Proposal for standardized definitions for efficacy end points in adjuvant breast cancer trials: the STEEP system. J Clin Oncol 2007, 25:2127-2132.
14. Coleman R, Woodward E, Brown J, et al. Safety of zoledronic acid and incidence of osteonecrosis of the jaw (ONJ) during adjuvant therapy in a randomised phase III trial (AZURE: BIG 01-04) for women with stage II/III breast cancer. Breast Cancer Res Treat 2011, 127:429-438.
15. Rathbone EJ, Brown JE, Marshall HC, et al. Osteonecrosis of the jaw and oral health-related quality of life after adjuvant zoledronic acid: an adjuvant zoledronic acid to reduce recurrence trial subprotocol (BIG1/04). J Clin Oncol 2013, 31:2685-2692.
16. Coleman R, Gnant M, Paterson A, et al. Effects of bisphosphonate treatment on recurrence and cause-specific mortality in women with early breast cancer: a meta-analysis of individual patient data from randomised trials. San Antonio Breast Cancer Symposium; San Antonio, TX, USA; Dec 10-14, 2013. Abstract S4-07.
17. Powles TJ, Paterson AE, McCloskey E, et al. Reduction in bone relapse and improved survival with oral clodronate for adjuvant treatment of operable breast cancer. Breast Cancer Res Treat 2006, 8:R13.
18. Diel IJ, Jaschke A, Solomayer EF, et al. Adjuvant oral clodronate improves the overall survival of primary breast cancer patients with micrometastases to the bone marrow-a long term follow up. Ann Oncol 2007, 19:2007-2011.
19. Saarto T, Vehmanen L, Virkkunen P, Blomqvist C Ten-year follow-up of a randomized controlled trial of adjuvant clodronate treatment in node-positive breast cancer patients. Acta Oncol 2004, 43:650-656.
20. Kristensen B, Ejlertsen B, Mouridsen HT, et al. Bisphosphonate treatment in primary breast cancer: results from a randomised comparison of oral pamidronate versus no pamidronate in patients with primary breast cancer. Acta Oncol 2008, 47:740-746.
21. Gnant M, Mlineritsch B, Stoeger H, et al. Adjuvant endocrine therapy plus zoledronic acid in premenopausal women with early-stage breast cancer: 62-month follow-up from the ABCSG-12 randomised trial. Lancet Oncol 2011, 12:631-641.
22. Gnant M, Mlinteritsch B, Luschin-Ebengreuth G, et al. Long-term follow-up in ABCSG-12: significantly improved overall survival with adjuvant zoledronic acid in premenopausal patients with endocrine-receptor-positive early breast cancer. Cancer Res 2011, 71(suppl). abstr S1-2.
23. Nicks KM, Fowler TW, Akel NS, et al. Bone turnover across the menopausal transition, the role of gonadal inhibins. Ann NY Acad Sci 2010, 1192:153-160.