The protective effect of zoledronic acid on bone loss in postmenopausal women with early breast cancer treated with sequential tamoxifen and letrozole: A prospective, randomized, phase II trial

Oncology

Volumn 81, Issue 5-6, 2012, Pages 298-305

  Safra, Tamar ^a   Bernstein Molho, Rinat ^a   Greenberg, Julia ^a   Pelles Avraham, Sharon ^a   Stephansky, Irina ^a   Sarid, David ^a   Inbar, Moshe J ^a   Stemmer, Salomon M ^a   Geffen, David B ^b  

^a TEL AVIV UNIVERSITY   (Israel)

^b BEN GURION UNIVERSITY OF THE NEGEV   (Israel)

Author keywords

Aromatase inhibitor; Bone loss; Breast cancer; Letrozole; Tamoxifen; Zoledronic acid

Indexed keywords

CALCIUM; HORMONE RECEPTOR; LETROZOLE; TAMOXIFEN; VITAMIN D; ZOLEDRONIC ACID;

ADULT; ARTHRALGIA; ARTICLE; BONE DENSITY; BREAST CANCER; CANCER CHEMOTHERAPY; CANCER HORMONE THERAPY; CANCER STAGING; CONTROLLED STUDY; DEPRESSION; DRUG EFFICACY; DRUG SAFETY; FATIGUE; FEMALE; FLU LIKE SYNDROME; FRACTURE; HOT FLUSH; HUMAN; JAW OSTEONECROSIS; KIDNEY DYSFUNCTION; LUMBAR SPINE; MAJOR CLINICAL STUDY; MYALGIA; OSTEOLYSIS; PHASE 2 CLINICAL TRIAL; POSTMENOPAUSE; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SCLERITIS; TREATMENT DURATION;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC AGENTS, HORMONAL; AROMATASE INHIBITORS; BONE DENSITY; BONE DENSITY CONSERVATION AGENTS; BREAST NEOPLASMS; DIPHOSPHONATES; DRUG THERAPY, COMBINATION; FEMALE; FOLLOW-UP STUDIES; HUMANS; IMIDAZOLES; MIDDLE AGED; NEOPLASM STAGING; NITRILES; OSTEOPOROSIS, POSTMENOPAUSAL; PROSPECTIVE STUDIES; TAMOXIFEN; TRIAZOLES;

EID: 82955165853     PISSN: 00302414     EISSN: 14230232     Source Type: Journal    
DOI: 10.1159/000334456     Document Type: Article

References (24)

1. Aebi S, Davidson T, Gruber G, Castiglione M, ESMO Guidelines Working Group: Primary breast cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 2010; 21(suppl):9-14.
2. Cuzick J, Sestak I, Baum M, Buzdar A, Howell A, Dowsett M, Forbes JF, ATAC/LATTE investigators: Effect of anastrozole and tamoxifen as adjuvant treatment for earlystage breast cancer: 10-year analysis of the ATAC trial. Lancet Oncol 2010; 11: 1135-1141.
3. BIG 1-98 Collaborative Group, Mouridsen H, Giobbie-Hurder A, Goldhirsch A, Thürlimann B, Paridaens R, Smith I, Mauriac L, Forbes JF, Price KN, Regan MM, Gelber RD, Coates AS: Letrozole therapy alone or in sequence with tamoxifen in women with breast cancer. N Engl J Med 2009; 766-776.
4. Jakesz R, Jonat W, Gnant M, Mittlboeck M, Greil R, Tausch C, Hilfrich J, Kwasny W, Menzel C, Samonigg H, Seifert M, Gademann G, Kaufmann M, Wolfgang J, ABCSG, GABG: Switching of postmenopausal women with endocrine-responsive early breast cancer to anastrozole after 2 years' adjuvant tamoxifen: combined results of ABCSG trial 8 and ARNO 95 trial. Lancet 2005; 366: 455-462. (Pubitemid 41111693)
5. Coombes RC, Kilburn LS, Snowdon CF, Paridaens R, Coleman RE, Jones SE, Jassem J, Van de Velde CJ, Delozier T, Alvarez I, Del Mastro L, Ortmann O, Diedrich K, Coates AS, Bajetta E, Holmberg SB, Dodwell D, Mickiewicz E, Andersen J, Lønning PE, Cocconi G, Forbes J, Castiglione M, Stuart N, Stewart A, Fallowfield LJ, Bertelli G, Hall E, Bogle RG, Carpentieri M, Colajori E, Subar M, Ireland E, Bliss JM: Survival and safety of exemestane versus tamoxifen after 2-3 years' tamoxifen treatment (Intergroup Exemestane Study): a randomised controlled trial. Lancet 2007; 369: 559-570.
6. Eastell R, Adams JE, Coleman RE, Howell A, Hannon RA, Cuzick J, Mackey JR, Beckmann MW, Clack G: Effect of anastrozole on bone mineral density: 5-year results from the anastrozole, tamoxifen, alone or in combination trial. J Clin Oncol 2008; 26: 1051-1057.
7. Coleman RE, Banks LM, Girgis SI, Kilburn LS, Vrdoljak E, Fox J, Cawthorn SJ, Patel A, Snowdon CF, Hall E, Bliss JM, Coombes RC, Intergroup Exemestane Study Group: Skeletal effects of exemestane on bone-mineral density, bone biomarkers, and fracture incidence in postmenopausal women with early breast cancer participating in the IES: a randomised controlled study. Lancet Oncol 2007; 8: 119-127. (Pubitemid 46158372)
8. Perez EA, Josse RG, Pritchard KI, Ingle JN, Martino S, Findlay BP, Shenkier TN, Tozer RG, Palmer MJ, Shepherd LE, Liu S, Tu D, Goss PE: Effect of letrozole versus placebo on bone mineral density in women with primary breast cancer completing 5 or more years of adjuvant tamoxifen: a companion study to NCIC CTG MA.17. J Clin Oncol 2006; 24: 3629-3635. (Pubitemid 46630537)
9. Howell A, Cuzick J, Baum M, Buzdar A, Dowsett M, Forbes JF, Hoctin-Boes G, Houghton J, Locker GY, Tobias JS, ATAC Trialists' Group: Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years' adjuvant treatment for breast cancer. Lancet 2005; 365: 60-62.
10. Thürlimann B, BIG 1-98 Collaborative & International Breast Cancer Study Groups: Letrozole versus tamoxifen as adjuvant endocrine therapy for postmenopausal women with receptor-positive breast cancer: update of the BIG 1-98 Primary Core Analysis (abstract 0161). Proceedings from Primary Therapy of Early Breast Cancer 2009, 11th International Conference, St. Gallen, 2009.
11. Goss PE, Ingle JN, Pater JL, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Cameron DA, Palmer MJ, Tu D: Late extended adjuvant treatment with letrozole improves outcome in women with early-stage breast cancer who complete 5 years of tamoxifen. J Clin Oncol 2008; 26: 1948-1955.
12. Zometa (zoledronic acid) injection (package insert). East Hanover, Novartis Pharmaceuticals, 2011.
13. Hadji P, Aapro MS, Body JJ, Bundred NJ, Brufsky A, Coleman RE, Gnant M, Guise T, Lipton A: Management of aromatase inhibitor-associated bone loss in postmenopausal women with breast cancer: practical guidance for prevention and treatment. Ann Oncol, DOI: 10.1093/annonc/mdr017.
14. Gnant M, Mlineritsch B, Luschin-Ebengreuth G, Kainberger F, Kässmann H, Piswanger-Sölkner JC, Seifert M, Ploner F, Menzel C, Dubsky P, Fitzal F, Bjelic-Radisic V, Steger G, Greil R, Marth C, Kubista E, Samonigg H, Wohlmuth P, Mittlböck M, Jakesz R, Austrian Breast and Colorectal Cancer Study Group (ABCSG): Adjuvant endocrine therapy plus zoledronic acid in premenopausal women with early-stage breast cancer: 5-year follow-up of the ABCSG-12 bonemineral density substudy. Lancet Oncol 2008; 9: 840-849.
15. Brufsky A, Harker G, Beck JT, Carroll R, Jin L, Warsi G, Argonza-Aviles E, Ericson S, Perez EA: The effect of zoledronic acid on aromatase inhibitor-associated bone loss in postmenopausal women with early breast cancer receiving adjuvant letrozole: the ZFAST study 5-year final follow-up (abstract 4083). Proceedings from the 32nd Annual San Antonio Breast Cancer Symposium, San Antonio, 2009.
16. DeBoer R, Bundred N, Eidtmann H, Llombert A, Neven P, von Minckwitz G, Martin N, Modi A, Coleman R: The effect of zoledronic acid on aromatase inhibitor associated bone loss in postmenopausal women with early breast cancer receiving adjuvant letrozole: the ZO-FAST study 5-year final follow-up (abstract P5-11-01). Proceedings from the 33rd Annual San Antonio Breast Cancer Symposium, San Antonio, 2010.
17. Zidan J, Keidar Z, Basher W, Israel O: Effects of tamoxifen on bone mineral density and metabolism in postmenopausal women with early-stage breast cancer. Med Oncol 2004; 21: 117-121. (Pubitemid 39108001)
18. VanderWalde A, Hurria A: Aging and osteoporosis in breast and prostate cancer. CA Cancer J Clin 2011; 61: 139-156.
19. Resch A, Biber E, Seifert M, Resch H: Evidence that tamoxifen preserves bone density in late postmenopausal women with breast cancer. Acta Oncol 1998; 37: 661-664. (Pubitemid 29066817)
20. Gnant M, Mlineritsch B, Stoeger H, Luschin-Ebengreuth G, Heck D, Steger G, Jakesz R, Singer C, Eidtmann H, Greil R: The carryover effect of adjuvant zoledronic acid: comparison of 48- and 62-month analyses of ABCSG-12 suggests that the benefits of combining zoledronic acid with adjuvant endocrine therapy persist long after completion of therapy (abstract P5-11-02). Proceedings from the San Antonio Breast Cancer Symposium, San Antonio, 2010.
21. Gnant M, Mlineritsch B, Schippinger W, Luschin-Ebengreuth G, Pöstlberger S, Menzel C, Jakesz R, Seifert M, Hubalek M, Bjelic-Radisic V, Samonigg H, Tausch C, Eidtmann H, Steger G, Kwasny W, Dubsky P, Fridrik M, Fitzal F, Stierer M, Rücklinger E, Greil R, ABCSG-12 Trial Investigators, Marth C: Endocrine therapy plus zoledronic acid in premenopausal breast cancer. N Engl J Med 2009; 360: 679-691.
22. Coleman RE, Thorpe HC, Cameron D, Dodwell D, Burkinshaw R, Keane M, Gil M, Houston SJ, Grieve RJ, Barrett-Lee PJ, Ritchie D, Davies C, Bell R: Adjuvant treatment with zoledronic acid in stage II/III breast cancer. The AZURE trial (BIG 01/04) (abstract S4-S5). Proceedings from the San Antonio Breast Cancer Symposium, San Antonio, 2010.
23. Eastell R, Adams J, Clack G, Howell A, Cuzick J, Mackey J, Beckmann MW, Coleman RE: Long-term effects of anastrozole on bone mineral density: 7-year results from the ATAC trial. Ann Oncol 2011; 22: 857-862.
24. Coleman RE, Banks LM, Girgis SI, Vrdoljak E, Fox J, Cawthorn SJ, Patel A, Bliss JM, Coombes RC, Kilburn LS: Reversal of skeletal effects of endocrine treatments in the Intergroup Exemestane Study. Breast Cancer Res Treat 2010; 124: 153-161.