Volltext-geprüfte Publikationen der systematischen Recherche bzw

Handrecherche

(vgl. Abschnitt 7.a)

Atula S et al.: Extended safety profile of oral clodronate after long-term use in primary breast cancer patients. Drug Safety 26(9): 661 - 671, 2003.

Ben-Aharon I et al.: Bisphosphonates in the adjuvant setting of breast cancer therapy--effect on survival: a systematic review and meta-analysis. PLOS ONE 8 (8): e70.044, 2013.

Brufsky AM et al.: Zoledronic acid effectively prevents aromatase inhibitor-associated bone loss in postmenopausal women with early breast cancer receiving adjuvant letrozole: Z-FAST study 36-month follow-up results. Clinical Breast Cancer 9 (2): 77 - 85, 2009.

Brufsky AM et al.: Final 5-year results of Z-FAST trial: adjuvant zoledronic acid maintains bone mass in postmenopausal breast cancer patients receiving letrozole. Cancer 118: 1.192 - 1.201, 2012.

Coleman R 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 Research and Treatment 127 (2): 429 - 438, 2011.

Coleman R et al.: Breast-cancer adjuvant therapy with zoledronic acid. New England Journal of Medicine 365 (15): 1.396 - 1.405, 2011.

Coleman R et al.: Zoledronic acid (zoledronate) for postmenopausal women with early breast cancer receiving adjuvant letrozole (ZO-FAST study): final 60-month results. Annals of Oncology 24 (2): 398 - 405, 2013.

Coleman R et al.: Adjuvant zoledronic acid in patients with early breast cancer: final efficay analysis of the AZURE (BIG 01/04) randomised open-label phase 3 trial. Lancet Oncology 15 (9): 997 - 1.006, 2014.

Diel IJ et al.: Reduction in new metastases in breast cancer. New England Journal of Medicine 339 (6): 357 - 363, 1998.

Diel IJ 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. Annals of

Oncology 19 (12): 2.007 – 2.011, 2008.

Early Breast Cancer Trialists´ Collaborative Group (EBCTC): Adjuvant bisphosphonate treatment in early breast cancer: meta-analyses of individual patient data from randomised trials. Lancet 386: 1.353 - 1.361, 2015.

Eidtmann H et al.: Efficacy of zoledronic acid in postmenopausal women with early breast cancer receiving adjuvant letrozole: 36-month results of the ZO-FAST study. Annals Oncology 21 (11): 2.188 - 2.194, 2010.

He M et al.: Adjuvant zoledronic acid therapy for patients with early stage breast cancer: an updated systematic review and meta-analysis. Journal of Hematology and Oncology 6 (1):

80, 2013.

23 Huang W-W et al.: Zoledronic acid as an adjuvant therapy in patients with breast cancer: A systematic review and meta-analysis. Journal of the National Comprehensive Cancer Networks 8 (3): 279 - 286, 2010.

Leal T et al.: Randomized trial of adjuvant zoledronic acid in postmenopausal women with high-risk breast cancer. Clinical Breast Cancer 10 (6): 471 - 476, 2010.

Mauri D et al.: Does adjuvant bisphosphonates in early breast cancer modify the natural course of the disease? A meta-analysis of randomized controlled trials. Journal of the National Comprehensive Cancer Networks 8 (3): 279 - 286, 2010.

O´Carrigan B et al.: Bisphosphonates and other bone agents for breast cancer. Cochrane Database Syst Rev. 2017 Oct 30; 10: CD003474. doi: 10.1002/14651858.CD003474.pub4.

Paterson AH et al.: Oral clodronate for adjuvant treatment of operable breast cancer

(National Surgical Adjuvant Breast and Bowel Project protocol B-34): a multicenter, placebo-controlled, randomised trial. Lancet Oncolology 13 (7): 734 - 742, 2012.

Powles T et al.: Randomized, placebo-controlled trial of clodronate in patients with primary operable breast cancer. Journal of Clininical Oncology 20 (15): 3.219 - 3.224, 2002.

Powles T et al.: Reduction in bone relapse and improved survival with oral clodronate for adjuvant treatment of operable breast cancer. Breast Cancer Res 8: R13, 2006.

Powles T et al.: Correction: Reduction in bone relapse and improved survival with oral clodronate for adjuvant treatment of operable breast cancer. Breast Cancer Res 8: 406, 2006.

Rathbone EJ 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 (BIG01/04). Journal of Clinical Oncology 31 (21): 2.685 - 2.691, 2013

Saarto T et al.: Adjuvant clodronate treatment does not reduce the frequency of skeletal metastases in node-positive breast cancer patients: 5-year results of a randomized controlled trial. Journal of Clinical Oncology 19 (1): 10 -17, 2001.

Saarto T et al.: Ten-year follow-up of a randomized controlled trial of adjuvant clodronate treatment in node-positive breast cancer patients. Acta Oncologica 43 (7): 650 - 656, 2004.

Saarto T et al.: Ten-year follow-up of 3 years of oral adjuvant clodronate therapy shows significant prevention of osteoporosis in early-stage breast cancer. Journal of Clinical Oncology 26 (26): 4-289 - 4.295, 2008.

Valachis A et al.: Adjuvant therapy with zoledronic acid in patients with breast cancer: a systematic review and meta-analysis. Oncologist 18 (4), 353-361, 2013. Journal of Clinical Oncology 31 (21): 2.685 - 2.691, 2013.

Yan T et al.: The efficacy of zoledronic acid in breast cancer adjuvant therapy: A meta-analysis of randomised controlled trials. European Journal of Cancer 48: 187 – 195, 2012.

Zhu J et al.: Oral adjuvant clodronate therapy could improve overall survival in early breast cancer: Results from an updated systematic review and meta-analysis. European Journal of Cancer 49, 2.086 – 2.092, 2013.

24 15.2 In Meta-Analysen genannte RCTs

(vgl. Abschnitt 7.b, Tabelle 3) Z-FAST

Brufsky AM, Harker WG, Beck JT, Bosserman L, Vogel C, Seidler C, et al. Final 5-year results of Z-FAST trial: adjuvant zoledronic acid maintains bone mass in postmenopausal breast cancer patients receiving letrozole. Cancer 118 (5): 1.192 – 1.201, 2012.

Brufsky AM, Bosserman LD, Caradonna RR, Haley BB, Jones CM, Moore HC, et al.

Zoledronic acid effectively prevents aromatase inhibitor-associated bone loss in

postmenopausal women with early breast cancer receiving adjuvant letrozole: Z-FAST study 36-month follow-up results. Clinical Breast Cancer 9 (2): 77 – 85, 2009.

Brufsky A, Bundred N, Coleman R, Lambert-Falls R, Mena R, Hadji P, et al. Integrated analysis of zoledronic acid for prevention of aromatase inhibitor-associated bone loss in postmenopausal women with early breast cancer receiving adjuvant letrozole. Oncologist 13 (5): 503 – 514, 2008.

Brufsky A, Harker WG, Beck JT, Carroll R, Tan-Chiu E, Seidler C, et al. Zoledronic acid inhibits adjuvant letrozoleinduced bone loss in postmenopausal women with early breast cancer. Journal of Clinical Oncology 25 (7): 829 – 836, 2007.

ZO-FAST

Coleman R, De Boer R, Eidtmann H, Llombart A, Davidson N, Neven P, et al. Zoledronic acid (zoledronate) for postmenopausal women with early breast cancer receiving adjuvant letrozole (ZO-FAST study): final 60- month results. Annals of Oncology 24 (2): 398 – 405, 2013.

Coleman R, De Boer R, Eidtmann H, Neven P, von Minckwitz G, Martin N, et al. Influence of delayed zoledronic acid initiation on disease-free survival in postmenopausal women with endocrine receptor-positive early breast cancer receiving adjuvant letrozole: exploratory analysis from the ZO-FAST trial. Cancer Research 71 (24 Suppl): P2–17-01, 2011.

De Boer R, Bundred N, Eidtmann H, Neven P, von Minckwitz G,MartinN, et al. Long-term survival outcomes among postmenopausal women with hormone receptor positive early breast cancer receiving adjuvant letrozole and zoledronic acid: 5-year follow-up of ZO-FAST.

Cancer Research 71 (24 Suppl): S1–3. 2011.

Eidtmann H, De Boer R, Bundred N, Llombart-Cussac A, Davidson N, Neven P, et al.

Efficacy of zoledronic acid in postmenopausal women with early breast cancer receiving adjuvant letrozole: 36-month results of the ZO-FAST Study. Annals of Oncology 21 (11):

2.188 – 2.194, 2010.

E-ZO-FAST

Llombart A, Frassoldati A, Paija O, Sleeboom HP, Jerusalem G, Mebis J, et al. Immediate administration of zoledronic acid reduces aromatase inhibitor-associated bone loss in

postmenopausal women with early breast cancer: 12- month analysis of the E-ZO-FAST trial.

Clinical Breast Cancer 12(1): 40 – 48, 2012.

Llombarto A, Frassoldati A, Paija O, Sleeboom HP, Jerusalem G, Mebis J, et al. Effect of zoledronic acid on aromatase inhibitor-associated bone loss in postmenopausal women with early breast cancer receiving adjuvant letrozole: E-ZO-FAST 36-month follow-up. ASCO

25 Breast Cancer Symposium; 2009; Chicago. Chicago: American Society of Clinical Oncology, 2009.

NATAN

Von Minckwitz G, Rezai M, Tesch H, Huober J, Gerber B, Zahm DM, et al. Zoledronate for patients with invasive residual disease after anthracyclines-taxane-based chemotherapy for early breast cancer - the phase III NeoAdjuvant Trial Add-oN (NaTaN) study (GBG 36/

ABCSG 29). European Journal of Cancer; 64:12 – 21, 2016.

Von Minckwitz G, Rezai M, Eidtmann H, Tesch H, Huober J, Gerber B, et al.: Postneo-adjuvant treatment with zoledronate in patients with tumor residuals after anthracyclines-taxane-based chemotherapy for primary breast cancer - the phase III NATAN study (GBG 36/ ABCSG XX). Cancer Research 73 (24 Suppl): S5–05, 2013.

AZURE

Coleman R, Cameron D, Dodwell D, Bell R, Wilson C, Rathbone E, et al. Adjuvant zoledronic acid in patients with early breast cancer: final efficacy analysis of the AZURE (BIG 01/04) randomised open-label phase 3 trial. Lancet Oncology 2014; 15 (9): 997 – 1.006, 2014.

Coleman RE, Rathbone EJ,Marshall HC,Wilson C, Brown JE, Gossiel F, et al. Vitamin D, but not bone turnover markers, predict relapse in women with early breast cancer: an AZURE translational study. Cancer Research 72 (24 Suppl):S6–4., 2012.

Coleman R, Woodward E, Brown J, Cameron D, Bell R, Dodwell D, 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 Research and Treatment 2011; 127 (2):429 –438, 2011.

Coleman R, Woodward E, Turner L, Marshall H, Collinson M, Dodwell D, et al. Impact of zoledronic acid on fractures, bone mineral density and bone remodeling in the AZURE trial (BIG 01-04). Cancer Research 2011; 71 (24 Suppl): P2–19-01.

Coleman RE, Marshall H, Cameron D, Dodwell D, Burkinshaw R, Keane M, et al. Breast-cancer adjuvant therapy with zoledronic acid. New England Journal of Medicine 2011; 365 (15):1396 – 1405. 2011.

Coleman RE, Thorpe HC, Cameron D, Dodwell D, Burkinshaw R, Keane M, et al. Adjuvant treatment with zoledronic acid in stage II/III breast cancer. The AZURE trial (BIG 01/04).

Cancer Research 70 (24 Suppl): S4–5, 2010.

Coleman RE, Winter MC, Cameron D, Bell R, Dodwell D, Keane MM, et al. The effects of adding zoledronic acid to neoadjuvant chemotherapy on tumour response: exploratory evidence for direct anti-tumour activity in breast cancer. British Journal of Cancer 102 (7):1.099 – 1.105, 2010.

Rathbone EJ, Brown JE, Marshall HC, Collinson M, Liversedge V, Murden GA, 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 (BIG01/04). Journal of Clinical Oncology 2013; 31 (21): 2.685–2.691, 2013.

26 ABCSG-12

Gnant M, Mlineritsch B, Stoeger H, Luschin-Ebengreuth G, Knauer M, Moik M, et al.

Zoledronic acid combined with adjuvant endocrine therapy of tamoxifen versus anastrozole plus ovarian function suppression in premenopausal early breast cancer: final analysis of the Austrian Breast and Colorectal Cancer Study Group Trial 12. Annals of Oncology 2015; Vol.

26, issue 2: 313 –320, 2015.

Gnant M, Mlineritsch B, Luschin-Ebengreuth G, Stoeger H, Dubsky P, Jakesz R, 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 Research 71: S1 – 2, 2011.

Gnant M, Mlineritsch B, Stoeger H, Luschin-Ebengreuth G, Heck D, Menzel C, et al.

Adjuvant endocrine therapy plus zoledronic acid in premenopausal women with earlystage breast cancer: 62-month follow-up from the ABCSG- 12 randomised trial. Lancet Oncology 12 (7): 631 –641, 2011.

Gnant M, Mlineritsch B, Stoeger H, Luschin-Ebengreuth G, Poestlberger S, Dubsky PC, et al.

Mature results from ABCSG-12: adjuvant ovarian suppression combined with tamoxifen or anastrozole, alone or in combination with zoledronic acid, in premenopausal women with endocrineresponsive early breast cancer. Journal of Clinical Oncology 2010 28 (15 Suppl):533, 2010.

Gnant M, Mlineritsch B, Schippinger W, Luschin- Ebengreuth G, Pöstlberger S, Menzel C, et al. Endocrine therapy plus zoledronic acid in premenopausal breast cancer. New England Journal of Medicine 360 (7): 679 –691, 2009.

NCCTG N03CC

Wagner-Johnston ND et al.: 5-year follow-up of a randomized controlled trial of immediate versus delayed zoledronic acid for prevention of bone loss in postmenopausal women with breast cancer starting letrozole after tamoxifen: N03CC (Alliance). Cancer. 121 (15): 2.537–

2.543, 2015.

HOBOE

Nuzzo F, Gallo C, Lastoria S, Di Maio M, Piccirillo MC, Gravina A, et al. Bone effect of adjuvant tamoxifen, letrozole or letrozole plus zoledronic acid in early-stage breast cancer:

the randomized phase 3 HOBOE study. Annals of Oncology 2012; 23: 2.027–2.033, 2012.

SWOG S0307

Gralow J, Barlow WE, Paterson AHG, Lew D, Stopeck A, Hayes DF, et al. Phase III trial of bisphosphonates as adjuvant therapy in primary breast cancer: SWOG/ Alliance/ECOG-ACRIN/NCIC Clinical Trials Group/ NRG Oncology study S0307. Journal of Clinical Oncology 33 (15 Suppl): 503. 0732–183, 2015.

Gralow J, Barlow WE, Paterson AHG, Lew D, Stopeck A, Hayes DF, et al. SWOG S0307 phase III trial of bisphosphonates as adjuvant therapy in primary breast cancer: comparison of toxicities and patient-stated preference for oral versus intravenous delivery. Journal of Clinical Oncoloy 32 (15 Suppl): 558, 2014.

27 Saarto

Saarto T, Vehmanen L, Blomqvist C, Elomaa I. Ten-year follow-up of 3 years of oral adjuvant clodronate therapy shows significant prevention of osteoporosis in early-stage breast cancer.

J Clin Oncol 26: 4.289 – 4.295, 2008.

Saarto T, Vehmanen L, Virkkunen P, Blomqvist C. Tenyear follow-up of a randomized controlled trial of adjuvant clodronate treatment in node-positive breast cancer patients. Acta Oncologica 43 (7): 650 –656, 2004.

Saarto T, Blomqvist C, Virkkunen P, Elomaa I. Adjuvant clodronate treatment does not reduce the frequency of skeletal metastases in node-positive breast cancer patients: 5 year results of a randomised controlled study. Journal of Clinical Oncology 19 (1): 10–17, 2001.

RMNHST

McCloskey E, Paterson A, Kanis J, Tahtela R, Powles T. Effect of oral clodronate on bone mass, bone turnover and subsequent metastases in women with primary breast cancer.

European Journal of Cancer 46 (3): 558–565, 2009.

Powles T, Paterson A, McCloskey E, Schein P, Scheffler B, Tidy A, et al. Reduction in bone relapse and improved survival with oral clodronate for adjuvant treatment of operable breast cancer. Breast Cancer Research 8 (2): 13, 2006.

Powles T, McCloskey E, Kurkilahti M, Kurkilahti M, Kanis J. Oral clodronate for the adjuvant treatment of operable breast cancer: results of a randomised, double-blind,

placebo-controlled multicenter trial. Journal of Clinical Oncology 22 (14 Suppl): 528, 2004.

Powles T, Paterson S, Kanis JA, McCloskey E, Ashley S, Tidy A, et al. Randomized,

placebo-controlled trial of clodronate in patients with primary operable breast cancer. Journal of Clinical Oncology 20.(15): 3.219–3.224, 2002.

Atula ST, Paterson AHG, Powles TJ, McLoskey EV, Nevalainen JI, Kanis JA. Extended safety profile of oral clodronate after long-term use in primary breast cancer patients. Drug Safety 26 (9): 661–671, 2003.

NSABP B-34

Paterson AH, Anderson SJ, Lembersky BC, Fehrenbacher L, Falkson CI, King KM, 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 Oncology 2012; Vol. 13, issue 7: 734 – 742, 2012.

Paterson AHG, Anderson SJ, Lembersky BC, Fehrenbacher L, Falkson CI, King KM, et al.

NSABP protocol B-34: a clinical trial comparing adjuvant clodronate vs. placebo in early stage breast cancer patients receiving systemic chemotherapy and/or tamoxifen or no therapy - final analysis. Cancer Research 71 (24 Suppl):S2–3, 2011.

Diel

Diel IJ, Jaschke A, Solomayer EF, Gollan C, Bastert G, Sohn C, et al. Adjuvant oral clodronate improves the overall survival of primary breast cancer patients with

micrometastases to the bone marrow: a long-term followup. Annals of Oncology 2008; 19 (12): 2.007 – 2.201, 2008

Diel IJ, Solomayer EF, Costa SD, Gollan C, Goerner R, Wallweiner D, et al. Reduction in new metastases in breast cancer with adjuvant clodronate treatment. New England Journal of Medicine 339 (6):357 – 363. 1998.

28 Jaschke A, Bastert G, Solomayer EF, Costa S, Scheutz F, Diel JJ. Adjuvant clodronate treatment improves the overall survival of primary breast cancer patients with

micrometastases to bone marrow: a long-term follow-up. Journal of Clinical Oncology 22 (14 Suppl): 529, 2004.

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