Addition of zoledronic acid to neoadjuvant chemotherapy does not enhance tumor response in patients with HER2-negative stage II/III breast cancer: the NEOZOTAC trial (BOOG 2010-01)

Annals of Oncology

Volumn 25, Issue 5, 2014, Pages 998-1004

  Charehbili, A ^a   van de Ven, S ^a   Smit, V T H B M ^a   Meershoek Klein Kranenbarg, E ^a   Hamdy, N A T ^a   Putter, H ^b   Heijns, J B ^c   van Warmerdam, L J C ^d   Kessels, L ^e   Dercksen, M ^f   Pepels, M J ^g   Maartense, E ^a   van Laarhoven, H W M ^h,i   Vriens, B ^j   Wasser, M N ^b   van Leeuwen Stok, A E ^k   Liefers, G J ^a   van de Velde, C J H ^a   Nortier, J W R ^a   Kroep, J R ^a  

^a Department of Clinical Oncology ^*

^b LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^c Ziekenhuis Amphia   (Netherlands)

^d CATHARINA HOSPITAL   (Netherlands)

^e DEVENTER HOSPITAL   (Netherlands)

^f MÁXIMA MEDICAL CENTER   (Netherlands)

^g ELKERLIEK HOSPITAL   (Netherlands)

^h RADBOUD UNIVERSITY NIJMEGEN   (Netherlands)

ⁱ ACADEMIC MEDICAL CENTER   (Netherlands)

^j MAASTRICHT UNIVERSITY MEDICAL CENTER   (Netherlands)

^k Dutch Breast Cancer Trialists' Group BOOG   (Netherlands)

more..

Author keywords

bisphosphonates; menopausal status; neoadjuvant chemotherapy; zoledronic acid

Indexed keywords

ANTINEOPLASTIC AGENT; BISPHOSPHONIC ACID DERIVATIVE; CYCLOPHOSPHAMIDE; DOCETAXEL; DOXORUBICIN; EPIDERMAL GROWTH FACTOR RECEPTOR 2; ERBB2 PROTEIN, HUMAN; IMIDAZOLE DERIVATIVE; TAXOID; ZOLEDRONIC ACID;

ADJUVANT CHEMOTHERAPY; ADJUVANT THERAPY; ADULT; AGED; BREAST NEOPLASMS; CANCER STAGING; CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; HUMAN; METABOLISM; MIDDLE AGED; MULTICENTER STUDY; PATHOLOGY; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; CYCLOPHOSPHAMIDE; DIPHOSPHONATES; DOXORUBICIN; FEMALE; HUMANS; IMIDAZOLES; MIDDLE AGED; NEOADJUVANT THERAPY; NEOPLASM STAGING; PROSPECTIVE STUDIES; RECEPTOR, ERBB-2; TAXOIDS; TREATMENT OUTCOME;

EID: 84911496889     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdu102     Document Type: Article

References (38)

1. Aft, R., Perez, J.R., Raje, N., et al. Could targeting bone delay cancer progression? Potential mechanisms of action of bisphosphonates. Crit Rev Oncol Hematol 82 (2012), 233–248.
2. Coleman, R.E., Adjuvant bisphosphonates in breast cancer: are we witnessing the emergence of a new therapeutic strategy?. Eur J Cancer 45 (2009), 1909–1915.
3. Fournier, P., Boissier, S., Filleur, S., et al. Bisphosphonates inhibit angiogenesis in vitro and testosterone-stimulated vascular regrowth in the ventral prostate in castrated rats. Cancer Res 62 (2002), 6538–6544.
4. Santini, D., Vincenzi, B., Galluzzo, S., et al. Repeated intermittent low-dose therapy with zoledronic acid induces an early, sustained, and long-lasting decrease of peripheral vascular endothelial growth factor levels in cancer patients. Clin Cancer Res 13 (2007), 4482–4486.
5. Gober, H.J., Kistowska, M., Angman, L., et al. Human T cell receptor gammadelta cells recognize endogenous mevalonate metabolites in tumor cells. J Exp Med 197 (2003), 163–168.
6. Rogers, T.L., Holen, I., Tumour macrophages as potential targets of bisphosphonates. J Transl Med, 9, 2011, 177.
7. Coscia, M., Quaglino, E., Iezzi, M., et al. Zoledronic acid repolarizes tumour-associated macrophages and inhibits mammary carcinogenesis by targeting the mevalonate pathway. J Cell Mol Med 14 (2010), 2803–2815.
8. Benzaid, I., Monkkonen, H., Stresing, V., et al. High phosphoantigen levels in bisphosphonate-treated human breast tumors promote Vgamma9Vdelta2 T-cell chemotaxis and cytotoxicity in vivo. Cancer Res 71 (2011), 4562–4572.
9. Ottewell, P.D., Monkkonen, H., Jones, M., et al. Antitumor effects of doxorubicin followed by zoledronic acid in a mouse model of breast cancer. J Natl Cancer Inst 100 (2008), 1167–1178.
10. Neville-Webbe, H.L., Rostami-Hodjegan, A., Evans, C.A., et al. Sequence- and schedule-dependent enhancement of zoledronic acid induced apoptosis by doxorubicin in breast and prostate cancer cells. Int J Cancer 113 (2005), 364–371.
11. Yan, T., Yin, W., Zhou, Q., et al. The efficacy of zoledronic acid in breast cancer adjuvant therapy: a meta-analysis of randomised controlled trials. Eur J Cancer 48 (2012), 187–195.
12. Coleman, R., Gnant, M., Morgan, G., et al. Effects of bone-targeted agents on cancer progression and mortality. J Natl Cancer Inst 104 (2012), 1059–1067.
13. 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 12 (2011), 631–641.
14. Coleman, R.E., Marshall, H., Cameron, D., et al. Breast-cancer adjuvant therapy with zoledronic acid. N Engl J Med 365 (2011), 1396–1405.
15. Coleman, R.E., 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 Symp, 2013 Abstract S4-07(11 March 2014, date last accessed) http://www.abstracts2view.com/sabcs13/view.php?nu=SABCS13L_3045&terms=.
16. Coleman, R.E., Winter, M.C., Cameron, D., et al. The effects of adding zoledronic acid to neoadjuvant chemotherapy on tumour response: exploratory evidence for direct anti-tumour activity in breast cancer. Br J Cancer 102 (2010), 1099–1105.
17. Aft, R.L., Naughton, M., Trinkaus, K., et al. Effect of (neo)adjuvant zoledronic acid on disease-free and overall survival in clinical stage II/III breast cancer. Br J Cancer 107 (2012), 7–11.
18. Ogston, K.N., Miller, I.D., Payne, S., et al. A new histological grading system to assess response of breast cancers to primary chemotherapy: prognostic significance and survival. Breast 12 (2003), 320–327.
19. Eisenhauer, E.A., Therasse, P., Bogaerts, J., et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45 (2009), 228–247.
20. Common Terminology Criteria for Adverse Events v4.0. NCI, NIH, DHHS. National Cancer Institute, 2009 29 May NIH publication #09-7473.
21. Coleman, R., de, B.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 24 (2013), 398–405.
22. De Vos, F.Y., van Laarhoven, H.W., Laven, J.S., et al. Menopausal status and adjuvant hormonal therapy for breast cancer patients: a practical guideline. Crit Rev Oncol Hematol 84 (2012), 252–260.
23. von, M.G., Kummel, S., Vogel, P., et al. Intensified neoadjuvant chemotherapy in early-responding breast cancer: phase III randomized GeparTrio study. J Natl Cancer Inst 100 (2008), 552–562.
24. Guarneri, V., Broglio, K., Kau, S.W., et al. Prognostic value of pathologic complete response after primary chemotherapy in relation to hormone receptor status and other factors. J Clin Oncol 24 (2006), 1037–1044.
25. Gianni, L., Baselga, J., Eiermann, W., et al. Feasibility and tolerability of sequential doxorubicin/paclitaxel followed by cyclophosphamide, methotrexate, and fluorouracil and its effects on tumor response as preoperative therapy. Clin Cancer Res 11 (2005), 8715–8721.
26. Rouzier, R., Perou, C.M., Symmans, W.F., et al. Breast cancer molecular subtypes respond differently to preoperative chemotherapy. Clin Cancer Res 11 (2005), 5678–5685.
27. Ring, A.E., Smith, I.E., Ashley, S., et al. Oestrogen receptor status, pathological complete response and prognosis in patients receiving neoadjuvant chemotherapy for early breast cancer. Br J Cancer 91 (2004), 2012–2017.
28. Eidtmann, H., de, B.R., Bundred, N., et al. Efficacy of zoledronic acid in postmenopausal women with early breast cancer receiving adjuvant letrozole: 36-month results of the ZO-FAST study. Ann Oncol 21 (2010), 2188–2194.
29. Hasegawa, Y., Kohno, N., Horiguchi, J., et al. A randomized controlled trial comparing zoledronic acid plus chemotherapy with chemotherapy alone as a neoadjuvant treatment in patients with HER2-negative primary breast cancer. Cancer Res, 72(24 suppl 3), 2012 abstract PD07-05.
30. Coleman, R., Hinsley, S., Bell, R., et al. Adjuvant therapy in early breast cancer with zoledronic acid (AZURE - BIG 01/04): final efficacy analysis. European Cancer Congress, 2013 (11 March 2014, date last accessed) http://eccamsterdam2013.ecco-org.eu/Scientific-Programme/Abstract-search.aspx?abstractid=8914.
31. Holen, I., Wang, N., Reeves, K.J., et al. Zoledronic acid specifically inhibits development of bone metastases in the post-menopausal setting—evidence from an in vivo breast cancer model. Cancer Res, 72(24 suppl 3), 2012 abstract PD07–08.
32. Aft, R., Naughton, M., Trinkauas, K., et al. Effect of zoledronic acid on disseminated tumour cells in women with locally advanced breast cancer: an open label, randomised, phase 2 trial. Lancet Oncol 11 (2010), 421–428.
33. Winter, M.C., Holen, I., Coleman, R.E., Exploring the anti-tumour activity of bisphosphonates in early breast cancer. Cancer Treat Rev 34 (2008), 453–475.
34. Weitzmann, M.N., Pacifici, R., Estrogen deficiency and bone loss: an inflammatory tale. J Clin Invest 116 (2006), 1186–1194.
35. Allavena, P., Mantovani, A., Immunology in the clinic review series; focus on cancer: tumour-associated macrophages: undisputed stars of the inflammatory tumour microenvironment. Clin Exp Immunol 167 (2012), 195–205.
36. Zeisberger, S.M., Odermatt, B., Marty, C., et al. Clodronate-liposome-mediated depletion of tumour-associated macrophages: a new and highly effective antiangiogenic therapy approach. Br J Cancer 95 (2006), 272–281.
37. Chinault, S.L., Prior, J.L., Kaltenbronn, K.M., et al. Breast cancer cell targeting by prenylation inhibitors elucidated in living animals with a bioluminescence reporter. Clin Cancer Res 18 (2012), 4136–4144.
38. Rogers, T.L., Wind, N., Hughes, R., et al. Macrophages as potential targets for zoledronic acid outside the skeleton-evidence from in vitro and in vivo models. Cell Oncol (Dordr) 36 (2013), 505–514.