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)
The role of zoledronic acid (ZA) when added to the neoadjuvant treatment of breast cancer (BC) in enhancing the clinical and pathological response of tumors is unclear. The effect of ZA on the antitumor effect of neoadjuvant chemotherapy has not prospectively been studied before. NEOZOTAC is a natio...
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| Veröffentlicht in: | Annals of oncology 2014-05, Vol.25 (5), p.998-1004 |
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| creator | Charehbili, A. van de Ven, S. Smit, V.T.H.B.M. Meershoek-Klein Kranenbarg, E. Hamdy, N.A.T. Putter, H. Heijns, J.B. van Warmerdam, L.J.C. Kessels, L. Dercksen, M. Pepels, M.J. Maartense, E. van Laarhoven, H.W.M. Vriens, B. Wasser, M.N. van Leeuwen-Stok, A.E. Liefers, G.J. van de Velde, C.J.H. Nortier, J.W.R. Kroep, J.R. |
| description | The role of zoledronic acid (ZA) when added to the neoadjuvant treatment of breast cancer (BC) in enhancing the clinical and pathological response of tumors is unclear. The effect of ZA on the antitumor effect of neoadjuvant chemotherapy has not prospectively been studied before.
NEOZOTAC is a national, multicenter, randomized study comparing the efficacy of TAC (docetaxel, adriamycin and cyclophosphamide i.v.) followed by granulocyte colony-stimulating factor on day 2 with or without ZA 4mg i.v. q 3 weeks inpatients withstage II/III, HER2-negative BC. We present data on the pathological complete response (pCR in breast and axilla), on clinical response using MRI, and toxicity. Post hoc subgroup analyses were undertaken to address the predictive value of menopausal status.
Addition of ZA to chemotherapy did not improve pCR rates (13.2% for TAC+ZA versus 13.3% for TAC). Postmenopausal women (N = 96) had a numerical benefit from ZA treatment (pCR 14.0% for TAC+ZA versus 8.7% for TAC, P = 0.42). Clinical objective response did not differ between treatment arms (72.9% versus 73.7%). There was no difference in grade III/IV toxicity between treatment arms.
Addition of ZA to neoadjuvant chemotherapy did not improve pathological or clinical response to chemotherapy. Further investigations are warranted in postmenopausal women with BC, since this subgroup might benefit from ZA treatment. |
| doi_str_mv | 10.1093/annonc/mdu102 |
| format | Article |
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NEOZOTAC is a national, multicenter, randomized study comparing the efficacy of TAC (docetaxel, adriamycin and cyclophosphamide i.v.) followed by granulocyte colony-stimulating factor on day 2 with or without ZA 4mg i.v. q 3 weeks inpatients withstage II/III, HER2-negative BC. We present data on the pathological complete response (pCR in breast and axilla), on clinical response using MRI, and toxicity. Post hoc subgroup analyses were undertaken to address the predictive value of menopausal status.
Addition of ZA to chemotherapy did not improve pCR rates (13.2% for TAC+ZA versus 13.3% for TAC). Postmenopausal women (N = 96) had a numerical benefit from ZA treatment (pCR 14.0% for TAC+ZA versus 8.7% for TAC, P = 0.42). Clinical objective response did not differ between treatment arms (72.9% versus 73.7%). There was no difference in grade III/IV toxicity between treatment arms.
Addition of ZA to neoadjuvant chemotherapy did not improve pathological or clinical response to chemotherapy. Further investigations are warranted in postmenopausal women with BC, since this subgroup might benefit from ZA treatment.</description><identifier>ISSN: 0923-7534</identifier><identifier>EISSN: 1569-8041</identifier><identifier>DOI: 10.1093/annonc/mdu102</identifier><identifier>PMID: 24585721</identifier><language>eng</language><publisher>Oxford: Elsevier Ltd</publisher><subject>Adult ; Aged ; Antineoplastic agents ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; bisphosphonates ; Breast Neoplasms - drug therapy ; Breast Neoplasms - metabolism ; Breast Neoplasms - pathology ; Chemotherapy, Adjuvant ; Cyclophosphamide - administration & dosage ; Diphosphonates - administration & dosage ; Docetaxel ; Doxorubicin - administration & dosage ; Female ; Gynecology. Andrology. Obstetrics ; Humans ; Imidazoles - administration & dosage ; Mammary gland diseases ; Medical sciences ; menopausal status ; Middle Aged ; Multiple tumors. Solid tumors. Tumors in childhood (general aspects) ; neoadjuvant chemotherapy ; Neoadjuvant Therapy ; Neoplasm Staging ; Pharmacology. Drug treatments ; Prospective Studies ; Receptor, ErbB-2 - metabolism ; Taxoids - administration & dosage ; Treatment Outcome ; Tumors ; Zoledronic Acid</subject><ispartof>Annals of oncology, 2014-05, Vol.25 (5), p.998-1004</ispartof><rights>2014 European Society for Medical Oncology</rights><rights>The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com. 2014</rights><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c443t-1a0251633a9efbe01540d3e7ff736ff3742ee1588146fce3da53b92c25e7bbb43</citedby><cites>FETCH-LOGICAL-c443t-1a0251633a9efbe01540d3e7ff736ff3742ee1588146fce3da53b92c25e7bbb43</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=28422783$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24585721$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Charehbili, A.</creatorcontrib><creatorcontrib>van de Ven, S.</creatorcontrib><creatorcontrib>Smit, V.T.H.B.M.</creatorcontrib><creatorcontrib>Meershoek-Klein Kranenbarg, E.</creatorcontrib><creatorcontrib>Hamdy, N.A.T.</creatorcontrib><creatorcontrib>Putter, H.</creatorcontrib><creatorcontrib>Heijns, J.B.</creatorcontrib><creatorcontrib>van Warmerdam, L.J.C.</creatorcontrib><creatorcontrib>Kessels, L.</creatorcontrib><creatorcontrib>Dercksen, M.</creatorcontrib><creatorcontrib>Pepels, M.J.</creatorcontrib><creatorcontrib>Maartense, E.</creatorcontrib><creatorcontrib>van Laarhoven, H.W.M.</creatorcontrib><creatorcontrib>Vriens, B.</creatorcontrib><creatorcontrib>Wasser, M.N.</creatorcontrib><creatorcontrib>van Leeuwen-Stok, A.E.</creatorcontrib><creatorcontrib>Liefers, G.J.</creatorcontrib><creatorcontrib>van de Velde, C.J.H.</creatorcontrib><creatorcontrib>Nortier, J.W.R.</creatorcontrib><creatorcontrib>Kroep, J.R.</creatorcontrib><creatorcontrib>on behalf of the Dutch Breast Cancer Research Group (BOOG)</creatorcontrib><creatorcontrib>Dutch Breast Cancer Research Group (BOOG)</creatorcontrib><title>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)</title><title>Annals of oncology</title><addtitle>Ann Oncol</addtitle><description>The role of zoledronic acid (ZA) when added to the neoadjuvant treatment of breast cancer (BC) in enhancing the clinical and pathological response of tumors is unclear. The effect of ZA on the antitumor effect of neoadjuvant chemotherapy has not prospectively been studied before.
NEOZOTAC is a national, multicenter, randomized study comparing the efficacy of TAC (docetaxel, adriamycin and cyclophosphamide i.v.) followed by granulocyte colony-stimulating factor on day 2 with or without ZA 4mg i.v. q 3 weeks inpatients withstage II/III, HER2-negative BC. We present data on the pathological complete response (pCR in breast and axilla), on clinical response using MRI, and toxicity. Post hoc subgroup analyses were undertaken to address the predictive value of menopausal status.
Addition of ZA to chemotherapy did not improve pCR rates (13.2% for TAC+ZA versus 13.3% for TAC). Postmenopausal women (N = 96) had a numerical benefit from ZA treatment (pCR 14.0% for TAC+ZA versus 8.7% for TAC, P = 0.42). Clinical objective response did not differ between treatment arms (72.9% versus 73.7%). There was no difference in grade III/IV toxicity between treatment arms.
Addition of ZA to neoadjuvant chemotherapy did not improve pathological or clinical response to chemotherapy. Further investigations are warranted in postmenopausal women with BC, since this subgroup might benefit from ZA treatment.</description><subject>Adult</subject><subject>Aged</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>bisphosphonates</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Breast Neoplasms - metabolism</subject><subject>Breast Neoplasms - pathology</subject><subject>Chemotherapy, Adjuvant</subject><subject>Cyclophosphamide - administration & dosage</subject><subject>Diphosphonates - administration & dosage</subject><subject>Docetaxel</subject><subject>Doxorubicin - administration & dosage</subject><subject>Female</subject><subject>Gynecology. Andrology. Obstetrics</subject><subject>Humans</subject><subject>Imidazoles - administration & dosage</subject><subject>Mammary gland diseases</subject><subject>Medical sciences</subject><subject>menopausal status</subject><subject>Middle Aged</subject><subject>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</subject><subject>neoadjuvant chemotherapy</subject><subject>Neoadjuvant Therapy</subject><subject>Neoplasm Staging</subject><subject>Pharmacology. Drug treatments</subject><subject>Prospective Studies</subject><subject>Receptor, ErbB-2 - metabolism</subject><subject>Taxoids - administration & dosage</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><subject>Zoledronic Acid</subject><issn>0923-7534</issn><issn>1569-8041</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkE1rFEEQhgdRzBo9epW6CPEwbn_Nl7d1WZOB4IDEi5ehp7s622Gne-juXYm_yx_ohIl6Ek8FxVPvSz1Z9pqS95Q0fC2d806tR32khD3JVrQom7wmgj7NVqRhPK8KLs6yFzHeEULKhjXPszMmirqoGF1lPzda22S9A2_ghz-gDt5ZBVJZDcmDQy_13fEkXQK1x9GnPQY53YP2GMH5BOj20imEdBx9gIBx8i4iWAeTTBZdivDdpj1c7b6w3OHtvDwhxCRvEdp23bYtDAFlnPMfcsIHmCvg86771t1stpCClQe4-Nh1l8AIJTmh715mz4w8RHz1OM-zr592N9ur_Lq7bLeb61wJwVNOJWEFLTmXDZoBCS0E0RwrYypeGsMrwRBpUddUlEYh17LgQ8MUK7AahkHw8yxfclXwMQY0_RTsKMN9T0n_YL9f7PeL_Zl_s_DTcRhR_6F_656Bt4-AjEoeTJg_tvEvVwvGqprP3MXC-eP0385qQXEWcbIY-qhm6wq1DahSr739x-Uv8HGxag</recordid><startdate>20140501</startdate><enddate>20140501</enddate><creator>Charehbili, A.</creator><creator>van de Ven, S.</creator><creator>Smit, V.T.H.B.M.</creator><creator>Meershoek-Klein Kranenbarg, E.</creator><creator>Hamdy, N.A.T.</creator><creator>Putter, H.</creator><creator>Heijns, J.B.</creator><creator>van Warmerdam, L.J.C.</creator><creator>Kessels, L.</creator><creator>Dercksen, M.</creator><creator>Pepels, M.J.</creator><creator>Maartense, E.</creator><creator>van Laarhoven, H.W.M.</creator><creator>Vriens, B.</creator><creator>Wasser, M.N.</creator><creator>van Leeuwen-Stok, A.E.</creator><creator>Liefers, G.J.</creator><creator>van de Velde, C.J.H.</creator><creator>Nortier, J.W.R.</creator><creator>Kroep, J.R.</creator><general>Elsevier Ltd</general><general>Oxford University Press</general><scope>6I.</scope><scope>AAFTH</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>20140501</creationdate><title>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)</title><author>Charehbili, A. ; van de Ven, S. ; Smit, V.T.H.B.M. ; Meershoek-Klein Kranenbarg, E. ; Hamdy, N.A.T. ; Putter, H. ; Heijns, J.B. ; van Warmerdam, L.J.C. ; Kessels, L. ; Dercksen, M. ; Pepels, M.J. ; Maartense, E. ; van Laarhoven, H.W.M. ; Vriens, B. ; Wasser, M.N. ; van Leeuwen-Stok, A.E. ; Liefers, G.J. ; van de Velde, C.J.H. ; Nortier, J.W.R. ; Kroep, J.R.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c443t-1a0251633a9efbe01540d3e7ff736ff3742ee1588146fce3da53b92c25e7bbb43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Antineoplastic agents</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>bisphosphonates</topic><topic>Breast Neoplasms - drug therapy</topic><topic>Breast Neoplasms - metabolism</topic><topic>Breast Neoplasms - pathology</topic><topic>Chemotherapy, Adjuvant</topic><topic>Cyclophosphamide - administration & dosage</topic><topic>Diphosphonates - administration & dosage</topic><topic>Docetaxel</topic><topic>Doxorubicin - administration & dosage</topic><topic>Female</topic><topic>Gynecology. Andrology. Obstetrics</topic><topic>Humans</topic><topic>Imidazoles - administration & dosage</topic><topic>Mammary gland diseases</topic><topic>Medical sciences</topic><topic>menopausal status</topic><topic>Middle Aged</topic><topic>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</topic><topic>neoadjuvant chemotherapy</topic><topic>Neoadjuvant Therapy</topic><topic>Neoplasm Staging</topic><topic>Pharmacology. Drug treatments</topic><topic>Prospective Studies</topic><topic>Receptor, ErbB-2 - metabolism</topic><topic>Taxoids - administration & dosage</topic><topic>Treatment Outcome</topic><topic>Tumors</topic><topic>Zoledronic Acid</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Charehbili, A.</creatorcontrib><creatorcontrib>van de Ven, S.</creatorcontrib><creatorcontrib>Smit, V.T.H.B.M.</creatorcontrib><creatorcontrib>Meershoek-Klein Kranenbarg, E.</creatorcontrib><creatorcontrib>Hamdy, N.A.T.</creatorcontrib><creatorcontrib>Putter, H.</creatorcontrib><creatorcontrib>Heijns, J.B.</creatorcontrib><creatorcontrib>van Warmerdam, L.J.C.</creatorcontrib><creatorcontrib>Kessels, L.</creatorcontrib><creatorcontrib>Dercksen, M.</creatorcontrib><creatorcontrib>Pepels, M.J.</creatorcontrib><creatorcontrib>Maartense, E.</creatorcontrib><creatorcontrib>van Laarhoven, H.W.M.</creatorcontrib><creatorcontrib>Vriens, B.</creatorcontrib><creatorcontrib>Wasser, M.N.</creatorcontrib><creatorcontrib>van Leeuwen-Stok, A.E.</creatorcontrib><creatorcontrib>Liefers, G.J.</creatorcontrib><creatorcontrib>van de Velde, C.J.H.</creatorcontrib><creatorcontrib>Nortier, J.W.R.</creatorcontrib><creatorcontrib>Kroep, J.R.</creatorcontrib><creatorcontrib>on behalf of the Dutch Breast Cancer Research Group (BOOG)</creatorcontrib><creatorcontrib>Dutch Breast Cancer Research Group (BOOG)</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Annals of oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Charehbili, A.</au><au>van de Ven, S.</au><au>Smit, V.T.H.B.M.</au><au>Meershoek-Klein Kranenbarg, E.</au><au>Hamdy, N.A.T.</au><au>Putter, H.</au><au>Heijns, J.B.</au><au>van Warmerdam, L.J.C.</au><au>Kessels, L.</au><au>Dercksen, M.</au><au>Pepels, M.J.</au><au>Maartense, E.</au><au>van Laarhoven, H.W.M.</au><au>Vriens, B.</au><au>Wasser, M.N.</au><au>van Leeuwen-Stok, A.E.</au><au>Liefers, G.J.</au><au>van de Velde, C.J.H.</au><au>Nortier, J.W.R.</au><au>Kroep, J.R.</au><aucorp>on behalf of the Dutch Breast Cancer Research Group (BOOG)</aucorp><aucorp>Dutch Breast Cancer Research Group (BOOG)</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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)</atitle><jtitle>Annals of oncology</jtitle><addtitle>Ann Oncol</addtitle><date>2014-05-01</date><risdate>2014</risdate><volume>25</volume><issue>5</issue><spage>998</spage><epage>1004</epage><pages>998-1004</pages><issn>0923-7534</issn><eissn>1569-8041</eissn><abstract>The role of zoledronic acid (ZA) when added to the neoadjuvant treatment of breast cancer (BC) in enhancing the clinical and pathological response of tumors is unclear. The effect of ZA on the antitumor effect of neoadjuvant chemotherapy has not prospectively been studied before.
NEOZOTAC is a national, multicenter, randomized study comparing the efficacy of TAC (docetaxel, adriamycin and cyclophosphamide i.v.) followed by granulocyte colony-stimulating factor on day 2 with or without ZA 4mg i.v. q 3 weeks inpatients withstage II/III, HER2-negative BC. We present data on the pathological complete response (pCR in breast and axilla), on clinical response using MRI, and toxicity. Post hoc subgroup analyses were undertaken to address the predictive value of menopausal status.
Addition of ZA to chemotherapy did not improve pCR rates (13.2% for TAC+ZA versus 13.3% for TAC). Postmenopausal women (N = 96) had a numerical benefit from ZA treatment (pCR 14.0% for TAC+ZA versus 8.7% for TAC, P = 0.42). Clinical objective response did not differ between treatment arms (72.9% versus 73.7%). There was no difference in grade III/IV toxicity between treatment arms.
Addition of ZA to neoadjuvant chemotherapy did not improve pathological or clinical response to chemotherapy. Further investigations are warranted in postmenopausal women with BC, since this subgroup might benefit from ZA treatment.</abstract><cop>Oxford</cop><pub>Elsevier Ltd</pub><pmid>24585721</pmid><doi>10.1093/annonc/mdu102</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Annals of oncology, 2014-05, Vol.25 (5), p.998-1004 |
| issn | 0923-7534 1569-8041 |
| language | eng |
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| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | Adult Aged Antineoplastic agents Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences bisphosphonates Breast Neoplasms - drug therapy Breast Neoplasms - metabolism Breast Neoplasms - pathology Chemotherapy, Adjuvant Cyclophosphamide - administration & dosage Diphosphonates - administration & dosage Docetaxel Doxorubicin - administration & dosage Female Gynecology. Andrology. Obstetrics Humans Imidazoles - administration & dosage Mammary gland diseases Medical sciences menopausal status Middle Aged Multiple tumors. Solid tumors. Tumors in childhood (general aspects) neoadjuvant chemotherapy Neoadjuvant Therapy Neoplasm Staging Pharmacology. Drug treatments Prospective Studies Receptor, ErbB-2 - metabolism Taxoids - administration & dosage Treatment Outcome Tumors Zoledronic Acid |
| title | 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) |
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