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.

Abstract:

:The AZURE trial is an ongoing phase III, academic, multi-centre, randomised trial designed to evaluate the role of zoledronic acid (ZOL) in the adjuvant therapy of women with stage II/III breast cancer. Here, we report the safety and tolerability profile of ZOL in this setting. Eligible patients received (neo)adjuvant chemotherapy and/or endocrine therapy and were randomised to receive neither additional treatment nor intravenous ZOL 4 mg. ZOL was administered after each chemotherapy cycle to exploit potential sequence-dependent synergy. ZOL was continued for 60 months post-randomisation (six doses in the first 6 months, eight doses in the following 24 months and five doses in the final 30 months). Serious (SAE) and non-serious adverse event (AE) data generated during the first 36 months on study were analysed for the safety population. 3,360 patients were recruited to the AZURE trial. The safety population comprised 3,340 patients (ZOL 1,665; control 1,675). The addition of ZOL to standard treatment did not significantly impact on chemotherapy delivery. SAE were similar in both treatment arms. No significant safety differences were seen apart from the occurrence of osteonecrosis of the jaw (ONJ) in the ZOL group (11 confirmed cases; 0.7%; 95% confidence interval 0.3-1.1%). ZOL in the adjuvant setting is well tolerated, and can be safely administered in addition to adjuvant therapy including chemotherapy. The adverse events were consistent with the known safety profile of ZOL, with a low incidence of ONJ.

authors

Coleman R,Woodward E,Brown J,Cameron D,Bell R,Dodwell D,Keane M,Gil M,Davies C,Burkinshaw R,Houston SJ,Grieve RJ,Barrett-Lee PJ,Thorpe H

doi

10.1007/s10549-011-1429-y

subject

Has Abstract

pub_date

2011-06-01 00:00:00

pages

429-38

issue

2

eissn

0167-6806

issn

1573-7217

journal_volume

127

pub_type

杂志文章,随机对照试验
  • Effects of toremifene (TOR) and tamoxifen (TAM) on serum lipids in postmenopausal patients with breast cancer.

    abstract::This study clarified the difference in the effects on serum lipids between toremifene (TOR) and tamoxifen (TAM). To remove influencing factors, we investigated adjuvant therapy for hormone receptor-positive patients with breast cancer without lymph node metastasis. The subjects were 65 patients who were enrolled in a ...

    journal_title:Breast cancer research and treatment

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验

    doi:10.1007/s10549-004-4384-z

    authors: Kusama M,Miyauchi K,Aoyama H,Sano M,Kimura M,Mitsuyama S,Komaki K,Doihara H

    更新日期:2004-11-01 00:00:00

  • Resveratrol suppresses growth of cancer stem-like cells by inhibiting fatty acid synthase.

    abstract::Resveratrol is a natural polyphenolic compound and has been shown to exhibit cardio-protective as well as anti-neoplastic effects on various types of cancers. However, the exact mechanism of its anti-tumor effect is not clearly defined. Resveratrol has been shown to have strong hypolipidemic effect on normal adipocyte...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章

    doi:10.1007/s10549-010-1300-6

    authors: Pandey PR,Okuda H,Watabe M,Pai SK,Liu W,Kobayashi A,Xing F,Fukuda K,Hirota S,Sugai T,Wakabayashi G,Koeda K,Kashiwaba M,Suzuki K,Chiba T,Endo M,Fujioka T,Tanji S,Mo YY,Cao D,Wilber AC,Watabe K

    更新日期:2011-11-01 00:00:00

  • PIK3CA mutations in serum DNA are predictive of recurrence in primary breast cancer patients.

    abstract::We attempted to develop a highly sensitive and specific method for the detection of circulating tumor DNA (ctDNA) using a digital PCR (dPCR) assay for PIK3CA mutations (i.e., H1047R, E545K, and E542K) in primary breast cancer patients. The sensitivity of the dPCR assay for the mutant alleles was examined using cell li...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章

    doi:10.1007/s10549-015-3322-6

    authors: Oshiro C,Kagara N,Naoi Y,Shimoda M,Shimomura A,Maruyama N,Shimazu K,Kim SJ,Noguchi S

    更新日期:2015-04-01 00:00:00

  • Lack of prognostic value of epidermal growth factor receptor in a series of 229 T1/T2, N0/N1 breast cancers, with well defined prognostic parameters.

    abstract::The prognostic value of epidermal growth factor receptor (EGF-R) was prospectively assessed in a series of 229 clinical T1-T2, N0-N1 breast carcinomas diagnosed between May 1987 and October 1989. EGF-R expression was determined by measuring the specific Bmax of 125I EGF to tumor plasma membrane preparations. Tumor wit...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章

    doi:10.1007/BF00666480

    authors: Bolla M,Chedin M,Colonna M,Marron-Charrière J,Rostaing-Puissant B,Pasquier D,Panh MH,Winckel P,Chambaz EM

    更新日期:1994-01-01 00:00:00

  • Peptide concentrations and mRNA expression of IGF-I, IGF-II and IGFBP-3 in breast cancer and their associations with disease characteristics.

    abstract:PURPOSE:To measure peptide concentrations and mRNA expression of the IGF Family in breast cancer and to examine their associations with the disease features. EXPERIMENTAL DESIGN:Fresh tumor samples were collected from 348 patients who underwent surgery for breast cancer. Tissue levels of mRNA and peptide of IGF-I, IGF...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章

    doi:10.1007/s10549-008-0046-x

    authors: Mu L,Katsaros D,Wiley A,Lu L,de la Longrais IA,Smith S,Khubchandani S,Sochirca O,Arisio R,Yu H

    更新日期:2009-05-01 00:00:00

  • Cellular localisation by in situ hybridisation of cathepsin D, stromelysin 3, and urokinase plasminogen activator RNAs in breast cancer.

    abstract::We have compared by RNA in situ hybridisation on serial cryo-sections the distribution of cathepsin D (cathD), stromelysin 3 (strom-3), and urokinase plasminogen activator (UPA) gene expression in different tissues of human benign and malignant mammary tumors. Cath-D expression was found to be higher in adenocarcinoma...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章

    doi:10.1007/BF01806676

    authors: Escot C,Zhao Y,Puech C,Rochefort H

    更新日期:1996-01-01 00:00:00

  • Health economic impact of risk group selection according to ASCO-recommended biomarkers uPA/PAI-1 in node-negative primary breast cancer.

    abstract::Invasion factors uPA/PAI-1 are guideline-recommended (ASCO, AGO) biomarkers for decision support regarding adjuvant chemotherapy (CTX) in women with primary breast cancer. They define a high-risk group with strong benefit from adjuvant CTX and a low-risk group with uncertain benefit and excellent survival without CTX....

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章,随机对照试验

    doi:10.1007/s10549-013-2496-z

    authors: Jacobs VR,Kates RE,Kantelhardt E,Vetter M,Wuerstlein R,Fischer T,Schmitt M,Jaenicke F,Untch M,Thomssen C,Harbeck N

    更新日期:2013-04-01 00:00:00

  • Gene-based analysis of the fibroblast growth factor receptor signaling pathway in relation to breast cancer in African American women: the AMBER consortium.

    abstract::We conducted gene-based analysis in 26 genes in the FGFR signaling pathway to identify genes carrying genetic variation affecting risk of breast cancer and the specific estrogen receptor (ER) subtypes. Tagging single-nucleotide polymorphisms (SNPs) for each gene were selected and genotyped on a customized Illumina Exo...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章

    doi:10.1007/s10549-015-3672-0

    authors: Ruiz-Narváez EA,Haddad SA,Lunetta KL,Yao S,Bensen JT,Sucheston-Campbell LE,Hong CC,Haiman CA,Olshan AF,Ambrosone CB,Palmer JR

    更新日期:2016-01-01 00:00:00

  • Ethanol promotes mammary tumor growth and angiogenesis: the involvement of chemoattractant factor MCP-1.

    abstract::Alcohol consumption is a risk factor for breast cancer in humans. Experimental studies indicate that alcohol exposure promotes malignant progression of mammary tumors. However, the underlying cellular and molecular mechanisms remain unclear. Alcohol induces a pro-inflammatory response by modulating the expression of c...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章

    doi:10.1007/s10549-011-1902-7

    authors: Wang S,Xu M,Li F,Wang X,Bower KA,Frank JA,Lu Y,Chen G,Zhang Z,Ke Z,Shi X,Luo J

    更新日期:2012-06-01 00:00:00

  • Management of brain metastases in breast cancer: a review of current practices and emerging treatments.

    abstract:PURPOSE:Breast cancer brain metastases (BCBM) are becoming an increasingly common diagnosis due to improved systemic control and more routine surveillance imaging. Treatment continues to require a multidisciplinary approach managing systemic and intracranial disease burden. Although, improvements have been made in the ...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章,评审

    doi:10.1007/s10549-020-05552-2

    authors: Mills MN,Figura NB,Arrington JA,Yu HM,Etame AB,Vogelbaum MA,Soliman H,Czerniecki BJ,Forsyth PA,Han HS,Ahmed KA

    更新日期:2020-04-01 00:00:00

  • Impact of port site scar on perception of patients with breast cancer: patient-reported outcomes.

    abstract:PURPOSE:As the number of survivors continues to increase with improvements in breast cancer treatment, greater emphasis has been placed on the aesthetic outcome following breast surgery. Effort is made to minimize scarring on the breast, yet patients who require a port for treatment inevitably have a scar on the upper ...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章

    doi:10.1007/s10549-018-4790-2

    authors: Voci A,Lee D,Ho E,Crane-Okada R,DiNome M

    更新日期:2018-08-01 00:00:00

  • Factors predicting in-breast tumor recurrence after breast-conserving surgery.

    abstract:PURPOSE:The main objectives of this study were to identify risk factors for local in-breast tumor recurrence after breast-conservation and to evaluate the impact of IBTR (in-breast tumor recurrence) on overall survival. METHODS:A total of 335 consecutive patients with 346 invasive and in situ breast cancers were treat...

    journal_title:Breast cancer research and treatment

    pub_type: 临床试验,杂志文章

    doi:10.1007/s10549-008-0187-y

    authors: Mechera R,Viehl CT,Oertli D

    更新日期:2009-07-01 00:00:00

  • Triple negative breast cancer: unmet medical needs.

    abstract::Triple negative breast cancer (TNBC) is an aggressive clinical phenotype characterized by lack of expression (or minimal expression) of estrogen receptor (ER) and progesterone receptor (PR) as well as an absence of human epidermal growth factor receptor-2 (HER2) overexpression. It shows substantial overlap with basal-...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章,评审

    doi:10.1007/s10549-010-1293-1

    authors: Pal SK,Childs BH,Pegram M

    更新日期:2011-02-01 00:00:00

  • Treatment of breast cancer through the application of irreversible electroporation using a novel minimally invasive single needle electrode.

    abstract::Irreversible electroporation (IRE) is a therapeutic technology for the ablation of soft tissues using electrodes to deliver intense but short electric pulses across a cell membrane, creating nanopores that lead to cell death. This phenomenon only affects the cell membrane, leaving the extracellular matrix and sensitiv...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章

    doi:10.1007/s10549-010-0803-5

    authors: Neal RE 2nd,Singh R,Hatcher HC,Kock ND,Torti SV,Davalos RV

    更新日期:2010-08-01 00:00:00

  • Breast cancer vascularity: color Doppler sonography and histopathology study.

    abstract::In this prospective study, the authors examined 50 patients with breast tumors (malignant, n = 32; benign, n = 18) to investigate the correlation between color Doppler flow mapping and histopathological findings and to evaluate the clinical significance of color Doppler mapping. Among the 32 patients with breast cance...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章

    doi:10.1007/BF01806510

    authors: Lee WJ,Chu JS,Huang CS,Chang MF,Chang KJ,Chen KM

    更新日期:1996-01-01 00:00:00

  • Inositol hexaphosphate (IP6) blocks proliferation of human breast cancer cells through a PKCdelta-dependent increase in p27Kip1 and decrease in retinoblastoma protein (pRb) phosphorylation.

    abstract::Inositol hexaphosphate (IP6) is a naturally occurring polyphosphorylated carbohydrate with demonstrated anti-proliferative and anti-cancer activity in mammary cells. We hypothesized that IP6 modulates cell cycle proteins by action on cytoplasmic signaling molecules. The effects of both pharmacological (2 mM) and physi...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章

    doi:10.1007/s10549-004-6456-5

    authors: Vucenik I,Ramakrishna G,Tantivejkul K,Anderson LM,Ramljak D

    更新日期:2005-05-01 00:00:00

  • Digital image analysis of Ki67 proliferation index in breast cancer using virtual dual staining on whole tissue sections: clinical validation and inter-platform agreement.

    abstract:PURPOSE:The Ki67 proliferation index is a prognostic and predictive marker in breast cancer. Manual scoring is prone to inter- and intra-observer variability. The aims of this study were to clinically validate digital image analysis (DIA) of Ki67 using virtual dual staining (VDS) on whole tissue sections and to assess ...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章

    doi:10.1007/s10549-018-4669-2

    authors: Koopman T,Buikema HJ,Hollema H,de Bock GH,van der Vegt B

    更新日期:2018-05-01 00:00:00

  • Clinicopathologic, mammographic, and sonographic features in 1,187 patients with pure ductal carcinoma in situ of the breast by estrogen receptor status.

    abstract::The clinicopathologic, mammographic, and sonographic findings in patients with pure ductal carcinoma in situ (DCIS) were assessed by estrogen receptor (ER) expression. After institutional review board approval, patients with pure DCIS evaluated from January 1996 to July 2009 with known ER status and available imaging ...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章

    doi:10.1007/s10549-013-2598-7

    authors: Rauch GM,Kuerer HM,Scoggins ME,Fox PS,Benveniste AP,Park YM,Lari SA,Hobbs BP,Adrada BE,Krishnamurthy S,Yang WT

    更新日期:2013-06-01 00:00:00

  • Antimetastatic action of the prostacyclin analogue cicaprost in experimental mammary tumors.

    abstract::In breast cancer, the survival rate strongly depends on the number of lymph nodes involved. A drug with a specific inhibitory activity on lymph node and organ metastases would therefore be a candidate for adjuvant therapy after surgery. Prostacyclin and its stable analogues have been shown to interfere with certain st...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章,评审

    doi:10.1007/BF01803791

    authors: Schneider MR,Schirner M,Lichtner RB,Graf H

    更新日期:1996-01-01 00:00:00

  • Carotenoids and breast cancer risk: a meta-analysis and meta-regression.

    abstract::The purpose of this article is to comprehensively summarize the associations between carotenoids and breast cancer and quantitatively estimate their dose-response relationships. We searched PubMed, Embase, and Cochrane databases (from January 1982 to 1 May 2011) and the references of the relevant articles in English w...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章,meta分析

    doi:10.1007/s10549-011-1723-8

    authors: Hu F,Wang Yi B,Zhang W,Liang J,Lin C,Li D,Wang F,Pang D,Zhao Y

    更新日期:2012-01-01 00:00:00

  • Minimal axillary lymph node involvement in breast cancer has different prognostic implications according to the staging procedure.

    abstract::It is still controversial whether the identification of micrometastases and isolated tumor cells in the axillary lymph nodes of patients with breast cancer has any prognostic value. We evaluated the prognostic role of isolated tumor cells and micrometastases in the axillary lymph nodes in 3,158 consecutive patients pT...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章

    doi:10.1007/s10549-009-0446-6

    authors: Montagna E,Viale G,Rotmensz N,Maisonneuve P,Galimberti V,Luini A,Intra M,Veronesi P,Mazzarol G,Pruneri G,Renne G,Torrisi R,Cardillo A,Cancello G,Goldhirsch A,Colleoni M

    更新日期:2009-11-01 00:00:00

  • Protein S and protein C level changes with adjuvant tamoxifen therapy in postmenopausal women.

    abstract::Tamoxifen citrate is a synthetic antiestrogen that provides survival benefit when given as adjuvant treatment in postmenopausal women with breast cancer. Venous thrombophlebitis may complicate tamoxifen treatment at a rate of approximately one per 800 treatment-years. To explore the possible procoagulant effects assoc...

    journal_title:Breast cancer research and treatment

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1007/BF00665973

    authors: Mamby CC,Love RR,Feyzi JM

    更新日期:1994-01-01 00:00:00

  • Strategies for the development of recombinant vaccines for the immunotherapy of breast cancer.

    abstract::The development of recombinant vaccines for specific immunotherapy of carcinoma represents a novel approach for the treatment of breast cancer and other tumor types. This article reviews the various parameters that should be considered in the development of recombinant vaccines. Several breast cancer associated antige...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章,评审

    doi:10.1007/BF01803781

    authors: Schlom J,Kantor J,Abrams S,Tsang KY,Panicali D,Hamilton JM

    更新日期:1996-01-01 00:00:00

  • Pathology of borderline HER-2/neu breast carcinoma: a biologically distinct phenotype.

    abstract:PURPOSE:The significance of HER-2/neu results obtained by immunohistochemical analyses (IHC) which are neither negative nor strongly positive is controversial. The incidence of fluorescence in situ hybridization (FISH) positivity in these tumors is small and the implication is that these borderline results represent la...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章

    doi:10.1007/s10549-005-9136-1

    authors: Killeen JL,Ortega-Lopez A,Shaha J,Shaha SH,Fu JB

    更新日期:2006-07-01 00:00:00

  • MMP-9 increases HER2/neu expression and alters apoptosis levels in human mammary epithelial cells (HMEC).

    abstract::HER2/neu overexpression leads to poorer prognosis and higher risk of disease reoccurrence in breast cancer patients. The causative factors responsible for increasing HER2/neu expression levels on mammary cells are not known. We investigated whether factors associated with inflammation or metastasis could induce HER2/n...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章

    doi:10.1007/s10549-012-2191-5

    authors: Fatunmbi M,Shelton J,Aronica SM

    更新日期:2012-09-01 00:00:00

  • The clinical value of preoperative wire localization of breast lesions by magnetic resonance imaging--a multicenter study.

    abstract::To evaluate the clinical value of MRI guided preoperative wire localization of clinically and mammographically occult lesions of the breast. In a multicenter study, we evaluated 132 preoperative MRI guided localizations. Median lesion size evaluated by MRI prior to wire localization was 9mm. MRI guided localization wa...

    journal_title:Breast cancer research and treatment

    pub_type: 临床试验,杂志文章,多中心研究

    doi:10.1023/a:1019668210290

    authors: Lampe D,Hefler L,Alberich T,Sittek H,Perlet C,Prat X,Taourel P,Amaya B,Koelbl H,Heywang-Kobrunner SH

    更新日期:2002-09-01 00:00:00

  • Maintenance of DNA content and erbB-2 alterations in intraductal and invasive phases of mammary cancer.

    abstract::Ductal carcinoma in situ (intraductal carcinoma) of the breast is a commonly recognized and curable clinical entity. Patients with intraductal carcinoma are at risk to develop invasive breast cancer presumably due to a transition from the noninvasive to the invasive phase of growth. Primary breast malignancies commonl...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章

    doi:10.1007/BF00689717

    authors: Iglehart JD,Kerns BJ,Huper G,Marks JR

    更新日期:1995-06-01 00:00:00

  • Effect of obesity on survival of women with breast cancer: systematic review and meta-analysis.

    abstract::Obesity is a risk factor for the development of new cases of breast cancer and also affects survival in women who have already been diagnosed with breast cancer. Early studies of obesity and breast cancer survival have been summarised in two meta-analyses, but the latest of these only included studies that recruited w...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章,meta分析,评审

    doi:10.1007/s10549-010-0990-0

    authors: Protani M,Coory M,Martin JH

    更新日期:2010-10-01 00:00:00

  • Prognostic value of histopathological DCIS features in a large-scale international interrater reliability study.

    abstract:PURPOSE:For optimal management of ductal carcinoma in situ (DCIS), reproducible histopathological assessment is essential to distinguish low-risk from high-risk DCIS. Therefore, we analyzed interrater reliability of histopathological DCIS features and assessed their associations with subsequent ipsilateral invasive bre...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章

    doi:10.1007/s10549-020-05816-x

    authors: Groen EJ,Hudecek J,Mulder L,van Seijen M,Almekinders MM,Alexov S,Kovács A,Ryska A,Varga Z,Andreu Navarro FJ,Bianchi S,Vreuls W,Balslev E,Boot MV,Kulka J,Chmielik E,Barbé E,de Rooij MJ,Vos W,Farkas A,Leeuwis-Fedoro

    更新日期:2020-10-01 00:00:00

  • Docetaxel metabolism is not altered by imatinib: findings from an early phase study in metastatic breast cancer.

    abstract::Docetaxel is primarily metabolized by CYP3A4 and susceptible to alterations in clearance by CYP3A4 inhibition and induction. Imatinib is a CYP3A4 inhibitor. A phase I study of docetaxel and imatinib in metastatic breast cancer (MBC) was conducted to test the hypothesis that imatinib decreased docetaxel clearance. Doce...

    journal_title:Breast cancer research and treatment

    pub_type: 杂志文章

    doi:10.1007/s10549-011-1413-6

    authors: Connolly RM,Rudek MA,Garrett-Mayer E,Jeter SC,Donehower MG,Wright LA,Zhao M,Fetting JH,Emens LA,Stearns V,Davidson NE,Baker SD,Wolff AC

    更新日期:2011-05-01 00:00:00