Fasching, Peter A., Jud, Sebastian M., Hauschild, Maik, Kuemmel, Sherko, Schuette, Martin, Warm, Matthias, Hanf, Volker, Grab, Dieter, Krocker, Jutta, Stickeler, Elmar, Kreienberg, Rolf, Mueller, Thomas, Kuehn, Thorsten, Wolf, Christopher, Kahlert, Steffen, Paepke, Stefan, Berghorn, Michael, Muth, Mathias, Baier, Monika, Wackwitz, Birgit, Schulz-Wendtland, Ruediger, Beckmann, Matthias W. and Lux, Michael P. (2014). FemZone trial: a randomized phase II trial comparing neoadjuvant letrozole and zoledronic acid with letrozole in primary breast cancer patients. BMC Cancer, 14. LONDON: BMC. ISSN 1471-2407

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Abstract

Background: The objective of this prospectively randomized phase II trial (Trial registration: EUCTR2004-004007-37-DE) was to compare the clinical response of primary breast cancer patients to neoadjuvant therapy with letrozole alone (LET) or letrozole and zoledronic acid (LET + ZOL). Methods: Patients were randomly assigned to receive either LET 2.5 mg/day (n = 79) or the combination of LET 2.5 mg/day and a total of seven infusions of ZOL 4 mg every 4 weeks (n = 89) for 6 months. Primary endpoint was clinical response rate as assessed by mammogram readings. The study was terminated prematurely due to insufficient recruitment. We report here on an exploratory analysis of this data. Results: Central assessment of tumor sizes during the treatment period was available for 131 patients (66 LET, 65 LET + ZOL). Clinical responses (complete or partial) were seen in 54.5% (95% CI: 41.8-66.9) of the patients in the LET arm and 69.2% (95% CI: 56.6-80.1) of those in the LET + ZOL arm (P = 0.106). A multivariate model showed an OR of 1.72 (95% CI: 0.83-3.59) for the experimental arm. Conclusion: No increase in the clinical response rate was observed with the addition of ZOL to a neoadjuvant treatment regimen with LET. However a trend towards a better reponse in the LET + ZOL arm could be observed. This trend is consistent with previous studies that have investigated the addition of ZOL to chemotherapy, and it may support the evidence for a direct antitumor action of zoledronic acid.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Fasching, Peter A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jud, Sebastian M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hauschild, MaikUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kuemmel, SherkoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schuette, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Warm, MatthiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hanf, VolkerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Grab, DieterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Krocker, JuttaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stickeler, ElmarUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kreienberg, RolfUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mueller, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kuehn, ThorstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wolf, ChristopherUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kahlert, SteffenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Paepke, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Berghorn, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Muth, MathiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baier, MonikaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wackwitz, BirgitUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schulz-Wendtland, RuedigerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Beckmann, Matthias W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lux, Michael P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-446019
DOI: 10.1186/1471-2407-14-66
Journal or Publication Title: BMC Cancer
Volume: 14
Date: 2014
Publisher: BMC
Place of Publication: LONDON
ISSN: 1471-2407
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
ENDOCRINE THERAPY; POSTMENOPAUSAL WOMEN; ADJUVANT THERAPY; CHEMOTHERAPY; ANASTROZOLE; TAMOXIFEN; BISPHOSPHONATES; APOPTOSIS; CELLSMultiple languages
OncologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/44601

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