FemZone trial: a randomized phase II trial comparing neoadjuvant letrozole and zoledronic acid with letrozole in primary breast cancer patients

Fasching P, Jud S, Hauschild M, Kuemmel S, Schuette M, Warm M, Hanf V, Grab D, Krocker J, Stickeler E, Kreienberg R, Mueller T, Kuehn T, Wolf C, Kahlert S, Paepke S, Berghorn M, Muth M, Baier M, Wackwitz B, Schulz-Wendtland R, Beckmann M, Lux MP (2014)

Publication Type: Journal article

Publication year: 2014

Journal

Book Volume: 14

Pages Range: 66

DOI: 10.1186/1471-2407-14-66

Abstract

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).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.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.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.

Authors with CRIS profile

Involved external institutions

Spital Rheinfelden Switzerland (CH) Kliniken Essen-Mitte Germany (DE) Universitätsklinikum Essen Germany (DE) Universitätsklinikum Köln Germany (DE) Klinikum Fürth Germany (DE) Klinikum Harlaching Germany (DE) Sana Kliniken AG Germany (DE) Universitätsklinikum Freiburg Germany (DE) Universitätsklinikum Ulm Germany (DE) Klinikum Stadt Hanau Germany (DE) Städtische Kliniken Esslingen Germany (DE) Medizinisches Zentrum Ulm Germany (DE) Ludwig-Maximilians-Universität (LMU) Germany (DE) Technische Universität München (TUM) Germany (DE) Allgemeines Krankenhaus Celle Germany (DE) Novartis AG Switzerland (CH)

How to cite

APA:

Fasching, P., Jud, S., Hauschild, M., Kuemmel, S., Schuette, M., Warm, M.,... Lux, M.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, 66. https://doi.org/10.1186/1471-2407-14-66

MLA:

Fasching, Peter, et al. "FemZone trial: a randomized phase II trial comparing neoadjuvant letrozole and zoledronic acid with letrozole in primary breast cancer patients." BMC Cancer 14 (2014): 66.

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