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




FemZone trial: a randomized phase II trial comparing neoadjuvant letrozole and zoledronic acid with letrozole in primary breast cancer patients - Download this document for free, or read online. Document in PDF available to download.

BMC Cancer

, 14:66

Clinical oncology

Abstract

BackgroundThe 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.

MethodsPatients 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.

ResultsCentral 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.

ConclusionNo 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.

KeywordsZoledronic acid Neoadjuvant treatment Breast cancer Letrozole Aromatase inhibitors Bisphosphonates Electronic supplementary materialThe online version of this article doi:10.1186-1471-2407-14-66 contains supplementary material, which is available to authorized users.

Peter A Fasching, Sebastian M Jud contributed equally to this work.

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Author: Peter A Fasching - Sebastian M Jud - Maik Hauschild - Sherko Kümmel - Martin Schütte - Matthias Warm - Volker Hanf - Di

Source: https://link.springer.com/







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