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

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• 作者：Peter A Fasching (21)
  Sebastian M Jud (21)
  Maik Hauschild (22)
  Sherko Kümmel (23)
  Martin Schütte (20)
  Matthias Warm (21) (22)
  Volker Hanf (23)
  Dieter Grab (20)
  Jutta Krocker (21)
  Elmar Stickeler (22)
  Rolf Kreienberg (23)
  Thomas Müller (20)
  Thorsten Kühn (21)
  Christopher Wolf (22)
  Steffen Kahlert (20)
  Stefan Paepke (23)
  Michael Berghorn (21)
  Mathias Muth (22)
  Monika Baier (22)
  Birgit Wackwitz (22)
  Rüdiger Schulz-Wendtland (23)
  Matthias W Beckmann (21)
  Michael P Lux (21)
  
• 关键词：Zoledronic acid ; Neoadjuvant treatment ; Breast cancer ; Letrozole ; Aromatase inhibitors ; Bisphosphonates
• 刊名：BMC Cancer
• 出版年：2014
• 出版时间：December 2014
• 年：2014
• 卷：14
• 期：1
• 全文大小：250 KB
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  33. The pre-publication history for this paper can be accessed here: http://www.biomedcentral.com/1471-2407/14/66/prepub
  
• 作者单位：Peter A Fasching (21)
  Sebastian M Jud (21)
  Maik Hauschild (22)
  Sherko Kümmel (23)
  Martin Schütte (20)
  Matthias Warm (21) (22)
  Volker Hanf (23)
  Dieter Grab (20)
  Jutta Krocker (21)
  Elmar Stickeler (22)
  Rolf Kreienberg (23)
  Thomas Müller (20)
  Thorsten Kühn (21)
  Christopher Wolf (22)
  Steffen Kahlert (20)
  Stefan Paepke (23)
  Michael Berghorn (21)
  Mathias Muth (22)
  Monika Baier (22)
  Birgit Wackwitz (22)
  Rüdiger Schulz-Wendtland (23)
  Matthias W Beckmann (21)
  Michael P Lux (21)
  
  21. Frauenklinik, Allgemeines Krankenhaus Celle, Celle, Germany
  22. Novartis Pharma GmbH, Nuremberg, Germany
  23. Institute of Diagnostic Radiology, Erlangen University Hospital, Friedrich Alexander University of Erlangen–Nuremberg, Erlangen, Germany
  20. Frauenklinik Grosshadern, Universit?tsklinik der Ludwig-Maximilians-Universit?t, Munich, Germany
  
• ISSN：1471-2407

文摘

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--9) or the combination of LET 2.5?mg/day and a total of seven infusions of ZOL 4?mg every 4?weeks (n--9) 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--.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.