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Intravenous pamidronate versus oral and intravenous clodronate in bone metastatic breast cancer: a randomized, open-label, non-inferiority Phase III trial

Intravenous pamidronate versus oral and intravenous clodronate in bone metastatic breast cancer: a randomized, open-label, non-inferiority Phase III trial Alexandra von Au,1 Eva Milloth,1 Ingo Diel,2 Stefan Stefanovic,1 Andre Hennigs,1 Markus Wallwiener,1 Joerg Heil,1 Michael Golatta,1 Joachim Rom,1...

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Main Authors: Au, Alexandra von (Author) , Milloth, Eva (Author) , Diel, Ingo J. (Author) , Stefanovic, Stefan (Author) , Hennigs, André (Author) , Wallwiener, Markus (Author) , Heil, Jörg (Author) , Golatta, Michael (Author) , Rom, Joachim (Author) , Sohn, Christof (Author) , Schneeweiss, Andreas (Author) , Schütz, Florian (Author) , Domschke, Christoph (Author)
Format: Article (Journal)
Language:English
Published: 8 July 2016
In: OncoTargets and therapy
Year: 2016, Volume: 9, Pages: 4173-4180
ISSN:1178-6930
DOI:10.2147/OTT.S103130
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.2147/OTT.S103130
Verlag, lizenzpflichtig, Volltext: https://www.dovepress.com/intravenous-pamidronate-versus-oral-and-intravenous-clodronate-in-bone-peer-reviewed-article-OTT
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Author Notes:Alexandra von Au, Eva Milloth, Ingo Diel, Stefan Stefanovic, Andre Hennigs, Markus Wallwiener, Joerg Heil, Michael Golatta, Joachim Rom, Christof Sohn, Andreas Schneeweiss, Florian Schuetz, Christoph Domschke
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Summary:Intravenous pamidronate versus oral and intravenous clodronate in bone metastatic breast cancer: a randomized, open-label, non-inferiority Phase III trial Alexandra von Au,1 Eva Milloth,1 Ingo Diel,2 Stefan Stefanovic,1 Andre Hennigs,1 Markus Wallwiener,1 Joerg Heil,1 Michael Golatta,1 Joachim Rom,1 Christof Sohn,1 Andreas Schneeweiss,1 Florian Schuetz,1 Christoph Domschke1 1Breast Unit, Department of Gynecology and Obstetrics, Heidelberg University Hospital, Heidelberg, 2CGG Clinic - Centrum für ganzheitliche Gynäkologie Mannheim, Mannheim, Germany Purpose: Patients with metastasized breast cancer often suffer from discomfort caused by metastatic bone disease. Thus, osteoprotection is an important part of therapy in breast cancer metastasized to bone, and bisphosphonates (BPs) are a major therapeutic option. In this study, our objectives were to compare the side effects of oral versus intravenous BP treatment and to assess their clinical effectiveness. Patients and methods: In this prospective randomized, open-label, non-inferiority trial, we enrolled breast cancer patients with at least one bone metastasis and an Eastern Cooperative Oncology Group performance status of 0-2. Patients were randomly assigned to one of the three treatment groups: A, 60 mg pamidronate intravenously q3w; B-iv, 900 mg clodronate intravenously q3w; and B-o, 2,400 mg oral clodronate daily. Assessments were performed at baseline and every 3 months thereafter. Results: Between 1995 and 1999, 321 patients with confirmed bone metastases from breast cancer were included in the study. At first follow-up, gastrointestinal (GI) tract side effects were most common, and adverse effects on the GI tract were more frequent in the oral treatment group (P=0.002 and P
Item Description:Gesehen am 04.06.2020
Physical Description:Online Resource
ISSN:1178-6930
DOI:10.2147/OTT.S103130

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