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Zoledronic Acid Add...
Zoledronic Acid Add-on Therapy for Standard-Risk Ewing Sarcoma Patients in the Ewing 2008R1 Trial
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- Koch, Raphael (författare)
- University of Münster
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- Haveman, Lianne (författare)
- Princess Maxima Center for Pediatric Oncology/Hematology
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- Ladenstein, Ruth (författare)
- Medical University of Vienna
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- Brichard, Benedicte (författare)
- Saint-Luc University Hospital
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- Jürgens, Heribert (författare)
- University Hospital Münster
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- Cyprova, Sona (författare)
- University Hospital Motol
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- van den Berg, Henk (författare)
- University of Amsterdam
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- Hassenpflug, Wolf (författare)
- University Medical Center Hamburg-Eppendorf
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- Raciborska, Anna (författare)
- National Research Institute of Mother and Child
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- Ek, Torben (författare)
- Queen Silvia Children’s Hospital
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- Baumhoer, Daniel (författare)
- University Hospital Basel
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- Egerer, Gerlinde (författare)
- University Hospital Heidelberg
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- Kager, Leo (författare)
- Medical University of Vienna
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- Renard, Marleen (författare)
- University Hospitals Leuven
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Hauser, Peter (författare)
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- Burdach, Stefan (författare)
- Technical University of Munich
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- Bovee, Judith V.M.G. (författare)
- Leiden University Medical Centre
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- Hong, Angela M. (författare)
- University of Sydney
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- Reichardt, Peter (författare)
- HELIOS Klinikum Berlin-Buch
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- Kruseova, Jarmila (författare)
- University Hospital Motol
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- Streitbürger, Arne (författare)
- University Hospital Essen
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- Kühne, Thomas (författare)
- University Children's Hospital, Basel
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- Kessler, Torsten (författare)
- University Hospital Münster
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- Bernkopf, Marie (författare)
- Medical University of Vienna
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- Butterfaß-Bahloul, Trude (författare)
- University of Münster
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- Dhooge, Catharina (författare)
- Ghent University Hospital
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- Bauer, Sebastian (författare)
- University of Duisburg-Essen
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- Kiss, János (författare)
- Semmelweis University
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- Paulussen, Michael (författare)
- Witten/Herdecke University
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- Bonar, Fiona (författare)
- Royal Prince Alfred Hospital
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- Ranft, Andreas (författare)
- University Hospital Essen,German Cancer Research Centre
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- Timmermann, Beate (författare)
- University Hospital Essen,German Cancer Research Centre
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- Rascon, Jelena (författare)
- Vilnius University
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Vieth, Volker (författare)
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- Kanerva, Jukka (författare)
- Helsinki University Central Hospital
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- Faldum, Andreas (författare)
- University of Münster
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- Hartmann, Wolfgang (författare)
- University Hospital Münster
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- Hjorth, Lars (författare)
- Lund University,Lunds universitet,Pediatrik, Lund,Sektion V,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Sena effekter efter barncancerbehandling,Forskargrupper vid Lunds universitet,LUCC: Lunds universitets cancercentrum,Övriga starka forskningsmiljöer,Paediatrics (Lund),Section V,Department of Clinical Sciences, Lund,Faculty of Medicine,Late effects after childhood cancer treatment,Lund University Research Groups,LUCC: Lund University Cancer Centre,Other Strong Research Environments,Skåne University Hospital
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- Bhadri, Vivek A. (författare)
- University of Sydney
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- Metzler, Markus (författare)
- University Hospital Erlangen
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- Gelderblom, Hans (författare)
- Leiden University Medical Centre
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- Dirksen, Uta (författare)
- German Cancer Research Centre,University Hospital Essen
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(creator_code:org_t)
- 2023
- 2023
- Engelska 12 s.
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Ingår i: Clinical cancer research : an official journal of the American Association for Cancer Research. - 1078-0432. ; 29:24, s. 5057-5068
- Relaterad länk:
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http://dx.doi.org/10...
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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Abstract
Ämnesord
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- PURPOSE: The phase III, open-label, prospective, multicenter, randomized Ewing 2008R1 trial (EudraCT2008-003658-13) was conducted in 12 countries to evaluate the effect of zoledronic acid (ZOL) maintenance therapy compared with no add-on regarding event-free survival (EFS, primary endpoint) and overall survival (OS) in standard-risk Ewing sarcoma (EWS). PATIENTS AND METHODS: Eligible patients had localized EWS with either good histologic response to induction chemotherapy and/or small tumors (<200 mL). Patients received six cycles of VIDE induction and eight cycles of VAI (male) or eight cycles of VAC (female) consolidation. ZOL treatment started parallel to the sixth consolidation cycle. Randomization was stratified by tumor site (pelvis/other). The two-sided adaptive inverse-normal four-stage design (planned sample size 448 patients, significance level 5%, power 80%) was changed after the first interim analysis using the Müller-Schäfer method. RESULTS: Between April 2010 and November 2018, 284 patients were randomized (142 ZOL/142 no add-on). With a median follow-up of 3.9 years, EFS was not significantly different between ZOL and no add-on group in the adaptive design (HR, 0.74; 95% CI, 0.43-1.28, P = 0.27, intention-to-treat). Three-year EFS rates were 84.0% (95% CI, 77.7%-90.8%) for ZOL vs. 81.7% (95% CI, 75.2%-88.8%) for no add-on. Results were similar in the per-protocol collective. OS was not different between groups. The 3-year OS was 92.8% (95% CI, 88.4%-97.5%) for ZOL and 94.6% (95% CI, 90.9%-98.6%) for no add-on. Noticeable more renal, neurologic, and gastrointestinal toxicities were observed for ZOL (P < 0.05). Severe renal toxicities occurred more often in the ZOL arm (P = 0.003). CONCLUSIONS: In patients with standard-risk localized EWS, there is no additional benefit from maintenance treatment with ZOL.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
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Koch, Raphael
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Haveman, Lianne
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Ladenstein, Ruth
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Brichard, Benedi ...
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Jürgens, Heriber ...
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Cyprova, Sona
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van den Berg, He ...
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Hassenpflug, Wol ...
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Raciborska, Anna
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Ek, Torben
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Baumhoer, Daniel
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Egerer, Gerlinde
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Kager, Leo
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Renard, Marleen
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Hauser, Peter
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Burdach, Stefan
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Bovee, Judith V. ...
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Hong, Angela M.
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Reichardt, Peter
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Kruseova, Jarmil ...
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Streitbürger, Ar ...
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Kühne, Thomas
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Kessler, Torsten
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Bernkopf, Marie
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Butterfaß-Bahlou ...
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Dhooge, Catharin ...
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Bauer, Sebastian
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Kiss, János
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Paulussen, Micha ...
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Bonar, Fiona
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Ranft, Andreas
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Timmermann, Beat ...
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Rascon, Jelena
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Vieth, Volker
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Kanerva, Jukka
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Faldum, Andreas
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Hartmann, Wolfga ...
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Hjorth, Lars
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Bhadri, Vivek A.
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Metzler, Markus
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Gelderblom, Hans
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Dirksen, Uta
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