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WFRF:(Bovee Judith V.M.G.)
 

Sökning: WFRF:(Bovee Judith V.M.G.) > Zoledronic Acid Add...

LIBRIS Formathandbok  (Information om MARC21)
FältnamnIndikatorerMetadata
00006610naa a2200781 4500
001oai:lup.lub.lu.se:dc42c69e-a828-4c92-9d75-84f6a36d15f1
003SwePub
008240103s2023 | |||||||||||000 ||eng|
024a https://lup.lub.lu.se/record/dc42c69e-a828-4c92-9d75-84f6a36d15f12 URI
024a https://doi.org/10.1158/1078-0432.CCR-23-19662 DOI
040 a (SwePub)lu
041 a engb eng
042 9 SwePub
072 7a art2 swepub-publicationtype
072 7a ref2 swepub-contenttype
100a Koch, Raphaelu University of Münster4 aut
2451 0a Zoledronic Acid Add-on Therapy for Standard-Risk Ewing Sarcoma Patients in the Ewing 2008R1 Trial
264 1c 2023
300 a 12 s.
520 a 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.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Cancer och onkologi0 (SwePub)302032 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Cancer and Oncology0 (SwePub)302032 hsv//eng
700a Haveman, Lianneu Princess Maxima Center for Pediatric Oncology/Hematology4 aut
700a Ladenstein, Ruthu Medical University of Vienna4 aut
700a Brichard, Benedicteu Saint-Luc University Hospital4 aut
700a Jürgens, Heribertu University Hospital Münster4 aut
700a Cyprova, Sonau University Hospital Motol4 aut
700a van den Berg, Henku University of Amsterdam4 aut
700a Hassenpflug, Wolfu University Medical Center Hamburg-Eppendorf4 aut
700a Raciborska, Annau National Research Institute of Mother and Child4 aut
700a Ek, Torbenu Queen Silvia Children’s Hospital4 aut
700a Baumhoer, Danielu University Hospital Basel4 aut
700a Egerer, Gerlindeu University Hospital Heidelberg4 aut
700a Kager, Leou Medical University of Vienna4 aut
700a Renard, Marleenu University Hospitals Leuven4 aut
700a Hauser, Peter4 aut
700a Burdach, Stefanu Technical University of Munich4 aut
700a Bovee, Judith V.M.G.u Leiden University Medical Centre4 aut
700a Hong, Angela M.u University of Sydney4 aut
700a Reichardt, Peteru HELIOS Klinikum Berlin-Buch4 aut
700a Kruseova, Jarmilau University Hospital Motol4 aut
700a Streitbürger, Arneu University Hospital Essen4 aut
700a Kühne, Thomasu University Children's Hospital, Basel4 aut
700a Kessler, Torstenu University Hospital Münster4 aut
700a Bernkopf, Marieu Medical University of Vienna4 aut
700a Butterfaß-Bahloul, Trudeu University of Münster4 aut
700a Dhooge, Catharinau Ghent University Hospital4 aut
700a Bauer, Sebastianu University of Duisburg-Essen4 aut
700a Kiss, Jánosu Semmelweis University4 aut
700a Paulussen, Michaelu Witten/Herdecke University4 aut
700a Bonar, Fionau Royal Prince Alfred Hospital4 aut
700a Ranft, Andreasu German Cancer Research Centre,University Hospital Essen4 aut
700a Timmermann, Beateu University Hospital Essen,German Cancer Research Centre4 aut
700a Rascon, Jelenau Vilnius University4 aut
700a Vieth, Volker4 aut
700a Kanerva, Jukkau Helsinki University Central Hospital4 aut
700a Faldum, Andreasu University of Münster4 aut
700a Hartmann, Wolfgangu University Hospital Münster4 aut
700a Hjorth, Larsu 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 Hospital4 aut0 (Swepub:lu)pedi-lhj
700a Bhadri, Vivek A.u University of Sydney4 aut
700a Metzler, Markusu University Hospital Erlangen4 aut
700a Gelderblom, Hansu Leiden University Medical Centre4 aut
700a Dirksen, Utau German Cancer Research Centre,University Hospital Essen4 aut
710a University of Münsterb Princess Maxima Center for Pediatric Oncology/Hematology4 org
773t Clinical cancer research : an official journal of the American Association for Cancer Researchg 29:24, s. 5057-5068q 29:24<5057-5068x 1078-0432
856u http://dx.doi.org/10.1158/1078-0432.CCR-23-1966y FULLTEXT
8564 8u https://lup.lub.lu.se/record/dc42c69e-a828-4c92-9d75-84f6a36d15f1
8564 8u https://doi.org/10.1158/1078-0432.CCR-23-1966

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