Sökning: WFRF:(Bovee Judith V.M.G.) > Zoledronic Acid Add...
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000 | 06610naa a2200781 4500 | |
001 | oai:lup.lub.lu.se:dc42c69e-a828-4c92-9d75-84f6a36d15f1 | |
003 | SwePub | |
008 | 240103s2023 | |||||||||||000 ||eng| | |
024 | 7 | a https://lup.lub.lu.se/record/dc42c69e-a828-4c92-9d75-84f6a36d15f12 URI |
024 | 7 | a https://doi.org/10.1158/1078-0432.CCR-23-19662 DOI |
040 | a (SwePub)lu | |
041 | a engb eng | |
042 | 9 SwePub | |
072 | 7 | a art2 swepub-publicationtype |
072 | 7 | a ref2 swepub-contenttype |
100 | 1 | a Koch, Raphaelu University of Münster4 aut |
245 | 1 0 | a Zoledronic Acid Add-on Therapy for Standard-Risk Ewing Sarcoma Patients in the Ewing 2008R1 Trial |
264 | 1 | c 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 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Cancer och onkologi0 (SwePub)302032 hsv//swe |
650 | 7 | a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Cancer and Oncology0 (SwePub)302032 hsv//eng |
700 | 1 | a Haveman, Lianneu Princess Maxima Center for Pediatric Oncology/Hematology4 aut |
700 | 1 | a Ladenstein, Ruthu Medical University of Vienna4 aut |
700 | 1 | a Brichard, Benedicteu Saint-Luc University Hospital4 aut |
700 | 1 | a Jürgens, Heribertu University Hospital Münster4 aut |
700 | 1 | a Cyprova, Sonau University Hospital Motol4 aut |
700 | 1 | a van den Berg, Henku University of Amsterdam4 aut |
700 | 1 | a Hassenpflug, Wolfu University Medical Center Hamburg-Eppendorf4 aut |
700 | 1 | a Raciborska, Annau National Research Institute of Mother and Child4 aut |
700 | 1 | a Ek, Torbenu Queen Silvia Children’s Hospital4 aut |
700 | 1 | a Baumhoer, Danielu University Hospital Basel4 aut |
700 | 1 | a Egerer, Gerlindeu University Hospital Heidelberg4 aut |
700 | 1 | a Kager, Leou Medical University of Vienna4 aut |
700 | 1 | a Renard, Marleenu University Hospitals Leuven4 aut |
700 | 1 | a Hauser, Peter4 aut |
700 | 1 | a Burdach, Stefanu Technical University of Munich4 aut |
700 | 1 | a Bovee, Judith V.M.G.u Leiden University Medical Centre4 aut |
700 | 1 | a Hong, Angela M.u University of Sydney4 aut |
700 | 1 | a Reichardt, Peteru HELIOS Klinikum Berlin-Buch4 aut |
700 | 1 | a Kruseova, Jarmilau University Hospital Motol4 aut |
700 | 1 | a Streitbürger, Arneu University Hospital Essen4 aut |
700 | 1 | a Kühne, Thomasu University Children's Hospital, Basel4 aut |
700 | 1 | a Kessler, Torstenu University Hospital Münster4 aut |
700 | 1 | a Bernkopf, Marieu Medical University of Vienna4 aut |
700 | 1 | a Butterfaß-Bahloul, Trudeu University of Münster4 aut |
700 | 1 | a Dhooge, Catharinau Ghent University Hospital4 aut |
700 | 1 | a Bauer, Sebastianu University of Duisburg-Essen4 aut |
700 | 1 | a Kiss, Jánosu Semmelweis University4 aut |
700 | 1 | a Paulussen, Michaelu Witten/Herdecke University4 aut |
700 | 1 | a Bonar, Fionau Royal Prince Alfred Hospital4 aut |
700 | 1 | a Ranft, Andreasu German Cancer Research Centre,University Hospital Essen4 aut |
700 | 1 | a Timmermann, Beateu University Hospital Essen,German Cancer Research Centre4 aut |
700 | 1 | a Rascon, Jelenau Vilnius University4 aut |
700 | 1 | a Vieth, Volker4 aut |
700 | 1 | a Kanerva, Jukkau Helsinki University Central Hospital4 aut |
700 | 1 | a Faldum, Andreasu University of Münster4 aut |
700 | 1 | a Hartmann, Wolfgangu University Hospital Münster4 aut |
700 | 1 | a 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 |
700 | 1 | a Bhadri, Vivek A.u University of Sydney4 aut |
700 | 1 | a Metzler, Markusu University Hospital Erlangen4 aut |
700 | 1 | a Gelderblom, Hansu Leiden University Medical Centre4 aut |
700 | 1 | a Dirksen, Utau German Cancer Research Centre,University Hospital Essen4 aut |
710 | 2 | a University of Münsterb Princess Maxima Center for Pediatric Oncology/Hematology4 org |
773 | 0 | t Clinical cancer research : an official journal of the American Association for Cancer Researchg 29:24, s. 5057-5068q 29:24<5057-5068x 1078-0432 |
856 | 4 | u http://dx.doi.org/10.1158/1078-0432.CCR-23-1966y FULLTEXT |
856 | 4 8 | u https://lup.lub.lu.se/record/dc42c69e-a828-4c92-9d75-84f6a36d15f1 |
856 | 4 8 | u https://doi.org/10.1158/1078-0432.CCR-23-1966 |
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