Zoledronic acid add-on therapy for standard-risk Ewing sarcoma patients in the Ewing 2008R1 trial
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064203%3A_____%2F23%3A10470165" target="_blank" >RIV/00064203:_____/23:10470165 - isvavai.cz</a>
Alternative codes found
RIV/00216208:11130/23:10470165
Result on the web
<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=CElIg~l_hV" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=CElIg~l_hV</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1158/1078-0432.CCR-23-1966" target="_blank" >10.1158/1078-0432.CCR-23-1966</a>
Alternative languages
Result language
angličtina
Original language name
Zoledronic acid add-on therapy for standard-risk Ewing sarcoma patients in the Ewing 2008R1 trial
Original language description
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 to no add-on regarding event-free (EFS, primary endpoint) and overall survival (OS) in standard-risk Ewing Sarcoma (EWS). PATIENTS AND METHODS: Eligible patients had localized EWS with either good histological response to induction chemotherapy and/or small tumors (<200ml). Patients received 6 cycles VIDE induction and 8 cycles VAI (male) or 8 cycles VAC (female) consolidation. ZOL treatment started parallel to the 6th consolidation cycle. Randomization was stratified by tumor site (pelvis/other). The two-sided adaptive inverse-normal 4-stage design (planned sample size 448 patients, significance level 5%, power 80%) was changed after the 1st interim analysis using Müller-Schäfer method. RESULTS: Between 04/2010 and 11/2018 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). 3-y-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 3y-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, neurological and gastrointestinal toxicities were observed for ZOL (p<0.05). Severe renal toxicities occurred more often in the ZOL arm (p=0.003). CONCLUSION: In patients with standard-risk localized EWS, there is no additional benefit from maintenance treatment with ZOL.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30204 - Oncology
Result continuities
Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2023
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Clinical Cancer Research
ISSN
1078-0432
e-ISSN
1557-3265
Volume of the periodical
29
Issue of the periodical within the volume
24
Country of publishing house
US - UNITED STATES
Number of pages
12
Pages from-to
5057-5068
UT code for WoS article
001158766400005
EID of the result in the Scopus database
2-s2.0-85180004716