Zoledronic acid add-on therapy for standard-risk Ewing sarcoma patients in the Ewing 2008R1 trial

Kód výsledku v 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>

Nalezeny alternativní kódy

RIV/00216208:11130/23:10470165

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

Zoledronic acid add-on therapy for standard-risk Ewing sarcoma patients in the Ewing 2008R1 trial

Popis výsledku v původním jazyce

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 (&lt;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&lt;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.

Název v anglickém jazyce

Zoledronic acid add-on therapy for standard-risk Ewing sarcoma patients in the Ewing 2008R1 trial

Popis výsledku anglicky

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 (&lt;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&lt;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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30204 - Oncology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2023

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Clinical Cancer Research

ISSN

1078-0432

e-ISSN

1557-3265

Svazek periodika

29

Číslo periodika v rámci svazku

24

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

12

Strana od-do

5057-5068

Kód UT WoS článku

001158766400005

EID výsledku v databázi Scopus

2-s2.0-85180004716