Prospective study of brentuximab vedotin in relapsed/refractory Hodgkin lymphoma patients who are not suitable for stem cell transplant or multi-agent chemotherapy

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F18%3A10411706" target="_blank" >RIV/00216208:11110/18:10411706 - isvavai.cz</a>

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=50qkeVJWyi" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=50qkeVJWyi</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1111/bjh.15539" target="_blank" >10.1111/bjh.15539</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Prospective study of brentuximab vedotin in relapsed/refractory Hodgkin lymphoma patients who are not suitable for stem cell transplant or multi-agent chemotherapy

Popis výsledku v původním jazyce

Some patients with relapsed/refractory Hodgkin lymphoma (HL) are not considered suitable for stem cell transplant (SCT) and have a poor prognosis. This phase IV study (NCT01990534) evaluated brentuximab vedotin (1 center dot 8 mg/kg intravenously once every 3 weeks) in 60 patients (aged &gt;= 18 years) with CD30-positive relapsed/refractory HL, a history of &gt;= 1 prior systemic chemotherapy regimen, who were considered unsuitable for SCT/multi-agent chemotherapy. Primary endpoint was overall response rate (ORR) per independent review facility (IRF). Secondary endpoints included duration of response (DOR), progression-free survival (PFS) per IRF, overall survival (OS), proportion proceeding to SCT and safety. The ORR was 50%, with 12% CR; 47% proceeded to SCT. Median DOR was 4 center dot 6 months and median duration of CR was 6 center dot 1 months. After a median follow-up of 6 center dot 9 and 16 center dot 6 months, median PFS and OS were 4 center dot 8 months (95% confidence interval, 3 center dot 0-5 center dot 3) and not reached, respectively; estimated OS rate was 86% at 12 months. Most common adverse events (&gt;= 10%) were peripheral neuropathy (35%), pyrexia (18%), diarrhoea and neutropenia (each 10%). Brentuximab vedotin showed notable activity with a safety profile consistent with known toxicities, and may act as a bridge to SCT, enabling high-risk patients who achieve suboptimal response to frontline/salvage chemotherapy/radiotherapy to receive potentially curative SCT.

Název v anglickém jazyce

Prospective study of brentuximab vedotin in relapsed/refractory Hodgkin lymphoma patients who are not suitable for stem cell transplant or multi-agent chemotherapy

Popis výsledku anglicky

Some patients with relapsed/refractory Hodgkin lymphoma (HL) are not considered suitable for stem cell transplant (SCT) and have a poor prognosis. This phase IV study (NCT01990534) evaluated brentuximab vedotin (1 center dot 8 mg/kg intravenously once every 3 weeks) in 60 patients (aged &gt;= 18 years) with CD30-positive relapsed/refractory HL, a history of &gt;= 1 prior systemic chemotherapy regimen, who were considered unsuitable for SCT/multi-agent chemotherapy. Primary endpoint was overall response rate (ORR) per independent review facility (IRF). Secondary endpoints included duration of response (DOR), progression-free survival (PFS) per IRF, overall survival (OS), proportion proceeding to SCT and safety. The ORR was 50%, with 12% CR; 47% proceeded to SCT. Median DOR was 4 center dot 6 months and median duration of CR was 6 center dot 1 months. After a median follow-up of 6 center dot 9 and 16 center dot 6 months, median PFS and OS were 4 center dot 8 months (95% confidence interval, 3 center dot 0-5 center dot 3) and not reached, respectively; estimated OS rate was 86% at 12 months. Most common adverse events (&gt;= 10%) were peripheral neuropathy (35%), pyrexia (18%), diarrhoea and neutropenia (each 10%). Brentuximab vedotin showed notable activity with a safety profile consistent with known toxicities, and may act as a bridge to SCT, enabling high-risk patients who achieve suboptimal response to frontline/salvage chemotherapy/radiotherapy to receive potentially curative SCT.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30205 - Hematology

Projekt

—

Návaznosti

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Rok uplatnění

2018

Kód důvěrnosti údajů

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

Název periodika

British Journal of Haematology

ISSN

0007-1048

e-ISSN

—

Svazek periodika

183

Číslo periodika v rámci svazku

3

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

11

Strana od-do

400-410

Kód UT WoS článku

000450015400008

EID výsledku v databázi Scopus

2-s2.0-85052817145