PET-guided treatment in patients with advanced-stage Hodgkin's lymphoma (HD18): final results of an open-label, international, randomised phase 3 trial by the German Hodgkin Study Group

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11120%2F17%3A43915709" target="_blank" >RIV/00216208:11120/17:43915709 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00064173:_____/18:N0000097

Výsledek na webu

<a href="http://dx.doi.org/10.1016/S0140-6736(17)32134-7" target="_blank" >http://dx.doi.org/10.1016/S0140-6736(17)32134-7</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/S0140-6736(17)32134-7" target="_blank" >10.1016/S0140-6736(17)32134-7</a>

Jazyk výsledku

angličtina

Název v původním jazyce

PET-guided treatment in patients with advanced-stage Hodgkin's lymphoma (HD18): final results of an open-label, international, randomised phase 3 trial by the German Hodgkin Study Group

Popis výsledku v původním jazyce

The intensive polychemotherapy regimen eBEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone in escalated doses) is very active in patients with advanced-stage Hodgkin&apos;s lymphoma, albeit at the expense of severe toxicities. Individual patients might be cured with less burdensome therapy. We investigated whether metabolic response determined by PET after two cycles of standard regimen eBEACOPP (PET-2) would allow adaption of treatment intensity, increasing it for PET-2-positive patients and reducing it for PET-2-negative patients. METHODS: In this open-label, randomised, parallel-group phase 3 trial, we recruited patients aged 18-60 years with newly diagnosed, advanced-stage Hodgkin&apos;s lymphoma in 301 hospitals and private practices in Germany, Switzerland, Austria, the Netherlands, and the Czech Republic. After central review of PET-2, patients were assigned (1:1) to one of two parallel treatment groups on the basis of their PET-2 result. Patients with positive PET-2 were randomised to receive six additional cycles of either standard eBEACOPP (8 x eBEACOPP in total) or eBEACOPP with rituximab (8 x R-eBEACOPP). Those with negative PET-2 were randomised between standard treatment with six additional cycles of eBEACOPP (8 x eBEACOPP) or experimental treatment with two additional cycles (4 x eBEACOPP). A protocol amendment in June, 2011, introduced a reduction of standard therapy to 6 x eBEACOPP; after this point, patients with positive PET-2 were no longer randomised and were all assigned to receive 6 x eBEACOPP and patients with negative PET-2 were randomly assigned to 6 x eBEACOPP (standard) or 4 x eBEACOPP (experimental).

Název v anglickém jazyce

PET-guided treatment in patients with advanced-stage Hodgkin's lymphoma (HD18): final results of an open-label, international, randomised phase 3 trial by the German Hodgkin Study Group

Popis výsledku anglicky

The intensive polychemotherapy regimen eBEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone in escalated doses) is very active in patients with advanced-stage Hodgkin&apos;s lymphoma, albeit at the expense of severe toxicities. Individual patients might be cured with less burdensome therapy. We investigated whether metabolic response determined by PET after two cycles of standard regimen eBEACOPP (PET-2) would allow adaption of treatment intensity, increasing it for PET-2-positive patients and reducing it for PET-2-negative patients. METHODS: In this open-label, randomised, parallel-group phase 3 trial, we recruited patients aged 18-60 years with newly diagnosed, advanced-stage Hodgkin&apos;s lymphoma in 301 hospitals and private practices in Germany, Switzerland, Austria, the Netherlands, and the Czech Republic. After central review of PET-2, patients were assigned (1:1) to one of two parallel treatment groups on the basis of their PET-2 result. Patients with positive PET-2 were randomised to receive six additional cycles of either standard eBEACOPP (8 x eBEACOPP in total) or eBEACOPP with rituximab (8 x R-eBEACOPP). Those with negative PET-2 were randomised between standard treatment with six additional cycles of eBEACOPP (8 x eBEACOPP) or experimental treatment with two additional cycles (4 x eBEACOPP). A protocol amendment in June, 2011, introduced a reduction of standard therapy to 6 x eBEACOPP; after this point, patients with positive PET-2 were no longer randomised and were all assigned to receive 6 x eBEACOPP and patients with negative PET-2 were randomly assigned to 6 x eBEACOPP (standard) or 4 x eBEACOPP (experimental).

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30205 - Hematology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2017

Kód důvěrnosti údajů

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

Název periodika

The Lancet

ISSN

0140-6736

e-ISSN

—

Svazek periodika

390

Číslo periodika v rámci svazku

10114

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

13

Strana od-do

2790-2802

Kód UT WoS článku

000418669800024

EID výsledku v databázi Scopus

2-s2.0-85040703989