Detail
Článek
Článek online
FT
Medvik - BMČ
  • Je něco špatně v tomto záznamu ?

Fixed-duration ibrutinib-venetoclax versus chlorambucil-obinutuzumab in previously untreated chronic lymphocytic leukaemia (GLOW): 4-year follow-up from a multicentre, open-label, randomised, phase 3 trial

CU. Niemann, T. Munir, C. Moreno, C. Owen, GA. Follows, O. Benjamini, A. Janssens, MD. Levin, T. Robak, M. Simkovic, S. Voloshin, V. Vorobyev, M. Yagci, L. Ysebaert, K. Qi, Q. Qi, P. Sinet, L. Parisi, S. Srinivasan, N. Schuier, K. Baeten, A....

. 2023 ; 24 (12) : 1423-1433. [pub] 20231106

Jazyk angličtina Země Anglie, Velká Británie

Typ dokumentu randomizované kontrolované studie, multicentrická studie, klinické zkoušky, fáze III, časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/bmc24000370
E-zdroje Online Plný text

NLK ProQuest Central od 2000-09-01 do Před 2 měsíci
Nursing & Allied Health Database (ProQuest) od 2000-09-01 do Před 2 měsíci
Health & Medicine (ProQuest) od 2000-09-01 do Před 2 měsíci
Public Health Database (ProQuest) od 2000-09-01 do Před 2 měsíci

Odkazy

PubMed 37944541
DOI 10.1016/s1470-2045(23)00452-7
Knihovny.cz E-zdroje

BACKGROUND: In the GLOW study, fixed-duration ibrutinib-venetoclax showed superior progression-free survival versus chlorambucil-obinutuzumab in patients with previously untreated chronic lymphocytic leukaemia who were older or had comorbidities, or both, at a median follow up of 27·7 months. In this Article, we report updated outcomes from GLOW after a 46-month median follow-up. METHODS: GLOW was a randomised, multicentre, phase 3 study done at 67 hospital centres across 14 countries. Patients aged 65 years and older or 18-64 years with previously untreated chronic lymphocytic leukaemia and a cumulative illness rating scale score of more than 6 or creatinine clearance less than 70 mL/min, or both, and an Eastern Cooperative Oncology Group performance status of 2 or less were randomly assigned (1:1) via an interactive web system with permuted blocks (block size of four) and stratified by IGHV mutational status and the presence of del11q aberration to the ibrutinib-venetoclax group (three cycles of ibrutinib lead-in [420 mg/day, orally], followed by 12 cycles of ibrutinib plus venetoclax [400 mg/day, orally, including a 5-week dose ramp-up]) or the chlorambucil-obinutuzumab group (six cycles of chlorambucil [0·5 mg/kg, orally, on days 1 and 15 of each cycle], and obinutuzumab [1000 mg, intravenously, on days 1 (or 100 mg on day 1 and 900 mg on day 2), 8, and 15 of cycle 1 and day 1 of cycles 2-6]). The primary endpoint was progression-free survival in the intention-to-treat population, assessed by an independent review committee. The safety population included all randomised patients who received at least one dose of the study treatment. This study is registered with ClinicalTrials.gov (NCT03462719) and the EU Clinical Trials Register (EudraCT 2017-004699-77). FINDINGS: Between May 4, 2018, and April 5, 2019, 211 patients (122 [58%] were male and 89 [42%] were female) were randomly assigned to receive ibrutinib-venetoclax (n=106) or chlorambucil-obinutuzumab (n=105). At a median of 46 months (IQR 43-47) of follow-up, progression-free survival remained superior for the ibrutinib-venetoclax group (hazard ratio 0·214 [95% CI 0·138-0·334]; p<0·0001); 42-month progression-free survival rates were 74·6% (95% CI 65·0-82·0) for ibrutinib-venetoclax and 24·8% (16·5-34·1) for chlorambucil-obinutuzumab. Following the primary analysis, one patient in the chlorambucil-obinutuzumab group had a serious adverse event of myelodysplastic syndrome. Treatment-related deaths were reported in one patient receiving ibrutinib-venetoclax (cardiac failure, pneumonia, and sinus node dysfunction) and in one patient receiving chlorambucil-obinutuzumab (pneumonia). There were 15 deaths in the ibrutinib-venetoclax group (of which three were due to post-treatment infections) and 30 deaths in the chlorambucil-obinutuzumab group (of which 10 were due to post-treatment infections). INTERPRETATION: After 4 years of follow-up, ibrutinib-venetoclax continues to significantly prolong progression-free survival (vs chemoimmunotherapy) in patients with previously untreated chronic lymphocytic leukaemia, supporting its use as a first-line option. FUNDING: Janssen Research & Development and Pharmacyclics.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc24000370
003      
CZ-PrNML
005      
20240213093132.0
007      
ta
008      
240109s2023 enk f 000 0|eng||
009      
AR
024    7_
$a 10.1016/S1470-2045(23)00452-7 $2 doi
035    __
$a (PubMed)37944541
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a enk
100    1_
$a Niemann, Carsten U $u Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: carsten.utoft.niemann@regionh.dk
245    10
$a Fixed-duration ibrutinib-venetoclax versus chlorambucil-obinutuzumab in previously untreated chronic lymphocytic leukaemia (GLOW): 4-year follow-up from a multicentre, open-label, randomised, phase 3 trial / $c CU. Niemann, T. Munir, C. Moreno, C. Owen, GA. Follows, O. Benjamini, A. Janssens, MD. Levin, T. Robak, M. Simkovic, S. Voloshin, V. Vorobyev, M. Yagci, L. Ysebaert, K. Qi, Q. Qi, P. Sinet, L. Parisi, S. Srinivasan, N. Schuier, K. Baeten, A. Howes, DB. Caces, AP. Kater
520    9_
$a BACKGROUND: In the GLOW study, fixed-duration ibrutinib-venetoclax showed superior progression-free survival versus chlorambucil-obinutuzumab in patients with previously untreated chronic lymphocytic leukaemia who were older or had comorbidities, or both, at a median follow up of 27·7 months. In this Article, we report updated outcomes from GLOW after a 46-month median follow-up. METHODS: GLOW was a randomised, multicentre, phase 3 study done at 67 hospital centres across 14 countries. Patients aged 65 years and older or 18-64 years with previously untreated chronic lymphocytic leukaemia and a cumulative illness rating scale score of more than 6 or creatinine clearance less than 70 mL/min, or both, and an Eastern Cooperative Oncology Group performance status of 2 or less were randomly assigned (1:1) via an interactive web system with permuted blocks (block size of four) and stratified by IGHV mutational status and the presence of del11q aberration to the ibrutinib-venetoclax group (three cycles of ibrutinib lead-in [420 mg/day, orally], followed by 12 cycles of ibrutinib plus venetoclax [400 mg/day, orally, including a 5-week dose ramp-up]) or the chlorambucil-obinutuzumab group (six cycles of chlorambucil [0·5 mg/kg, orally, on days 1 and 15 of each cycle], and obinutuzumab [1000 mg, intravenously, on days 1 (or 100 mg on day 1 and 900 mg on day 2), 8, and 15 of cycle 1 and day 1 of cycles 2-6]). The primary endpoint was progression-free survival in the intention-to-treat population, assessed by an independent review committee. The safety population included all randomised patients who received at least one dose of the study treatment. This study is registered with ClinicalTrials.gov (NCT03462719) and the EU Clinical Trials Register (EudraCT 2017-004699-77). FINDINGS: Between May 4, 2018, and April 5, 2019, 211 patients (122 [58%] were male and 89 [42%] were female) were randomly assigned to receive ibrutinib-venetoclax (n=106) or chlorambucil-obinutuzumab (n=105). At a median of 46 months (IQR 43-47) of follow-up, progression-free survival remained superior for the ibrutinib-venetoclax group (hazard ratio 0·214 [95% CI 0·138-0·334]; p<0·0001); 42-month progression-free survival rates were 74·6% (95% CI 65·0-82·0) for ibrutinib-venetoclax and 24·8% (16·5-34·1) for chlorambucil-obinutuzumab. Following the primary analysis, one patient in the chlorambucil-obinutuzumab group had a serious adverse event of myelodysplastic syndrome. Treatment-related deaths were reported in one patient receiving ibrutinib-venetoclax (cardiac failure, pneumonia, and sinus node dysfunction) and in one patient receiving chlorambucil-obinutuzumab (pneumonia). There were 15 deaths in the ibrutinib-venetoclax group (of which three were due to post-treatment infections) and 30 deaths in the chlorambucil-obinutuzumab group (of which 10 were due to post-treatment infections). INTERPRETATION: After 4 years of follow-up, ibrutinib-venetoclax continues to significantly prolong progression-free survival (vs chemoimmunotherapy) in patients with previously untreated chronic lymphocytic leukaemia, supporting its use as a first-line option. FUNDING: Janssen Research & Development and Pharmacyclics.
650    _2
$a lidé $7 D006801
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a ženské pohlaví $7 D005260
650    12
$a chronická lymfatická leukemie $x farmakoterapie $7 D015451
650    _2
$a následné studie $7 D005500
650    _2
$a chlorambucil $7 D002699
650    12
$a pneumonie $x chemicky indukované $7 D011014
650    _2
$a protokoly protinádorové kombinované chemoterapie $x škodlivé účinky $7 D000971
655    _2
$a randomizované kontrolované studie $7 D016449
655    _2
$a multicentrická studie $7 D016448
655    _2
$a klinické zkoušky, fáze III $7 D017428
655    _2
$a časopisecké články $7 D016428
700    1_
$a Munir, Talha $u St James's Hospital, Leeds, UK
700    1_
$a Moreno, Carol $u Hospital de la Santa Creu i Sant Pau, Autonomous University of Barcelona, Josep Carreras Leukaemia Research Institute, Barcelona, Spain
700    1_
$a Owen, Carolyn $u Tom Baker Cancer Centre, Calgary, AB, Canada
700    1_
$a Follows, George A $u Addenbrookes Hospital, Cambridge, UK
700    1_
$a Benjamini, Ohad $u Sheba Medical Center, Ramat Gan, Israel
700    1_
$a Janssens, Ann $u UZ Leuven Gasthuisberg, Leuven, Belgium
700    1_
$a Levin, Mark-David $u Albert Schweitzer Hospital, Dordrecht, Netherlands
700    1_
$a Robak, Tadeusz $u Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland
700    1_
$a Simkovic, Martin $u 4th Department of Internal Medicine-Haematology, Faculty of Medicine in Hradec Králové, University Hospital and Charles University in Prague, Hradec Králové, Czech Republic
700    1_
$a Voloshin, Sergey $u Russian Scientific and Research Institute of Hematology and Transfusiology, St Petersburg, Russia
700    1_
$a Vorobyev, Vladimir $u SP Botkin Moscow City Clinical Hospital, Moscow, Russia
700    1_
$a Yagci, Munci $u Gazi Universitesi Tip Fakultesi, Ankara, Türkiye
700    1_
$a Ysebaert, Loic $u Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France
700    1_
$a Qi, Keqin $u Janssen Research & Development, Titusville, NJ, USA
700    1_
$a Qi, Qianya $u Janssen Research & Development, Raritan, NJ, USA
700    1_
$a Sinet, Pierre $u Janssen Research & Development, Bridgewater, NJ, USA
700    1_
$a Parisi, Lori $u Janssen Research & Development, Raritan, NJ, USA
700    1_
$a Srinivasan, Srimathi $u Oncology Translational Research, Janssen Research & Development, Lower Gwynedd Township, PA, USA
700    1_
$a Schuier, Natasha $u Janssen Research & Development, Raritan, NJ, USA
700    1_
$a Baeten, Kurt $u Janssen Research & Development, Beerse, Belgium
700    1_
$a Howes, Angela $u Janssen Research & Development, High Wycombe, UK
700    1_
$a Caces, Donne Bennett $u Janssen Research & Development, Raritan, NJ, USA
700    1_
$a Kater, Arnon P $u Amsterdam University Medical Centers, Cancer Center Amsterdam, University of Amsterdam, Amsterdam, Netherlands
773    0_
$w MED00011558 $t Lancet oncology $x 1474-5488 $g Roč. 24, č. 12 (2023), s. 1423-1433
856    41
$u https://pubmed.ncbi.nlm.nih.gov/37944541 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y - $z 0
990    __
$a 20240109 $b ABA008
991    __
$a 20240213093129 $b ABA008
999    __
$a ok $b bmc $g 2049185 $s 1210064
BAS    __
$a 3
BAS    __
$a PreBMC-MEDLINE
BMC    __
$a 2023 $b 24 $c 12 $d 1423-1433 $e 20231106 $i 1474-5488 $m Lancet oncology $n Lancet Oncol. $x MED00011558
LZP    __
$a Pubmed-20240109

Najít záznam

Citační ukazatele

Možnosti archivace