-
Something wrong with this record ?
Zanubrutinib Versus Bendamustine and Rituximab in Patients With Treatment-Naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Median 5-Year Follow-Up of SEQUOIA
M. Shadman, T. Munir, T. Robak, JR. Brown, BS. Kahl, P. Ghia, K. Giannopoulos, M. Šimkovič, A. Österborg, L. Laurenti, PA. Walker, SS. Opat, H. Ciepluch, R. Greil, M. Hanna, M. Tani, M. Trněný, D. Brander, IW. Flinn, S. Grosicki, E. Verner, A....
Language English Country United States
Document type Journal Article, Clinical Trial, Phase III, Randomized Controlled Trial, Multicenter Study, Comparative Study
PubMed
39647999
DOI
10.1200/jco-24-02265
Knihovny.cz E-resources
- MeSH
- Bendamustine Hydrochloride * administration & dosage therapeutic use MeSH
- Leukemia, Lymphocytic, Chronic, B-Cell * drug therapy mortality MeSH
- Progression-Free Survival MeSH
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Follow-Up Studies MeSH
- Piperidines therapeutic use administration & dosage adverse effects MeSH
- Antineoplastic Combined Chemotherapy Protocols * therapeutic use adverse effects MeSH
- Pyrazoles * therapeutic use administration & dosage adverse effects MeSH
- Pyrimidines * therapeutic use administration & dosage adverse effects MeSH
- Rituximab * administration & dosage therapeutic use adverse effects MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.SEQUOIA (ClinicalTrials.gov identifier: NCT03336333) is a phase III, randomized, open-label trial that compared the oral Bruton tyrosine kinase inhibitor zanubrutinib to bendamustine plus rituximab (BR) in treatment-naïve patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The initial prespecified analysis (median follow-up, 26.2 months) and subsequent analysis (43.7 months) found superior progression-free survival (PFS; the primary end point) in patients who received zanubrutinib compared with BR. At a median follow-up of 61.2 months, median PFS was not reached in zanubrutinib-treated patients; median PFS was 44.1 months in BR-treated patients (hazard ratio [HR], 0.29; one-sided P = .0001). Prolonged PFS was seen with zanubrutinib versus BR in patients with mutated immunoglobulin heavy-chain variable region (IGHV) genes (HR, 0.40; one-sided P = .0003) and unmutated IGHV genes (HR, 0.21 [95% CI, 0.14 to 0.33]; one-sided P < .0001). Median overall survival (OS) was not reached in either treatment arm; estimated 60-month OS rates were 85.8% and 85.0% in zanubrutinib- and BR-treated patients, respectively. No new safety signals were detected. Adverse events were as expected with zanubrutinib; rate of atrial fibrillation was 7.1%. At a median follow-up of 61.2 months, the results supported the initial SEQUOIA findings and suggested that zanubrutinib was a favorable treatment option for untreated patients with CLL/SLL.
Alfred Health and Monash University Melbourne VIC Australia
Cancer Cluster Salzburg Salzburg Austria
Concord Repatriation General Hospital Concord NSW Australia
Copernicus Memorial Hospital Medical University of Łódź Łódź Poland
Dana Farber Cancer Institute Boston MA
Department of Chemotherapy of Hemoblastosis Blokhin Russian Cancer Research Center Moscow Russia
Department of Haematology Waitemata District Health Board Takapuna New Zealand
Department of Hematology Copernicus Regional Oncology Centre Gdansk Poland
Department of Hematology Karolinska University Hospital Solna Stockholm Sweden
Experimental Hematooncology Department Medical University of Lublin Lublin Poland
Fondazione Policlinico Universitario A Gemelli IRCCS Rome Italy
Fred Hutchinson Cancer Center University of Washington Seattle WA
Haematology Leeds Teaching Hospitals NHS Trust Leeds United Kingdom
Hematologic Malignancies and Cellular Therapy Duke University School of Medicine Durham NC
Hematology Department Centre Hospitalier du Mans Le Mans France
Hematology Department St John's Cancer Centre Lublin Poland
Hematology Unit Santa Maria delle Croci Hospital Ravenna Italy
Hôpital de Pontchaillou Rennes France
IRCCS Ospedale San Raffaele Milano Italy
Maria Skłodowska Curie National Research Institute of Oncology Kraków Poland
Peninsula Health and Peninsula Private Hospital Frankston Melbourne VIC Australia
Salzburg Cancer Research Institute Center for Clinical Cancer and Immunology Trials Salzburg Austria
Siteman Cancer Center Washington University School of Medicine St Louis MO
Tennessee Oncology OneOncology Nashville TN
The 1st Affiliated Hospital of Nanjing Medical University Jiangsu Province Hospital Nanjing China
References provided by Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc25009734
- 003
- CZ-PrNML
- 005
- 20250429134654.0
- 007
- ta
- 008
- 250415s2025 xxu f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1200/JCO-24-02265 $2 doi
- 035 __
- $a (PubMed)39647999
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a xxu
- 100 1_
- $a Shadman, Mazyar $u Fred Hutchinson Cancer Center, University of Washington, Seattle, WA $1 https://orcid.org/0000000233656562
- 245 10
- $a Zanubrutinib Versus Bendamustine and Rituximab in Patients With Treatment-Naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Median 5-Year Follow-Up of SEQUOIA / $c M. Shadman, T. Munir, T. Robak, JR. Brown, BS. Kahl, P. Ghia, K. Giannopoulos, M. Šimkovič, A. Österborg, L. Laurenti, PA. Walker, SS. Opat, H. Ciepluch, R. Greil, M. Hanna, M. Tani, M. Trněný, D. Brander, IW. Flinn, S. Grosicki, E. Verner, A. Tedeschi, S. de Guibert, G. Tumyan, K. Laribi, JA. García-Marco, JY. Li, T. Tian, Y. Liu, R. Korolkiewicz, A. Szeto, CS. Tam, W. Jurczak
- 520 9_
- $a Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.SEQUOIA (ClinicalTrials.gov identifier: NCT03336333) is a phase III, randomized, open-label trial that compared the oral Bruton tyrosine kinase inhibitor zanubrutinib to bendamustine plus rituximab (BR) in treatment-naïve patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The initial prespecified analysis (median follow-up, 26.2 months) and subsequent analysis (43.7 months) found superior progression-free survival (PFS; the primary end point) in patients who received zanubrutinib compared with BR. At a median follow-up of 61.2 months, median PFS was not reached in zanubrutinib-treated patients; median PFS was 44.1 months in BR-treated patients (hazard ratio [HR], 0.29; one-sided P = .0001). Prolonged PFS was seen with zanubrutinib versus BR in patients with mutated immunoglobulin heavy-chain variable region (IGHV) genes (HR, 0.40; one-sided P = .0003) and unmutated IGHV genes (HR, 0.21 [95% CI, 0.14 to 0.33]; one-sided P < .0001). Median overall survival (OS) was not reached in either treatment arm; estimated 60-month OS rates were 85.8% and 85.0% in zanubrutinib- and BR-treated patients, respectively. No new safety signals were detected. Adverse events were as expected with zanubrutinib; rate of atrial fibrillation was 7.1%. At a median follow-up of 61.2 months, the results supported the initial SEQUOIA findings and suggested that zanubrutinib was a favorable treatment option for untreated patients with CLL/SLL.
- 650 _2
- $a lidé $7 D006801
- 650 12
- $a chronická lymfatická leukemie $x farmakoterapie $x mortalita $7 D015451
- 650 12
- $a bendamustin hydrochlorid $x aplikace a dávkování $x terapeutické užití $7 D000069461
- 650 12
- $a rituximab $x aplikace a dávkování $x terapeutické užití $x škodlivé účinky $7 D000069283
- 650 12
- $a pyrimidiny $x terapeutické užití $x aplikace a dávkování $x škodlivé účinky $7 D011743
- 650 12
- $a pyrazoly $x terapeutické užití $x aplikace a dávkování $x škodlivé účinky $7 D011720
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 12
- $a protokoly protinádorové kombinované chemoterapie $x terapeutické užití $x škodlivé účinky $7 D000971
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 _2
- $a senioři $7 D000368
- 650 _2
- $a následné studie $7 D005500
- 650 _2
- $a lidé středního věku $7 D008875
- 650 _2
- $a piperidiny $x terapeutické užití $x aplikace a dávkování $x škodlivé účinky $7 D010880
- 650 _2
- $a doba přežití bez progrese choroby $7 D000077982
- 650 _2
- $a senioři nad 80 let $7 D000369
- 650 _2
- $a dospělí $7 D000328
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a klinické zkoušky, fáze III $7 D017428
- 655 _2
- $a randomizované kontrolované studie $7 D016449
- 655 _2
- $a multicentrická studie $7 D016448
- 655 _2
- $a srovnávací studie $7 D003160
- 700 1_
- $a Munir, Talha $u Haematology, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom
- 700 1_
- $a Robak, Tadeusz $u Copernicus Memorial Hospital, Medical University of Łódź, Łódź, Poland $1 https://orcid.org/0000000234116357
- 700 1_
- $a Brown, Jennifer R $u Dana-Farber Cancer Institute, Boston, MA $1 https://orcid.org/0000000320404961
- 700 1_
- $a Kahl, Brad S $u Siteman Cancer Center, Washington University School of Medicine, St Louis, MO $1 https://orcid.org/0000000304596609
- 700 1_
- $a Ghia, Paolo $u Università Vita-Salute San Raffaele, Milano, Italy $u IRCCS Ospedale San Raffaele, Milano, Italy $1 https://orcid.org/0000000337507342 $7 xx0314871
- 700 1_
- $a Giannopoulos, Krzysztof $u Experimental Hematooncology Department, Medical University of Lublin, Lublin, Poland $u Hematology Department, St John's Cancer Centre, Lublin, Poland $1 https://orcid.org/0000000301354030
- 700 1_
- $a Šimkovič, 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 $1 https://orcid.org/0000000303315334 $7 xx0117538
- 700 1_
- $a Österborg, Anders $u Department of Hematology, Karolinska University Hospital Solna, Stockholm, Sweden
- 700 1_
- $a Laurenti, Luca $u Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
- 700 1_
- $a Walker, Patricia A $u Peninsula Health and Peninsula Private Hospital, Frankston, Melbourne, VIC, Australia
- 700 1_
- $a Opat, Stephen S $u Lymphoma Research Group, School of Clinical Sciences at Monash Health, Monash University, Clayton, VIC, Australia $1 https://orcid.org/0000000203086458
- 700 1_
- $a Ciepluch, Hanna $u Department of Hematology, Copernicus Regional Oncology Centre, Gdansk, Poland
- 700 1_
- $a Greil, Richard $u Third Medical Department With Hematology, Medical Oncology, Rheumatology and Infectiology, Paracelsus Medical University, Salzburg, Austria $u Salzburg Cancer Research Institute Center for Clinical Cancer and Immunology Trials, Salzburg, Austria $u Cancer Cluster Salzburg, Salzburg, Austria $1 https://orcid.org/0000000244623694
- 700 1_
- $a Hanna, Merit $u Department of Haematology, Waitemata District Health Board, Takapuna, New Zealand
- 700 1_
- $a Tani, Monica $u Hematology Unit, Santa Maria delle Croci Hospital, Ravenna, Italy
- 700 1_
- $a Trněný, Marek $u First Department of Medicine, First Faculty of Medicine, Charles University, General Hospital, Prague, Czech Republic $1 https://orcid.org/0000000269526073 $7 nlk20000083659
- 700 1_
- $a Brander, Danielle $u Hematologic Malignancies and Cellular Therapy, Duke University School of Medicine, Durham, NC $1 https://orcid.org/0000000295812807
- 700 1_
- $a Flinn, Ian W $u Tennessee Oncology/OneOncology, Nashville, TN $1 https://orcid.org/000000016724290X
- 700 1_
- $a Grosicki, Sebastian $u Department of Hematology and Cancer Prevention, School of Public Health, Silesian Medical University, Katowice, Poland
- 700 1_
- $a Verner, Emma $u Concord Repatriation General Hospital, Concord, NSW, Australia $u University of Sydney, Sydney, NSW, Australia $1 https://orcid.org/0009000449452574
- 700 1_
- $a Tedeschi, Alessandra $u Department of Hematology, Azienda Socio Sanitaria Territoriali Grande Ospedale Metropolitano Niguarda, Milan, Italy
- 700 1_
- $a de Guibert, Sophie $u Hôpital de Pontchaillou, Rennes, France
- 700 1_
- $a Tumyan, Gayane $u Department of Chemotherapy of Hemoblastosis, Blokhin Russian Cancer Research Center, Moscow, Russia
- 700 1_
- $a Laribi, Kamel $u Hematology Department, Centre Hospitalier du Mans, Le Mans, France $1 https://orcid.org/0000000155897570
- 700 1_
- $a García-Marco, José A $u Unidad de Citogenetica Molecular, Servicio de Hematología, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain
- 700 1_
- $a Li, Jian-Yong $u The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, China
- 700 1_
- $a Tian, Tian $u BeiGene USA, Inc, San Mateo, CA
- 700 1_
- $a Liu, Yu $u BeiGene USA, Inc, San Mateo, CA
- 700 1_
- $a Korolkiewicz, Roman $u BeiGene USA, Inc, San Mateo, CA
- 700 1_
- $a Szeto, Andy $u BeiGene USA, Inc, San Mateo, CA $1 https://orcid.org/0000000291956520
- 700 1_
- $a Tam, Constantine S $u Alfred Health and Monash University, Melbourne, VIC, Australia $1 https://orcid.org/0000000297595017
- 700 1_
- $a Jurczak, Wojciech $u Maria Skłodowska-Curie National Research Institute of Oncology, Kraków, Poland
- 773 0_
- $w MED00002596 $t Journal of clinical oncology $x 1527-7755 $g Roč. 43, č. 7 (2025), s. 780-787
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/39647999 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y - $z 0
- 990 __
- $a 20250415 $b ABA008
- 991 __
- $a 20250429134650 $b ABA008
- 999 __
- $a ok $b bmc $g 2311231 $s 1246815
- BAS __
- $a 3
- BAS __
- $a PreBMC-MEDLINE
- BMC __
- $a 2025 $b 43 $c 7 $d 780-787 $e 20241208 $i 1527-7755 $m Journal of clinical oncology $n J Clin Oncol $x MED00002596
- LZP __
- $a Pubmed-20250415
