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

ROBUST: A Phase III Study of Lenalidomide Plus R-CHOP Versus Placebo Plus R-CHOP in Previously Untreated Patients With ABC-Type Diffuse Large B-Cell Lymphoma

GS. Nowakowski, A. Chiappella, RD. Gascoyne, DW. Scott, Q. Zhang, W. Jurczak, M. Özcan, X. Hong, J. Zhu, J. Jin, D. Belada, JM. Bergua, F. Piazza, H. Mócikova, AL. Molinari, DH. Yoon, F. Cavallo, M. Tani, K. Yamamoto, K. Izutsu, K. Kato, M....

. 2021 ; 39 (12) : 1317-1328. [pub] 20210223

Jazyk angličtina Země Spojené státy americké

Typ dokumentu klinické zkoušky, fáze III, srovnávací studie, časopisecké články, randomizované kontrolované studie, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc22004443

PURPOSE: Patients with the activated B-cell-like (ABC) subtype of diffuse large B-cell lymphoma (DLBCL) historically showed inferior survival with standard rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). Phase II studies demonstrated that adding the immunomodulatory agent lenalidomide to R-CHOP improved outcomes in ABC-type DLBCL. The goal of the global, phase III ROBUST study was to compare lenalidomide plus R-CHOP (R2-CHOP) with placebo/R-CHOP in previously untreated, ABC-type DLBCL. METHODS: Histology and cell-of-origin type were prospectively analyzed by central pathology prior to random assignment and study treatment. Patients with ABC-DLBCL received lenalidomide oral 15 mg/d, days 1-14/21 plus standard R-CHOP21 versus placebo/R-CHOP21 for six cycles. The primary end point was progression-free survival (PFS) per independent central radiology review. RESULTS: A total of 570 patients with ABC-DLBCL (n = 285 per arm) were stratified by International Prognostic Index score, age, and bulky disease, and randomly assigned to R2-CHOP or placebo/R-CHOP. Baseline demographics were similar between arms. Most patients completed six cycles of treatment: 74% R2-CHOP and 84% placebo/R-CHOP. The most common grade 3/4 adverse events for R2-CHOP versus placebo/R-CHOP were neutropenia (60% v 48%), anemia (22% v 14%), thrombocytopenia (17% v 11%), and leukopenia (14% v 15%). The primary end point of PFS was not met, with a hazard ratio of 0.85 (95% CI, 0.63 to 1.14) and P = .29; median PFS has not been reached for either arm. PFS trends favoring R2-CHOP over placebo/R-CHOP were seen in patients with higher-risk disease. CONCLUSION: ROBUST is the first DLBCL phase III study to integrate biomarker-driven identification of eligible ABC patients. Although the ROBUST trial did not meet the primary end point of PFS in all patients, the safety profile of R2-CHOP was consistent with individual treatments with no new safety signals.

4th Department of Internal Medicine Hematology Charles University Hospital and Faculty of Medicine Hradec Králové Czech Republic

AOU Città della Salute e della Scienza di Torino Turin Italy

Beijing Cancer Hospital Beijing China

Cancer Hospital Fudan University Shanghai China

Centre for Lymphoid Cancer British Columbia Cancer Vancouver British Columbia Canada

Clinical Research and Development Celgene Corporation Summit NJ

Department of Hematology and Cell Therapy Aichi Cancer Center Hospital Nagoya Japan

Department of Hematology Ankara University Ankara Turkey

Department of Internal Medicine and Haematology Faculty Hospital Kralovske Vinohrady Prague Czech Republic

Department of Medicine and Biosystemic Science Kyushu University Faculty of Medicine Fukuoka City Japan

Department of Oncology Asan Medical Center University of Ulsan College of Medicine Seoul South Korea

Department of Statistical Programming Celgene Corporation Overland Park KS

Division of Hematology A O U Città della Salute e della Scienza Hospital and University Torino Italy

Division of Hematology Department of Medicine University of Padova and Azienda Ospedaliera di Padova Padova Italy

Division of Hematology Mayo Clinic Rochester MN

Harbin Medical University Cancer Hospital Harbin Heilongjiang China

Maria Sklodowska Curie Institute Oncology Centre Cracow Poland

National Cancer Center Hospital Tokyo Japan

Servicio de Hematologia Hospital Universitario San Pedro de Alcántara Cáceres Spain

The 1st Affiliated Hospital of Medical School of Zhejiang University 1st Hospital of Zhejiang Province Hangzhou Zhejiang China

Translational Development Precision Medicine and Companion Diagnostics Celgene Corporation Summit NJ

U O Ematologia Dipartimento Oncologia e Ematologia Ospedale Santa Maria delle Croci Ravenna Italy

UO Ematologia Ospedale Degli Infermi Rimini Italy

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc22004443
003      
CZ-PrNML
005      
20220127145233.0
007      
ta
008      
220113s2021 xxu f 000 0|eng||
009      
AR
024    7_
$a 10.1200/JCO.20.01366 $2 doi
035    __
$a (PubMed)33621109
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxu
100    1_
$a Nowakowski, Grzegorz S $u Division of Hematology, Mayo Clinic, Rochester, MN
245    10
$a ROBUST: A Phase III Study of Lenalidomide Plus R-CHOP Versus Placebo Plus R-CHOP in Previously Untreated Patients With ABC-Type Diffuse Large B-Cell Lymphoma / $c GS. Nowakowski, A. Chiappella, RD. Gascoyne, DW. Scott, Q. Zhang, W. Jurczak, M. Özcan, X. Hong, J. Zhu, J. Jin, D. Belada, JM. Bergua, F. Piazza, H. Mócikova, AL. Molinari, DH. Yoon, F. Cavallo, M. Tani, K. Yamamoto, K. Izutsu, K. Kato, M. Czuczman, S. Hersey, A. Kilcoyne, J. Russo, K. Hudak, J. Zhang, S. Wade, TE. Witzig, U. Vitolo
520    9_
$a PURPOSE: Patients with the activated B-cell-like (ABC) subtype of diffuse large B-cell lymphoma (DLBCL) historically showed inferior survival with standard rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). Phase II studies demonstrated that adding the immunomodulatory agent lenalidomide to R-CHOP improved outcomes in ABC-type DLBCL. The goal of the global, phase III ROBUST study was to compare lenalidomide plus R-CHOP (R2-CHOP) with placebo/R-CHOP in previously untreated, ABC-type DLBCL. METHODS: Histology and cell-of-origin type were prospectively analyzed by central pathology prior to random assignment and study treatment. Patients with ABC-DLBCL received lenalidomide oral 15 mg/d, days 1-14/21 plus standard R-CHOP21 versus placebo/R-CHOP21 for six cycles. The primary end point was progression-free survival (PFS) per independent central radiology review. RESULTS: A total of 570 patients with ABC-DLBCL (n = 285 per arm) were stratified by International Prognostic Index score, age, and bulky disease, and randomly assigned to R2-CHOP or placebo/R-CHOP. Baseline demographics were similar between arms. Most patients completed six cycles of treatment: 74% R2-CHOP and 84% placebo/R-CHOP. The most common grade 3/4 adverse events for R2-CHOP versus placebo/R-CHOP were neutropenia (60% v 48%), anemia (22% v 14%), thrombocytopenia (17% v 11%), and leukopenia (14% v 15%). The primary end point of PFS was not met, with a hazard ratio of 0.85 (95% CI, 0.63 to 1.14) and P = .29; median PFS has not been reached for either arm. PFS trends favoring R2-CHOP over placebo/R-CHOP were seen in patients with higher-risk disease. CONCLUSION: ROBUST is the first DLBCL phase III study to integrate biomarker-driven identification of eligible ABC patients. Although the ROBUST trial did not meet the primary end point of PFS in all patients, the safety profile of R2-CHOP was consistent with individual treatments with no new safety signals.
650    _2
$a dospělí $7 D000328
650    _2
$a senioři $7 D000368
650    _2
$a senioři nad 80 let $7 D000369
650    _2
$a protokoly protinádorové kombinované chemoterapie $x aplikace a dávkování $x škodlivé účinky $7 D000971
650    _2
$a cyklofosfamid $x aplikace a dávkování $x škodlivé účinky $7 D003520
650    _2
$a doxorubicin $x aplikace a dávkování $x škodlivé účinky $7 D004317
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a lidé $7 D006801
650    _2
$a lenalidomid $x aplikace a dávkování $x škodlivé účinky $7 D000077269
650    _2
$a difúzní velkobuněčný B-lymfom $x farmakoterapie $x mortalita $7 D016403
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a lidé středního věku $7 D008875
650    _2
$a prednison $x aplikace a dávkování $x škodlivé účinky $7 D011241
650    _2
$a rituximab $x aplikace a dávkování $x škodlivé účinky $7 D000069283
650    _2
$a vinkristin $x aplikace a dávkování $x škodlivé účinky $7 D014750
650    _2
$a mladý dospělý $7 D055815
655    _2
$a klinické zkoušky, fáze III $7 D017428
655    _2
$a srovnávací studie $7 D003160
655    _2
$a časopisecké články $7 D016428
655    _2
$a randomizované kontrolované studie $7 D016449
655    _2
$a práce podpořená grantem $7 D013485
700    1_
$a Chiappella, Annalisa $u Division of Hematology, A.O.U. Città della Salute e della Scienza Hospital and University, Torino, Italy
700    1_
$a Gascoyne, Randy D $u Centre for Lymphoid Cancer, British Columbia Cancer, Vancouver, British Columbia, Canada
700    1_
$a Scott, David W $u Centre for Lymphoid Cancer, British Columbia Cancer, Vancouver, British Columbia, Canada
700    1_
$a Zhang, Qingyuan $u Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
700    1_
$a Jurczak, Wojciech $u Maria Sklodowska-Curie Institute-Oncology Centre, Cracow, Poland
700    1_
$a Özcan, Muhit $u Department of Hematology, Ankara University, Ankara, Turkey
700    1_
$a Hong, Xiaonan $u Cancer Hospital, Fudan University, Shanghai, China
700    1_
$a Zhu, Jun $u Beijing Cancer Hospital, Beijing, China
700    1_
$a Jin, Jie $u The First Affiliated Hospital of Medical School of Zhejiang University, First Hospital of Zhejiang Province, Hangzhou, Zhejiang, China
700    1_
$a Belada, David $u Fourth Department of Internal Medicine-Hematology, Charles University Hospital and Faculty of Medicine, Hradec Králové, Czech Republic
700    1_
$a Bergua, Juan Miguel $u Servicio de Hematologia, Hospital Universitario San Pedro de Alcántara, Cáceres, Spain
700    1_
$a Piazza, Francesco $u Division of Hematology, Department of Medicine, University of Padova and Azienda Ospedaliera di Padova, Padova, Italy
700    1_
$a Mócikova, Heidi $u Department of Internal Medicine and Haematology, Faculty Hospital Kralovske Vinohrady, Prague, Czech Republic
700    1_
$a Molinari, Anna Lia $u UO Ematologia, Ospedale Degli Infermi, Rimini, Italy
700    1_
$a Yoon, Dok Hyun $u Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
700    1_
$a Cavallo, Federica $u AOU Città della Salute e della Scienza di Torino, Turin, Italy
700    1_
$a Tani, Monica $u U.O. Ematologia, Dipartimento Oncologia e Ematologia, Ospedale Santa Maria delle Croci, Ravenna, Italy
700    1_
$a Yamamoto, Kazuhito $u Department of Hematology and Cell Therapy, Aichi Cancer Center Hospital, Nagoya, Japan
700    1_
$a Izutsu, Koji $u National Cancer Center Hospital, Tokyo, Japan
700    1_
$a Kato, Koji $u Department of Medicine and Biosystemic Science, Kyushu University Faculty of Medicine, Fukuoka City, Japan
700    1_
$a Czuczman, Myron $u Clinical Research and Development, Celgene Corporation, Summit, NJ
700    1_
$a Hersey, Sarah $u Translational Development, Precision Medicine and Companion Diagnostics, Celgene Corporation, Summit, NJ
700    1_
$a Kilcoyne, Adrian $u Clinical Research and Development, Celgene Corporation, Summit, NJ
700    1_
$a Russo, Jacqueline $u Clinical Research and Development, Celgene Corporation, Summit, NJ
700    1_
$a Hudak, Krista $u Clinical Research and Development, Celgene Corporation, Summit, NJ
700    1_
$a Zhang, Jingshan $u Clinical Research and Development, Celgene Corporation, Summit, NJ
700    1_
$a Wade, Steve $u Department of Statistical Programming, Celgene Corporation, Overland Park, KS
700    1_
$a Witzig, Thomas E $u Division of Hematology, Mayo Clinic, Rochester, MN
700    1_
$a Vitolo, Umberto $u Division of Hematology, A.O.U. Città della Salute e della Scienza Hospital and University, Torino, Italy
773    0_
$w MED00002596 $t Journal of clinical oncology : official journal of the American Society of Clinical Oncology $x 1527-7755 $g Roč. 39, č. 12 (2021), s. 1317-1328
856    41
$u https://pubmed.ncbi.nlm.nih.gov/33621109 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y p $z 0
990    __
$a 20220113 $b ABA008
991    __
$a 20220127145229 $b ABA008
999    __
$a ok $b bmc $g 1751800 $s 1155592
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2021 $b 39 $c 12 $d 1317-1328 $e 20210223 $i 1527-7755 $m Journal of clinical oncology $n J. clin. Oncol. $x MED00002596
LZP    __
$a Pubmed-20220113

Najít záznam

Citační ukazatele

Možnosti archivace