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

Frontline bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP) versus rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in transplantation-ineligible patients with newly diagnosed mantle cell lymphoma: final overall survival results of a randomised, open-label, phase 3 study

T. Robak, J. Jin, H. Pylypenko, G. Verhoef, N. Siritanaratkul, J. Drach, M. Raderer, J. Mayer, J. Pereira, G. Tumyan, R. Okamoto, S. Nakahara, P. Hu, C. Appiani, S. Nemat, F. Cavalli, LYM-3002 investigators,

. 2018 ; 19 (11) : 1449-1458. [pub] 20181019

Jazyk angličtina Země Anglie, Velká Británie

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

Perzistentní odkaz   https://www.medvik.cz/link/bmc19028140
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 30348538
DOI 10.1016/s1470-2045(18)30685-5
Knihovny.cz E-zdroje

BACKGROUND: In the LYM-3002 study, the efficacy and safety of frontline bortezomib plus rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP) and rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) were compared in transplant-ineligible patients with untreated, newly diagnosed, mantle cell lymphoma. We report the final overall survival and safety outcomes for patients in the long-term follow-up phase after the primary progression-free-survival endpoint was met. METHODS: LYM-3002 was a randomised, open-label, phase 3 study done at 128 clinical centres in 28 countries in Asia, Europe, North America, and South America. Adult patients with confirmed stage II-IV previously untreated mantle cell lymphoma, Eastern Cooperative Oncology Group performance status score of 2 or less, who were ineligible for bone marrow transplantation, were randomly assigned (1:1) to receive six or eight 21-day cycles of VR-CAP (intravenous rituximab 375 mg/m2, cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, and bortezomib 1·3 mg/m2, plus oral prednisone 100 mg/m2) or R-CHOP (intravenous vincristine 1·4 mg/m2 [2 mg maximum], rituximab 375 mg/m2, cyclophosphamide 750 mg/m2, and doxorubicin 50 mg/m2, plus oral prednisone 100 mg/m2). Randomisation was done according to a computer-generated randomisation schedule prepared by the sponsor; permuted blocks central randomisation was used (block size of 4), and was stratified by International Prognostic Index score and disease stage at diagnosis. The primary endpoint of this final analysis was overall survival, which was analysed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT00722137, and is closed to new participants with follow-up completed. FINDINGS: Between May 22, 2008, and Dec 5, 2011, 487 patients were enrolled and randomly assigned. 268 patients (140 in the VR-CAP group and 128 in the R-CHOP group) were included in the follow-up analysis, which included patients with data available after the primary analysis clinical cutoff date of Dec 2, 2013. After median follow-up of 82·0 months (IQR 74·1-94·2), median overall survival was significantly longer in the VR-CAP group than in the R-CHOP group (90·7 months [95% CI 71·4 to not estimable] vs 55·7 months [47·2 to 68·9]; hazard ratio 0·66 [95% CI 0·51-0·85]; p=0·001). Three new adverse events were reported since the primary analysis cutoff (one each of grade 4 lung adenocarcinoma and grade 4 gastric cancer in the VR-CAP group, and one case of grade 2 pneumonia in the R-CHOP group). 103 (42%) of 243 patients in the VR-CAP group, and 138 (57%) of 244 in the R-CHOP group died; the most common cause of death was progressive disease. INTERPRETATIONS: Compared with R-CHOP, VR-CAP was associated with significantly longer survival, and had a manageable and expected safety profile. Our results support further assessment of VR-CAP in patients with previously untreated mantle cell lymphoma. FUNDING: Janssen Research & Development.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc19028140
003      
CZ-PrNML
005      
20190815105622.0
007      
ta
008      
190813s2018 enk f 000 0|eng||
009      
AR
024    7_
$a 10.1016/S1470-2045(18)30685-5 $2 doi
035    __
$a (PubMed)30348538
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a enk
100    1_
$a Robak, Tadeusz $u Department of Hematology, Copernicus Memorial Hospital, Medical University of Lodz, Łodź, Poland. Electronic address: robaktad@csk.umed.lodz.pl.
245    10
$a Frontline bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP) versus rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in transplantation-ineligible patients with newly diagnosed mantle cell lymphoma: final overall survival results of a randomised, open-label, phase 3 study / $c T. Robak, J. Jin, H. Pylypenko, G. Verhoef, N. Siritanaratkul, J. Drach, M. Raderer, J. Mayer, J. Pereira, G. Tumyan, R. Okamoto, S. Nakahara, P. Hu, C. Appiani, S. Nemat, F. Cavalli, LYM-3002 investigators,
520    9_
$a BACKGROUND: In the LYM-3002 study, the efficacy and safety of frontline bortezomib plus rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP) and rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) were compared in transplant-ineligible patients with untreated, newly diagnosed, mantle cell lymphoma. We report the final overall survival and safety outcomes for patients in the long-term follow-up phase after the primary progression-free-survival endpoint was met. METHODS: LYM-3002 was a randomised, open-label, phase 3 study done at 128 clinical centres in 28 countries in Asia, Europe, North America, and South America. Adult patients with confirmed stage II-IV previously untreated mantle cell lymphoma, Eastern Cooperative Oncology Group performance status score of 2 or less, who were ineligible for bone marrow transplantation, were randomly assigned (1:1) to receive six or eight 21-day cycles of VR-CAP (intravenous rituximab 375 mg/m2, cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, and bortezomib 1·3 mg/m2, plus oral prednisone 100 mg/m2) or R-CHOP (intravenous vincristine 1·4 mg/m2 [2 mg maximum], rituximab 375 mg/m2, cyclophosphamide 750 mg/m2, and doxorubicin 50 mg/m2, plus oral prednisone 100 mg/m2). Randomisation was done according to a computer-generated randomisation schedule prepared by the sponsor; permuted blocks central randomisation was used (block size of 4), and was stratified by International Prognostic Index score and disease stage at diagnosis. The primary endpoint of this final analysis was overall survival, which was analysed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT00722137, and is closed to new participants with follow-up completed. FINDINGS: Between May 22, 2008, and Dec 5, 2011, 487 patients were enrolled and randomly assigned. 268 patients (140 in the VR-CAP group and 128 in the R-CHOP group) were included in the follow-up analysis, which included patients with data available after the primary analysis clinical cutoff date of Dec 2, 2013. After median follow-up of 82·0 months (IQR 74·1-94·2), median overall survival was significantly longer in the VR-CAP group than in the R-CHOP group (90·7 months [95% CI 71·4 to not estimable] vs 55·7 months [47·2 to 68·9]; hazard ratio 0·66 [95% CI 0·51-0·85]; p=0·001). Three new adverse events were reported since the primary analysis cutoff (one each of grade 4 lung adenocarcinoma and grade 4 gastric cancer in the VR-CAP group, and one case of grade 2 pneumonia in the R-CHOP group). 103 (42%) of 243 patients in the VR-CAP group, and 138 (57%) of 244 in the R-CHOP group died; the most common cause of death was progressive disease. INTERPRETATIONS: Compared with R-CHOP, VR-CAP was associated with significantly longer survival, and had a manageable and expected safety profile. Our results support further assessment of VR-CAP in patients with previously untreated mantle cell lymphoma. FUNDING: Janssen Research & Development.
650    _2
$a senioři $7 D000368
650    _2
$a myší monoklonální protilátky $x aplikace a dávkování $x škodlivé účinky $7 D058846
650    _2
$a protokoly protinádorové kombinované chemoterapie $x aplikace a dávkování $x škodlivé účinky $7 D000971
650    _2
$a bortezomib $x aplikace a dávkování $x škodlivé účinky $7 D000069286
650    _2
$a cyklofosfamid $x aplikace a dávkování $x škodlivé účinky $7 D003520
650    _2
$a progrese nemoci $7 D018450
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 lymfom z plášťových buněk $x farmakoterapie $x mortalita $x patologie $7 D020522
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a lidé středního věku $7 D008875
650    _2
$a staging nádorů $7 D009367
650    _2
$a prednison $x aplikace a dávkování $x škodlivé účinky $7 D011241
650    _2
$a doba přežití bez progrese choroby $7 D000077982
650    _2
$a rituximab $x aplikace a dávkování $x škodlivé účinky $7 D000069283
650    _2
$a časové faktory $7 D013997
650    _2
$a vinkristin $x aplikace a dávkování $x škodlivé účinky $7 D014750
651    _2
$a Asie $7 D001208
651    _2
$a Evropa $7 D005060
651    _2
$a Severní Amerika $7 D009656
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 multicentrická studie $7 D016448
655    _2
$a randomizované kontrolované studie $7 D016449
655    _2
$a práce podpořená grantem $7 D013485
700    1_
$a Jin, Jie $u Department of Hematology, The First Affiliated Hospital of Zhejiang University College of Medicine, Hangzhou, China.
700    1_
$a Pylypenko, Halyna $u Department of Hematology, Cherkassy Regional Oncology Center, Cherkassy, Ukraine.
700    1_
$a Verhoef, Gregor $u Department of Hematology, UZ Leuven Gasthuisberg Hematologie, Leuven, Belgium.
700    1_
$a Siritanaratkul, Noppadol $u Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
700    1_
$a Drach, Johannes $u Allgemeines Krankenhaus der Stadt Wien, Vienna, Austria.
700    1_
$a Raderer, Markus $u Department of Internal Medicine I, Division of Oncology, Medical University of Vienna, Vienna General Hospital, Vienna, Austria.
700    1_
$a Mayer, Jiri $u Department of Internal Medicine Hematology and Oncology, Masaryk University Hospital Brno, Brno, Czech Republic.
700    1_
$a Pereira, Juliana $u Hospital Das Clinicas Da Faculdade De Medicina Da USP, São Paulo, Brazil.
700    1_
$a Tumyan, Gayane $u Cancer Research Center Rams, N N Blokhin Academy of Medical Science, Moscow, Russia.
700    1_
$a Okamoto, Rumiko $u Chibanishi General Hospital, Chiba, Japan.
700    1_
$a Nakahara, Susumu $u Janssen Pharmaceuticals, Tokyo, Japan.
700    1_
$a Hu, Peter $u Janssen Research & Development, Raritan, NJ, USA.
700    1_
$a Appiani, Carlos $u Janssen Research & Development, Raritan, NJ, USA.
700    1_
$a Nemat, Sepideh $u Janssen Research & Development, High Wycombe, UK.
700    1_
$a Cavalli, Franco $u Oncology Institute of Southern Switzerland, Ospedale San Giovanni, Bellinzona, Switzerland.
710    2_
$a LYM-3002 investigators
773    0_
$w MED00011558 $t The Lancet. Oncology $x 1474-5488 $g Roč. 19, č. 11 (2018), s. 1449-1458
856    41
$u https://pubmed.ncbi.nlm.nih.gov/30348538 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y a $z 0
990    __
$a 20190813 $b ABA008
991    __
$a 20190815105850 $b ABA008
999    __
$a ok $b bmc $g 1433289 $s 1066600
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2018 $b 19 $c 11 $d 1449-1458 $e 20181019 $i 1474-5488 $m Lancet oncology $n Lancet Oncol. $x MED00011558
LZP    __
$a Pubmed-20190813

Najít záznam

Citační ukazatele

Pouze přihlášení uživatelé

Možnosti archivace