• Je něco špatně v tomto záznamu ?

Management of adverse events associated with ixazomib plus lenalidomide/dexamethasone in relapsed/refractory multiple myeloma

S. Kumar, P. Moreau, P. Hari, MV. Mateos, H. Ludwig, C. Shustik, T. Masszi, A. Spencer, R. Hájek, K. Romeril, I. Avivi, AM. Liberati, MC. Minnema, H. Einsele, S. Lonial, D. Berg, J. Lin, N. Gupta, DL. Esseltine, PG. Richardson,

. 2017 ; 178 (4) : 571-582. [pub] 20170509

Jazyk angličtina Země Anglie, Velká Británie

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

Perzistentní odkaz   https://www.medvik.cz/link/bmc17030821

The oral proteasome inhibitor ixazomib is approved in the United States, European Union and other countries, in combination with oral lenalidomide and dexamethasone (Rd), for the treatment of patients with multiple myeloma who have received at least one prior therapy. Approval was based on the global, randomised, double-blind, placebo-controlled Phase III TOURMALINE-MM1 study of ixazomib-Rd (IRd) versus placebo-Rd in patients with relapsed/refractory multiple myeloma. IRd resulted in a significant improvement in progression-free survival versus placebo-Rd (median: 20·6 vs. 14·7 months; hazard ratio 0·74). Common toxicities observed more commonly with IRd versus placebo-Rd were thrombocytopenia, nausea, vomiting, diarrhoea, constipation, rash, peripheral neuropathy, peripheral oedema and back pain; these were generally grade 1/2 in severity except for thrombocytopenia (19% vs. 9% grade 3/4), which appeared manageable and reversible, with no differences between arms in significant bleeding or dose discontinuations. No cumulative toxicities were observed, indicating the potential feasibility of long-term IRd treatment. Safety data from TOURMALINE-MM1 are reviewed and guidance for managing clinically relevant adverse events associated with IRd is provided. Most toxicities were manageable with supportive care and dose delays or reductions as needed. Clinicians should be aware of and understand these potential side effects to optimise and prolong patient benefit.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc17030821
003      
CZ-PrNML
005      
20171025115402.0
007      
ta
008      
171025s2017 enk f 000 0|eng||
009      
AR
024    7_
$a 10.1111/bjh.14733 $2 doi
035    __
$a (PubMed)28485007
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a enk
100    1_
$a Kumar, Shaji $u Division of Hematology, Mayo Clinic, Rochester, MN, USA.
245    10
$a Management of adverse events associated with ixazomib plus lenalidomide/dexamethasone in relapsed/refractory multiple myeloma / $c S. Kumar, P. Moreau, P. Hari, MV. Mateos, H. Ludwig, C. Shustik, T. Masszi, A. Spencer, R. Hájek, K. Romeril, I. Avivi, AM. Liberati, MC. Minnema, H. Einsele, S. Lonial, D. Berg, J. Lin, N. Gupta, DL. Esseltine, PG. Richardson,
520    9_
$a The oral proteasome inhibitor ixazomib is approved in the United States, European Union and other countries, in combination with oral lenalidomide and dexamethasone (Rd), for the treatment of patients with multiple myeloma who have received at least one prior therapy. Approval was based on the global, randomised, double-blind, placebo-controlled Phase III TOURMALINE-MM1 study of ixazomib-Rd (IRd) versus placebo-Rd in patients with relapsed/refractory multiple myeloma. IRd resulted in a significant improvement in progression-free survival versus placebo-Rd (median: 20·6 vs. 14·7 months; hazard ratio 0·74). Common toxicities observed more commonly with IRd versus placebo-Rd were thrombocytopenia, nausea, vomiting, diarrhoea, constipation, rash, peripheral neuropathy, peripheral oedema and back pain; these were generally grade 1/2 in severity except for thrombocytopenia (19% vs. 9% grade 3/4), which appeared manageable and reversible, with no differences between arms in significant bleeding or dose discontinuations. No cumulative toxicities were observed, indicating the potential feasibility of long-term IRd treatment. Safety data from TOURMALINE-MM1 are reviewed and guidance for managing clinically relevant adverse events associated with IRd is provided. Most toxicities were manageable with supportive care and dose delays or reductions as needed. Clinicians should be aware of and understand these potential side effects to optimise and prolong patient benefit.
650    _2
$a aplikace orální $7 D000284
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 škodlivé účinky $x terapeutické užití $7 D000971
650    _2
$a sloučeniny boru $x aplikace a dávkování $x škodlivé účinky $7 D001896
650    _2
$a dexamethason $x aplikace a dávkování $x škodlivé účinky $7 D003907
650    _2
$a vztah mezi dávkou a účinkem léčiva $7 D004305
650    _2
$a dvojitá slepá metoda $7 D004311
650    _2
$a rozvrh dávkování léků $7 D004334
650    _2
$a léková dermatitida $x etiologie $x terapie $7 D003875
650    _2
$a následné studie $7 D005500
650    _2
$a glycin $x aplikace a dávkování $x škodlivé účinky $x analogy a deriváty $7 D005998
650    _2
$a krevní nemoci $x chemicky indukované $x terapie $7 D006402
650    _2
$a lidé $7 D006801
650    _2
$a počet leukocytů $7 D007958
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a lidé středního věku $7 D008875
650    _2
$a mnohočetný myelom $x farmakoterapie $7 D009101
650    _2
$a nauzea $x chemicky indukované $x terapie $7 D009325
650    _2
$a nemoci periferního nervového systému $x chemicky indukované $x terapie $7 D010523
650    _2
$a počet trombocytů $7 D010976
650    _2
$a thalidomid $x aplikace a dávkování $x škodlivé účinky $x analogy a deriváty $7 D013792
650    _2
$a zvracení $x chemicky indukované $x terapie $7 D014839
655    _2
$a klinické zkoušky, fáze III $7 D017428
655    _2
$a časopisecké články $7 D016428
655    _2
$a multicentrická studie $7 D016448
655    _2
$a randomizované kontrolované studie $7 D016449
700    1_
$a Moreau, Philippe $u University Hospital Hôtel Dieu, Nantes, France.
700    1_
$a Hari, Parameswaran $u Division of Hematology and Oncology, Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, WI, USA.
700    1_
$a Mateos, Maria-Victoria $u Servicio de Hematología, Hospital Universitario de Salamanca, Salamanca, Spain.
700    1_
$a Ludwig, Heinz $u Wilhelminenspital der Stadt Wien, Vienna, Austria.
700    1_
$a Shustik, Chaim $u McGill University Health Center, Royal Victoria Hospital, Montreal, Canada.
700    1_
$a Masszi, Tamas $u Department of Haematology and Stem Cell Transplantation, St István and St László Hospital, Semmelweis University, Budapest, Hungary.
700    1_
$a Spencer, Andrew $u Alfred Health-Monash University, Melbourne, Australia.
700    1_
$a Hájek, Roman $u Department of Haematooncology, University Hospital Ostrava, Ostrava, Czech Republic.
700    1_
$a Romeril, Kenneth $u Wellington Blood and Cancer Centre, Wellington Regional Hospital, Wellington, New Zealand.
700    1_
$a Avivi, Irit $u Department of Haematology and Bone Marrow Transplantation, Tel Aviv Medical Centre, Tel Aviv, Israel. $7 gn_A_00010373
700    1_
$a Liberati, Anna M $u University of Perugia, SC Oncoematologia AO S. Maria di Terni, Terni, Italy.
700    1_
$a Minnema, Monique C $u Department of Haematology, UMC Utrecht Cancer Centre, Utrecht, The Netherlands.
700    1_
$a Einsele, Hermann $u Universitätsklinik Würzburg, Medizinische Klinik und Poliklinik II, Würzburg, Germany.
700    1_
$a Lonial, Sagar $u Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA, USA.
700    1_
$a Berg, Deborah $u Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.
700    1_
$a Lin, Jianchang $u Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.
700    1_
$a Gupta, Neeraj $u Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.
700    1_
$a Esseltine, Dixie-Lee $u Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.
700    1_
$a Richardson, Paul G $u Dana-Farber Cancer Institute, Boston, MA, USA.
773    0_
$w MED00009374 $t British journal of haematology $x 1365-2141 $g Roč. 178, č. 4 (2017), s. 571-582
856    41
$u https://pubmed.ncbi.nlm.nih.gov/28485007 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y a $z 0
990    __
$a 20171025 $b ABA008
991    __
$a 20171025115444 $b ABA008
999    __
$a ok $b bmc $g 1254414 $s 991848
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2017 $b 178 $c 4 $d 571-582 $e 20170509 $i 1365-2141 $m British journal of haematology $n Br J Haematol $x MED00009374
LZP    __
$a Pubmed-20171025

Najít záznam

Citační ukazatele

    Možnosti archivace