-
Je něco špatně v tomto záznamu ?
Adjuvant Nivolumab versus Ipilimumab in Resected Stage III/IV Melanoma: 5-Year Efficacy and Biomarker Results from CheckMate 238
J. Larkin, M. Del Vecchio, M. Mandalá, H. Gogas, AM. Arance Fernandez, S. Dalle, CL. Cowey, M. Schenker, JJ. Grob, V. Chiarion-Sileni, I. Marquez-Rodas, MO. Butler, AM. Di Giacomo, MR. Middleton, J. Lutzky, L. de la Cruz-Merino, P. Arenberger, V....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu časopisecké články, práce podpořená grantem
NLK
Free Medical Journals
od 1995 do Před 1 rokem
Freely Accessible Science Journals
od 1995
Open Access Digital Library
od 1995-01-01
Open Access Digital Library
od 1995-01-01
- MeSH
- adjuvancia imunologická terapeutické užití MeSH
- antigeny CD274 MeSH
- antigeny CD279 terapeutické užití MeSH
- biologické markery MeSH
- ipilimumab terapeutické užití MeSH
- lidé MeSH
- lokální recidiva nádoru farmakoterapie MeSH
- melanom * farmakoterapie genetika patologie MeSH
- nivolumab * aplikace a dávkování MeSH
- protokoly antitumorózní kombinované chemoterapie terapeutické užití MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
PURPOSE: In the phase III CheckMate 238 study, adjuvant nivolumab significantly improved recurrence-free survival (RFS) and distant metastasis-free survival versus ipilimumab in patients with resected stage IIIB-C or stage IV melanoma, with benefit sustained at 4 years. We report updated 5-year efficacy and biomarker findings. PATIENTS AND METHODS: Patients with resected stage IIIB-C/IV melanoma were stratified by stage and baseline programmed death cell ligand 1 (PD-L1) expression and received nivolumab 3 mg/kg every 2 weeks or ipilimumab 10 mg/kg every 3 weeks for four doses and then every 12 weeks, both intravenously for 1 year until disease recurrence, unacceptable toxicity, or withdrawal of consent. The primary endpoint was RFS. RESULTS: At a minimum follow-up of 62 months, RFS with nivolumab remained superior to ipilimumab (HR = 0.72; 95% confidence interval, 0.60-0.86; 5-year rates of 50% vs. 39%). Five-year distant metastasis-free survival (DMFS) rates were 58% with nivolumab versus 51% with ipilimumab. Five-year overall survival (OS) rates were 76% with nivolumab and 72% with ipilimumab (75% data maturity: 228 of 302 planned events). Higher levels of tumor mutational burden (TMB), tumor PD-L1, intratumoral CD8+ T cells and IFNγ-associated gene expression signature, and lower levels of peripheral serum C-reactive protein were associated with improved RFS and OS with both nivolumab and ipilimumab, albeit with limited clinically meaningful predictive value. CONCLUSIONS: Nivolumab is a proven adjuvant treatment for resected melanoma at high risk of recurrence, with sustained, long-term improvement in RFS and DMFS compared with ipilimumab and high OS rates. Identification of additional biomarkers is needed to better predict treatment outcome. See related commentary by Augustin and Luke, p. 3253.
Aix Marseille University Hôpital de la Timone Marseille France
Bristol Myers Squibb Princeton New Jersey
Center for Immuno Oncology University Hospital of Siena Siena Italy
Churchill Hospital Oxford United Kingdom
Fondazione IRCCS Istituto Nazionale dei Tumori Milan Italy
Gallipoli Medical Research Foundation Greenslopes Private Hospital Greenslopes Queensland Australia
General University Hospital Gregorio Marañón and CIBERONC Madrid Spain
H Lee Moffitt Cancer Center Tampa Florida
Hospices Civils de Lyon Pierre Bénite France
Hospital Clínic de Barcelona Barcelona Spain
IEO European Institute of Oncology IRCCS Milan Italy
Istituto Nazionale Tumori IRCCS Fondazione G Pascale Naples Italy
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health New York
Mount Vernon Hospital Middlesex United Kingdom
National and Kapodistrian University of Athens Athens Greece
Oncology Center Sf Nectarie Ltd Craiova Romania
Papa Giovanni XIII Hospital Bergamo Italy
Princess Margaret Cancer Centre Toronto Ontario Canada
Sylvester Comprehensive Cancer Center Miami Florida
Tasman Health Care Southport QLD Australia
Texas Oncology Baylor Charles A Sammons Cancer Center Dallas Texas
The Royal Marsden NHS Foundation Trust London United Kingdom
University of Michigan Rogel Cancer Center Ann Arbor Michigan
Citace poskytuje Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc23016449
- 003
- CZ-PrNML
- 005
- 20231026105813.0
- 007
- ta
- 008
- 231013s2023 xxu f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1158/1078-0432.CCR-22-3145 $2 doi
- 035 __
- $a (PubMed)37058595
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a xxu
- 100 1_
- $a Larkin, James $u The Royal Marsden NHS Foundation Trust, London, United Kingdom $1 https://orcid.org/0000000155699523
- 245 10
- $a Adjuvant Nivolumab versus Ipilimumab in Resected Stage III/IV Melanoma: 5-Year Efficacy and Biomarker Results from CheckMate 238 / $c J. Larkin, M. Del Vecchio, M. Mandalá, H. Gogas, AM. Arance Fernandez, S. Dalle, CL. Cowey, M. Schenker, JJ. Grob, V. Chiarion-Sileni, I. Marquez-Rodas, MO. Butler, AM. Di Giacomo, MR. Middleton, J. Lutzky, L. de la Cruz-Merino, P. Arenberger, V. Atkinson, AG. Hill, LA. Fecher, M. Millward, PD. Nathan, NI. Khushalani, P. Queirolo, C. Ritchings, M. Lobo, M. Askelson, H. Tang, S. Dolfi, PA. Ascierto, J. Weber
- 520 9_
- $a PURPOSE: In the phase III CheckMate 238 study, adjuvant nivolumab significantly improved recurrence-free survival (RFS) and distant metastasis-free survival versus ipilimumab in patients with resected stage IIIB-C or stage IV melanoma, with benefit sustained at 4 years. We report updated 5-year efficacy and biomarker findings. PATIENTS AND METHODS: Patients with resected stage IIIB-C/IV melanoma were stratified by stage and baseline programmed death cell ligand 1 (PD-L1) expression and received nivolumab 3 mg/kg every 2 weeks or ipilimumab 10 mg/kg every 3 weeks for four doses and then every 12 weeks, both intravenously for 1 year until disease recurrence, unacceptable toxicity, or withdrawal of consent. The primary endpoint was RFS. RESULTS: At a minimum follow-up of 62 months, RFS with nivolumab remained superior to ipilimumab (HR = 0.72; 95% confidence interval, 0.60-0.86; 5-year rates of 50% vs. 39%). Five-year distant metastasis-free survival (DMFS) rates were 58% with nivolumab versus 51% with ipilimumab. Five-year overall survival (OS) rates were 76% with nivolumab and 72% with ipilimumab (75% data maturity: 228 of 302 planned events). Higher levels of tumor mutational burden (TMB), tumor PD-L1, intratumoral CD8+ T cells and IFNγ-associated gene expression signature, and lower levels of peripheral serum C-reactive protein were associated with improved RFS and OS with both nivolumab and ipilimumab, albeit with limited clinically meaningful predictive value. CONCLUSIONS: Nivolumab is a proven adjuvant treatment for resected melanoma at high risk of recurrence, with sustained, long-term improvement in RFS and DMFS compared with ipilimumab and high OS rates. Identification of additional biomarkers is needed to better predict treatment outcome. See related commentary by Augustin and Luke, p. 3253.
- 650 _2
- $a lidé $7 D006801
- 650 12
- $a nivolumab $x aplikace a dávkování $7 D000077594
- 650 _2
- $a ipilimumab $x terapeutické užití $7 D000074324
- 650 _2
- $a antigeny CD274 $7 D060890
- 650 _2
- $a antigeny CD279 $x terapeutické užití $7 D061026
- 650 _2
- $a protokoly antitumorózní kombinované chemoterapie $x terapeutické užití $7 D000971
- 650 _2
- $a lokální recidiva nádoru $x farmakoterapie $7 D009364
- 650 12
- $a melanom $x farmakoterapie $x genetika $x patologie $7 D008545
- 650 _2
- $a adjuvancia imunologická $x terapeutické užití $7 D000276
- 650 _2
- $a biologické markery $7 D015415
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a práce podpořená grantem $7 D013485
- 700 1_
- $a Del Vecchio, Michele $u Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy $1 https://orcid.org/0000000190602512
- 700 1_
- $a Mandalá, Mario $u Papa Giovanni XIII Hospital, Bergamo, Italy $1 https://orcid.org/0000000188468959
- 700 1_
- $a Gogas, Helen $u National and Kapodistrian University of Athens, Athens, Greece $1 https://orcid.org/0000000204512885
- 700 1_
- $a Arance Fernandez, Ana M $u Hospital Clínic de Barcelona, Barcelona, Spain $1 https://orcid.org/0000000328961957
- 700 1_
- $a Dalle, Stéphane $u Hospices Civils de Lyon, Pierre Bénite, France $1 https://orcid.org/0000000234234548
- 700 1_
- $a Cowey, Charles Lance $u Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, Texas $1 https://orcid.org/0000000297265309
- 700 1_
- $a Schenker, Michael $u Oncology Center Sf Nectarie Ltd., Craiova, Romania $1 https://orcid.org/0000000326456391
- 700 1_
- $a Grob, Jean-Jacques $u Aix Marseille University, Hôpital de la Timone, Marseille, France $1 https://orcid.org/000000020667153X
- 700 1_
- $a Chiarion-Sileni, Vanna $u Veneto Institute of Oncology IOV - IRCCS, Padua, Italy $1 https://orcid.org/0000000191919124
- 700 1_
- $a Marquez-Rodas, Ivan $u General University Hospital Gregorio Marañón and CIBERONC, Madrid, Spain $1 https://orcid.org/000000022476668X
- 700 1_
- $a Butler, Marcus O $u Princess Margaret Cancer Centre, Toronto, Ontario, Canada $1 https://orcid.org/0000000298407057
- 700 1_
- $a Di Giacomo, Anna Maria $u Center for Immuno-Oncology, University Hospital of Siena, Siena, Italy $1 https://orcid.org/0000000193152158
- 700 1_
- $a Middleton, Mark R $u Churchill Hospital, Oxford, United Kingdom $1 https://orcid.org/0000000301671685
- 700 1_
- $a Lutzky, Jose $u Sylvester Comprehensive Cancer Center, Miami, Florida $1 https://orcid.org/0000000295032130
- 700 1_
- $a de la Cruz-Merino, Luis $u Hospital Universitario Virgen Macarena, Clinical Oncology Department, University of Seville, Seville, Spain $1 https://orcid.org/0000000253330535
- 700 1_
- $a Arenberger, Petr $u Charles University Third Faculty of Medicine and University Hospital Kralovske Vinohrady, Prague, Czech Republic $1 https://orcid.org/0000000248005877 $7 nlk19990072992
- 700 1_
- $a Atkinson, Victoria $u Gallipoli Medical Research Foundation, Greenslopes Private Hospital, Greenslopes, Queensland, Australia $1 https://orcid.org/0000000298069019
- 700 1_
- $a Hill, Andrew G $u Tasman Health Care, Southport, QLD, Australia $1 https://orcid.org/0009000195519141
- 700 1_
- $a Fecher, Leslie A $u University of Michigan Rogel Cancer Center, Ann Arbor, Michigan $1 https://orcid.org/0000000265347457
- 700 1_
- $a Millward, Michael $u University of Western Australia and Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia $1 https://orcid.org/0000000217441617 $7 xx0113999
- 700 1_
- $a Nathan, Paul D $u Mount Vernon Hospital, Middlesex, United Kingdom $1 https://orcid.org/0000000223273250
- 700 1_
- $a Khushalani, Nikhil I $u H. Lee Moffitt Cancer Center, Tampa, Florida $1 https://orcid.org/0000000236364143
- 700 1_
- $a Queirolo, Paola $u IEO, European Institute of Oncology IRCCS, Milan, Italy $1 https://orcid.org/0000000299176633
- 700 1_
- $a Ritchings, Corey $u Bristol Myers Squibb, Princeton, New Jersey $1 https://orcid.org/0000000292409211
- 700 1_
- $a Lobo, Maurice $u Bristol Myers Squibb, Princeton, New Jersey $1 https://orcid.org/0009000846746744
- 700 1_
- $a Askelson, Margarita $u Bristol Myers Squibb, Princeton, New Jersey $1 https://orcid.org/0000000191337693
- 700 1_
- $a Tang, Hao $u Bristol Myers Squibb, Princeton, New Jersey $1 https://orcid.org/0000000346537244
- 700 1_
- $a Dolfi, Sonia $u Bristol Myers Squibb, Princeton, New Jersey $1 https://orcid.org/0000000194544583
- 700 1_
- $a Ascierto, Paolo A $u Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale", Naples, Italy $1 https://orcid.org/000000028322475X
- 700 1_
- $a Weber, Jeffrey $u Laura and Isaac Perlmutter Cancer Center at NYU Langone Health, New York $1 https://orcid.org/0000000249622957
- 773 0_
- $w MED00001121 $t Clinical cancer research : an official journal of the American Association for Cancer Research $x 1557-3265 $g Roč. 29, č. 17 (2023), s. 3352-3361
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/37058595 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y - $z 0
- 990 __
- $a 20231013 $b ABA008
- 991 __
- $a 20231026105807 $b ABA008
- 999 __
- $a ok $b bmc $g 2000145 $s 1202811
- BAS __
- $a 3
- BAS __
- $a PreBMC-MEDLINE
- BMC __
- $a 2023 $b 29 $c 17 $d 3352-3361 $e 2023Sep01 $i 1557-3265 $m Clinical cancer research $n Clin Cancer Res $x MED00001121
- LZP __
- $a Pubmed-20231013
