-
Je něco špatně v tomto záznamu ?
Final results from PRIME: randomized phase III study of panitumumab with FOLFOX4 for first-line treatment of metastatic colorectal cancer
JY. Douillard, S. Siena, J. Cassidy, J. Tabernero, R. Burkes, M. Barugel, Y. Humblet, G. Bodoky, D. Cunningham, J. Jassem, F. Rivera, I. Kocákova, P. Ruff, M. Błasińska-Morawiec, M. Smakal, JL. Canon, M. Rother, KS. Oliner, Y. Tian, F. Xu, R. Sidhu,
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, randomizované kontrolované studie, práce podpořená grantem
Elsevier Open Archive Journals od 1990 do Před 1 rokem
Odkazy
PubMed
24718886
DOI
10.1093/annonc/mdu141
Knihovny.cz E-zdroje
- MeSH
- dospělí MeSH
- fluorouracil aplikace a dávkování škodlivé účinky MeSH
- geny ras MeSH
- kolorektální nádory farmakoterapie genetika patologie MeSH
- kvalita života MeSH
- leukovorin aplikace a dávkování škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- metastázy nádorů MeSH
- monoklonální protilátky aplikace a dávkování škodlivé účinky MeSH
- organoplatinové sloučeniny aplikace a dávkování škodlivé účinky MeSH
- protokoly antitumorózní kombinované chemoterapie aplikace a dávkování škodlivé účinky MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
BACKGROUND: The Panitumumab Randomized trial In combination with chemotherapy for Metastatic colorectal cancer to determine Efficacy (PRIME) demonstrated that panitumumab-FOLFOX4 significantly improved progression-free survival (PFS) versus FOLFOX4 as first-line treatment of wild-type (WT) KRAS metastatic colorectal cancer (mCRC), the primary end point of the study. PATIENTS AND METHODS: Patients were randomized 1:1 to panitumumab 6.0 mg/kg every 2 weeks + FOLFOX4 (arm 1) or FOLFOX4 (arm 2). This prespecified final descriptive analysis of efficacy and safety was planned for 30 months after the last patient was enrolled. RESULTS: A total of 1183 patients were randomized. Median PFS for WT KRAS mCRC was 10.0 months [95% confidence interval (CI) 9.3-11.4 months] for arm 1 and 8.6 months (95% CI 7.5-9.5 months) for arm 2; hazard ratio (HR) = 0.80; 95% CI 0.67-0.95; P = 0.01. Median overall survival (OS) for WT KRAS mCRC was 23.9 months (95% CI 20.3-27.7 months) for arm 1 and 19.7 months (95% CI 17.6-22.7 months) for arm 2; HR = 0.88; 95% CI 0.73-1.06; P = 0.17 (68% OS events). An exploratory analysis of updated survival (>80% OS events) was carried out which demonstrated improvement in OS; HR = 0.83; 95% CI 0.70-0.98; P = 0.03 for WT KRAS mCRC. The adverse event profile was consistent with the primary analysis. CONCLUSIONS: In WT KRAS mCRC, PFS was improved, objective response was higher, and there was a trend toward improved OS with panitumumab-FOLFOX4, with significant improvement in OS observed in an updated analysis of survival in patients with WT KRAS mCRC treated with panitumumab + FOLFOX4 versus FOLFOX4 alone (P = 0.03). These data support a positive benefit-risk profile for panitumumab-FOLFOX4 for patients with previously untreated WT KRAS mCRC. KRAS testing is critical to select appropriate patients for treatment with panitumumab.
Department of Biostatistics Amgen Inc Thousand Oaks
Department of Global Development Amgen Inc Thousand Oaks USA
Department of Medical Oncology Centre René Gauducheau Nantes France
Department of Medical Oncology Hospital de Gastroenterología Buenos Aires Argentina
Department of Medical Oncology Hospital Universitario Marqués de Valdecilla Santander Spain
Department of Medical Oncology Université Catholique de Louvain Brussels Belgium
Department of Medical Oncology Vall d'Hebron University Hospital Barcelona Spain
Department of Medical Sciences Amgen Inc Thousand Oaks
Department of Medicine Division of Hematology Oncology Mount Sinai Hospital Toronto Canada
Department of Oncology and Hematology Grand Hôpital de Charleroi Charleroi Belgium
Department of Oncology and Radiotherapy Medical University of Gdańsk Gdańsk Poland
Department of Oncology Szent Laszlo Hospital Budapest Hungary
Department of Oncology The Credit Valley Hospital Mississauga Canada
Division of Medical Oncology Ospedale Niguarda Ca' Granda Milan Italy
Gastrointestinal Unit The Royal Marsden NHS Foundation Trust London UK
Oncology Department Masarykuv Onkologicky Ustav Brno Czech Republic
Proliferative Diseases Branch Copernicus Memorial Hospital Lodz Poland
- 000
- 00000naa a2200000 a 4500
- 001
- bmc15032044
- 003
- CZ-PrNML
- 005
- 20151008105856.0
- 007
- ta
- 008
- 151005s2014 enk f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1093/annonc/mdu141 $2 doi
- 035 __
- $a (PubMed)24718886
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a enk
- 100 1_
- $a Douillard, J Y $u Department of Medical Oncology, Centre René Gauducheau, Nantes, France jean-yves.douillard@ico.unicancer.fr.
- 245 10
- $a Final results from PRIME: randomized phase III study of panitumumab with FOLFOX4 for first-line treatment of metastatic colorectal cancer / $c JY. Douillard, S. Siena, J. Cassidy, J. Tabernero, R. Burkes, M. Barugel, Y. Humblet, G. Bodoky, D. Cunningham, J. Jassem, F. Rivera, I. Kocákova, P. Ruff, M. Błasińska-Morawiec, M. Smakal, JL. Canon, M. Rother, KS. Oliner, Y. Tian, F. Xu, R. Sidhu,
- 520 9_
- $a BACKGROUND: The Panitumumab Randomized trial In combination with chemotherapy for Metastatic colorectal cancer to determine Efficacy (PRIME) demonstrated that panitumumab-FOLFOX4 significantly improved progression-free survival (PFS) versus FOLFOX4 as first-line treatment of wild-type (WT) KRAS metastatic colorectal cancer (mCRC), the primary end point of the study. PATIENTS AND METHODS: Patients were randomized 1:1 to panitumumab 6.0 mg/kg every 2 weeks + FOLFOX4 (arm 1) or FOLFOX4 (arm 2). This prespecified final descriptive analysis of efficacy and safety was planned for 30 months after the last patient was enrolled. RESULTS: A total of 1183 patients were randomized. Median PFS for WT KRAS mCRC was 10.0 months [95% confidence interval (CI) 9.3-11.4 months] for arm 1 and 8.6 months (95% CI 7.5-9.5 months) for arm 2; hazard ratio (HR) = 0.80; 95% CI 0.67-0.95; P = 0.01. Median overall survival (OS) for WT KRAS mCRC was 23.9 months (95% CI 20.3-27.7 months) for arm 1 and 19.7 months (95% CI 17.6-22.7 months) for arm 2; HR = 0.88; 95% CI 0.73-1.06; P = 0.17 (68% OS events). An exploratory analysis of updated survival (>80% OS events) was carried out which demonstrated improvement in OS; HR = 0.83; 95% CI 0.70-0.98; P = 0.03 for WT KRAS mCRC. The adverse event profile was consistent with the primary analysis. CONCLUSIONS: In WT KRAS mCRC, PFS was improved, objective response was higher, and there was a trend toward improved OS with panitumumab-FOLFOX4, with significant improvement in OS observed in an updated analysis of survival in patients with WT KRAS mCRC treated with panitumumab + FOLFOX4 versus FOLFOX4 alone (P = 0.03). These data support a positive benefit-risk profile for panitumumab-FOLFOX4 for patients with previously untreated WT KRAS mCRC. KRAS testing is critical to select appropriate patients for treatment with panitumumab.
- 650 _2
- $a dospělí $7 D000328
- 650 _2
- $a senioři $7 D000368
- 650 _2
- $a senioři nad 80 let $7 D000369
- 650 _2
- $a monoklonální protilátky $x aplikace a dávkování $x škodlivé účinky $7 D000911
- 650 _2
- $a protokoly antitumorózní kombinované chemoterapie $x aplikace a dávkování $x škodlivé účinky $7 D000971
- 650 _2
- $a kolorektální nádory $x farmakoterapie $x genetika $x patologie $7 D015179
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 _2
- $a fluorouracil $x aplikace a dávkování $x škodlivé účinky $7 D005472
- 650 _2
- $a geny ras $7 D011905
- 650 _2
- $a lidé $7 D006801
- 650 _2
- $a leukovorin $x aplikace a dávkování $x škodlivé účinky $7 D002955
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a lidé středního věku $7 D008875
- 650 _2
- $a metastázy nádorů $7 D009362
- 650 _2
- $a organoplatinové sloučeniny $x aplikace a dávkování $x škodlivé účinky $7 D009944
- 650 _2
- $a kvalita života $7 D011788
- 655 _2
- $a klinické zkoušky, fáze III $7 D017428
- 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 Siena, S $u Division of Medical Oncology, Ospedale Niguarda Ca' Granda, Milan, Italy.
- 700 1_
- $a Cassidy, J $u Division of Cancer Sciences and Molecular Pathology, The Beatson West of Scotland Cancer Centre, Glasgow, UK.
- 700 1_
- $a Tabernero, J $u Department of Medical Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.
- 700 1_
- $a Burkes, R $u Department of Medicine, Division of Hematology/Oncology, Mount Sinai Hospital, Toronto, Canada.
- 700 1_
- $a Barugel, M $u Department of Medical Oncology, Hospital de Gastroenterología, Buenos Aires, Argentina.
- 700 1_
- $a Humblet, Y $u Department of Medical Oncology, Université Catholique de Louvain, Brussels, Belgium.
- 700 1_
- $a Bodoky, G $u Department of Oncology, Szent Laszlo Hospital, Budapest, Hungary.
- 700 1_
- $a Cunningham, D $u Gastrointestinal Unit, The Royal Marsden NHS Foundation Trust, London, UK.
- 700 1_
- $a Jassem, J $u Department of Oncology and Radiotherapy, Medical University of Gdańsk, Gdańsk, Poland.
- 700 1_
- $a Rivera, F $u Department of Medical Oncology, Hospital Universitario Marqués de Valdecilla, Santander, Spain.
- 700 1_
- $a Kocákova, I $u Oncology Department, Masarykuv Onkologicky Ustav, Brno, Czech Republic.
- 700 1_
- $a Ruff, P $u Department of Medical Oncology, University of Witwatersrand Faculty of Health Sciences, Johannesburg, South Africa.
- 700 1_
- $a Błasińska-Morawiec, M $u Proliferative Diseases Branch, Copernicus Memorial Hospital, Lodz, Poland.
- 700 1_
- $a Smakal, M $u Department of Oncology, Institut Onkologie a Rehabilitace na Plesi s.r.o., Nová Ves pod Pleší, Czech Republic.
- 700 1_
- $a Canon, J L $u Department of Oncology and Hematology, Grand Hôpital de Charleroi, Charleroi, Belgium.
- 700 1_
- $a Rother, M $u Department of Oncology, The Credit Valley Hospital, Mississauga, Canada.
- 700 1_
- $a Oliner, K S $u Department of Medical Sciences, Amgen, Inc., Thousand Oaks.
- 700 1_
- $a Tian, Y $u Department of Biostatistics, Amgen, Inc., Thousand Oaks.
- 700 1_
- $a Xu, F $u Department of Biostatistics, Amgen, Inc., Thousand Oaks.
- 700 1_
- $a Sidhu, R $u Department of Global Development, Amgen, Inc., Thousand Oaks, USA.
- 773 0_
- $w MED00000432 $t Annals of oncology official journal of the European Society for Medical Oncology ESMO $x 1569-8041 $g Roč. 25, č. 7 (2014), s. 1346-55
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/24718886 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y a $z 0
- 990 __
- $a 20151005 $b ABA008
- 991 __
- $a 20151008110043 $b ABA008
- 999 __
- $a ok $b bmc $g 1092920 $s 915170
- BAS __
- $a 3
- BAS __
- $a PreBMC
- BMC __
- $a 2014 $b 25 $c 7 $d 1346-55 $e 20140408 $i 1569-8041 $m Annals of oncology $n Ann Oncol $x MED00000432
- LZP __
- $a Pubmed-20151005