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

High-Dose Chemotherapy Compared With Standard Chemotherapy and Lung Radiation in Ewing Sarcoma With Pulmonary Metastases: Results of the European Ewing Tumour Working Initiative of National Groups, 99 Trial and EWING 2008

U. Dirksen, B. Brennan, MC. Le Deley, N. Cozic, H. van den Berg, V. Bhadri, B. Brichard, L. Claude, A. Craft, S. Amler, N. Gaspar, H. Gelderblom, R. Goldsby, R. Gorlick, HE. Grier, JM. Guinbretiere, P. Hauser, L. Hjorth, K. Janeway, H. Juergens,...

. 2019 ; 37 (34) : 3192-3202. [pub] 20190925

Jazyk angličtina Země Spojené státy americké

Typ dokumentu srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie, Research Support, N.I.H., Extramural, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc20023408

Grantová podpora
U10 CA098413 NCI NIH HHS - United States
U10 CA098543 NCI NIH HHS - United States
U10 CA180886 NCI NIH HHS - United States
U10 CA180899 NCI NIH HHS - United States

PURPOSE: The R2Pulm trial was conducted to evaluate the effect of busulfan-melphalan high-dose chemotherapy with autologous stem-cell rescue (BuMel) without whole-lung irradiation (WLI) on event-free survival (main end point) and overall survival, compared with standard chemotherapy with WLI in Ewing sarcoma (ES) presenting with pulmonary and/or pleural metastases. METHODS: From 2000 to 2015, we enrolled patients younger than 50 years of age with newly diagnosed ES and with only pulmonary or pleural metastases. Patients received chemotherapy with six courses of vincristine, ifosfamide, doxorubicin, and etoposide (VIDE) and one course of vincristine, dactinomycin, and ifosfamide (VAI) before either BuMel or seven courses of VAI and WLI (VAI plus WLI) by randomized assignment. The analysis was conducted as intention to treat. The estimates of the hazard ratio (HR), 95% CI, and P value were corrected for the three previous interim analyses by the inverse normal method. RESULTS: Of 543 potentially eligible patients, 287 were randomly assigned to VAI plus WLI (n = 143) or BuMel (n = 144). Selected patients requiring radiotherapy to an axial primary site were excluded from randomization to avoid excess organ toxicity from interaction between radiotherapy and busulfan. Median follow-up was 8.1 years. We did not observe any significant difference in survival outcomes between treatment groups. Event-free survival was 50.6% versus 56.6% at 3 years and 43.1% versus 52.9% at 8 years, for VAI plus WLI and BuMel patients, respectively, resulting in an HR of 0.79 (95% CI, 0.56 to 1.10; P = .16). For overall survival, the HR was 1.00 (95% CI, 0.70 to 1.44; P = .99). Four patients died as a result of BuMel-related toxicity, and none died after VAI plus WLI. Significantly more patients in the BuMel arm experienced severe acute toxicities than in the VAI plus WLI arm. CONCLUSION: In ES with pulmonary or pleural metastases, there is no clear benefit from BuMel compared with conventional VAI plus WLI.

Birmingham Women and Children's Hospital Birmingham United Kingdom

Centre Hospitalier Universitaire Tours France

Centre Léon Bérard Lyon

Centre Oscar Lambret Lille

Centre Oscar Lambret Lille France

Charles University Prague Czech Republic

Children's Hospital of Philadelphia and University of Pennsylvania Philadelphia PA

Chris O'Brien Lifehouse Camperdown NSW Australia

Cliniques Universitaires Saint Luc Brussels Belgium

Dana Farber Boston Children's Cancer and Blood Disorder Center Boston MA

Emma Children Hospital Amsterdam University Medical Centres Amsterdam the Netherlands

Five Time Therapeutics South San Francisco CA

France

Friedrich Loeffler Institute Greifswald Insel Riems Germany

Gustave Roussy Université Paris Saclay Villejuif France

Gustave Roussy Villejuif France

Hôpital René Huguenin Saint Cloud France

Institut Curie Paris France

Institute of Pediatric Onco Haematology Lyon France

Leiden University Medical Center Leiden the Netherlands

Lund University Lund Sweden

MD Anderson Cancer Center Houston TX

Medical University of Vienna Vienna Austria

Nationwide Children's Hospital and The Ohio State University College of Medicine Columbus OH

Northern Institute for Cancer Research Newcastle Upon Tyne United Kingdom

Royal Manchester Children's Hospital Manchester United Kingdom

Royal Marsden Foundation NHS Trust London United Kingdom

Seattle Children's Hospital Seattle WA

Semmelweis University Budapest Hungary

Universitaetskinderklinik Muenster Muenster Germany

Université Paris Saclay Villejuif France

University Children's Hospital Basel Basel Switzerland

University College Hospital London United Kingdom

University Hospital Essen Essen Germany

University of Birmingham Birmingham United Kingdom

University of California Davis Sacramento CA

University of California San Francisco Benioff Children's Hospital San Francisco CA

University of Leeds Liverpool United Kingdom

University of Southern California Los Angeles CA

Westfalian Wilhelms University Muenster Muenster

Witten Herdecke University Datteln Germany

000      
00000naa a2200000 a 4500
001      
bmc20023408
003      
CZ-PrNML
005      
20201214125946.0
007      
ta
008      
201125s2019 xxu f 000 0|eng||
009      
AR
024    7_
$a 10.1200/JCO.19.00915 $2 doi
035    __
$a (PubMed)31553693
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxu
100    1_
$a Dirksen, Uta $u University Hospital Essen, Essen, Germany.
245    10
$a High-Dose Chemotherapy Compared With Standard Chemotherapy and Lung Radiation in Ewing Sarcoma With Pulmonary Metastases: Results of the European Ewing Tumour Working Initiative of National Groups, 99 Trial and EWING 2008 / $c U. Dirksen, B. Brennan, MC. Le Deley, N. Cozic, H. van den Berg, V. Bhadri, B. Brichard, L. Claude, A. Craft, S. Amler, N. Gaspar, H. Gelderblom, R. Goldsby, R. Gorlick, HE. Grier, JM. Guinbretiere, P. Hauser, L. Hjorth, K. Janeway, H. Juergens, I. Judson, M. Krailo, J. Kruseova, T. Kuehne, R. Ladenstein, C. Lervat, SL. Lessnick, I. Lewis, C. Linassier, P. Marec-Berard, N. Marina, B. Morland, H. Pacquement, M. Paulussen, RL. Randall, A. Ranft, G. Le Teuff, K. Wheatley, J. Whelan, R. Womer, O. Oberlin, DS. Hawkins, Euro-E.W.I.N.G. 99 and Ewing 2008 Investigators,
520    9_
$a PURPOSE: The R2Pulm trial was conducted to evaluate the effect of busulfan-melphalan high-dose chemotherapy with autologous stem-cell rescue (BuMel) without whole-lung irradiation (WLI) on event-free survival (main end point) and overall survival, compared with standard chemotherapy with WLI in Ewing sarcoma (ES) presenting with pulmonary and/or pleural metastases. METHODS: From 2000 to 2015, we enrolled patients younger than 50 years of age with newly diagnosed ES and with only pulmonary or pleural metastases. Patients received chemotherapy with six courses of vincristine, ifosfamide, doxorubicin, and etoposide (VIDE) and one course of vincristine, dactinomycin, and ifosfamide (VAI) before either BuMel or seven courses of VAI and WLI (VAI plus WLI) by randomized assignment. The analysis was conducted as intention to treat. The estimates of the hazard ratio (HR), 95% CI, and P value were corrected for the three previous interim analyses by the inverse normal method. RESULTS: Of 543 potentially eligible patients, 287 were randomly assigned to VAI plus WLI (n = 143) or BuMel (n = 144). Selected patients requiring radiotherapy to an axial primary site were excluded from randomization to avoid excess organ toxicity from interaction between radiotherapy and busulfan. Median follow-up was 8.1 years. We did not observe any significant difference in survival outcomes between treatment groups. Event-free survival was 50.6% versus 56.6% at 3 years and 43.1% versus 52.9% at 8 years, for VAI plus WLI and BuMel patients, respectively, resulting in an HR of 0.79 (95% CI, 0.56 to 1.10; P = .16). For overall survival, the HR was 1.00 (95% CI, 0.70 to 1.44; P = .99). Four patients died as a result of BuMel-related toxicity, and none died after VAI plus WLI. Significantly more patients in the BuMel arm experienced severe acute toxicities than in the VAI plus WLI arm. CONCLUSION: In ES with pulmonary or pleural metastases, there is no clear benefit from BuMel compared with conventional VAI plus WLI.
650    _2
$a mladiství $7 D000293
650    _2
$a dospělí $7 D000328
650    _2
$a protokoly antitumorózní kombinované chemoterapie $x aplikace a dávkování $x škodlivé účinky $7 D000971
650    _2
$a nádory kostí $x mortalita $x patologie $x terapie $7 D001859
650    _2
$a dítě $7 D002648
650    _2
$a předškolní dítě $7 D002675
650    _2
$a progrese nemoci $7 D018450
650    _2
$a ženské pohlaví $7 D005260
650    12
$a transplantace hematopoetických kmenových buněk $x škodlivé účinky $x mortalita $7 D018380
650    _2
$a lidé $7 D006801
650    _2
$a kojenec $7 D007223
650    _2
$a nádory plic $x mortalita $x sekundární $x terapie $7 D008175
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a lidé středního věku $7 D008875
650    12
$a neoadjuvantní terapie $x škodlivé účinky $x mortalita $7 D020360
650    _2
$a lokální recidiva nádoru $7 D009364
650    _2
$a pneumektomie $7 D011013
650    _2
$a doba přežití bez progrese choroby $7 D000077982
650    _2
$a adjuvantní radioterapie $7 D018714
650    _2
$a hodnocení rizik $7 D018570
650    _2
$a rizikové faktory $7 D012307
650    _2
$a Ewingův sarkom $x mortalita $x sekundární $x terapie $7 D012512
650    _2
$a časové faktory $7 D013997
650    _2
$a autologní transplantace $7 D014182
650    _2
$a mladý dospělý $7 D055815
651    _2
$a Evropa $7 D005060
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 Research Support, N.I.H., Extramural $7 D052061
655    _2
$a práce podpořená grantem $7 D013485
700    1_
$a Brennan, Bernadette $u Royal Manchester Children's Hospital, Manchester, United Kingdom.
700    1_
$a Le Deley, Marie-Cécile $u Centre Oscar Lambret, Lille; and Université Paris-Saclay, Villejuif, France.
700    1_
$a Cozic, Nathalie $u Gustave Roussy, Villejuif, France.
700    1_
$a van den Berg, Henk $u Emma Children Hospital - Amsterdam University Medical Centres, Amsterdam, the Netherlands.
700    1_
$a Bhadri, Vivek $u Chris O'Brien Lifehouse, Camperdown, NSW, Australia.
700    1_
$a Brichard, Bénédicte $u Cliniques Universitaires Saint Luc, Brussels, Belgium.
700    1_
$a Claude, Line $u Centre Léon Bérard, Lyon; France.
700    1_
$a Craft, Alan $u Northern Institute for Cancer Research, Newcastle Upon Tyne, United Kingdom.
700    1_
$a Amler, Susanne $u Westfalian Wilhelms University Muenster, Muenster; and Friedrich- Loeffler Institute, Greifswald-Insel Riems, Germany.
700    1_
$a Gaspar, Natalie $u Gustave Roussy, Villejuif, France.
700    1_
$a Gelderblom, Hans $u Leiden University Medical Center, Leiden, the Netherlands.
700    1_
$a Goldsby, Robert $u University of California San Francisco Benioff Children's Hospital, San Francisco, CA.
700    1_
$a Gorlick, Richard $u MD Anderson Cancer Center, Houston, TX.
700    1_
$a Grier, Holcombe E $u Dana-Farber/Boston Children's Cancer and Blood Disorder Center, Boston, MA.
700    1_
$a Guinbretiere, Jean-Marc $u Hôpital René-Huguenin, Saint-Cloud, France.
700    1_
$a Hauser, Peter $u Semmelweis University, Budapest, Hungary.
700    1_
$a Hjorth, Lars $u Lund University, Lund, Sweden.
700    1_
$a Janeway, Katherine $u Dana-Farber/Boston Children's Cancer and Blood Disorder Center, Boston, MA.
700    1_
$a Juergens, Heribert $u Universitaetskinderklinik Muenster, Muenster, Germany.
700    1_
$a Judson, Ian $u Royal Marsden Foundation NHS Trust, London, United Kingdom.
700    1_
$a Krailo, Mark $u University of Southern California, Los Angeles, CA.
700    1_
$a Kruseova, Jarmila $u Charles University Prague, Czech Republic.
700    1_
$a Kuehne, Thomas $u University Children's Hospital Basel, Basel, Switzerland.
700    1_
$a Ladenstein, Ruth $u Medical University of Vienna, Vienna, Austria.
700    1_
$a Lervat, Cyril $u Centre Oscar Lambret, Lille, France.
700    1_
$a Lessnick, Stephen L $u Nationwide Children's Hospital and The Ohio State University College of Medicine, Columbus, OH.
700    1_
$a Lewis, Ian $u University of Leeds, Liverpool, United Kingdom.
700    1_
$a Linassier, Claude $u Centre Hospitalier Universitaire, Tours, France.
700    1_
$a Marec-Berard, Perrine $u Institute of Pediatric Onco-Haematology, Lyon, France.
700    1_
$a Marina, Neyssa $u Five Time Therapeutics, South San Francisco, CA.
700    1_
$a Morland, Bruce $u Birmingham Women and Children's Hospital, Birmingham, United Kingdom.
700    1_
$a Pacquement, Hélène $u Institut Curie, Paris, France.
700    1_
$a Paulussen, Michael $u Witten/Herdecke University, Datteln, Germany.
700    1_
$a Randall, R Lor $u University of California Davis, Sacramento, CA.
700    1_
$a Ranft, Andreas $u Gustave Roussy, Université Paris-Saclay, Villejuif, France.
700    1_
$a Le Teuff, Gwénaël $u University of Birmingham, Birmingham, United Kingdom.
700    1_
$a Wheatley, Keith $u University College Hospital, London, United Kingdom.
700    1_
$a Whelan, Jeremy $u Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, PA.
700    1_
$a Womer, Richard $u Seattle Children's Hospital, Seattle, WA.
700    1_
$a Oberlin, Odile $u Gustave Roussy, Villejuif, France.
700    1_
$a Hawkins, Douglas S $u Seattle Children's Hospital, Seattle, WA.
710    2_
$a Euro-E.W.I.N.G. 99 and Ewing 2008 Investigators
773    0_
$w MED00002596 $t Journal of clinical oncology : official journal of the American Society of Clinical Oncology $x 1527-7755 $g Roč. 37, č. 34 (2019), s. 3192-3202
856    41
$u https://pubmed.ncbi.nlm.nih.gov/31553693 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y a $z 0
990    __
$a 20201125 $b ABA008
991    __
$a 20201214125944 $b ABA008
999    __
$a ok $b bmc $g 1595727 $s 1114084
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2019 $b 37 $c 34 $d 3192-3202 $e 20190925 $i 1527-7755 $m Journal of clinical oncology $n J. clin. Oncol. $x MED00002596
GRA    __
$a U10 CA098413 $p NCI NIH HHS $2 United States
GRA    __
$a U10 CA098543 $p NCI NIH HHS $2 United States
GRA    __
$a U10 CA180886 $p NCI NIH HHS $2 United States
GRA    __
$a U10 CA180899 $p NCI NIH HHS $2 United States
LZP    __
$a Pubmed-20201125

Najít záznam

Citační ukazatele

Možnosti archivace