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

EURAMOS-1, an international randomised study for osteosarcoma: results from pre-randomisation treatment

JS. Whelan, SS. Bielack, N. Marina, S. Smeland, G. Jovic, JM. Hook, M. Krailo, J. Anninga, T. Butterfass-Bahloul, T. Böhling, G. Calaminus, M. Capra, C. Deffenbaugh, C. Dhooge, M. Eriksson, AM. Flanagan, H. Gelderblom, A. Goorin, R. Gorlick, G....

. 2015 ; 26 (2) : 407-14. [pub] 20141124

Jazyk angličtina Země Anglie, Velká Británie

Typ dokumentu časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc16010689

BACKGROUND: Four international study groups undertook a large study in resectable osteosarcoma, which included two randomised controlled trials, to determine the effect on survival of changing post-operative chemotherapy based on histological response. PATIENTS AND METHODS: Patients with resectable osteosarcoma aged ≤40 years were treated with the MAP regimen, comprising pre-operatively of two 5-week cycles of cisplatin 120 mg/m(2), doxorubicin 75 mg/m(2), methotrexate 12 g/m(2) × 2 (MAP) and post-operatively two further cycles of MAP and two cycles of just MA. Patients were randomised after surgery. Those with ≥10% viable tumour in the resected specimen received MAP or MAP with ifosfamide and etoposide. Those with <10% viable tumour were allocated to MAP or MAP followed by pegylated interferon. Longitudinal evaluation of quality of life was undertaken. RESULTS: Recruitment was completed to the largest osteosarcoma study to date in 75 months. Commencing March 2005, 2260 patients were registered from 326 centres across 17 countries. About 1334 of 2260 registered patients (59%) were randomised. Pre-operative chemotherapy was completed according to protocol in 94%. Grade 3-4 neutropenia affected 83% of cycles and 59% were complicated by infection. There were three (0.13%) deaths related to pre-operative chemotherapy. At definitive surgery, 50% of patients had at least 90% necrosis in the resected specimen. CONCLUSIONS: New models of collaboration are required to successfully conduct trials to improve outcomes of patients with rare cancers; EURAMOS-1 demonstrates achievability. Considerable regulatory, financial and operational challenges must be overcome to develop similar studies in the future. The trial is registered as NCT00134030 and ISRCTN 67613327.

Bone Tumor Reference Center at the Institute of Pathology University Hospital Basel Basel Switzerland

British Columbia Children's Hospital University of British Columbia Vancouver Canada

Center for Clinical Trials University Hospital Münster Münster Germany

Children's Hospital of Philadelphia University of Pennsylvania School of Medicine Philadelphia

Children's Oncology Group Arcadia USA

Cincinnati Children's Hospital Medical Center Cincinnati

Cooperative Osteosarcoma Study Group Klinikum Stuttgart Olgahospital Stuttgart Germany

Dana Farber Cancer Institute Boston

Department of General Orthopedics and Tumor Orthopedics University Hospital Muenster Muenster Germany

Department of Oncology Oslo University Hospital Norwegian Radium Hospital Scandinavian Sarcoma Group Oslo Norway

Department of Oncology University College Hospital London UK

Department of Pathology Boston Children's Hospital Boston USA

Department of Pediatric Hematology Oncology University Hospital Prague Czech Republic

Department of Pediatric Radiology University Medical Center Hamburg Eppendorf Hamburg Germany

Department of Pediatrics and Medical Oncology Leiden University Medical Center Leiden The Netherlands

Department of Radiation Oncology Medical Center Hamburg Eppendorf Hamburg Germany

Division of Cancer Surgery and Transplantation and Scandinavian Sarcoma Group Oslo University Hospital Oslo Institute for Clinical Medicine University of Oslo Oslo Norway

H Lee Moffit Cancer Centre and Research Institute Tampa

IWK Health Center Dalhousie University Halifax Canada

Lucile Salter Packard Childrens Hospital Stanford Palo Alto USA

Mayo Clinic Rochester USA

Medical Research Council Clinical Trials Unit at University College London London UK

Memorial Sloan Kettering Cancer Center New?York

Memorial Sloan Kettering Cancer Center New?York Orthopedic Surgery Johns Hopkins Baltimore USA

Our Lady's Children's Hospital Dublin Ireland

Primary Children's Hospital and Huntsman Cancer Institute University of Utah Salt Lake City

Royal National Orthopaedic Hospital Stanmore Cancer Institute University College London London UK

Royal Orthopaedic Hospital Birmingham UK

Section of Pediatric Hematology Oncology Montefiore Medical Center Bronx USA

Skane University Hospital Lund University Lund Sweden

St Anna Children's Hospital Vienna Austria

Stanford University Medical Center Pediatric Hematology Oncology Palo Alto USA

Texas Children's Cancer Centre Baylor College of Medicine Houston

University Children's Hospital Basel Basel Switzerland

University Hospital Ghent Gent Belgium

University Hospital of Muenster Muenster Germany

University of Helsinki and HUSLAB Helsinki Finland

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc16010689
003      
CZ-PrNML
005      
20160725112239.0
007      
ta
008      
160408s2015 enk f 000 0|eng||
009      
AR
024    7_
$a 10.1093/annonc/mdu526 $2 doi
024    7_
$a 10.1093/annonc/mdu526 $2 doi
035    __
$a (PubMed)25421877
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a enk
100    1_
$a Whelan, J S $u Department of Oncology, University College Hospital, London, UK.
245    10
$a EURAMOS-1, an international randomised study for osteosarcoma: results from pre-randomisation treatment / $c JS. Whelan, SS. Bielack, N. Marina, S. Smeland, G. Jovic, JM. Hook, M. Krailo, J. Anninga, T. Butterfass-Bahloul, T. Böhling, G. Calaminus, M. Capra, C. Deffenbaugh, C. Dhooge, M. Eriksson, AM. Flanagan, H. Gelderblom, A. Goorin, R. Gorlick, G. Gosheger, RJ. Grimer, KS. Hall, K. Helmke, PC. Hogendoorn, G. Jundt, L. Kager, T. Kuehne, CC. Lau, GD. Letson, J. Meyer, PA. Meyers, C. Morris, H. Mottl, H. Nadel, R. Nagarajan, RL. Randall, P. Schomberg, R. Schwarz, LA. Teot, MR. Sydes, M. Bernstein, . ,
520    9_
$a BACKGROUND: Four international study groups undertook a large study in resectable osteosarcoma, which included two randomised controlled trials, to determine the effect on survival of changing post-operative chemotherapy based on histological response. PATIENTS AND METHODS: Patients with resectable osteosarcoma aged ≤40 years were treated with the MAP regimen, comprising pre-operatively of two 5-week cycles of cisplatin 120 mg/m(2), doxorubicin 75 mg/m(2), methotrexate 12 g/m(2) × 2 (MAP) and post-operatively two further cycles of MAP and two cycles of just MA. Patients were randomised after surgery. Those with ≥10% viable tumour in the resected specimen received MAP or MAP with ifosfamide and etoposide. Those with <10% viable tumour were allocated to MAP or MAP followed by pegylated interferon. Longitudinal evaluation of quality of life was undertaken. RESULTS: Recruitment was completed to the largest osteosarcoma study to date in 75 months. Commencing March 2005, 2260 patients were registered from 326 centres across 17 countries. About 1334 of 2260 registered patients (59%) were randomised. Pre-operative chemotherapy was completed according to protocol in 94%. Grade 3-4 neutropenia affected 83% of cycles and 59% were complicated by infection. There were three (0.13%) deaths related to pre-operative chemotherapy. At definitive surgery, 50% of patients had at least 90% necrosis in the resected specimen. CONCLUSIONS: New models of collaboration are required to successfully conduct trials to improve outcomes of patients with rare cancers; EURAMOS-1 demonstrates achievability. Considerable regulatory, financial and operational challenges must be overcome to develop similar studies in the future. The trial is registered as NCT00134030 and ISRCTN 67613327.
650    _2
$a mladiství $7 D000293
650    _2
$a protokoly protinádorové kombinované chemoterapie $x terapeutické užití $7 D000971
650    _2
$a nádory kostí $x farmakoterapie $x chirurgie $7 D001859
650    _2
$a dítě $7 D002648
650    _2
$a cisplatina $x aplikace a dávkování $x škodlivé účinky $7 D002945
650    _2
$a kombinovaná terapie $7 D003131
650    _2
$a doxorubicin $x aplikace a dávkování $x škodlivé účinky $7 D004317
650    _2
$a etoposid $x aplikace a dávkování $x škodlivé účinky $7 D005047
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a lidé $7 D006801
650    _2
$a ifosfamid $x aplikace a dávkování $x škodlivé účinky $7 D007069
650    _2
$a interferon alfa $x aplikace a dávkování $x škodlivé účinky $7 D016898
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a methotrexát $x aplikace a dávkování $x škodlivé účinky $7 D008727
650    _2
$a neoadjuvantní terapie $7 D020360
650    _2
$a osteosarkom $x farmakoterapie $x chirurgie $7 D012516
650    _2
$a polyethylenglykoly $x aplikace a dávkování $x škodlivé účinky $7 D011092
650    _2
$a kvalita života $7 D011788
650    _2
$a výzkumný projekt $7 D012107
650    _2
$a mladý dospělý $7 D055815
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 Bielack, S S $u Cooperative Osteosarcoma Study Group (COSS), Klinikum Stuttgart - Olgahospital, Stuttgart, Germany.
700    1_
$a Marina, N $u Stanford University Medical Center, Pediatric Hematology/Oncology, Palo Alto, USA.
700    1_
$a Smeland, S $u Division of Cancer, Surgery and Transplantation, and Scandinavian Sarcoma Group, Oslo University Hospital, Oslo Institute for Clinical Medicine, University of Oslo, Oslo, Norway.
700    1_
$a Jovic, G $u Medical Research Council Clinical Trials Unit at University College London, London, UK.
700    1_
$a Hook, J M $u Medical Research Council Clinical Trials Unit at University College London, London, UK.
700    1_
$a Krailo, M $u Children's Oncology Group, Arcadia, USA.
700    1_
$a Anninga, J $u Department of Pediatrics and Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands. $7 gn_A_00007144
700    1_
$a Butterfass-Bahloul, T $u Center for Clinical Trials, University Hospital Münster, Münster, Germany.
700    1_
$a Böhling, T $u University of Helsinki and HUSLAB, Helsinki, Finland.
700    1_
$a Calaminus, G $u University Hospital of Muenster, Muenster, Germany.
700    1_
$a Capra, M $u Our Lady's Children's Hospital, Dublin, Ireland.
700    1_
$a Deffenbaugh, C $u Lucile Salter Packard Childrens Hospital Stanford, Palo Alto, USA.
700    1_
$a Dhooge, C $u University Hospital Ghent, Gent, Belgium.
700    1_
$a Eriksson, M $u Skane University Hospital, Lund University, Lund, Sweden.
700    1_
$a Flanagan, A M $u Royal National Orthopaedic Hospital, Stanmore Cancer Institute, University College London, London, UK.
700    1_
$a Gelderblom, H $u Department of Pediatrics and Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands.
700    1_
$a Goorin, A $u Dana-Farber Cancer Institute, Boston.
700    1_
$a Gorlick, R $u Section of Pediatric Hematology/Oncology, Montefiore Medical Center, Bronx, USA.
700    1_
$a Gosheger, G $u Department of General Orthopedics and Tumor Orthopedics, University Hospital Muenster, Muenster, Germany.
700    1_
$a Grimer, R J $u Royal Orthopaedic Hospital, Birmingham, UK.
700    1_
$a Hall, K S $u Department of Oncology, Oslo University Hospital, Norwegian Radium Hospital, Scandinavian Sarcoma Group, Oslo, Norway.
700    1_
$a Helmke, K $u Department of Pediatric Radiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
700    1_
$a Hogendoorn, P C W $u Department of Pediatrics and Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands.
700    1_
$a Jundt, G $u Bone Tumor Reference Center at the Institute of Pathology, University Hospital Basel, Basel, Switzerland.
700    1_
$a Kager, L $u St Anna Children's Hospital, Vienna, Austria.
700    1_
$a Kuehne, T $u University Children's Hospital Basel, Basel, Switzerland.
700    1_
$a Lau, C C $u Texas Children's Cancer Centre, Baylor College of Medicine, Houston.
700    1_
$a Letson, G D $u H. Lee Moffit Cancer Centre & Research Institute, Tampa.
700    1_
$a Meyer, J $u Children's Hospital of Philadelphia, University of Pennsylvania School of Medicine, Philadelphia.
700    1_
$a Meyers, P A $u Memorial Sloan-Kettering Cancer Center, New?York.
700    1_
$a Morris, C $u Memorial Sloan-Kettering Cancer Center, New?York Orthopedic Surgery, Johns Hopkins, Baltimore, USA.
700    1_
$a Mottl, H $u Department of Pediatric Hematology Oncology, University Hospital, Prague, Czech Republic.
700    1_
$a Nadel, H $u British Columbia Children's Hospital, University of British Columbia, Vancouver, Canada.
700    1_
$a Nagarajan, R $u Cincinnati Children's Hospital Medical Center, Cincinnati.
700    1_
$a Randall, R L $u Primary Children's Hospital and Huntsman Cancer Institute, University of Utah, Salt Lake City.
700    1_
$a Schomberg, P $u Mayo Clinic, Rochester, USA.
700    1_
$a Schwarz, R $u Department of Radiation Oncology, Medical Center Hamburg-Eppendorf, Hamburg, Germany.
700    1_
$a Teot, L A $u Department of Pathology, Boston Children's Hospital, Boston, USA.
700    1_
$a Sydes, M R $u Medical Research Council Clinical Trials Unit at University College London, London, UK m.sydes@ucl.ac.uk.
700    1_
$a Bernstein, M $u IWK Health Center, Dalhousie University, Halifax, Canada.
700    1_
$a ,
773    0_
$w MED00000432 $t Annals of oncology official journal of the European Society for Medical Oncology ESMO $x 1569-8041 $g Roč. 26, č. 2 (2015), s. 407-14
856    41
$u https://pubmed.ncbi.nlm.nih.gov/25421877 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y a $z 0
990    __
$a 20160408 $b ABA008
991    __
$a 20160725112457 $b ABA008
999    __
$a ok $b bmc $g 1114118 $s 935057
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2015 $b 26 $c 2 $d 407-14 $e 20141124 $i 1569-8041 $m Annals of oncology $n Ann Oncol $x MED00000432
LZP    __
$a Pubmed-20160408

Najít záznam

Citační ukazatele

Možnosti archivace