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

Whelan, J.S. ; Bielack, S.S. ; Marina, N. ; Smeland, S. ; Jovic, G. ; Hook, J.M. ; Krailo, M. ; Anninga, J. ; Butterfass-Bahloul, T. ; Böhling, T. ; Calaminus, G. ; Capra, M. ; Deffenbaugh, C. ; Dhooge, C. ; Eriksson, M. ; Flanagan, A.M. ; Gelderblom, H. ; Goorin, A. ; Gorlick, R. ; Gosheger, G. ; Grimer, R.J. ; Hall, K.S. ; Helmke, K. ; Hogendoorn, P.C.W. ; Jundt, G. ; Kager, L. ; Kuehne, T. ; Lau, C.C. ; Letson, G.D. ; Meyer, J. ; Meyers, P.A. ; Morris, C. ; Mottl, H. ; Nadel, H. ; Nagarajan, R. ; Randall, R.L. ; Schomberg, P. ; Schwarz, R. ; Teot, L.A. ; Sydes, M.R. ; Bernstein, M. ; Pickering, James ; Joffe, Nicola ; Kevric, Matthias ; Sorg, Benjamin ; Villaluna, Doojduen ; Wang, Caroline ; Perisoglou, Martha ; Trani, Leonardo ; Potratz, Jenny ; Carrle, Dorothe ; Wilhelm, Miriam ; Zils, Katja ; Teske, Carmen

Annals of oncology, 2015-02, Vol.26 (2), p.407-414 [Periódico revisado por pares]

England: Elsevier Ltd

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Título:
EURAMOS-1, an international randomised study for osteosarcoma: results from pre-randomisation treatment
Autor: Whelan, J.S. ; Bielack, S.S. ; Marina, N. ; Smeland, S. ; Jovic, G. ; Hook, J.M. ; Krailo, M. ; Anninga, J. ; Butterfass-Bahloul, T. ; Böhling, T. ; Calaminus, G. ; Capra, M. ; Deffenbaugh, C. ; Dhooge, C. ; Eriksson, M. ; Flanagan, A.M. ; Gelderblom, H. ; Goorin, A. ; Gorlick, R. ; Gosheger, G. ; Grimer, R.J. ; Hall, K.S. ; Helmke, K. ; Hogendoorn, P.C.W. ; Jundt, G. ; Kager, L. ; Kuehne, T. ; Lau, C.C. ; Letson, G.D. ; Meyer, J. ; Meyers, P.A. ; Morris, C. ; Mottl, H. ; Nadel, H. ; Nagarajan, R. ; Randall, R.L. ; Schomberg, P. ; Schwarz, R. ; Teot, L.A. ; Sydes, M.R. ; Bernstein, M. ; Pickering, James ; Joffe, Nicola ; Kevric, Matthias ; Sorg, Benjamin ; Villaluna, Doojduen ; Wang, Caroline ; Perisoglou, Martha ; Trani, Leonardo ; Potratz, Jenny ; Carrle, Dorothe ; Wilhelm, Miriam ; Zils, Katja ; Teske, Carmen
Assuntos: Adolescent ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Bone Neoplasms - drug therapy ; Bone Neoplasms - surgery ; Cancer and Oncology ; Cancer och onkologi ; Child ; Cisplatin - administration & dosage ; Cisplatin - adverse effects ; Clinical Medicine ; Combined Modality Therapy ; Doxorubicin - administration & dosage ; Doxorubicin - adverse effects ; Etoposide - administration & dosage ; Etoposide - adverse effects ; Female ; Humans ; Ifosfamide - administration & dosage ; Ifosfamide - adverse effects ; Interferon-alpha - administration & dosage ; Interferon-alpha - adverse effects ; international collaboration ; Klinisk medicin ; Male ; Medical and Health Sciences ; Medicin och hälsovetenskap ; Methotrexate - administration & dosage ; Methotrexate - adverse effects ; Neoadjuvant Therapy ; Original ; osteosarcoma ; Osteosarcoma - drug therapy ; Osteosarcoma - surgery ; Polyethylene Glycols - administration & dosage ; Polyethylene Glycols - adverse effects ; Quality of Life ; randomised controlled trial ; Research Design ; trial conduct ; Young Adult
É parte de: Annals of oncology, 2015-02, Vol.26 (2), p.407-414
Notas: See supplementary Material, available at Annals of Oncology online.
Presented in part at American Society of Clinical Oncology Annual Meeting Chicago 2012.
Both authors contributed equally.
Descrição: This manuscript describes the experience from registration until randomisation for a cohort of 2260 patients with osteosarcoma who joined the EURAMOS-1 trial. This includes pre-operative chemotherapy and surgery. It sets out the practical issues in collaboration and in achieving randomisation. 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 with resectable osteosarcoma aged ≤40 years were treated with the MAP regimen, comprising pre-operatively of two 5-week cycles of cisplatin 120 mg/m2, doxorubicin 75 mg/m2, methotrexate 12 g/m2 × 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. 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. 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.
Editor: England: Elsevier Ltd
Idioma: Inglês

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

England: Elsevier Ltd

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