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| Annals of oncology : official journal of the European Society for Medical Oncology / ESMO. 2014 Nov 24. pii: mdu526. doi: 10.1093/annonc/mdu526. pmc: PMC4304379 |
| EURAMOS-1, an international randomised study for osteosarcoma: results from pre-randomisation treatment. |
| Whelan JS1, Bielack SS2, Marina N3, Smeland S4, Jovic G5, Hook JM6, Krailo M7, Anninga J8, Butterfass-Bahloul T9, Böhling T10, Calaminus G11, Capra M12, Deffenbaugh C13, Dhooge C14, Eriksson M15, Flanagan AM16, Gelderblom H17, Goorin A18, Gorlick R19, Gosheger G20, Grimer RJ21, Hall KS22, Helmke K23, Hogendoorn PC24, Jundt G25, Kager L26, Kuehne T27, Lau CC28, Letson GD29, Meyer J30, Meyers PA31, Morris C32, Mottl H33, Nadel H34, Nagarajan R35, Randall RL36, Schomberg P37, Schwarz R38, Teot LA39, Sydes MR40, Bernstein M41 |
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Abstract 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. |
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© The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. |
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KEYWORDS: international collaboration, osteosarcoma, randomised controlled trial, trial conduct |
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Publikations ID: 25421877 Quelle: öffnen |
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