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
Department of Oncology, University College Hospital, London, UK.
Cooperative Osteosarcoma Study Group (COSS), Klinikum Stuttgart - Olgahospital, Stuttgart, Germany.
Ann Oncol. 2015 Feb;26(2):407-14. doi: 10.1093/annonc/mdu526. Epub 2014 Nov 24.
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/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.
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.
四个国际研究小组对可切除骨肉瘤进行了一项大型研究，其中包括两项随机对照试验，以确定根据组织学反应改变术后化疗对生存率的影响。
年龄≤40岁的可切除骨肉瘤患者接受MAP方案治疗，该方案术前包括两个为期5周的周期，顺铂120mg/m²、阿霉素75mg/m²、甲氨蝶呤12g/m²×2（MAP），术后再进行两个周期的MAP和两个周期的MA。患者术后随机分组。切除标本中存活肿瘤≥10%的患者接受MAP或联合异环磷酰胺和依托泊苷的MAP治疗。存活肿瘤<10%的患者被分配接受MAP治疗或MAP后接受聚乙二醇化干扰素治疗。对生活质量进行了纵向评估。
在75个月内完成了迄今为止最大规模的骨肉瘤研究的招募工作。从2005年3月开始，来自17个国家326个中心的2260名患者登记入组。2260名登记患者中约1334名（59%）被随机分组。94%的患者按照方案完成了术前化疗。3-4级中性粒细胞减少影响了83%的周期，59%的周期并发感染。有3例（0.13%）死亡与术前化疗有关。在根治性手术时，50%的患者切除标本中至少有90%的坏死。
需要新的合作模式来成功开展试验，以改善罕见癌症患者的治疗结果；EURAMOS-1证明了其可行性。未来开展类似研究必须克服相当多的监管、资金和运营挑战。该试验已注册为NCT00134030和ISRCTN 67613327。
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