Journal
JOURNAL OF CLINICAL ONCOLOGY
Volume 33, Issue 20, Pages 2279-U92Publisher
AMER SOC CLINICAL ONCOLOGY
DOI: 10.1200/JCO.2014.60.0734
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Funding
- National Cancer Institute
- European Science Foundation under the EUROCORES Program European Clinical Trials from the European Commission [ERASCT-2003-980409]
- DG Research, FP6 [MM/NG/EMRC/0202]
- St Anna Kinderkrebsforschung (Austria)
- Fonds National de la Recherche Scientifique (Belgium)
- Fonds voor Wetenschappelijk Onderzoek-Vlaanderen (Belgium)
- Parents Organisation (Czech Republic)
- Danish Medical Research Council (Denmark)
- Academy of Finland (Finland)
- Deutsche Forschungsgemeinschaft [BI 1045/1-1, 1-2]
- Deutsche Krebshilfe [50-2723-Bi2]
- Federal Ministry of Education and Research (Germany) [BMBF 01KN1105]
- Semmelweis Foundation (Hungary)
- Council for Medical Research (the Netherlands)
- Research Council of Norway (Norway)
- Scandinavian Sarcoma Group (Sweden)
- Swiss Paediatric Oncology Group (Switzerland)
- Cancer Research UK (United Kingdom) [CRUK/05/013]
- Medical Research Council (United Kingdom)
- National Institute for Health Research at University College London Hospitals, and Biomedical Research Centre (United Kingdom)
- Medical Research Council [MC_EX_UU_G0400248, MC_UU_12023/11, MC_UU_12023/28, MC_EX_G0400248] Funding Source: researchfish
- MRC [MC_EX_UU_G0400248, MC_UU_12023/28, MC_UU_12023/11, MC_EX_G0400248] Funding Source: UKRI
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Purpose EURAMOS-1, an international randomized controlled trial, investigated maintenance therapy with pegylated interferon alfa-2b (IFN-alpha-2b) in patients whose osteosarcoma showed good histologic response (good response) to induction chemotherapy. Patients and Methods At diagnosis, patients age <= 40 years with resectable high-grade osteosarcoma were registered. Eligibility after surgery for good response random assignment included >= two cycles of preoperative MAP (methotrexate, doxorubicin, and cisplatin), macroscopically complete surgery of primary tumor, < 10% viable tumor, and no disease progression. These patients were randomly assigned to four additional cycles MAP with or without IFN-alpha-2b (0.5 to 1.0 mu g/kg per week subcutaneously, after chemotherapy until 2 years postregistration). Outcome measures were event-free survival (EFS; primary) and overall survival and toxicity (secondary). Results Good response was reported in 1,041 of 2,260 registered patients; 716 consented to random assignment (MAP, n = 359; MAP plus IFN-alpha-2b, n = 357), with baseline characteristics balanced by arm. A total of 271 of 357 started IFN-alpha-2b; 105 stopped early, and 38 continued to receive treatment at data freeze. Refusal and toxicity were the main reasons for never starting IFN-alpha-2b and for stopping prematurely, respectively. Median IFN-alpha-2b duration, if started, was 67 weeks. A total of 133 of 268 patients who started IFN-alpha-2b and provided toxicity information reported grade >= 3 toxicity during IFN-alpha-2b treatment. With median follow-up of 44 months, 3-year EFS for all 716 randomly assigned patients was 76% (95% CI, 72% to 79%); 174 EFS events were reported (MAP, n = 93; MAP plus IFN-alpha-2b, n = 81). Hazard ratio was 0.83 (95% CI, 0.61 to 1.12; P = .214) from an adjusted Cox model. Conclusion At the preplanned analysis time, MAP plus IFN-alpha-2b was not statistically different from MAP alone. A considerable proportion of patients never started IFN-alpha-2b or stopped prematurely. Long-term follow-up for events and survival continues. (C) 2015 American Society of Clinical Oncology.
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