Methotrexate, Doxorubicin, and Cisplatin (MAP) Plus Maintenance Pegylated Interferon Alfa-2b Versus MAP Alone in Patients With Resectable High-Grade Osteosarcoma and Good Histologic Response to Preoperative MAP: First Results of the EURAMOS-1 Good Response Randomized Controlled Trial
- Bielack, S.S.
- Smeland, S.
- Whelan, J.S.
- Marina, N.
- Jovic, G.
- Hook, J.M.
- Krailo, M.D.
- Gebhardt, M.
- Papai, Z.
- Meyer, J.
- Nadel, H.
- Randall, R.L.
- Deffenbaugh, C.
- Nagarajan, R.
- Brennan, B.
- Letson, G.D.
- Teot, L.A.
- Goorin, A.
- Baumhoer, D.
- Kager, L.
- Werner, M.
- Lau, C.C.
- Hall, K.
- Gelderblom, H.
- Meyers, P.
- Gorlick, R.
- Windhager, R.
- Helmke, K.
- Eriksson, M.
- Hoogerbrugge, P.M.
- Schomberg, P.
- Tunn, P.U.
- Kuhne, T.
- Jurgens, H.
- Berg, H. van den
- Bohling, T.
- Picton, S.
- Renard, M.
- Reichardt, P.
- Gerss, J.
- Butterfass-Bahloul, T.
- Morris, C.
- Hogendoorn, P.C.
- Seddon, B.
- Calaminus, G.
- Michelagnoli, M.
- Dhooge, C.
- Sydes, M.R.
- Bernstein, M.
DOIAbstract
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 /= two cycles of preoperative MAP (methotrexate, doxorubicin, and cisplatin), macroscopically complete surgery of primary tumor, /= 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....
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