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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.
J Clin Oncol
July 2015
Stefan S. Bielack, Klinikum Stuttgart-Olgahospital, Stuttgart; Mathias Werner, Helios Klinikum Emil von Behring; Per-Ulf Tunn, Helios Klinikum Berlin-Buch, Berlin; Knut Helmke, Altonaer Kinderkrankenhaus, Hamburg; Heribert Jürgens, Gabriele Calaminus, Joachim Gerss, and Trude Butterfass-Bahloul, Universitätsklinikum Münster, Münster; Peter Reichardt, Klinik für Interdisziplinäre Onkologie, Bad Saarow, Germany; Sigbjørn Smeland and Kirsten Sundby Hall, Oslo University Hospital; Kirsten Sundby Hall, Norwegian Radium Hospital, Oslo, Norway; Jeremy S. Whelan, University College London Hospitals; Gordana Jovic, Jane M. Hook, and Matthew R. Sydes, University College London; Beatrice Seddon and Maria Michelagnoli, University College Hospital, London; Bernadette Brennan, Christie Hospital and Royal Manchester Children's Hospital, Manchester; Susan Picton, Leeds University Hospital, Leeds, United Kingdom; Neyssa Marina, Stanford University Medical Center; Claudia Deffenbaugh, Lucille Salter Packard Children's Hospital, Palo Alto; Mark D. Krailo, Children's Oncology Group, Arcadia, CA; Mark Gebhardt and Allen Goorin, Dana-Farber Cancer Institute; Mark Gebhardt and Lisa A. Teot, Children's Hospital Boston, Boston, MA; Zsuzsanna Pápai, National Medical Center, Budapest, Hungary; James Meyer, Children's Hospital of Philadelphia and University of Pennsylvania School of Medicine, Philadelphia, PA; Helen Nadel, British Columbia Children's Hospital and University of British Columbia, Vancouver, British Columbia; Mark Bernstein, Dalhousie University, Halifax, Nova Scotia, Canada; R. Lor Randall, University of Utah, Salt Lake City, UT; Rajaram Nagarajan, Cincinnati Children's Hospital Medical Center, Cincinnati, OH; G. Douglas Letson, H. Lee Moffit Cancer Center and Research Institute, Tampa, FL; Daniel Baumhoer, Universitätsspital Basel; Thomas Kühne, University Children's Hospital Basel, Basel, Switzerland; Leo Kager, St Anna's Children Hospital; Reinhard Windhager, Medica
Purpose: EURAMOS-1, an international randomized controlled trial, investigated maintenance therapy with pegylated interferon alfa-2b (IFN-α-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.