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J Clin Oncol. 2015 Jul 10;33(20):2279-87. doi: 10.1200/JCO.2014.60.0734. Epub 2015 Jun 1.

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.

Collaborators (205)

Hayani A, Kwon J, Kanwar V, Frantz C, Hale G, Lurie RH, Walterhouse D, Bomgaars L, Bryant N, Lobel J, Howell D, Sadanandan S, Mott CS, Mody R, Glennon C, Ferguson W, Li X, Atkinson M, Kaplan J, Katzenstein H, Abromowitch M, Golden C, Crouse V, Maloney K, Kuerbitz S, Reddy A, Mascarenhas L, Balis F, Ritchey A, Yu L, Bostrom B, Hetherington M, Dome J, Lowe E, Perentesis J, Pawlowska A, Thompson M, Lee A, Isakoff M, Granger MM, Kelly M, Termuhlen A, Beaty O, Campus M, Ricafort R, Halpern S, Wistinghausen B, Kirkpatrick G, Ranalli M, Howell D, Howell D, Sandler E, Schwartz J, Bernstein J, Ozkaynak M, Kamalakar P, Stork L, Neuberg R, McGregor L, Boklan J, Bryant P, Barnette P, Felgenhauer J, Roberts W, Olson J, Woods-Swafford W, Schwartz K, Fallon R, Luke CP, Clark J, Brecher M, Rifkin-Zenenberg S, Christopher S, Halligan G, Woods GP, Sawaf H, Bonilla M, Furman W, De Alarcon P, Luke S, Chang E, Gowda N, Calderwood S, Hill J, Razzouk B, Clavell L, Kobrinsky N, Wagner K, Greenfield D, Grayson G, Hawkins D, Wiley J, Cooper R, Brandt G, Kerr K, Brook S, Parker R, Thompson TC, Tebbi C, Regueira O, Broxson E, Cohen A, Redner A, Stein D, Wittman B, Howell D, WoodJohnson R, Drachtman R, Becton D, Balagtas JM, Goldsby R, Cohn S, Slayton W, Wilkinson R, Schmidt M, Greenwood M, York T, Keuker C, Barredo J, Neglia J, Megason G, Coccia P, Hill C, Gold S, McNall-Knapp R, Andolina J, Wilson F, Langevin AM, Winick N, Homans A, Dunsmore K, De Santes K, McLean T, Howell D, Hayashi R, Wang Z, Aledo A, Oak R, Weinblatt M, Kadan-Lottick N, Prasannan L, Rodriguez-Galindo C, Chaffee S, Christie C, Johnson M, Kreissman S, Grossi M, Pais R, Fryberger S, McDonough C, Appel B, Dickens D, Schorin M, Cohen K, Permanente-Oakland K, Bergstrom S, Bertolone S, Monteleone P, Linda L, Daw N, Howell D, Larsen E, Magnuson MO, McManus M, Irwin R, Kempert P, Arndt C, Lenarsky C, Kraveka J, Hanif I, Steinherz P, Johnston J, Jasty R, Hanson R, Estrada J, Gera R, Raetz E, Strother D, Blair A, Haq M, Strahlendorf C, Silva M, Samson Y, Cairney A, Halton J, Michon B, Mpofu C, Abish S, Desai SJ, Grant R, Yhap M, Goodyear LA, Portwine C, Downie P, Cole C, Mechinaud F, Irving H, Barbaric D, McCowage G, Kirby M, Ammann R, Ansari M, Popovic MB, Sullivan M, Gomez F.

Author information

1
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

Erratum in

Abstract

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. These patients were randomly assigned to four additional cycles MAP with or without IFN-α-2b (0.5 to 1.0 μg/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-α-2b, n = 357), with baseline characteristics balanced by arm. A total of 271 of 357 started IFN-α-2b; 105 stopped early, and 38 continued to receive treatment at data freeze. Refusal and toxicity were the main reasons for never starting IFN-α-2b and for stopping prematurely, respectively. Median IFN-α-2b duration, if started, was 67 weeks. A total of 133 of 268 patients who started IFN-α-2b and provided toxicity information reported grade ≥ 3 toxicity during IFN-α-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-α-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-α-2b was not statistically different from MAP alone. A considerable proportion of patients never started IFN-α-2b or stopped prematurely. Long-term follow-up for events and survival continues.

PMID:
26033801
PMCID:
PMC4486345
DOI:
10.1200/JCO.2014.60.0734
[Indexed for MEDLINE]
Free PMC Article

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