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  • Bielack, Stefan S (author)

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

  • Article/chapterEnglish2015

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  • 2015
  • electronicrdacarrier

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  • LIBRIS-ID:oai:lup.lub.lu.se:d28df80f-9433-4f99-98e7-bd5b425390d9
  • https://lup.lub.lu.se/record/7508515URI
  • https://doi.org/10.1200/JCO.2014.60.0734DOI

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  • Language:English
  • Summary in:English

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  • Subject category:art swepub-publicationtype
  • Subject category:ref swepub-contenttype

Notes

  • 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.

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  • Whelan, Jeremy S (author)
  • Marina, Neyssa (author)
  • Jovic, Gordana (author)
  • Hook, Jane M (author)
  • Krailo, Mark D (author)
  • Gebhardt, Mark (author)
  • Pápai, Zsuzsanna (author)
  • Meyer, James (author)
  • Nadel, Helen (author)
  • Randall, R Lor (author)
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  • Brennan, Bernadette (author)
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  • Teot, Lisa A (author)
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  • Lau, Ching C (author)
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  • Eriksson, MikaelLund University,Lunds universitet,Tumörmikromiljö,Sektion I,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Tumor microenvironment,Section I,Department of Clinical Sciences, Lund,Faculty of Medicine(Swepub:lu)onk-mer (author)
  • Hoogerbrugge, Peter M (author)
  • Schomberg, Paula (author)
  • Tunn, Per-Ulf (author)
  • Kühne, Thomas (author)
  • Jürgens, Heribert (author)
  • van den Berg, Henk (author)
  • Böhling, Tom (author)
  • Picton, Susan (author)
  • Renard, Marleen (author)
  • Reichardt, Peter (author)
  • Gerss, Joachim (author)
  • Butterfass-Bahloul, Trude (author)
  • Morris, Carol (author)
  • Hogendoorn, Pancras C W (author)
  • Seddon, Beatrice (author)
  • Calaminus, Gabriele (author)
  • Michelagnoli, Maria (author)
  • Dhooge, Catharina (author)
  • Sydes, Matthew R (author)
  • Bernstein, Mark (author)
  • TumörmikromiljöSektion I (creator_code:org_t)

Related titles

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