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Methotrexate, Doxor...
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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
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electronicrdacarrier
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LIBRIS-ID:oai:lup.lub.lu.se:d28df80f-9433-4f99-98e7-bd5b425390d9
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https://lup.lub.lu.se/record/7508515URI
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https://doi.org/10.1200/JCO.2014.60.0734DOI
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Language:English
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Summary in:English
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Subject category:art swepub-publicationtype
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Subject category:ref swepub-contenttype
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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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Smeland, Sigbjørn
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Whelan, Jeremy S
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Marina, Neyssa
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Jovic, Gordana
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Hook, Jane M
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Krailo, Mark D
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Gebhardt, Mark
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Pápai, Zsuzsanna
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Meyer, James
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Nadel, Helen
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Randall, R Lor
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Deffenbaugh, Claudia
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Nagarajan, Rajaram
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Brennan, Bernadette
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Letson, G Douglas
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Teot, Lisa A
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Goorin, Allen
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Baumhoer, Daniel
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Kager, Leo
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Werner, Mathias
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Lau, Ching C
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Sundby Hall, Kirsten
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Gelderblom, Hans
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Meyers, Paul
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Gorlick, Richard
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Windhager, Reinhard
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Helmke, Knut
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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
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Hoogerbrugge, Peter M
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Schomberg, Paula
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Tunn, Per-Ulf
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Kühne, Thomas
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Jürgens, Heribert
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van den Berg, Henk
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Böhling, Tom
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Picton, Susan
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Renard, Marleen
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Reichardt, Peter
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Gerss, Joachim
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Butterfass-Bahloul, Trude
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Morris, Carol
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Hogendoorn, Pancras C W
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Seddon, Beatrice
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Calaminus, Gabriele
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Michelagnoli, Maria
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Dhooge, Catharina
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Sydes, Matthew R
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Bernstein, Mark
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TumörmikromiljöSektion I
(creator_code:org_t)
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In:Journal of Clinical Oncology33:20, s. 2279-22871527-7755
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Bielack, Stefan ...
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Smeland, Sigbjør ...
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Whelan, Jeremy S
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Marina, Neyssa
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Jovic, Gordana
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Hook, Jane M
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Krailo, Mark D
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Gebhardt, Mark
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Pápai, Zsuzsanna
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Meyer, James
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Nadel, Helen
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Randall, R Lor
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Deffenbaugh, Cla ...
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Nagarajan, Rajar ...
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Brennan, Bernade ...
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Letson, G Dougla ...
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Teot, Lisa A
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Goorin, Allen
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Baumhoer, Daniel
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Kager, Leo
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Werner, Mathias
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Lau, Ching C
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Sundby Hall, Kir ...
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Gelderblom, Hans
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Meyers, Paul
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Gorlick, Richard
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Windhager, Reinh ...
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Helmke, Knut
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Eriksson, Mikael
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Hoogerbrugge, Pe ...
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Schomberg, Paula
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Tunn, Per-Ulf
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Kühne, Thomas
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Jürgens, Heriber ...
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van den Berg, He ...
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Böhling, Tom
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Picton, Susan
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Renard, Marleen
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Reichardt, Peter
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Gerss, Joachim
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Butterfass-Bahlo ...
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Morris, Carol
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Hogendoorn, Panc ...
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Seddon, Beatrice
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Calaminus, Gabri ...
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Michelagnoli, Ma ...
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Dhooge, Catharin ...
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Sydes, Matthew R
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Bernstein, Mark
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