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
Open accessAbstract
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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A subsequent international study explored the efficacy of IFNα in osteosarcoma and did not show any activity.
“A subsequent international study explored the efficacy of IFNα and did not show any activity 82 .”
From Osteosarcoma (2022) · cites this paper as [82]
Maintenance therapy with IFNα was not of any benefit in patients with a good response.
“In addition, maintenance therapy with IFNα was not of any benefit in those with a good response 82 .”
From Osteosarcoma (2022) · cites this paper as [82]
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- Authors
- Bielack, S. S., Smeland, S., Whelan, J. S., Marina, N., Jovic, G., Hook, J. M., Krailo, M. D., Gebhardt, M., Pápai, 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., Sundby Hall, K., Gelderblom, H., Meyers, P., Gorlick, R., Windhager, R., Helmke, K., Eriksson, M., Hoogerbrugge, P. M., Schomberg, P., Tunn, P.-U., Kühne, T., Jürgens, H., van den Berg, H., Böhling, T., Picton, S., Renard, M., Reichardt, P., Gerss, J., Butterfass-Bahloul, T., Morris, C., Hogendoorn, P. C. W., Seddon, B., Calaminus, G., Michelagnoli, M., Dhooge, C., Sydes, M. R., & Bernstein, M.
- Affiliations
- Oslo University Hospital (NO)
- 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,...
- Corresponding author
- Sydes, Matthew R.
- ORCID
- Bielack, Stefan S.
- Smeland, Sigbjørn
- Whelan, Jeremy S.
- Marina, Neyssa
- Jovic, Gordana
- Krailo, Mark D.
- Pápai, Zsuzsanna
- Nadel, Helen
- Randall, R. Lor
- Nagarajan, Rajaram
- Brennan, Bernadette
- Letson, G. Douglas
- Baumhoer, Daniel
- Kager, Leo
- Werner, Mathias
- Gelderblom, Hans
- Meyers, Paul
- Gorlick, Richard
- Hoogerbrugge, Peter M.
- Tunn, Per-Ulf
- Kühne, Thomas
- Böhling, Tom
- Reichardt, Peter
- Gerss, Joachim
- Morris, Carol
- Hogendoorn, Pancras C.W.
- Seddon, Beatrice
- Calaminus, Gabriele
- Dhooge, Catharina
- Sydes, Matthew R.
- Bernstein, Mark
- Venue
- Journal of Clinical Oncology
- Published
- 2015-07-10
- Volume
- 33
- Issue
- 20
- Pages
- 2279-2287
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- PMC
- PMC4486345
- OpenAlex
- W2095599995
- Cited by
- 422
- References
- 35
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- 29.27
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- en
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- Medical Research Council (MC_UU_12023/28)
- National Cancer Institute (U10CA180899, U10CA098543)
- NIH Clinical Center
- Children's Hospital of Pittsburgh
- Cliniques Universitaires Saint-Luc
- Madigan Army Medical Center
- Cilag
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Sarcoma Diagnosis and Treatment
- Health Sciences › Medicine › Rheumatology › Bone Tumor Diagnosis and Treatments
- Health Sciences › Medicine › Reproductive Medicine › Ovarian cancer diagnosis and treatment
- Keywords
- osteosarcoma, peginterferon alfa-2b, maintenance therapy, neoadjuvant chemotherapy, event-free survival, overall survival, treatment toxicity, young adults, interferon alfa-2b
- MeSH terms
- Interferon alpha-2, Adolescent, Adult, Antineoplastic Combined Chemotherapy Protocols, Asia, Australia, Bone Neoplasms, Child, Child, Preschool, Cisplatin, Doxorubicin, Europe, Female, Humans, Male, Methotrexate, North America, Osteotomy, Polyethylene Glycols, Recombinant Proteins, Risk Factors, Osteosarcoma, Time Factors, Proportional Hazards Models, Treatment Outcome, Interferon-alpha, Chemotherapy, Adjuvant, Disease Progression, Disease-Free Survival, Neoadjuvant Therapy, Kaplan-Meier Estimate, Young Adult, Neoplasm Grading
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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