EURAMOS-1, an international randomised study for osteosarcoma: Results from pre-randomisation treatment

Annals of Oncology

Volumn 26, Issue 2, 2015, Pages 407-414

  Whelan, J S ^a   Bielack, S S ^b   Marina, N ^c   Smeland, S ^d,e   Jovic, G ^f   Hook, J M ^f   Krailo, M ^g   Anninga, J ^h   Butterfass Bahloul, T ⁱ   Böhling, Tom ^j   Calaminus, G ⁱ   Capra, M ^k   Deffenbaugh, C ^l   Dhooge, C ^m   Eriksson, M ⁿ   Flanagan, A M ^f,o   Gelderblom, H ^h   Goorin, A ^p   Gorlick, R ^q   Gosheger, G ⁱ   Grimer, R J ^r   Hall, K S ^s   Helmke, K ^t   Hogendoorn, P C W ^h   Jundt, G ^u   Kager, L ^v   Kuehne, T ^w   Lau, C C ^x   Letson, G D ^y   Meyer, J ^z   Meyers, P A ^aa   Morris, C ^aa,ab   Mottl, H ^ac   Nadel, H ^ad   Nagarajan, R ^ae   Randall, R L ^af   Schomberg, P ^ag   Schwarz, R ^t   Teot, L A ^ah   Sydes, Matthew R ^f   Bernstein, M ^ai   Pickering, James ^aj   Joffe, Nicola ^aj   Kevric, Matthias ^aj   Sorg, Benjamin ^aj   Villaluna, Doojduen ^aj   Wang, Caroline ^aj   Perisoglou, Martha ^aj   Trani, Leonardo ^aj   Potratz, Jenny ^aj   Carrle, Dorothe ^aj   Wilhelm, Miriam ^aj   Zils, Katja ^aj   Teske, Carmen ^aj   more..

^a UNIVERSITY COLLEGE HOSPITAL   (United Kingdom)

^b OLGAHOSPITAL   (Germany)

^c STANFORD UNIVERSITY MEDICAL CENTER   (United States)

^d OSLO UNIVERSITY HOSPITAL   (Norway)

^e UNIVERSITY OF OSLO   (Norway)

^f UNIVERSITY COLLEGE LONDON   (United Kingdom)

^g CHILDREN S ONCOLOGY GROUP   (United States)

^h LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

ⁱ UNIVERSITY HOSPITAL MÜNSTER   (Germany)

^j UNIVERSITY OF HELSINKI   (Finland)

^k OUR LADY S CHILDREN S HOSPITAL   (Ireland)

^l LUCILE PACKARD CHILDREN S HOSPITAL   (United States)

^m GHENT UNIVERSITY HOSPITAL   (Belgium)

ⁿ LUND UNIVERSITY HOSPITAL   (Sweden)

^o ROYAL NATIONAL ORTHOPAEDIC HOSPITAL   (United Kingdom)

^p DANA FARBER CANCER INSTITUTE   (United States)

^q MONTEFIORE MEDICAL CENTER   (United States)

^r ROYAL ORTHOPAEDIC HOSPITAL   (United Kingdom)

^s OSLO UNIVERSITY HOSPITAL   (Norway)

^t UNIVERSITY MEDICAL CENTER HAMBURG EPPENDORF   (Germany)

^u UNIVERSITY HOSPITAL BASEL   (Switzerland)

^v ST ANNA CHILDREN S HOSPITAL   (Austria)

^w UNIVERSITY CHILDREN S HOSPITAL   (Switzerland)

^x BAYLOR COLLEGE OF MEDICINE   (United States)

^y H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

^z UNIVERSITY OF PENNSYLVANIA   (United States)

^aa MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^ab JOHNS HOPKINS UNIVERSITY   (United States)

^ac CHARLES UNIVERSITY   (Czech Republic)

^ad UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^ae CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER   (United States)

^af UNIVERSITY OF UTAH   (United States)

^ag MAYO CLINIC   (United States)

^ah BOSTON CHILDREN S HOSPITAL   (United States)

^ai DALHOUSIE UNIVERSITY   (Canada)

^aj Medical Center Hamburg Eppendorf ^*

more..

Author keywords

International collaboration; Osteosarcoma; Randomised controlled trial; Trial conduct

Indexed keywords

CEPEGINTERFERON ALPHA2B; CISPLATIN; DOXORUBICIN; ETOPOSIDE; IFOSFAMIDE; METHOTREXATE; ALPHA INTERFERON; ANTINEOPLASTIC AGENT; MACROGOL DERIVATIVE; PEG-IFN-SA;

ADOLESCENT; ADULT; ARTICLE; CANCER MORTALITY; CANCER SURGERY; CANCER SURVIVAL; CHILD; CONTROLLED STUDY; DRUG MEGADOSE; DRUG RESPONSE; EVENT FREE SURVIVAL; FEMALE; HUMAN; INFANT; LONGITUDINAL STUDY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NEWBORN; OSTEOSARCOMA; OUTCOME ASSESSMENT; PRESCHOOL CHILD; PRIORITY JOURNAL; QUALITY OF LIFE; QUALITY OF LIFE ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; ROTATIONPLASTY; SCHOOL CHILD; SURGICAL MORTALITY; SURVIVAL TIME; TOXIC EPIDERMAL NECROLYSIS; TREATMENT DURATION; YOUNG ADULT; BONE NEOPLASMS; CLINICAL TRIAL; METHODOLOGY; MULTIMODALITY CANCER THERAPY; NEOADJUVANT THERAPY;

ADOLESCENT; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BONE NEOPLASMS; CHILD; CISPLATIN; COMBINED MODALITY THERAPY; DOXORUBICIN; ETOPOSIDE; FEMALE; HUMANS; IFOSFAMIDE; INTERFERON-ALPHA; MALE; METHOTREXATE; NEOADJUVANT THERAPY; OSTEOSARCOMA; POLYETHYLENE GLYCOLS; QUALITY OF LIFE; RESEARCH DESIGN; YOUNG ADULT;

EID: 84966477902     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdu526     Document Type: Article

References (28)

1. Whelan J, McTiernan A, Cooper N et al. Incidence and survival of malignant bone sarcomas in England 1979-2007. Int J Cancer 2011; 131: E508-E517.
2. Marina N, Bielack S, Whelan J et al. International collaboration is feasible in trials for rare conditions: the EURAMOS experience. Cancer Treat Res 2009; 152: 339-353.
3. Rosen G, Murphy ML, Huvos AG et al. Chemotherapy, en bloc resection, and prosthetic bone replacement in the treatment of osteogenic sarcoma. Cancer 1976; 37: 1-11.
4. Bacci G, Picci P, Ruggieri P et al. Primary chemotherapy and delayed surgery (neoadjuvant chemotherapy) for osteosarcoma of the extremities. Cancer 1990; 65: 2539-2553.
5. Whelan JS, Jinks RC, McTiernan A et al. Survival from high-grade localised extremity osteosarcoma: combined results and prognostic factors from three European Osteosarcoma Intergroup randomised controlled trials. Ann Oncol 2012; 23: 1607-1616.
6. Marina N, Bielack S, Whelan J et al. International collaboration is feasible in trials for rare conditions: the EURAMOS experience. In Jaffe N, Bruland OS, Bielack S (eds), Pediatric and Adolescent Osteosarcoma Series: Cancer Treatment and Research, Vol. 152. 2010; 339-354.
7. Barlow CF, Priebe CJ, Mulliken JB et al. Spastic diplegia as a complication of interferon alfa-2a treatment of hemangiomas of infancy. J Pediatr 1998; 132: 527-530.
8. Meyers PA, Schwartz CL, Krailo M et al. Osteosarcoma: a randomized, prospective trial of the addition of ifosfamide and/or muramyl tripeptide to cisplatin, doxorubicin, and high-dose methotrexate. J Clin Oncol 2005; 23: 2004-2011.
9. Goorin AM, Harris MB, Bernstein M et al. Phase II/III trial of etoposide and highdose ifosfamide in newly diagnosed metastatic osteosarcoma: a Pediatric Oncology Group trial. J Clin Oncol 2002; 20: 426-433.
10. Aaronson NK, Ahmedzai S, Bergman B et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993; 85: 365-376.
11. Varni JW, Burwinkle TM, Katz ER et al. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer 2002; 94: 2090-2106.
12. Calaminus G, Weinspach S, Teske C, Gobel U. Quality of life in children and adolescents with cancer. First results of an evaluation of 49 patients with the PEDQOL questionnaire. Klin Padiatr 2000; 212: 211-215.
13. Cancer Therapy Evaluation Program. Common Terminology Criteria for Adverse Events, Version 3.0, DCTD, NCI, NIH, DHHS. http://ctep.cancer.gov/protocol Development/electronic_applications/ctc.htm#ctc_archive:2006 (28 Nov 2014, date last accessed).
14. George SL, Desu MM. Planning the size and duration of a clinical trial studying the time to some critical event. J Chronic Dis 1974; 27: 15-24.
15. Ferrari S, Smeland S, Mercuri M et al. Neoadjuvant chemotherapy with high-dose ifosfamide, high-dose methotrexate, cisplatin, and doxorubicin for patients with localized osteosarcoma of the extremity: a joint study by the Italian and Scandinavian Sarcoma Groups. J Clin Oncol 2005; 23: 8845-8852.
16. Le Deley MC, Guinebretiere JM, Gentet JC et al. SFOP OS94: a randomised trial comparing preoperative high-dose methotrexate plus doxorubicin to high-dose methotrexate plus etoposide and ifosfamide in osteosarcoma patients. Eur J Cancer 2007; 43: 752-761.
17. Lewis IJ, Nooij MA, Whelan J et al. Improvement in histologic response but not survival in osteosarcoma patients treated with intensified chemotherapy: a randomized phase III trial of the European Osteosarcoma Intergroup. J Natl Cancer Inst 2007; 99: 112-128.
18. Smeland S, Muller C, Alvegard TA et al. Scandinavian Sarcoma Group Osteosarcoma Study SSG VIII: prognostic factors for outcome and the role of replacement salvage chemotherapy for poor histological responders. Eur J Cancer 2003; 39: 488-494.
19. Whelan J, Patterson D, Perisoglou M et al. The role of interferons in the treatment of osteosarcoma. Pediatr Blood Cancer 2010; 54: 350-354.
20. Schwartz CL, Wexler LH, Devidas M et al. P9754 therapeutic intensification in non-metastatic osteosarcoma: a COG trial. J Clin Oncol (Meeting Abstracts) 2004; 22: abstr 8514.
21. Gentet JC, Brunat-Mentigny M, Demaille MC et al. Ifosfamide and etoposide in childhood osteosarcoma. A phase II study of the French Society of Paediatric Oncology. Eur J Cancer 1997; 33: 232-237.
22. Rosen G, Forscher C, Lowenbraun S et al. Synovial sarcoma. Uniform response of metastases to high dose ifosfamide. Cancer 1994; 73: 2506-2511.
23. Bielack SS. Osteosarcoma: time to move on? Eur J Cancer 2010; 46: 1942-1945.
24. Fern L, Davies S, Eden T et al. Rates of inclusion of teenagers and young adults in England into National Cancer Research Network clinical trials: report from the National Cancer Research Institute (NCRI) Teenage and Young Adult Clinical Studies Development Group. Br J Cancer 2008; 99: 1967-1974.
25. Fern LA, Lewandowski JA, Coxon KM et al. Available, accessible, aware, appropriate, and acceptable: a strategy to improve participation of teenagers and young adults in cancer trials. Lancet Oncol 2014; 15: e341-e350.
26. McTiernan A, Jinks RC, Sydes MR et al. Presence of chemotherapy-induced toxicity predicts improved survival in patients with localised extremity osteosarcoma treated with doxorubicin and cisplatin: a report from the European Osteosarcoma Intergroup. Eur J Cancer 2012; 48: 703-712.
27. Pearce S, Lavender V, Brownsdon A et al. Perceptions of participants and professionals in bone sarcoma clinical trials: implications for study design and conduct. Eur J Cancer 2013; 49(suppl 2): A3819.
28. Bielack S, Smeland S, Whelan J et al. MAP plus maintenance pegylated interferon a-2b (MAPIfn) 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" randomization. J Clin Oncol 2013; 31(suppl): LBA10504.