EURAMOS-1: A trial of the European and American
Lead Research Organisation:
University College London
Department Name: UNLISTED
Abstract
Four international study groups undertook a large study in resectable osteosarcoma, which included two randomised controlled trials, to determine the effect on survival of changing post-operative chemotherapy based on histological response.
Technical Summary
A randomised trial of the European and American Osteosarcoma Study Group to optimise treatment strategies for patients with resectable osteosarcoma based on histological response to pre-operative chemotherapy. Osteosarcoma is the most common bone cancer in children, adolescents, and youn adults, but is still a rare disease with an annual incidence of 2-3 million/year. The most common primary sites are the distal femur and proximal tibia, and 15-20% of patients have clinically detectable metastases at the time of diagnosis. The outcome for patients with osteosarcoma was poor before the use of effective chemotherapy, with 2-year overall survival in the region of 15-20%. The administration of multi-agent chemotherapy has dramatically improved the outcome. Most current series report 3-year disease-free survival rates of 60-70% following the administration of pre-operative multi-agent chemotherapy followed by surgical resection and continuation of chemotherapy post-operatively. These positive results, however, apply only to young patients with localised extremity tumours, while other patients - which make up at least one third of all affected individuals - have traditionally been excluded from prospective randomised trials. Judging from case series and cumulative analyses, their outcome is still considerably worse, with survival rates in the order of no more than 20-30% for patients with primary metastatic osteosarcomas or osteosarcomas of the axial skeleton.
Organisations
People |
ORCID iD |
Publications
Anninga J
(2014)
Workshop report on the 2nd Joint ENCCA/EuroSARC European bone sarcoma network meeting: integration of clinical trials with tumour biology
in Clinical Sarcoma Research
Bielack SS
(2015)
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.
in Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Calaminus G
(2019)
Quality of Life of Patients With Osteosarcoma in the European American Osteosarcoma Study-1 (EURAMOS-1): Development and Implementation of a Questionnaire Substudy.
in JMIR research protocols
Smeland S
(2019)
Survival and prognosis with osteosarcoma: outcomes in more than 2000 patients in the EURAMOS-1 (European and American Osteosarcoma Study) cohort.
in European journal of cancer (Oxford, England : 1990)
Whelan JS
(2015)
EURAMOS-1, an international randomised study for osteosarcoma: results from pre-randomisation treatment.
in Annals of oncology : official journal of the European Society for Medical Oncology
Guideline Title | UK guidelines for the management of bone sarcomas |
Description | British Sarcoma Group: UK guidelines for the management of bone sarcomas (in BMC Clinical Sarcoma Research) |
Geographic Reach | National |
Policy Influence Type | Citation in clinical guidelines |
Impact | Not known |
URL | https://clinicalsarcomaresearch.biomedcentral.com/articles/10.1186/s13569-016-0047-1 |
Guideline Title | ESMO-PaedCan-EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up (2018) |
Description | Cited in clinical guidelines -- ESMO-PaedCan-EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up (2018) |
Geographic Reach | Europe |
Policy Influence Type | Citation in clinical guidelines |
URL | https://academic.oup.com/annonc/article/29/Supplement_4/iv79/5115250 |
Guideline Title | BMJ Best Practice -- Osteosarcoma: The right clinical information, right where it's needed |
Description | Cited in clinical guidelines -- EURAMOS-1 -- BMJ Best Practice (Feb-2019) |
Geographic Reach | National |
Policy Influence Type | Citation in clinical guidelines |
URL | https://bestpractice.bmj.com/topics/en-gb/780/pdf/780.pdf |
Guideline Title | NCCN Clinical Practice Guidelines in Oncology Bone Cancer |
Description | National Comprehensive Cancer Network - EURAMOS-1 Good Responders |
Geographic Reach | North America |
Policy Influence Type | Citation in clinical guidelines |
Impact | Not known |
URL | https://emedicine.medscape.com/article/1256857-guidelines |
Guideline Title | NCCN Clinical Practice Guidelines in Oncology Bone Cancer |
Description | National Comprehensive Cancer Network - EURAMOS-1 Poor Responders |
Geographic Reach | North America |
Policy Influence Type | Citation in clinical guidelines |
URL | https://emedicine.medscape.com/article/1256857-guidelines |
Description | EURAMOS good responders lay summary |
Form Of Engagement Activity | A magazine, newsletter or online publication |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Participants in your research and patient groups |
Results and Impact | Lay summary of trial results (First results of the EURAMOS-1: Information for trial participants and families) was prepared and made available via the trial website and sent to investigators to give to participants. Unknown |
Year(s) Of Engagement Activity | 2013 |
URL | http://www.euramos.org |
Description | EURAMOS-1 Overview at NCRI 2015 |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Professional Practitioners |
Results and Impact | Presentation of EURAMOS-1 design, results (particularly Poor Response randomisation) and implications at UK National Cancer Research Institute 2015 conference by Jeremy Whelan (UCL, London). This was an invited talk to a session on clinical trials in rare cancers. |
Year(s) Of Engagement Activity | 2015 |
Description | EURAMOS-1 Poor Responders at CTOS 2014 |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | The results of the Poor Response randomisation of the EURAMOS-1 were presented for the first time at the Connective Tissue Oncology Society meeting 2015 in Berlin, Germany, by Neyssa Marina (Stanford, CA, USA), one of the lead clinicians for the trial. The analysis were done and the slides prepared by MRC CTU at UCL. This will change practice despite not finding in favour of the research arm. A paper was submitted for publication late in 2015. |
Year(s) Of Engagement Activity | 2014 |
Description | EURAMOS-1 infographic |
Form Of Engagement Activity | A magazine, newsletter or online publication |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Study participants or study members |
Results and Impact | We produced an infographic to summarise some of the key EURAMOS-1 results. This was distributed via social media, and to study participants. |
Year(s) Of Engagement Activity | 2016 |
URL | http://www.ctu.mrc.ac.uk/news/2016/euramos_results_26082016 |
Description | EURAMOS-1 results and collaboration: Basel, Switzerland Oct-2015 (Bielack) |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Professional Practitioners |
Results and Impact | Presentation by German lead clinician for EURAMOS-1, Stefan Bielack at Jahrestagung der Deutschen, Österreichischen und Schweizerischen Gesellschaften für Hämatologie und Onkologie Osteosarkome [Annual Meeting of the German, Austrian and Swiss Societies for Hematology and Medical Oncology] 2015 entitled "Therapeutischer Rückschlag bei Non-Respondern? Was nun?" [Therapeutic setback for non-responders: what now?] 09. - 13. Oktober 2015, Basel, CH |
Year(s) Of Engagement Activity | 2015 |
Description | EURAMOS-1 results and collaboration: Florence, Italy Apr-2015 (Bielack) |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Professional Practitioners |
Results and Impact | Presentation by German lead clinician for EURAMOS-1, Stefan Bielack at Italian Sarcoma Group (ISG) Meeting "Intergroup-Multicentric studies in rare sarcomas: the lesson of EURAMOS 1." 10-11 April 2015 in Florence, Italy |
Year(s) Of Engagement Activity | 2015 |
Description | EURAMOS-1 results and collaboration: Muenster, Germany Feb-2015 (Bielack) |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Professional Practitioners |
Results and Impact | Presentation by German lead clinician for EURAMOS-1, Stefan Bielack at German Sarkomkonferenz 2015 "Osteosarkomstudie EURAMOS-1 (NCT00134030, ISRCTN 67613327): Ergebnisse der randomisierten Fragestellungen" 26. - 28. February 2015, Münster, Germany: |
Year(s) Of Engagement Activity | 2015 |
Description | EURAMOS-1 results and collaboration: Tokyo Feb-2015 (Bielack) |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Presentation by German lead clinician for EURAMOS-1, Stefan Bielack at 1st International Symposium on Recent Global Advances in Cancer Research entitled "Rare Cancers: Seeking for Ideal Medical Care -- Bielack S: European and intercontinental collaboration in osteosarcoma: Challenges and results." February 12-13, 2015, Tokyo, Japan: |
Year(s) Of Engagement Activity | 2015 |
Description | EURAMOS-1 surgery data: oral presentation at CTOS 2015 |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Data on surgery in EURAMOS-1 trial were presented orally at the Connective Tissue Oncology Society meeting 2015 in Salt Lake City, UT, USA. The presentation was given by surgeon Rob Grimer. The analyses were led by, and slides prepared by, MRC CTU at UCL. |
Year(s) Of Engagement Activity | 2015 |
Description | EURAMOS-1 surgery data: oral presentation at ISOLS 2015 |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Data on surgery in EURAMOS-1 trial were presented orally at the International Society Of Limb Salvage meeting 2015 in Florida, USA. The presentation was given by surgeon Rob Grimer. The analyses were led by, and slides prepared by, MRC CTU at UCL. |
Year(s) Of Engagement Activity | 2015 |
Description | Overview of EURAMOS-1 trial at BSG 2015 |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Professional Practitioners |
Results and Impact | Presentation by Matt Sydes at the British Sarcoma Group 2015 national conference in Nottingham 2015. The presentation gave an overview of the whole of the EURAMOS-1 trial to the appropriate clinical audience. This is the main national sarcoma conference for the UK. |
Year(s) Of Engagement Activity | 2015 |
Description | Presentation of the EURAMOS-1 Poor Responders randomisation first results |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | Yes |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | First results of this important comparison were presented at international conferences. More presentations will follow in China, UK and Germany, at least, given by the lead investigators. A paper is in development. MAP chemotherapy will the international standard of care. |
Year(s) Of Engagement Activity | 2014 |
URL | https://www.ctos.org/PDFs/CTOS%202014%20AM%20FP%20complete%20rfs%20electronic.pdf |