The results of the EURAMOS-1 trial show that adding the drugs ifosfamide and etoposide to standard chemotherapy does not help patients with osteosarcoma whose tumour has responded poorly to previous standard chemotherapy. These results were published today in the Lancet Oncology journal.
Osteosarcoma is a rare type of bone cancer. It mainly affects young adults, adolescents and children. Currently, the standard treatment is chemotherapy with three drugs called MAP (methotrexate, doxorubicin and cisplatin), followed by surgery, followed by further chemotherapy with the same three drugs. The EURAMOS-1 trial was designed to see if the length of time people lived:
- without the disease coming back again and
- without the disease getting worse and
- without other tumours developing and
- without dying
could be improved by adding drugs to standard post-operative chemotherapy.
All patients had MAP chemotherapy and then surgery. After surgery, doctors assessed whether the patient’s tumour had responded well or poorly to the pre-operative chemotherapy. 618 patients whose tumour had responded poorly to pre-operative chemotherapy were randomised to receive either standard post-operative chemotherapy, or standard post-operative chemotherapy plus two extra drugs, ifosfamide and etoposide (MAPIE).
The results published today show that adding ifosfamide and etoposide to standard post-operative chemotherapy did not improve how long participants survived without either the disease coming back again or getting worse, or new tumours developing, or dying (event-free survival). Adding ifosfamide and etoposide also increased the numbers of severe side-effects participants had. More people in the MAPIE group have developed a second cancer other than osteosarcoma than in the MAP group. However, the numbers were small (10 on MAPIE compared to 3 on MAP). We cannot yet be sure this difference was caused by the chemotherapy.
These results convincingly show that ifosfamide and etoposide should not be added to standard chemotherapy with methotrexate, doxorubicin and cisplatin for osteosarcoma that has responded poorly to MAP. Participants in the trial are still being followed-up to help us understand the long-term effects of the two treatments.
As osteosarcoma is a rare disease there have been few trials done to find out how best to treat it. EURAMOS-1 is the biggest ever trial of how to treat osteosarcoma. It shows that we can carry out big trials for rare diseases, through international collaboration. EURAMOS-1 took part in hospitals throughout Europe (including Austria, Belgium, Czech Republic, Denmark, Finland, Germany, Hungary, Ireland, The Netherlands, Norway, Sweden, Switzerland and the UK), the USA and Canada, Australia and New Zealand.