A randomised trial of chemotherapy with or without granulocyte colony stimulating factor (G-CSF) in operable osteosarcoma
Can a substance called G-CSF help in the treatment of people with bone cancer?
What was this study about?
MRC CTU worked with researchers across Europe in a number of countries to try to find better treatments for people with osteosarcoma. Before this trial was developed, they had concluded that two chemotherapy drugs (cisplatin and doxorubicin) were the best treatment, along with an operation to remove the cancer. But the chemotherapy caused unwanted side effects, which often meant that further treatment had to be delayed, or the amount of the drugs reduced. The aim of the BO06 trial was to see whether adding a substance called granulocyte colony stimulating factor (G-CSF) meant that chemotherapy could be given more intensively over a shorter period, and therefore help people to live longer.
What difference did this study make?
This trial suggested that giving G-CSF did not help people with osteosarcoma to live longer, or to live longer without experiencing disease progression. However, giving chemotherapy (with cisplatin and doxorubicin) more intensively did increase the amount of chemotherapy that patients received and there was an improvement in response rate by the time of surgery.
The results of this study called into question whether or not patients' responses to chemotherapy before surgery can be used to accurately predict future outcomes in trials of this disease.
Type of study
Who funded the study?
This trial was funded by the Medical Research Council and the European Organisation for Research and Treatment of Cancer. The pharmaceutical companies Amgen/Roche and Chugai paid for some of the cost of the G-CSF.
When did it take place?
This trial recruited patients between 1993 and 2002. The results were published in 2007.
Who was included?
497 patients with osteosarcoma that could be operated on chose to join the study. They were randomised into two groups. People in one group were given G-CSF with chemotherapy every two weeks. People in the second group were given chemotherapy every three weeks without G-CSF. Everyone had surgery after 6 weeks.