Study on a tool for evaluating survival in patients operated on for bone metastases
Project objectives
The primary objective of this observational study, of an international multicenter nature, is the validation of a system capable of estimating the probability of survival at 3 and 12 months of the patient suffering from bone metastases and undergoing surgery for fractures on metastases, or for lesions metastatic disease that places the bone at risk of fracture (impending fractures).
A secondary objective is the determination of risk factors related to oncological pathology, surgery and the type of implant in patients affected by bone metastases and requiring orthopedic surgery.
Knowing the estimate of survival, patients with reduced life expectancies can be treated with less invasive methods and therefore more compatible with their clinical picture. Conversely, patients with a higher estimate of survival following surgery will be able to make use of more complex interventions and with implants designed to last longer, even if this implies an increased perioperative surgical risk and a longer duration of rehabilitation.
The study consists of two phases:
- The first phase, retrospective, now concluded, consisted in the validation of the clinical and laboratory data and of the survival of the patients in a retrospective way. The collected data were subsequently compared with those collected in the United States and Sweden. The findings were published in 2015 in BMC Cancer (How do we estimate survival? External validation of a tool for survival estimation in patients with metastatic bone disease-decision analysis and comparison of three international patient populations. BMC Cancer, 2015 May 22;15:424. doi: 10.1186/s12885-015-1396-5).
- The second phase, which will begin in 2016, consists in the validation of the survival estimation system in a prospective manner, and foresees a duration of 18 months. Since this is a validation of the survival estimation system, the data collection will be independent of the patient's treatment, and will not cause any change in the normal clinical and/or surgical management of the patient affected by bone metastases.
Official website: www.pathfx.org
Start and end date
2014 - 2018
Project managers
- Prof. Vincenzo Denaro
- Dr. Alberto Di Martino
- Dr. Nicola Papapietro
Coordinating institution of the project
National Study Group on Bone Metastases of the Italian Society of Orthopedics and Traumatology (SIOT)
Other Institutions involved
- All institutions belonging to the National Study Group on Bone Metastases of the Italian Society of Orthopedics and Traumatology (SIOT) (13 centers in Italy)
- Memorial Sloan Kettering Cancer Center, New York
- Karolinska University Hospital, Stockholm, Sweden
Funding source
No profit