Metformin as Maintenance Therapy in Patients With Bone Sarcoma and High Risk of Relapse
Status:
Recruiting
Trial end date:
2027-07-01
Target enrollment:
Participant gender:
Summary
Primitive bone sarcoma are rare tumors with low options of therapy for patient treatment.
1. OSTEOSARCOMA VERY POOR RESPONDER COHORT. Necrosis on primitive localized osteosarcoma
represents one of the principal prognostic factors. Nowadays, for localized osteosarcoma
there is no maintenance therapy that have shown to be effective.
In ISG-OS1 study in patients with necrosis < 60% had an event free survival (EFS) at 3
yrs of 20% (Ferrari S ) in a more recent analysis (Tsuda Y 2020) patients with a
necrosis <60% had a 3 y EFS of 35% .
2. OSTEOSARCOMA AND EWING'S SARCOMA AFTER FIRST RELAPSE Maintenance therapy after Complete
Remission occurring after Ewing's sarcoma or osteosarcoma patients is not a standard
rule.
These patients when free from disease, after first relapse, are more likely to face a second
relapse. EFS at ONE YEAR after first relapse in osteosarcoma is shown in literature to be
around 21% (Leary SE 2013) and 16% (Tirtei E 2017). The EFS at ONE YEAR after first relapse
in Ewing's sarcoma is inferior to 20% (Barker 2005, Ferrari S 2015). A maintenance therapy
with low toxicity in these high risk patients could be an option.
Metformin has been reported to a reduce the incidence of different type of cancer in diabetic
patients. Metformin is well tolerated in diabetics an it is used in other conditions in non
diabetic, as ovarian polycystic syndrome, metabolic syndrome and obesity. Metformin has been
employed as chemoprevention related to its mechanism of action in breast cancer (NCT01101438
) and in pediatric cancer together with chemotherapy (NCT01528046).
This study aim to explore the effectiveness of metformin (a low cost and well tolerated drug)
as maintenance therapy in osteosarcoma and Ewing sarcoma patients at high risk of relapse.