Metastatic Bone Tumor
Conditions
Brief summary
Bone tumors make up about 3-5% of childhood cancers and less than 1% of cancers in adults. Of these, osteosarcoma (OSS) is the most commonly diagnosed primary malignant bone tumor. OSS is a primary mesenchymal malignant tumor of bone characterized by the production of osteoid or immature bone by the malignant cells. Despite its rarity, OSS is the most common primary malignancy of bone in children and adolescents, and the fifth most common malignancy among adolescents and young adults aged 15 to 19 years. Ewing sarcoma (ES) is the second most frequent bone tumors in children and may arise also in soft tissues. This disease encompasses tumors formerly known as Askin's tumor, Peripheral Neuroectodermal Tumor (PNET) and the Ewing Sarcoma Family of Tumors (ESFT). Chondrosarcoma are rare sarcoma reputed chemorefractory in the non-operable setting and for which little is known in terms of palliative management with systemic treatments. Despite adequate loco-regional treatment, up to 40% of patients with sarcoma, soft tissue or bone, will develop metastatic disease. When metastases are detected, the standard of care is based on palliative chemotherapy with a median survival in this setting of only 18 months. A slight improvement has been obtained over years thank to registration of a couple of drugs such as Trabectedin and Pazopanib, the first antiangiogenic registered for soft tissue sarcoma patients. Pazopanib is routinely prescribed worldwide after failure of first line chemotherapy in soft tissue sarcoma. However, bone tumors have not benefited from these small advances yet and treatment still rely on chemotherapy combining doxorubicine cisplatinum and ifosfamide. There is no standard in relapse and palliative settings, and after failure of these agents the survival is very poor. Bone sarcomas are therefore tumors with very little available data and low level of evidence on palliative systemic treatments in clinical trials and in the real life setting. The primary objective of the METABONE study is to conduct a retrospective descriptive analysis of clinic-biological profiles, patterns of care and modalities of treatment for a set of patients with malignant bone tumors in a real-life national setting.
Interventions
OTHERAny cancer treatment
chemotherapy, surgery, radiotherapy, interventional radiology.
Sponsors
French Sarcoma Group
Institut Bergonié
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged \>= 12 years * Informed consent obtained for inclusion in the databases * Histology of Ewing's sarcoma type, osteosarcoma, chondrosarcoma * Diagnostic between 2008 and 2018
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Next Treatment (TNT) | 5 years | time from the systemic treatment onset to the next treatment or death due to any cause, whichever comes first |
| Overall Survival (OS) | 5 years | Interval between the diagnosis of metastatic disease or the first-line systemic therapy onset and the time of death. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Metastatic Osteosarcoma Patients aged ≥ 12 years 1/ with a diagnosis of osteosarcoma made by an expert pathologist from one of the French network centers (RESOS), 2/ with an initial diagnosis made from 2008 to 2018, 3/ with a metastatic disease (either synchronous or metachronous), 4/ treated in one of the 11 participating national reference centers designated by the French National Cancer Institute for the management of bone sarcomas
Any cancer treatment: chemotherapy, surgery, radiotherapy, interventional radiology. | 262 |
| Metastatic Chondrosarcoma Patients aged ≥12 years (1) with a diagnosis of chondrosarcoma made by an expert pathologist from one of the French network centers, (2) with an initial diagnosis made from 2008 to 2018, (3) with a metastatic disease (either synchronous or metachronous), (4) treated in one of the nine participating national reference centers designated by the French National Cancer Institute for the management of bone sarcomas
Any cancer treatment: chemotherapy, surgery, radiotherapy, interventional radiology. | 127 |
| Ewing's Sarcoma Any cancer treatment: chemotherapy, surgery, radiotherapy, interventional radiology. | 156 |
| Total | 545 |
Baseline characteristics
| Characteristic | Metastatic Chondrosarcoma | Ewing's Sarcoma | Total | Metastatic Osteosarcoma |
|---|---|---|---|---|
| Age, Continuous | 63 years | 21 years | 40 years | 27 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment France | 127 participants | 156 participants | 389 participants | 262 participants |
| Sex: Female, Male Female | 43 Participants | 44 Participants | 199 Participants | 112 Participants |
| Sex: Female, Male Male | 84 Participants | 112 Participants | 346 Participants | 150 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 172 / 262 | 93 / 127 | 115 / 156 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Overall Survival (OS)
Interval between the diagnosis of metastatic disease or the first-line systemic therapy onset and the time of death.
Time frame: 5 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Metastatic Osteosarcoma | Overall Survival (OS) | 21.5 months |
| Metastatic Chondrosarcoma | Overall Survival (OS) | 12.7 months |
| Ewing's Sarcoma | Overall Survival (OS) | 26.6 months |
Primary
Time to Next Treatment (TNT)
time from the systemic treatment onset to the next treatment or death due to any cause, whichever comes first
Time frame: 5 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Metastatic Osteosarcoma | Time to Next Treatment (TNT) | 8.2 months |
| Metastatic Chondrosarcoma | Time to Next Treatment (TNT) | 4.6 months |
| Ewing's Sarcoma | Time to Next Treatment (TNT) | 12.5 months |