Bone Sarcoma, Refractory Tumor, Soft Tissue Sarcoma
Conditions
Keywords
Fruquintinib, Osteosarcoma, Ewing sarcoma, Soft Tissue Sarcomas, TKIs
Brief summary
This multicenter retrospective study assessed the efficacy and safety of fruquintinib-based treatment in patients with refractory bone and soft tissue sarcomas after several lines of TKIs' resistance.
Detailed description
The short-lived duration of disease control and secondary drug resistance have posed a threat to the effect of TKIs. Fruquintinib is a novel TKI with a high selectivity of VEGFR-1,2,3 without metabolism by liver enzymes and was approved for application in mCRC. Serious drug resistance and the unique characteristics of fruquintinib have prompted us to verify whether this drug can reverse TKIs' resistance at a higher dose.
Interventions
DRUGFruquintinib
For patients with pulmonary metastasis only, we mostly gave them fruquintinib with 7 mg in adults and 3-5 mg in children (\<10 years) orally per day (5 days on and 2 days off). If patients were extrapulmonary metastasis, we usually used combinations with metronomic chemotherapy (2/3 or 3/5 or even 1/2 of the usual dose) or immunotherapy.
Sponsors
Peking University People's Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed bone or soft tissue sarcomas; 2. Progressed after several lines of therapy; 3. Previously treated with other TKIs before fruquintinib; 4. Received fruquintinib-based treatment; 5. Measurable lesions according to the Response Evaluation Criteria for Solid Tumors (RECIST) version1.1; 6. Eastern Cooperative Oncology Group (ECOG) performance status ≤3
Exclusion criteria
1. Failure to complete regular follow-up after administration. 2. Discontinued the fruquintinib-based treatment due to neither progression nor unacceptable toxicity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 4months | The time from the first administration of fruquintinib to the date of first documentation of disease progression or death, whichever occurred first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 1year | OS was calculated from the use of fruquintinib until death from any cause |
| ORR | 1year | ORR was defined as the proportion of patients with the best overall response of complete or partial response(CR+PR) according to the Response Evaluation Criteria for Solid Tumors(RECIST) version 1.1. |
| DCR | 1year | DCR was defined as the proportion of patients with the best overall response of complete or partial response or stable disease(CR+PR+SD) according to RECIST 1.1. |
| AEs | 1year | AEs were graded and recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events(CTCAE ) version 5.0. |
Countries
China
Outcome results
None listed