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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Fruquintinib treatment group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fruquintinib | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | The time from the first administration of fruquintinib to the date of first documentation of disease progression or death, whichever occurred first. | 4months |
| Measure | Description | Time Frame |
|---|---|---|
| OS | OS was calculated from the use of fruquintinib until death from any cause | 1year |
| ORR | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who received fruquintinib-based treatment with refractory bone and soft tissue sarcomas in Peking University People's Hospital and The Second Affiliated Hospital ZheJiang University School of Medicine was included.
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| Name | Affiliation | Role |
|---|---|---|
| Lu Xie, M.D. | Musculoskeletal Tumor Center of Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| D001859 | Bone Neoplasms |
| D012509 | Sarcoma |
| D009369 | Neoplasms |
| D012516 | Osteosarcoma |
| D012512 | Sarcoma, Ewing |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| ID | Term |
|---|---|
| C000591844 | HMPL-013 |
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|
| 1year |
| DCR | 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. | 1year |
| AEs | AEs were graded and recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events(CTCAE ) version 5.0. | 1year |
| D009370 | Neoplasms by Histologic Type |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |