Efficacy, Toxicity
Conditions
Keywords
apatinib, tyrosine-kinase inhibitors, osteosarcoma, Ewing sarcoma, chondrosarcoma, soft-tissue sarcoma
Brief summary
Anti-angiogenesis Tyrosine kinase inhibitors (TKIs) have been proved to show promising effects on prolonging progression-free survival (PFS) for advanced sarcoma after failure of standard multimodal Therapy. Methylsulfonic apatinib is one of those TKIs which specifically inhibits VEGFR-2. This study summarizes the experience of three Peking University affiliated hospitals in off-label use of apatinib in the treatment of extensively pre-treated sarcoma.
Detailed description
The investigators retrospectively analysed files of patients with advanced sarcoma not amenable to curative treatment, who were receiving an apatinib-containing regimen between June 1, 2015 and December 1, 2016. Fifty-six patients were included: 22 osteosarcoma, 10 Ewing's sarcoma, 3 chondrosarcoma and 21 soft tissue sarcoma.
Interventions
DRUGMethylsulfonic apatinib
Anti-angiogenesis Tyrosine kinase inhibitor which specifically inhibits VEGFR-2.
Sponsors
Peking University Shougang Hospital
Peking University International Hospital
Peking University People's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 1\) histologically confirmed high-grade sarcoma; * 2\) initial treatment in the orthopedic oncology departments of the three affiliated hospitals of Peking University; * 3\) tumors not amenable to curative treatment or inclusion in clinical trials; * 4\) unresectable local advanced lesions or multiple metastatic lesions that could not be cured by local therapy; * 5\) measurable lesions according to Response Evaluation Criteria for Solid Tumors (RECIST1.1) \[8\]; * 6\) Eastern Cooperative Oncology Group performance status 0 or 1 \[9\]; and 7) acceptable hematologic, hepatic, and renal function.
Exclusion criteria
* had been previously exposed to other TKIs; * had central nervous system metastasis; * had other kinds of malignant tumors at the same time; had cardiac insufficiency or arrhythmia; * had uncontrolled complications such as diabetes mellitus, coagulation disorders, urine protein ≥ ++ and so on; * had pleural or peritoneal effusion that needs to be handled by surgical treatment; * combined with other infections or wounds * were pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate | 3 month | CR+PR accroding to RECIST 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival, PFS | 4 months and 6 months | PFS was defined as time from the start of using apatinib until disease progression or death, whichever occurred first. |
| duration of response, DOR | 4 months | The time from appearance of response or stable disease to progression or death was thus considered the DOR |
| Overall Survival,OS | 12 months | OS was defined as time from the start of using apatinib until death. |
| toxicity | 12 months | accroding to the Common Terminology Criteria for Adverse Events 4.0 |
Countries
China
Outcome results
None listed