Effect of Drug, Secondary Resistance, Toxicity, Drug
Conditions
Keywords
osteosarcoma, apatinib, ifosfamide and etoposide, prognosis, toxicity
Brief summary
Today, using a multi-modal approach consisting of preoperative (neoadjuvant) systemic polychemotherapy followed by local surgical therapy and then postoperative (adjuvant) chemotherapy, long-term, disease-free survival can be achieved in 60- 70% of osteosarcoma patients. However treatment options for osteosarcomas, especially in the setting of metastatic or unresectable disease, are very scarce. Apatinib has been proved to be an effective agent to prolong progression-free survival in advanced osteosarcoma. But after 4-6 months' treatment, secondary resistance always occurred with musculoskeletal lesions' progression or new metastasis. Nowadays giving therapeutic doses of IE concurrently with anti-angiogenesis tyrosine kinase inhibitors is a conceptually attractive strategy for treating patients with refractory osteosarcoma according to prospective trial of lenvatinib +IE reported by Gaspar et al at 2019 ESMO and 2020 ESMO. Thus This study was designed to review our experience in real world for off-label use and characterize the toxicity profile of concurrent apatinib+IE and IE alone in patients with relapsed or refractory osteosarcoma.
Interventions
DRUGApatinib Mesylate
apatinib orally daily and ifosfamide 1.8mg/m2/d d1-3, etoposide 100mg/m2/d d1-3
DRUGifosfamide and etoposide
ifosfamide and etoposide
Sponsors
Peking University Shougang Hospital
Peking University People's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* histological diagnosis of osteosarcoma (confirmed by central pathological review by an expert pathologist from the Peking University People's Hospital) * objective disease progression within 3 months prior to treatment according to RECIST 1.1 * previously treated with one to two lines of chemotherapy for metastatic disease * have an adequate performance status (adults:Eastern Cooperative Oncology Group \[ECOG\] performance status of 0-1;children aged \>12 years: a score of ≥60% on the Karnofsky performance scale; children aged ≤12 years a score of ≥60% on the Lansky scale)
Exclusion criteria
* a life expectancy of less than 3 months * patients had to have adequate bone marrow function, normal renal function, normal liver function, and normal pancreatic function * no other malignant tumors * no malignant pleural and peritoneal effusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| event-free survival | 24 months | from start treatment to any events/death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival | 24 months | from start treatment to progression/death |
| overall survival | 24 months | from start treatment to death |
Countries
China
Outcome results
None listed