Apatinib for Advanced Sarcoma: Results From Multiple Institutions' Off-label Use

Peking University

Status: Completed

Conditions: Efficacy; Toxicity

Treatments: Drug: Methylsulfonic apatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT03491371

PKUPH-sarcoma 01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 4 patient groups

osteosarcoma

Experimental group

Description:

all patients had been given apatinib alone

Treatment:

Drug: Methylsulfonic apatinib

Ewing sarcoma

Experimental group

Description:

Some of patients had been given apatinib alone while some of them had been given apatinib+everolimus

Treatment:

Drug: Methylsulfonic apatinib

soft tissue sarcoma

Experimental group

Description:

Some of the patients had been given apatinib alone while some of the patients had been given apatinib together with GT chemotherapy, which was gemcitabine 1000 mg/m2 d1,8 and docetaxel 75 mg/m2 d8 once every 21 day.

Treatment:

Drug: Methylsulfonic apatinib

Chondrosarcoma

Experimental group

Description:

Patients were given apatinib alone

Treatment:

Drug: Methylsulfonic apatinib