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

The Effectivity and Toxicity of Methylsulfonic Apatinib for Extensively Pre-treated Advanced Sarcoma: a Multicentric Retrospective Study in China

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.

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.

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.