Apatinib for Advanced Osteosarcoma After Failure of Standard Multimodal Therapy

After standard multimodal therapy, the prognosis of relapsed and unresectable high-grade osteosarcoma is dismal and unchanged over the last decades.Thus, the investigators explored apatinib activity in patients with relapsed and unresectable osteosarcoma after the failure of first-line or second-line chemotherapy. Patients \>16 years, progressing after standard treatment, were eligible to receive 500 mg or 750 mg of apatinib once daily until progression or unacceptable toxicity. The primary end point was progression-free survival (PFS) at 4 months and objective response rate (ORR). Secondary objectives were PFS, overall survival (OS), clinical benefit rate (CBR), defined as no progression at 6 months and safety.

Sex

All

Minimum age

16 Years

Inclusion Criteria:

* age \>16 years;
* diagnosis confirmed histologically and reviewed centrally;
* prior treatment (completed \>4 weeks before trial entry) consisted of standard high-grade osteosarcoma chemotherapy agents including doxorubicin, cisplatin, high- dose methotrexate, and ifosfamide; metastatic relapsed and unresectable progressive disease (PD);
* Eastern Cooperative Oncology Group performance status 0-1 with a life expectancy \>3 months;
* adequate renal, hepatic, and hemopoietic function;
* normal or controlled blood pressure;
* surgery and/or radiotherapy completion at least 1 month before enrollment.

Exclusion Criteria:

* no pulmonary artery or venous tumor embolus;
* previously exposed to other TKIs;
* central nervous system metastasis;
* have had other kinds of malignant tumors at the same time;
* cardiac insufficiency or arrhythmia;
* uncontrolled complications, such as diabetes mellitus and so on;
* coagulation disorders;
* urine protein≥ ++;
* pleural or peritoneal effusion that needs to be handled by surgical treatment;
* combined with other infections or wounds.

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