Abstract
e16523 Background: To study safety and efficacy of apatinib, a vascular endothelial growth factor receptor-2 (VEGF2) inhibitor, in combination with radiotherapy in patients with bone metastatic prostate cancer (BMPC), based on potential synergistic antitumor activities of apatinib and Radiation Therapy (RT). Methods: In a dose escalation study, 18 patients (6/cohort) received apatinib at 250 mg every other day, 250 mg or 500 mg daily. The 250 mg daily cohort was expanded to 19 patients in combination with RT (6 Gy/fraction, 5 fraction in total), comparing with the RT alone cohort with 10 patients. Evaluations included adverse events (AEs), prostate specific antigen (PSA) levels, radiographic evaluation and pain relief. Results: In the dose escalation patients, common apatinib-related AEs (arAEs) were fatigue (11, 61%), anorexia 10, 55%), hand foot syndrome (9, 50%), proteinuria (8, 44%), and HTN (8, 44%). Grade 3 arAEs included HTN, proteinuria, and liver dysfunction. No treatment-related death occurred. In the apatinib plus RT cohort, AEs were increased comparing to either apatinib alone or RT alone; The combination cohort showed improvement in pain control. Conclusions: In BMPC patients, apatinib at less than 500 mg daily dose as mono-therapy had tolerable toxicity, consistent with previous reports in patients with other tumors. Apatinib at dose of 250mg daily combining with RT improved pain control while the overall AEs were manageable. Further studies are needed in large sample size trials. Clinical trial information: NCT02998242.
Published Version
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