Conventional chemotherapy agents such as doxorubicinare not curative and new therapies for metastatic sarcomas are urgently needed. Apatinib (YN968D1) as a novel tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 2 (VEGFR-2) has been widely used as monotherapy or combined treatments. We performed a retrospective study with stage IV sarcoma cohort to investigate the efficacy of Apatinib with or without chemotherapy.
The information of 74 sarcoma patients in stage IV treated in Tianjin Medical University Cancer Hospital was collected and approved by the Institutional Review Board. Of these patients, 15 patients underwent Apatinib + traditional chemotherapy (combined group), and 59 received Apatinib as monotherapy (control group).
We recruited 74 patients in this trial from Sep. 2015 to Apr. 2019. In the combined group, 6 of 15 patients (40.0%) recorded as partial response (PR), 7 of 15 patients (46.7%) recorded as stable disease (SD) and 2 patients (13.3%) was progressive disease (PD). The control group showed that 9 patients experienced PR (15.3%), 25 patients (42.4%) was SD and 25 patients (42.4%) was PD. The ORR (40.00% versus 15.25%, P = 0.034) and the DCR (86.67% versus 57.63%, P = 0.037) in the combined group showed significant higher than that of the control group. The median PFS of the combined group and control groups was 7.6 months and 7.9 months (P = 0.410). The median OS of the combined group and control group was 12.9 months and 17.3 months, respectively (P = 0.826). The mPFS and mOS shown no significant difference might due to the shorter follow-up time and small case number. Common AEs in combined group included hypertension (n = 7, 46.67%), hand-foot syndrome (n = 7, 46.67%), proteinuria (n = 8, 53.33%), anorexia (n = 4, 26.67%), fatigue (n = 4, 26.67%), transaminase increased (n = 4, 26.67%), diarrhea (n = 7, 46.67%), and anemia (n = 8, 53.33%), which all happened more frequently than in control group. No grade 4 AEs occurred, but 3 patients (20%) suffered from grade 3 AEs, which were mainly hypertension, hand-foot syndrome and proteinuria.
Chemotherapy combined with apatinib significantly increases the response rate and shows manageable adverse events.
Clinical trial identification
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All authors have declared no conflicts of interest.