Efficacy and Safety of Endostar® Combined with Chemotherapy in Patients with Advanced Soft Tissue Sarcomas

Abstract

<b>Background:</b> Soft tissue sarcomas (STS) are a heterogeneous group of tumors, and approximately 40-50%of patients with STS develop metastatic disease. The median overall survival of those patients was 12 monthsand their 5-year survival rate was 8%. Therefore, study on more effective treatment, especially the targetingtherapies, is urgently needed. <br/><b>Objective</b>: To evaluate the efficacy and safety of Endostar® combined withchemotherapy in patients with advanced STS. <br/><b>Methods</b>: A retrospective case-series study was conducted inCancer Institute of PLA, Xinqiao Hospital. A total of 71 patients suffering from advanced STS (IIB - IV) wereincluded, of whom 49 cases treated with chemotherapy alone were defined as the control group and the rest 22cases treated with the traditional chemotherapy combined with Endostar® were defined as the test group. Theshort-term therapeutic effects including objective response rate (ORR), disease control rate (DCR) and safetywere evaluated in the two groups. In the follow-up, progression-free survival (PFS) and overall survival (OS)were also observed. <br/><b>Results</b>: In the test and control groups, the ORR was 18.2% and 12.2%, respectively (P =0.767), and the DCR was 86.4% and 61.2%, respectively (P=0.034). The median time to progression in the testand control groups was 120 days and 70 days with significant difference (P = 0.017), while the median overallsurvival was 452 days and 286 days without significant difference (P = 0.503). The one-year survival rate in thetest group and control group was 56.2% and 35.4%, respectively, while the two-year survival rate was 30.2% and26.5%, respectively. No significant difference in the side effects was found between the two groups. <br/><b>Conclusions</b>:Endostar® combined with chemotherapy resulted in a higher DCR and longer PFS in the patients with advancedSTS, and the toxicity was tolerable.