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目的软组织肉瘤(soft tissue sarcomas,STS)是一种罕见的异质性恶性肿瘤,约80%患者术后两年内出现远处转移,且以多柔比星为基础的一线化疗,疗效依然不理想。本研究评价化疗联合重组人血管内皮抑素(恩度)治疗转移性软组织肉瘤的疗效及安全性。方法回顾性分析天津医科大学肿瘤医院2007-01-01-2015-06-30收治的66例转移性STS病例,其中44例接受单纯化疗作为对照组,22例接受化疗联合恩度作为试验组。短期疗效评价包括客观反应率(objective response rate,ORR)、疾病控制率(diaease control,DCR)和安全性评价。随访观察无进展生存期(progression-free survival,PFS)和总生存期(overall survival,OS)。结果对照组和试验组ORR分别为13.6%和22.7%(χ~2=0.341,P=0.559),DCR分别为59.1%和77.3%(χ~2=2.135,P=0.144)。对照组和试验组的中位PFS分别为6.9个月(95%CI为4.4~9.5)和12.5个月(95%CI为8.2~16.8),差异有统计学意义(χ~2=4.882,P=0.027),中位OS分别为15.4个月(95%CI为10.2~20.7)和23.4个月(95%CI为16.4~30.3),差异有统计学意义,χ~2=4.506,P=0.034。对照组和试验组的1年生存率分别为58.1%和85.0%,2年生存率分别为24.6%和48.6%。大多数不良反应为轻到中度的呕吐,腹泻、骨髓抑制和心脏毒性,比较两组的不良反应差异无统计学意义,P>0.05。结论虽然化疗联合恩度没能控制转移性STS疾病进展,但是延长了患者的PFS及OS,且不良反应可以耐受。
Purpose Soft tissue sarcoma (STS) is a rare heterogeneous malignant tumor. About 80% of patients have distant metastasis within two years after operation, and doxorubicin-based first-line chemotherapy is still unsatisfactory . This study evaluated the efficacy and safety of chemotherapy combined with recombinant human endostatin (Endostar) in the treatment of metastatic soft tissue sarcoma. Methods A retrospective analysis of 66 patients with metastatic STS admitted to Tumor Hospital of Tianjin Medical University from January 2007 to January 2015 was performed. Among them, 44 patients received simple chemotherapy as control group and 22 patients received combined chemotherapy with Endue as experimental group. Short-term outcome measures include objective response rate (ORR), disease control rate (DCR) and safety assessment. Follow-up progression-free survival (PFS) and overall survival (OS) were observed. Results The ORR of control group and experimental group were 13.6% and 22.7%, respectively (χ ~ 2 = 0.341, P = 0.559), and the DCR were 59.1% and 77.3% respectively (χ ~ 2 = 2.135, P = 0.144). Median PFS in the control and experimental groups were 6.9 months (95% CI, 4.4 to 9.5) and 12.5 months (95% CI, 8.2 to 16.8), respectively, with significant differences (χ ~ 2 = 4.882, P = 0.027). The median OS was 15.4 months (95% CI 10.2 to 20.7) and 23.4 months (95% CI 16.4 to 30.3), respectively, with a statistically significant difference, χ ~ 2 = 4.506, P = 0.034 . The 1-year survival rates of the control and experimental groups were 58.1% and 85.0%, respectively, and the 2-year survival rates were 24.6% and 48.6%, respectively. The majority of adverse reactions were mild to moderate vomiting, diarrhea, myelosuppression and cardiotoxicity. There was no significant difference in adverse reactions between the two groups (P> 0.05). Conclusions Although chemotherapy combined with Endue failed to control the progression of metastatic STS disease, PFS and OS were prolonged and adverse reactions could be tolerated.