Wang Yitian, Lu Minxun, Zhou Yong, Zhou Sisi, Yu Xinzhu, Tang Fan, Luo Yi, Zhang Wenli, Duan Hong, Min Li, Tu Chongqi
Department of Orthopedics, West China Hospital, Sichuan University, Chengdu 610041, Sichuan, People's Republic of China.
Cancer Manag Res. 2020 Jul 1;12:5255-5264. doi: 10.2147/CMAR.S254296. eCollection 2020.
Synovial sarcoma (SS) is a highly aggressive soft-tissue sarcoma (STS) with poor prognosis. Tyrosine kinase inhibitor (TKI) has shown a promising impact on advanced STS patients. This study aimed to evaluate the efficacy and safety of apatinib, an oral multi-TKI, which especially inhibited vascular endothelial growth factor receptor, as second-line therapy for patients with advanced SS.
This retrospective analysis included 21 advanced SS patients, who had a poor response to anthracycline-based chemotherapy alone or combined with ifosfamide at least one cycle. All the patients received an apatinib containing regimen between May 2016 and October 2019 in our institution. Apatinib 500-750 mg (250 mg for patients younger than 10) was given daily. Tumor responses were assessed by response evaluation criteria in solid tumors. Survival analysis was performed by the Kaplan-Meier test, and a safety profile was recorded.
The median follow-up was 15.2 months (95% CI, 12.2-NE). Nine (42.9%) patients had partial response (PR), and eight (38.1%) had stable disease. The median progression-free survival (PFS) was 13.1 months (95% CI, 6.7-NE). The 6- and 12-month PFS rates were 76.2% (95% CI, 60.0-96.8) and 55.4% (95% CI, 37.3-82.3), respectively. Additionally, the median overall survival (OS) was 15.5 months (95% CI, 10.7-NE). The 6- and 12-month OS rates were 81.0% (95% CI, 65.8, 99.6) and 64.9% (95% CI, 46.9-90.0), respectively. Moreover, the objective response rate was 42.9% (9/21) for advanced SS patients. The disease control rate was 81.0% (17/21). For the nine patients with the best response of PR, the median duration of response was 7.7 months.
Apatinib was proved to be a potential second-line treatment option for advanced SS patients with chemo-resistance. Apatinib showed promising efficacy and acceptable safety profile in advanced SS, with considerable OS and particularly PFS. Indeed, further multicenter studies with a longer follow-up time are needed to fully determine the clinical application of apatinib in advanced SS.
滑膜肉瘤（SS）是一种侵袭性很强的软组织肉瘤（STS），预后较差。酪氨酸激酶抑制剂（TKI）已显示出对晚期STS患者有良好疗效。本研究旨在评估阿帕替尼（一种口服多靶点TKI，尤其可抑制血管内皮生长因子受体）作为晚期SS患者二线治疗的疗效和安全性。
本回顾性分析纳入了21例晚期SS患者，这些患者单独使用蒽环类化疗药物或联合异环磷酰胺至少一个周期后疗效不佳。2016年5月至2019年10月期间，所有患者在我们机构接受了含阿帕替尼的治疗方案。阿帕替尼剂量为500 - 750mg（10岁以下患者为250mg），每日给药。采用实体瘤疗效评价标准评估肿瘤反应。通过Kaplan-Meier检验进行生存分析，并记录安全性。
中位随访时间为15.2个月（95%CI，12.2 - 未达到）。9例（42.9%）患者出现部分缓解（PR），8例（38.1%）病情稳定。中位无进展生存期（PFS）为13.1个月（95%CI，6.7 - 未达到）。6个月和12个月的PFS率分别为76.2%（95%CI，60.0 - 96.8）和55.4%（95%CI，37.3 - 82.3）。此外，中位总生存期（OS）为15.5个月（95%CI，10.7 - 未达到）。6个月和12个月的OS率分别为81.0%（95%CI，65.8, 99.6）和64.9%（95%CI，46.9 - 90.0）。而且，晚期SS患者的客观缓解率为42.9%（9/21）。疾病控制率为81.0%（17/21）。对于9例达到最佳PR反应的患者，中位反应持续时间为7.7个月。
阿帕替尼被证明是晚期化疗耐药SS患者的一种潜在二线治疗选择。阿帕替尼在晚期SS中显示出有前景的疗效和可接受的安全性，有可观的OS，尤其是PFS。确实，需要进一步开展多中心研究并延长随访时间，以全面确定阿帕替尼在晚期SS中的临床应用。
