Lancet oncol:西地尼布为肺泡软组织肉瘤患者带来新的治疗希望

2019-06-04 QQ MedSci原创

肺泡软组织肉瘤(ASPS)是一种罕见的对化疗无反应的软组织肉瘤。西地尼布,一种酪氨酸激酶抑制剂,在非随机研究中展现出治疗ASPS的活性。现研究人员开展一双盲的、安慰剂为对照的随机2期试验,旨在区分西地尼布的疗效和ASPS的惰性特征。研究人员招募年满16岁的已转移的ASPS患者,要求ECOG评分0-1分、预期寿命超过12周、骨髓和肝肾功能良好。受试者在本研究开始前4周未进行抗癌治疗(除了缓解性放疗)

肺泡软组织肉瘤(ASPS)是一种罕见的对化疗无反应的软组织肉瘤。西地尼布,一种酪氨酸激酶抑制剂,在非随机研究中展现出治疗ASPS的活性。现研究人员开展一双盲的、安慰剂为对照的随机2期试验,旨在区分西地尼布的疗效和ASPS的惰性特征。

研究人员招募年满16岁的已转移的ASPS患者,要求ECOG评分0-1分、预期寿命超过12周、骨髓和肝肾功能良好。受试者在本研究开始前4周未进行抗癌治疗(除了缓解性放疗)。按2:1将受试者随机分至西地尼布组或安慰剂组,予以西地尼布(30mg 口服 1/日)或安慰剂,持续24周。主要结点是24周时靶标志物病损直径总和的百分比变化或进展速度。

2011年7月15日-2016年7月29日,共招募了48位受试者,其中23位女性(48%),中位年龄31岁(IQR 27-45);随机分至西地尼布组(32位)或安慰剂组(16位)。中位随访34.3个月(IQR 23.7-55.6)。西地尼布组中4位患者不能进行结点评估(1位未开始治疗,3位24周时未进行扫描)。对于可评估的受试者,西地尼布组和安慰剂组患者靶标志物病损直径的总和变化比例分别为-8.3%(IQR -26.5至5.9)和13.4%(1.1-21.3,p=0.0010)。西地尼布组最常见的3级副反应是高血压(6例[19%])和腹泻(2例[6%])。12位患者发生15例严重副反应;其中12例发生在西地尼布组,最常见的症状是脱水(2例)、呕吐(2例)和蛋白尿(2例)。一例可能与治疗相关的死亡(颅内出血)。

鉴于ASPS的转移率高,长期预后差,加上传统化疗疗效欠佳,研究人员发现西地尼布在该疾病中具有显著的临床活性,有望为这类患者带来新的希望。

原始出处:

Ian Judson,et al.
Cediranib in patients with alveolar soft-part sarcoma (CASPS): a double-blind, placebo-controlled, randomised, phase 2 trial. The Lancet Oncology. May 31, 2019. https://doi.org/10.1016/S1470-2045(19)30215-3

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    2020-05-12 howi
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    2019-10-24 minlingfeng
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    2019-06-06 qilu_qi