Clin Cancer Res:阿西替尼可显著提高复发/转移性腺样囊性癌的无进展生存率

2021-07-30 Nebula MedSci原创

阿西替尼可显著提高复发/转移性腺样囊性癌的无进展生存率

腺样囊性癌 (ACC) 又称圆柱瘤或圆柱瘤型腺癌。腺样囊性癌占涎腺肿瘤的5%~10%,在涎腺恶性肿瘤中占24%。好发于涎腺,以发生在腭腺者常见。大涎腺虽然较少,但为颌下腺和舌下腺好发的肿瘤。在腮腺肿瘤中仅占2%~3%。男女发病率无大差异,或女性稍多。最多见的年龄是40~60岁。

化疗在腺样囊性癌中的作用尚存在争议,因为 ACC 通常较为稳定,无需化疗,因而缺乏相关的随机试验。近日,“Clin Cancer Res”杂志上新发表的一项多中心、前瞻性的随机II期试验,首次评估了阿昔替尼(与观察对比)用于 ACC 的疗效。

该研究招募了在过去9个月内病情进展的复发性/转移性ACC患者,1:1随机分至阿西替尼组(5 mg,2/日)或观察组。观察组患者病情进展后允许交叉至阿西替尼组。主要终点是6个月无进展生存(PFS)率。次要终点包括客观缓解率(ORR)、总生存率(OS)、PFS、缓解持续时间和不良事件。

两个治疗组的PFS和OS

共招募了60位患者,被随机分至两组,对54位患者进行了缓解性评估。中位随访25.4个月后,阿西替尼组和观察组的6个月PFS率分别是73.0%和23.0%。阿西替尼组的中位PFS明显长于观察组(10.8 vs 2.8 个月;p<0.001)。阿西替尼组的ORR为0%,但疾病控制率为100%,而观察组的疾病控制率仅51.9%。阿西替尼组的中位OS未达到,观察组的是27.2个月(p=0.226)。阿西替尼组最常见的不良反应有口腔黏膜炎和疲劳。

综上,在这项随机试验中,与观察相比,阿西替尼显著提高了ACC患者的6个月PFS率

原始出处:

Eun Joo Kang, et al. Randomized phase II study of axitinib versus observation in patients with recurred or metastatic adenoid cystic carcinoma. Clin Cancer Res July 27 2021 DOI:10.1158/1078-0432.CCR-21-1061

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