奈非那韦单药治疗难治性腺样囊性癌的疗效：一项II期临床试验的结果。
Efficacy of nelfinavir as monotherapy in refractory adenoid cystic carcinoma: Results of a phase II clinical trial.
作者信息
Hoover Andrew C, Milhem Mohammed M, Anderson Carryn M, Sun Wenqing, Smith Brian J, Hoffman Henry T, Buatti John M
机构信息
Department of Radiation Oncology, University of Iowa Hospitals and Clinics, Iowa City, Iowa.
出版信息
Head Neck. 2015 May;37(5):722-6. doi: 10.1002/hed.23664. Epub 2014 Jun 18.
BACKGROUND
Adenoid cystic carcinomas (ACCs) are malignant salivary gland tumors noteworthy for high rates of late failure with limited salvage therapy options. We have previously shown increased Akt signaling is common in ACC and the human immunodeficiency virus (HIV) protease inhibitor nelfinavir (NFV) inhibits in vitro tumor growth by suppressing Akt signaling. This phase II trial was conducted to determine progression-free survival in response to NFV in patients with recurrent/endstage ACC who have failed standard therapies.
METHODS
Eligible patients had recurrent or end-stage ACC and measureable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. NFV was provided at 1250 mg twice daily.
RESULTS
Among 15 trial participants, median progression-free survival was 5.5 months (lower 95% bound 4.4 months). No patient achieved a RECIST partial or complete response to therapy.
CONCLUSION
NFV monotherapy does not result in a meaningful improvement in clinical outcomes among patients with recurrent ACC.
背景
腺样囊性癌（ACC）是恶性唾液腺肿瘤，其晚期复发率高且挽救治疗选择有限，值得关注。我们之前已经表明，Akt信号通路的激活在ACC中很常见，并且人类免疫缺陷病毒（HIV）蛋白酶抑制剂奈非那韦（NFV）通过抑制Akt信号通路来抑制体外肿瘤生长。本II期试验旨在确定标准治疗失败的复发/终末期ACC患者接受NFV治疗后的无进展生存期。
方法
符合条件的患者患有复发性或终末期ACC，且根据实体瘤疗效评价标准（RECIST）有可测量的疾病。NFV的给药剂量为每日两次，每次1250mg。
结果
在15名试验参与者中，无进展生存期的中位数为5.5个月（95%下限为4.4个月）。没有患者达到RECIST标准的部分或完全缓解。
结论
NFV单药治疗在复发性ACC患者中并未导致临床结局有显著改善。
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