吉非替尼用于晚期唾液腺癌患者的II期研究。
Phase II study of gefitinib in patients with advanced salivary gland cancers.
作者信息
Jakob John A, Kies Merrill S, Glisson Bonnie S, Kupferman Michael E, Liu Diane D, Lee J Jack, El-Naggar Adel K, Gonzalez-Angulo Ana M, Blumenschein George R
机构信息
Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas; Hematology/Medical Oncology Division, Northeast Ohio Medical University, Medina, Ohio.
出版信息
Head Neck. 2015 May;37(5):644-9. doi: 10.1002/hed.23647. Epub 2015 Mar 30.
BACKGROUND
The purpose of this study was to determine the antitumor activity of the epidermal growth factor receptor (EGFR) inhibitor gefitinib in patients with recurrent/metastatic salivary gland cancer.
METHODS
We conducted a phase II study in adenoid cystic carcinoma (ACC) and non-ACC. Gefitinib was administered 250 mg orally daily. The primary endpoint was tumor response. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and disease control rates. EGFR and human epidermal growth factor receptor 2 (HER2) expression were evaluated and correlated with outcomes.
RESULTS
Thirty-seven patients were enrolled in this study, and 36 were evaluable (18 with ACC and 18 with non-ACC). No responses were observed. Median PFS was 4.3 months and 2.1 months, and median OS was 25.9 months and 16 months for patients with ACC and non-ACC, respectively. The disease control rate at 8 weeks was higher in patients with ACC. No unexpected toxicities occurred. EGFR and HER2 overexpression did not correlate with outcomes.
CONCLUSION
We did not observe significant clinical activity of gefitinib in advanced salivary gland cancer. NCT00509002.
背景
本研究旨在确定表皮生长因子受体（EGFR）抑制剂吉非替尼对复发/转移性唾液腺癌患者的抗肿瘤活性。
方法
我们对腺样囊性癌（ACC）和非ACC患者进行了一项II期研究。吉非替尼每日口服250毫克。主要终点为肿瘤反应。次要终点包括无进展生存期（PFS）、总生存期（OS）和疾病控制率。评估了EGFR和人表皮生长因子受体2（HER2）的表达，并将其与结果进行关联。
结果
本研究共纳入37例患者，其中36例可评估（18例ACC患者和18例非ACC患者）。未观察到反应。ACC患者和非ACC患者的中位PFS分别为4.3个月和2.1个月，中位OS分别为25.9个月和16个月。ACC患者8周时的疾病控制率更高。未发生意外毒性。EGFR和HER2过表达与结果无关。
结论
我们未观察到吉非替尼在晚期唾液腺癌中有显著的临床活性。NCT00509002。
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