Phase II study of gefitinib in patients with advanced salivary gland cancers.

Phase II study of gefitinib in patients with advanced salivary gland cancers.
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DOI:
10.1002/hed.23647
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发表时间:
2015-05
期刊:
Head & neck
影响因子:
--
通讯作者:
Blumenschein GR Jr
Blumenschein GR Jr
中科院分区:
其他
文献类型:
--
作者:
Jakob JA;Kies MS;Glisson BS;Kupferman ME;Liu DD;Lee JJ;El-Naggar AK;Gonzalez-Angulo AM;Blumenschein GR Jr

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Determine the antitumor activity of the epidermal growth factor receptor (EGFR) inhibitor gefitinib in patients with recurrent/metastatic salivary gland cancer. Phase II study in adenoid cystic (ACC) and non-adenoid cystic (non-ACC) carcinomas. Gefitinib was administered 250mg orally daily. Primary endpoint was tumor response. Secondary endpoints included progression-free survival (PFS), overall survival (OS) and disease control rates (DCR). EGFR and HER2 expression were evaluated and correlated with outcomes. Thirty-seven patients were enrolled, 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. DCR at 8 weeks was higher in ACC patients. No unexpected toxicities occurred. EGFR and HER2 overexpression did not correlate with outcomes. We did not observe significant clinical activity of gefitinib in advanced salivary gland cancer. NCT00509002.
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