Phase II study of gefitinib in patients with advanced salivary gland cancers
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...
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Published in | Head & neck Vol. 37; no. 5; pp. 644 - 649 |
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Main Authors | , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
United States
Blackwell Publishing Ltd
01.05.2015
Wiley Subscription Services, Inc |
Subjects | |
Online Access | Get full text |
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Summary: | 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. © 2015 Wiley Periodicals, Inc. Head Neck 37: 644–649, 2015 |
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Bibliography: | ark:/67375/WNG-G67BWQXD-N istex:A692C574584BECDA3311131CBE6698934F798F3C ArticleID:HED23647 This study was supported by Astra-Zeneca - No. institutional grant IRUSIRE0198 This work was presented in part at the American Society for Clinical Oncology, Orlando, Florida, May 13 to 17, 2005. Ehab Y. Hanna, MD, Editor, was recused from consideration of this manuscript. |
ISSN: | 1043-3074 1097-0347 |
DOI: | 10.1002/hed.23647 |