Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2015 May;37(5):644-9.
doi: 10.1002/hed.23647. Epub 2015 Mar 30.

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

John A Jakob  1 , Merrill S Kies, Bonnie S Glisson, Michael E Kupferman, Diane D Liu, J Jack Lee, Adel K El-Naggar, Ana M Gonzalez-Angulo, George R Blumenschein Jr
Affiliations
Clinical Trial

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

John A Jakob et al. Head Neck. 2015 May.

Abstract

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.

Keywords: adenoid cystic carcinoma; gefitinib; non-adenoid cystic carcinoma; response to therapy; salivary gland cancer.

PubMed Disclaimer

Figures

FIGURE 1
FIGURE 1
Maximal percentage of tumor reduction for target lesions by Response Evaluation Criteria in Solid Tumors Committee (RECIST). Percentages are calculated using the summed unidimensional measurements of target lesions per RECIST.
FIGURE 2
FIGURE 2
Progression-free survival (A) and overall survival (B) for patients with adenoid cystic carcinoma (ACC) and non-ACC malignant salivary gland tumors treated with gefitinib.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Adelstein DJ, Rodriguez CP. What is new in the management of salivary gland cancers? Curr Opin Oncol. 2011;23:249–53. - PubMed
    1. Speight PM, Barrett AW. Salivary gland tumours. Oral Dis. 2002;8(5):229–40. - PubMed
    1. NCCN. National Comprehensive Cancer Network v2.2012 ed. 2012. [Accessed 11/6/212]. Head and Neck Cancers: Salivary Gland Cancers.
    1. Vered M, Braunstein E, Buchner A. Immunohistochemical study of epidermal growth factor receptor in adenoid cystic carcinoma of salivary gland origin. Head Neck. 2002;24:632–6. - PubMed
    1. Choi S, Sano D, Cheung M, Zhao M, Jasser SA, Ryan AJ, Mao L, Chen WT, El-Naggar AK, Myers JN. Vandetanib inhibits growth of adenoid cystic carcinoma in an orthotopic nude mouse model. Clin Cancer Res. 2008;14:5081–9. - PubMed

Publication types

MeSH terms

Associated data