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Phase II study of gefitinib in patients with advanced salivary gland cancers
John A Jakob1, Merrill S Kies, Bonnie S Glisson
1Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas; Hematology/Medical Oncology Division, Northeast Ohio Medical University, Medina, Ohio.
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.
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