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

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

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 Jr

Head & neck

2015

2015-05

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.

80 and over; Adenocarcinoma/drug therapy/mortality/pathology; adenoid cystic carcinoma; Adenoid Cystic/*drug therapy/mortality/pathology; Adult; Aged; Antineoplastic Agents/*therapeutic use; Carcinoma; Disease-Free Survival; Dose-Response Relationship; Drug; Drug Administration Schedule; Female; gefitinib; Gefitinib; Humans; Local/*drug therapy/mortality/pathology; Male; Maximum Tolerated Dose; Middle Aged; Neoplasm Invasiveness/pathology; Neoplasm Recurrence; Neoplasm Staging; non-adenoid cystic carcinoma; Prognosis; Quinazolines/*therapeutic use; Remission Induction; response to therapy; salivary gland cancer; Salivary Gland Neoplasms/*drug therapy/mortality/pathology; Survival Analysis; Treatment Outcome

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