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

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.

• Authors: John A Jakob, 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
• Journal: Head & neck (Head Neck) Vol. 37 Issue 5 Pg. 644-9 (May 2015) ISSN: 1097-0347 [Electronic] United States
• PMID: 24585506 (Publication Type: Clinical Trial, Phase II, Comparative Study, Controlled Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2015 Wiley Periodicals, Inc.

Chemical References

• Antineoplastic Agents
• Quinazolines
• Gefitinib

Topics

• Adenocarcinoma (drug therapy, mortality, pathology)
• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Agents (therapeutic use)
• Carcinoma, Adenoid Cystic (drug therapy, mortality, pathology)
• Disease-Free Survival
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Female
• Gefitinib
• Humans
• Male
• Maximum Tolerated Dose
• Middle Aged
• Neoplasm Invasiveness (pathology)
• Neoplasm Recurrence, Local (drug therapy, mortality, pathology)
• Neoplasm Staging
• Prognosis
• Quinazolines (therapeutic use)
• Remission Induction
• Salivary Gland Neoplasms (drug therapy, mortality, pathology)
• Survival Analysis
• Treatment Outcome