Gefitinib in patients with malignant mesothelioma: a phase II study by the Cancer and Leukemia Group B.
Journal Article (Clinical Trial;Journal Article)
PURPOSE: The Cancer and Leukemia Group B conducted a phase II study of gefitinib, an inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase, in patients with previously untreated malignant mesothelioma. EXPERIMENTAL DESIGN: Eligible patients had unresectable pleural or peritoneal mesothelioma, measurable disease, no prior therapy, and performance status 0-1 by Cancer and Leukemia Group B criteria. Gefitinib (500 mg p.o.) was administered once a day for 21 days. Patients underwent restaging after every two cycles. Therapy was continued until disease progression or unacceptable toxicity. RESULTS: The most common grade 3 toxicities were diarrhea (16%) and nausea (12%). Of 43 patients enrolled, 1 patient (2%) had a complete response, 1 patient (2%) had a partial response, 21 (49%) had stable disease lasting two to eight cycles, 15 (35%) had progressive disease, and 5 (12%) had early deaths. One-year survival was 32% [95% confidence interval (CI), 21-50%]. Median survival and failure-free survival were 6.8% (95% CI, 3.5-10.3) and 2.6 months (95% CI, 1.5-4.0), respectively. The 3-month failure-free survival was 40% (95% CI, 25-56%). EGFR expression score by immunohistochemistry done in 28 patients was categorized as low (EGFR 1+ or 2+) or high (EGFR 3+) expression: 97% had EGFR overexpression (2+ or 3+). The median and 3-month failure-free survival were 3.6 months and 40% for those patients with low EGFR expression compared with 8.1 and 40% for those with high EGFR expression. CONCLUSIONS: Although 97% of patients with mesothelioma had EGFR overexpression, gefitinib was not active in malignant mesothelioma. EGFR expression does not correlate with failure-free survival.
Full Text
Duke Authors
Cited Authors
- Govindan, R; Kratzke, RA; Herndon, JE; Niehans, GA; Vollmer, R; Watson, D; Green, MR; Kindler, HL; Cancer and Leukemia Group B (CALGB 30101),
Published Date
- March 15, 2005
Published In
Volume / Issue
- 11 / 6
Start / End Page
- 2300 - 2304
PubMed ID
- 15788680
International Standard Serial Number (ISSN)
- 1078-0432
Digital Object Identifier (DOI)
- 10.1158/1078-0432.CCR-04-1940
Language
- eng
Conference Location
- United States