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Published on: August 11, 2017
A phase II study of gefitinib in patients with metastatic melanoma
Sapna P Patel1, Kevin B Kim, Nicholas E Papadopoulos
1Department of Melanoma Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, Texas 77030, USA.
Abstract:
Gefitinib is an inhibitor of the epidermal growth factor receptor, which is frequently expressed on both choroidal and nonchoroidal melanoma cells. We evaluated the clinical efficacy of gefitinib in patients with metastatic melanoma. Patients with stage IV or unresectable stage III melanoma and Zubrod performance status of less than or equal to 2 were eligible. Previous systemic treatment for metastatic disease was required. The dose of oral gefitinib was 250 mg administered daily, and tumor response was evaluated every 6 weeks. Forty-six patients with nonchoroidal melanoma and six with choroidal melanoma were treated, and 48 were evaluable for response. The median age was 62.5 years. Forty-one patients (79%) had stage M1c disease. There were no drug-related grade 4 or 5 adverse events, and fatigue was the only grade 3 adverse event that occurred in more than 5% of patients. Two patients (4%) had partial responses and 13 patients (27%) had disease stabilization. The two responders had a median duration of response of 10.9 months. The median overall progression-free survival was 1.4 months and the median overall survival was 9.7 months. Among the patients with sufficient tissues obtained before and 6 weeks after starting gefitinib administration, there were no notable trends in the changes of the tumoral expression of p-ERK1/2, p-AKT, PAK1, and serum levels of vascular endothelial growth factor or IL-8 with treatment. We concluded that gefitinib was well tolerated but had minimal clinical efficacy as a single-agent therapy for unselected patients with metastatic melanoma.
Insights
Gefitinib, an epidermal growth factor receptor inhibitor, showed minimal efficacy in metastatic melanoma patients. While well-tolerated, it offered limited clinical benefit as a single therapy for unselected cases.
Area of Science:
- Oncology
- Melanoma Research
- Pharmacology
Background:
- Epidermal growth factor receptor (EGFR) is often expressed on melanoma cells.
- Metastatic melanoma remains a significant clinical challenge with limited treatment options.
Purpose of the Study:
- To evaluate the clinical efficacy and safety of gefitinib in patients with metastatic melanoma.
- To assess gefitinib's impact on tumor response and survival in advanced melanoma.
Main Methods:
- A clinical trial involving patients with stage III or IV metastatic melanoma.
- Oral administration of gefitinib at 250 mg daily, with tumor response assessed every 6 weeks.
- Evaluation of adverse events and survival outcomes, including progression-free and overall survival.
Main Results:
- Gefitinib was well-tolerated with no grade 4 or 5 adverse events; fatigue was the most common grade 3 event.
- Two patients (4%) achieved partial responses, and 13 (27%) had disease stabilization.
- Median progression-free survival was 1.4 months and median overall survival was 9.7 months.
Conclusions:
- Gefitinib demonstrates minimal clinical efficacy as a single-agent therapy for unselected patients with metastatic melanoma.
- The drug is well-tolerated, suggesting potential for combination therapies or specific patient subsets.
- Further research is needed to identify biomarkers predictive of response to EGFR inhibition in melanoma.
