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Gefitinib for patients with incurable cutaneous squamous cell carcinoma: A single-arm phase II clinical trial
William N William1, Lei Feng2, Renata Ferrarotto1
1Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, Texas.
Background:
Preclinical data demonstrate a key role for the epidermal growth factor receptor (EGFR) in the carcinogenesis of cutaneous squamous cell carcinomas (CSCCs). There are, however, limited data on the efficacy of EGFR inhibitors in incurable, recurrent, and/or metastatic CSCC.
Objective:
To determine the response rate to gefitinib in patients with CSCC not amenable to curative therapy including surgery or radiation.
Methods:
This was a single-arm phase II study. A total of 40 patients were treated with gefitinib, 250 mg orally daily, until disease progression or intolerable toxicities. The prespecified target response rate of interest was 20%.
Results:
The overall response rate was 16% (95% confidence interval, 0.06-0.32; 6 partial responses in 37 evaluable patients). An additional 13 patients (35%) had stable disease at 8 weeks. The median durations of response and progression-free survival were 31.4 months (95% confidence interval, 3.91-not applicable) and 3.8 months (95% confidence interval, 2.2-5.7), respectively. The side effect profile was consistent with the previous experience with gefitinib in other tumor types.
Limitations:
This was a single-institution, single-arm study. The prespecified target response rate was not met.
Conclusion:
Gefitinib demonstrated modest activity in incurable CSCC, with a favorable adverse event profile.
Insights
Gefitinib showed modest activity in advanced cutaneous squamous cell carcinoma (CSCC), with a 16% response rate. This EGFR inhibitor offers a favorable side effect profile for patients with incurable CSCC.
Area of Science:
- Oncology
- Dermatology
- Pharmacology
Background:
- Epidermal growth factor receptor (EGFR) plays a critical role in cutaneous squamous cell carcinoma (CSCC) development.
- Limited data exist on EGFR inhibitor efficacy in advanced, incurable CSCC.
Purpose of the Study:
- To evaluate the response rate of gefitinib in patients with incurable CSCC.
- To assess the safety and efficacy of gefitinib in this patient population.
Main Methods:
- A single-arm, phase II clinical trial.
- 40 patients with incurable CSCC received gefitinib 250 mg orally daily.
- Treatment continued until disease progression or unacceptable toxicity.
Main Results:
- The overall response rate was 16% (6 partial responses in 37 evaluable patients).
- Stable disease was observed in 35% of patients at 8 weeks.
- Median duration of response was 31.4 months; median progression-free survival was 3.8 months.
Conclusions:
- Gefitinib demonstrated modest clinical activity in incurable CSCC.
- The drug was generally well-tolerated, with an adverse event profile consistent with prior gefitinib studies.
- The study did not meet its prespecified target response rate of 20%.
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