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Clinical Trial
. 2017 Dec;77(6):1110-1113.e2.
doi: 10.1016/j.jaad.2017.07.048. Epub 2017 Sep 28.

Gefitinib for patients with incurable cutaneous squamous cell carcinoma: A single-arm phase II clinical trial

William N William Jr  1 , Lei Feng  2 , Renata Ferrarotto  3 , Lawrence Ginsberg  4 , Merrill Kies  3 , Scott Lippman  5 , Bonnie Glisson  3 , Edward S Kim  6
Affiliations
Clinical Trial

Gefitinib for patients with incurable cutaneous squamous cell carcinoma: A single-arm phase II clinical trial

William N William Jr et al. J Am Acad Dermatol. 2017 Dec.

Abstract

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.

Keywords: clinical trial; cutaneous squamous cell carcinoma; epidermal growth factor receptor; gefitinib; skin cancer; tyrosine kinase inhibitor.

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Conflict of interest statement

Conflict of interest statement: Dr. William N. William Jr. has received honoraria from AstraZeneca, Roche, and Genentech not related to this work as a speaker and has received research grants from Eli Lilly, Bristol Myers Squibb, Merck, Astellas Pharmaceuticals, and Boehringer Ingelheim. Dr. Edward Kim has received grants/research funding and honoraria from Astra Zeneca as a consultant. All other authors do not have conflicts of interest to disclose.

References

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