Dataset Information

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

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.

SUBMITTER: William WN

PROVIDER: S-EPMC5685879 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

William William N WN Feng Lei L Ferrarotto Renata R Ginsberg Lawrence L Kies Merrill M Lippman Scott S Glisson Bonnie B Kim Edward S ES

Journal of the American Academy of Dermatology 20170928 6

<h4>Background</h4>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.<h4>Objective</h4>To determine the response rate to gefitinib in patients with CSCC not amenable to curative therapy including surgery or radiation.<h4>Methods</h4>This was a single-arm phase II study. A tota ...[more]

PMID: 28964539

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Dataset Information

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

Background

Objective

Methods

Results

Limitations

Conclusion

Publications

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

Similar Datasets

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