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

JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

卷:77

Article

William, William N., Jr.¹  Feng, Lei²  Ferrarotto, Renata¹  Ginsberg, Lawrence³  Kies, Merrill¹  Lippman, Scott^1,4  Glisson, Bonnie¹  Kim, Edward S.^1,5 

[1] Univ Texas MD Anderson Canc Ctr, Dept Thorac Head & Neck Med Oncol, 1515 Holcombe Blvd,Unit 432, Houston, TX 77030 USA

[2] Univ Texas MD Anderson Canc Ctr, Dept Biostat, Houston, TX 77030 USA

[3] Univ Texas MD Anderson Canc Ctr, Dept Diagnost Radiol, Houston, TX 77030 USA

[4] Univ Calif San Diego, Moores Canc Ctr, La Jolla, CA 92093 USA

[5] Carolinas HealthCare Syst, Levine Canc Inst, Charlotte, NC USA

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

DOI  :  10.1016/j.jaad.2017.07.048

来源: Elsevier

【 摘 要 】

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.

【 授权许可】

Free