Gefitinib for patients with incurable cutaneous squamous cell carcinoma: A single-arm phase II clinical trial - 23/11/17
, Lei Feng, MS b, Renata Ferrarotto, MD a, Lawrence Ginsberg, MD c, Merrill Kies, MD a, Scott Lippman, MD a, d, Bonnie Glisson, MD a, Edward S. Kim, MD a, eAbstract |
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.
Le texte complet de cet article est disponible en PDF.Key words : clinical trial, cutaneous squamous cell carcinoma, epidermal growth factor receptor, gefitinib, skin cancer, tyrosine kinase inhibitor
Abbreviations used : CI, CSCC, ORR
Plan
| Drs Glisson and Kim contributed equally to this article. |
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| Supported by a grant from AstraZeneca Pharmaceuticals. AstraZeneca Pharmaceuticals had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication. This work was also supported by National Institutes of Health grant P30 CA016672-36. |
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| Disclosure: Dr 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 Kim has received grants/research funding and honoraria from Astra Zeneca as a consultant. Drs Feng, Ferrarotto, Ginsberg, Kies, and Lippman have no conflicts of interest to declare. |
Vol 77 - N° 6
P. 1110 - décembre 2017 Retour au numéro
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