Histological Characterization and Differentiation of Rash From Other Epidermal Growth Factor Receptor (EGFR) Inhibitors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the microscopic findings of skin rash associated with the use of chemotherapeutic anticancer agents known as epidermal growth factor inhibitors (EGFRIs).

Detailed Description
-----------------
Epidermal growth factor (EGF) and its receptor, the EGFR, are known to be key drivers in cellular proliferation and survival. Malignant tumors result from uncontrolled cell proliferation. The use of drugs which target the EGF receptor has offered patients with non-small cell lung cancer, pancreatic cancer, head and neck cancer, and colorectal cancer additional targeted anti-cancer therapy in addition to their chemotherapeutic regimens. As a result of increased use of these EGFR inhibitors, adverse events have emerged involving the skin, hair, nails and eyes. While the EGFR inhibitors block the signal transduction that interfere with cellular proliferation and survival of cancerous cells, they also affect the normal EGF function in the skin (papulopustular rash), hair, and nails. In this study, we seek to histologically characterize the papulopustular rash in patients who have been treated with lapatinib and compare our findings with those associated with three other EGFRIs, cetuximab, erlotinib and panitumumab.

Official Title
-----------------
Histological Characterization and Differentiation of Rash From Other EGFR Inhibitors

Conditions
-----------------
Skin Rash

Intervention / Treatment
-----------------
* Procedure: Skin Biopsy of Skin Rash Secondary to EGFRI Use


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated with lapatinib who developed skin toxicities and were biopsied. Patients treated with erlotinib, cetuximab, or panitumumab who have been biopsied for skin rash. Exclusion Criteria: Patients who do not fit above criteria.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| L<br>Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash. | Procedure: Skin Biopsy of Skin Rash Secondary to EGFRI Use<br>* Patients who were treated with lapatinib, cetuximab, panitumumab or erlotinib who subsequently developed a skin rash have been biopsied as standard of care. The biopsies will be used for this study.<br>|
| C<br>Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash. | Procedure: Skin Biopsy of Skin Rash Secondary to EGFRI Use<br>* Patients who were treated with lapatinib, cetuximab, panitumumab or erlotinib who subsequently developed a skin rash have been biopsied as standard of care. The biopsies will be used for this study.<br>|
| P<br>Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash. | Procedure: Skin Biopsy of Skin Rash Secondary to EGFRI Use<br>* Patients who were treated with lapatinib, cetuximab, panitumumab or erlotinib who subsequently developed a skin rash have been biopsied as standard of care. The biopsies will be used for this study.<br>|
| E<br>Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash. | Procedure: Skin Biopsy of Skin Rash Secondary to EGFRI Use<br>* Patients who were treated with lapatinib, cetuximab, panitumumab or erlotinib who subsequently developed a skin rash have been biopsied as standard of care. The biopsies will be used for this study.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
skin rash, lapatinib, cetuximab, erlotinib, panitumumab