Squamous Cell Carcinoma Clinical Trial
Official title:
Phase II Study of Afatinib Plus Chemotherapy in Patients With Esophageal and Lung Squamous Cell Carcinoma
As a 2nd generation EGFR-TKI that irreversibly binds to EGFR receptors, afatinib is currently
recommended as the standard first-line treatment for EGFR mutation-positive lung cancer, and
clinical studies are also being actively conducted in other types of carcinomas characterized
by EGFR gene mutation and overexpression.
The overall results from previous studies of gefitinib and erlotinib as EGFR TKIs , as well
as from preceding studies of afatinib - a 2nd generation EGFR TKI - suggest the possibility
of an effective therapy in esophageal cancer or squmaous lung cancer. In this phase II trial,
afatinib shall be administered to patients with squamous cell carcinoma of esophagus or lung
squamous cell carcinoma to evaluate its effects and toxicity. Also, biomarkers to predict
responses to afatinib shall be explored through further studies.
As a 2nd generation EGFR-TKI that irreversibly binds to EGFR receptors, In a phase III study
LUX-lung 8 in patients with squamous lung cancer, afatinib monotherapy showed longer
progression-free disease survival than erlotinib therapy. afatinib is currently recommended
as the standard first-line treatment for EGFR mutation-positive lung cancer, and clinical
studies are also being actively conducted in other types of carcinomas characterized by EGFR
gene mutation and overexpression. Thirty (30) solid cancer patients were included in a phase
I trial of afatinib, and of them, a patient with esophageal cancer had partial response.
Taken together, based upon the results from clinical trials of afatinib conducted so far, 7
out of 15 esophageal cancer patients achieved clinical responses of 3 months or longer.
Hence, the overall results from previous studies of gefitinib and erlotinib as EGFR TKIs and
our study of dacomitinib, as well as from preceding studies of afatinib - a 2nd generation
EGFR TKI - suggest the possibility of an effective therapy in esophageal cancer or squmaous
lung cancer. In this phase II trial, afatinib shall be administered to patients with squamous
cell carcinoma of esophagus or lung squamous cell carcinoma to evaluate its effects and
toxicity. Also, biomarkers to predict responses to afatinib shall be explored through further
studies.
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