Gefitinib in Non-Small Cell Lung Cancer: A Prospective Study at South Egypt Cancer Institute

Background: Lung cancer is a major health concern worldwide; representing
the second most common cancer, and the leading cause of cancer-related
mortality in both sexes. Gefitinib is a tyrosine kinase inhibitor against epidermal
growth factor receptor that is considered a potential therapy for metastatic non-
small cell lung cancer. Based on limited data among the Egyptian people, our
study was conducted to evaluate gefitinib therapy in metastatic lung
adenocarcinoma.
Patients and methods: This study is a prospective cohort study aiming to
evaluate the efficacy and safety of gefitinib as a first-line therapy for patients
with metastatic lung adenocarcinoma who harbor epidermal growth factor
receptor gene activating mutations; and who started to receive gefitinib therapy
at South Egypt Cancer Institute during the period from January 1st, 2020 to
December 31st, 2022.
Results: Seventy eight eligible patients with metastatic epidermal growth factor
receptor-mutated lung adenocarcinoma were enrolled in our study. The tumor
overall response rate was 41%; whereas disease control rate was 87.2%. Non-
smokers, smaller primary tumor size (≤5 cm), patients with single-organ
metastases, tumors of grade 1 or 2; and low mitotic index were all associated
with significantly higher response rates. Pointing to survival outcomes; the
median progression-free survival was 23.3 months; while the median overall
survival was 31.0 months. Multivariate analyses of both progression-free
survival and overall survival indicated that non-smoking, primary tumor-related
presenting symptoms; and metastases limited to a single organ were
independent predictors of improved survival with gefitinib therapy. Safety
analysis demonstrated that gefitinib therapy was safe with no grade IV or V
adverse events; and no treatment discontinuation due to intolerability.
Conclusions: Gefitinib is an effective and well-tolerated therapy for first-line
treatment of metastatic, epidermal growth factor receptor-mutated lung
adenocarcinoma. Moreover, smoking status, primary tumor size, number of
metastatic organs, tumor grade; and mitotic index proved to be significant
factors favorly affecting the efficacy of gefitinib therapy.