Multi-Institutional Randomized Phase II Trial of Gefitinib for Previously Treated Patients With Advanced...

Area of Science:

• Oncology
• Pharmacology

Background:

• Non-small-cell lung cancer (NSCLC) is a leading cause of cancer-related mortality.
• Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors represent a targeted therapy approach for NSCLC.
• Pretreated advanced NSCLC patients often have limited treatment options.

Purpose of the Study:

• To evaluate the efficacy and tolerability of two gefitinib doses (250 mg and 500 mg daily) in pretreated advanced NSCLC patients.
• To determine the objective tumor response rates and symptom improvement with gefitinib therapy.
• To assess the safety profile and adverse events associated with gefitinib treatment.

Main Methods:

• A randomized, double-blind, parallel-group, multicenter phase II trial.
• 210 patients with advanced NSCLC previously treated with chemotherapy were randomized.
• Patients received either 250 mg or 500 mg of oral gefitinib once daily.

Main Results:

• Similar efficacy was observed between the 250 mg/d and 500 mg/d gefitinib groups.
• Objective tumor response rates were approximately 18.4-19.0%, with symptom improvement in 37.0-40.3% of patients.
• The 250 mg/d dose exhibited a more favorable adverse event profile, with lower withdrawal rates compared to 500 mg/d.

Conclusions:

• Gefitinib demonstrated clinically meaningful antitumor activity and symptom relief in pretreated advanced NSCLC.
• The 250 mg/d dose of gefitinib offers a favorable tolerability profile.
• Gefitinib 250 mg/d is a significant novel treatment option for patients with pretreated advanced NSCLC.