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Multi-Institutional Randomized Phase II Trial of Gefitinib for Previously Treated Patients With Advanced
Masahiro Fukuoka1, Seiji Yano1, Giuseppe Giaccone1
1From the Kinki University School of Medicine, Osaka City University School of Medicine, and AstraZeneca, Osaka, Tokushima University School of Medicine, Tokushima, National Cancer Center, Central Hospital, and Japanese Foundation for Cancer Research, Tokyo, National Cancer Center, East Hospital, Chiba, Kanagawa Cancer Center, Yokohama, and National Shikoku Cancer Center, Matsuyama, Japan; C.R.L.C.C. Rene Gauducheau, Saint-Herblain, France; University Hospital Gasthuisberg, Leuven, Belgium; Centre for Developmental Cancer Therapeutics, Melbourne, Australia; Mary Potter Oncology Centre, Pretoria, South Africa; Academic Hospital Free University, Amsterdam, the Netherlands; AstraZeneca, Wilmington, DE; AstraZeneca, Alderley Park, United Kingdom; and Vall d'Hebron University Hospital, Barcelona, Spain.
Purpose:
To evaluate the efficacy and tolerability of two doses of gefitinib (Iressa [ZD1839]; AstraZeneca, Wilmington, DE), a novel epidermal growth factor receptor tyrosine kinase inhibitor, in patients with pretreated advanced non-small-cell lung cancer (NSCLC).
Patients And Methods:
This was a randomized, double-blind, parallel-group, multicenter phase II trial. Two hundred ten patients with advanced NSCLC who were previously treated with one or two chemotherapy regimens (at least one containing platinum) were randomized to receive either 250-mg or 500-mg oral doses of gefitinib once daily.
Results:
Efficacy was similar for the 250- and 500-mg/d groups. Objective tumor response rates were 18.4% (95% confidence interval [CI], 11.5 to 27.3) and 19.0% (95% CI, 12.1 to 27.9); among evaluable patients, symptom improvement rates were 40.3% (95% CI, 28.5 to 53.0) and 37.0% (95% CI, 26.0 to 49.1); median progression-free survival times were 2.7 and 2.8 months; and median overall survival times were 7.6 and 8.0 months, respectively. Symptom improvements were recorded for 69.2% (250 mg/d) and 85.7% (500 mg/d) of patients with a tumor response. Adverse events (AEs) at both dose levels were generally mild (grade 1 or 2) and consisted mainly of skin reactions and diarrhea. Drug-related toxicities were more frequent in the higher-dose group. Withdrawal due to drug-related AEs was 1.9% and 9.4% for patients receiving gefitinib 250 and 500 mg/d, respectively.
Conclusion:
Gefitinib showed clinically meaningful antitumor activity and provided symptom relief as second- and third-line treatment in these patients. At 250 mg/d, gefitinib had a favorable AE profile. Gefitinib 250 mg/d is an important, novel treatment option for patients with pretreated advanced NSCLC.
Insights
Gefitinib demonstrated significant antitumor activity and symptom relief in pretreated advanced non-small-cell lung cancer (NSCLC) patients. The 250 mg/d dose showed a favorable safety profile, making it a valuable treatment option.
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.
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