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Oral Gefitinib Results in Radiographic Disease Regression and Symptom Improvement in Patients with Non-Small-Cell Lung Cancer

Patients taking oral gefitinib, an epidermal growth factor receptor-tyrosine kinase inhibitor, showed radiographic regressions and improved symptoms of their non-small-cell lung cancer (NSCLC), according to the findings from a double-blind, phase 2 trial conducted in 30 oncology centres in the United States.

"These findings support the use of gefitinib for the treatment of patients with NSCLC who have received cisplatin or carboplatin and docetaxel, and other agents," writes Mark G. Kris, MD, Memorial Sloan-Kettering Cancer Center, New York, and colleagues. Between November 2000 and April 2001, the researchers randomised 221 patients to received 2 daily oral gefitinib tablets at 250 mg each or 1 gefitinib tablet at 250 mg plus 1 matching placebo tablet. The patients all had stage IIIB or IV NSCLC.

Baseline characteristics were similar between the 102 patients (mean age 61 years, 42 female) in the 250 mg gefitinib group and the 114 patients (mean age 62 years, 51 female) in the 500 mg gefitinib group. Overall, 79% of the patient population had disease progression and 18% had intolerable toxicity after their last chemotherapy regimen, and 58% of the patients had undergone 3 or more prior chemotherapy regimens.

Over a median 56 days in the study, the 250 mg group had a symptom improvement rate of 43% compared with 35% over a median of 53 days in the 500 mg group. These improvements occurred after 1 week of treatment in 55% of the 250 mg group and in 58% of the 500 mg group. The response rates (all partial) were 12% and 9% and the median durations of radiographic response were 7 months and 6 months for the 250 mg and 500 mg groups, respectively.

The investigators observed symptom improvement and radiographic responses in all subgroups but found that patients with adenocarcinoma (incidence of 79% in women and 58% in men) more commonly had improved symptoms (43%) than patients with other histologic types of NSCLC (30%). Patients with adenocarcinoma had response rates of 13% compared with 4% for other types of NSCLC.

Adverse effects of gefitinib were generally mild and reversible. Overall, 62% and 75% of patients reported skin toxicity and 57% and 75% reported diarrhoea in the 250 mg and 500 mg groups, respectively, while there was no case of interstitial lung disease. Drug-related adverse events led to study withdrawal in 1 patient in the 250 mg group and in 5 patients in the 500 mg group. All cause mortality at 60 days was 8.8% in the 250 mg group compared with 18% in the 500 mg group.

"This trial demonstrated that oral gefitinib given once daily caused rapid symptom improvement and tumour regressions in patients with NSCLC," the authors conclude.

JAMA 2003;290:2149-2158. "Efficacy of Gefitinib, an Inhibitor of the Epidermal Growth Factor Receptor Tyrosine Kinase, in Symptomatic Patients With Non–Small Cell Lung Cancer: A Randomized Trial"

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