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Gefitinib Promising New Drug for Treatment of Non-Small Cell Lung Cancer

Gefitinib, a synthetic anilinoquinazoline, can successfully prolong survival in a subset of patients with non-small cell lung cancer, according to a new study from the Netherlands.

Gefitinib is an orally available inhibitor of the tyrosine kinase domain of the epidermal growth factor receptor (EGFR). Its antitumour activity can be observed at doses as low as 250 mg/day. Dr A. Haringhuizen, Department of Thoracic oncology, The Netherlands Cancer Institute, Amsterdam, and colleagues reported on a 16-month retrospective analysis of 100 patients with documented non-small cell lung cancer (NSCLC), enrolled in the AstraZeneca Expanded Access Program which offered compassionate use of gefitinib.

Gefitinib tablets, daily dose 250 mg, were supplied for an indefinite period until disease progression, unacceptable toxicity or death. At the time of analysis, 26 patients were still receiving gefitinib. Retrospective final analysis were performed for response, survival and toxicity in 92 patients, mean age 58 years. One third had a performance status (PS) 2 or better , 86% had stage IV disease, 62% had adenocarcinoma, 92.5% had prior chemotherapy.

Grade 1-2 skin rashes were observed in 34% of patients and diarrhoea in 22%. Nausea and vomiting, anorexia and desquamation or itching were not frequently reported. Overall gefitinib toxicity was modest.

The objective response rate was 8.7% and the duration of the response ranged from 1.2 to 15.8+ months. Clinical benefit was observed in 21 patients despite radiological signs of disease progression. Palliative radiotherapy was administered to 24 patients while they were receiving gefitinib and excellent symptomatic responses were obtained without extra toxicities.

In patients with NSCLC with poor prognostic characteristics, an objective response rate close to 9% and a disease control rate above 45% confirm the excellent single-agent activity of gefitinib.

"Our data suggest that gefitinib, when given to patients with a reasonable performance status failing on platinum-based chemotherapy, might have a similar efficacy as docetaxel which is accepted as a standard second-line treatment for NSCLC. This underlines the need for a randomised comparison of these two drugs", add the authors.

Ann Oncol 2004 May;15:5:786-92 "Gefitinib as a last treatment option for non-small-cell lung cancer: durable disease control in a subset of patients"

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