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Eighteen months later, she was found to have lymphadenopathy of the right supraclavicular nodes. Fine needle aspiration cytology of the lymph node indicated adenocarcinoma. She started gefitinib therapy for recurrent lung cancer with EGFR mutation (exon 19 deletion) in January 2008. Four months afterward, computed tomography (CT) showed her right supraclavicular nodes had shrunk dramatically. Treatment with gefitinib was continued. Thereafter, no disease progression was observed throughout her approximately 8-year gefitinib treatment, and gefitinib was terminated in November 2016. Although the patient received no other treatment, she has suffered no recurrence in the 4 years since. A review of the literature, including our case, is also presented.

Gefitinib (Iressa, ZD1839, AstraZeneca Japan) was approved by the Japanese Ministry of Health, Labor and Welfare (MHLW) in July 2002 for the treatment of inoperable or recurrent non-small cell lung cancer (NSCLC). In Japan, up until the end of January 2003, approximately 23 500 people had received gefitinib and 183 deaths had been attributed to the drug. Acute lung disease and/or interstitial pneumonitis were implicated in 173 deaths. In this article we shall give a brief description of gefitinib, an outline of the experience with this drug in Japan and in Western countries, and also our opinion on what should be learnt from this story.

Gefitinib is a tyrosine kinase inhibitor. It works by targeting and blocking epidermal growth factor receptor (EGFR) tyrosine kinase. In some cancers, this receptor is overactive, causing cells to grow and divide too fast. By inhibiting EGFR, gefitinib prevents the uncontrolled growth of cells that contributes to tumor growth. Your oncology team will test your tumor for this abnormality, which must be present in order to receive the medication.

The Predicted Environmental Concentration (PEC) / Predicted No Effect Concentration (PNEC) ratio is 6.31 x 10-4 , which means use of Gefitinib is predicted to present an insignificant risk to the environment.

Gefitinib (Iressa®, ZD1839) is a tyrosine kinase inhibitor that targets the intracellular domain of the epidermal growth factor receptor (EGFR), thereby blocking signal transduction pathways that are implicated in the proliferation and survival of cancer cells.1 Phase 1 trials on gefitinib defined a range of doses from 250 to 500 mg to be used in phase II studies.2 The toxicity observed in Phase I studies was mild and consisted mainly of skin rash and diarrhea.2 Phase II studies on patients with advanced previously-treated non-small cell lung cancer showed similar results for both 250 and 500 mg daily dosages.3 In these patients an objective response rate of between 10 and 20% has consistently been achieved and around an additional 40% of patients have derived clinical benefit due to disease stabilization. Furthermore, this clinical benefit has translated into improved quality of life for these patients.