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Lung Cancer Case Report Gefitinib-induced Acute Kidney Injury in a Patient with Advanced NSCLC Harbouring an EGFR-activating Mutation Ourania Romanidou 1,2 and Raffaele Califano 1,3 1. Consultant in Medical Oncology, Cancer Research UK Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK; 2. Department of Medical Oncology, Papageorgiou General Hospital, Thessaloniki, Greece; 3. Consultant in Medical Oncology, Department of Medical Oncology, University Hospital of South Manchester, Manchester, UK Abstract Gefitinib, erlotinib or afatinib represent standard of care as first-line treatment for advanced non-small cell lung cancer (NSCLC) harbouring an activating mutation of epidermal growth factor receptor (EGFR). The toxicity profile of these drugs is well known with rash, diarrhoea, nausea, anorexia, fatigue and derangement of liver function being the most commonly observed adverse events. We report a case of an 82-year-old patient with EGFR-mutant advanced NSCLC who developed gefitinib-induced acute kidney injury, which slowly improved on discontinuation of the drug. Keywords Gefitinib, erlotinib, afatinib, non-small cell lung cancer, acute renal failure, adverse event, adenocarcinoma, EGFR mutation Disclosure: Ourania Romanidou and Raffaele Califano have no conflicts of interest to declare. No funding was received in the publication of this article. Compliance with Ethics Guidelines: Procedures were followed in accordance with the responsible committee on human experimentation and with the Helsinki Declaration of 1975 and subsequent revisions. Informed consent was received from the patient involved in the study. Open Access: This article is published under the Creative Commons Attribution Noncommercial License, which permits any non-commercial use, distribution, adaptation and reproduction provided the original author(s) and source are given appropriate credit. Received: 20 April 2015 Accepted: 12 May 2015 Citation: European Oncology & Haematology, 2015;11(1):41–3 Correspondence: Raffaele Califano, Cancer Research UK Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, M20 4BX, UK. E: raffaele.califano@christie.nhs.uk Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), such as gefitinib, erlotinib or afatinib, are standard of care as first-line treatment for advanced non-small cell lung cancer (NSCLC) harbouring EGFR-activating mutations. 1 Adverse events associated with gefitinib are well known and include rash, pruritus, diarrhoea, nausea, anorexia, fatigue, derangement of liver function tests and, rarely, interstitial lung disease. Renal impairment was not recorded as an adverse event in randomised phase III trials evaluating gefitinib as first-line therapy in advanced EGFR-mutant NSCLC. 2–4 Gefitinib metabolism is mainly hepatic and its excretion predominantly gastrointestinal. Renal elimination accounts for less than 4  % of an administered dose 5 and it has safely been administered to patients with chronic renal impairment. 6 While cases of acute kidney injury have been reported with other anti-EGFR treatments, such as cetuximab, 7 it has not been reported with gefitinib in the Western population. We report a case of a patient with EGFR-mutant advanced NSCLC who developed acute kidney injury during treatment with gefitinib, which slowly improved on discontinuation of the drug. metastases. Computed tomography (CT) of the chest and abdomen confirmed a 6 cm left upper lobe mass invading the mediastinum and pulmonary artery with bilateral lung metastases and associated left pleural thickening. Endobronchial biopsy of the left upper lobe bronchus revealed NSCLC positive for cytokeratin 7 (CK7), thyroid transcription factor 1 (TTF1) and cytokeratin 5/6 (CK5/6), consistent with NSCLC not otherwise specified (NOS). Mutation analysis, using Roche Cobas EGFR assay, demonstrated an EGFR-activating mutation in exon 21 (c.2573T>G (Leu858.Arg)). His past medical history included diet-controlled type 2 diabetes with no microvascular complications and hypertension managed with perindopril 8 mg once daily (OD) and amlodipine 10 mg OD. His Eastern Cooperative Oncology Group (ECOG) performance status (PS) was 1 and baseline objective examination was unremarkable. Baseline full blood count and biochemistry were within normal range except for a mildly deranged serum creatinine (sCr) of 125 µmol/l (normal range 50–120 µmol/l) with an estimated glomerular filtration rate (eGFR) of 40 ml/min using Cockroft and Gault formula, indicating a pre-existing element of chronic kidney disease (Kidney Disease Outcomes Quality Initiative Chronic Kidney Disease Stage 3). Case Report An 82-year-old Caucasian male ex-smoker presented with a 4-month history of productive cough. Chest radiograph revealed a left hilar mass with multiple bilateral opacities in keeping with intrapulmonary Tou ch MEdi c a l MEdia He was started on first-line gefitinib (250 mg/day) on 4 July 2012. On day 28, he was well and reported an improvement in his cough. The only adverse event experienced was common toxicity criteria (CTC) 41