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Drug Saf. 2011 Mar 1;34(3):175-86. doi: 10.2165/11586540-000000000-00000.

A benefit-risk assessment of erlotinib in non-small-cell lung cancer and pancreatic cancer.

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Department of Medical Oncology and Translational Research, 251 General Airforce Hospital, Athens, Greece.


Non-small-cell lung cancer (NSCLC) and pancreatic cancer represent two major causes of cancer-related morbidity and mortality worldwide. Conventional cytotoxic agents seem to have reached a therapeutic plateau in the last decade but prognosis remains dismal for both tumour types. Recent advances in molecular biology have allowed the development of novel molecular agents that target specific pathways implicated in the process of neoplastic transformation. Epidermal growth factor receptor (EGFR) represents an appealing therapeutic target in both malignancies and a number of EGFR-targeting agents have recently been approved for the first- or second-line treatment of locally advanced, recurrent or metastatic disease. Erlotinib, an orally administered EGFR tyrosine kinase inhibitor has recently received approval by both the US FDA and the European Medicines Agency (EMA) for the treatment of advanced NSCLC after chemotherapy failure and in combination with gemcitabine for the treatment of advanced pancreatic cancer, on the basis of large, randomized, phase III trials that demonstrated survival benefit over standard therapy or best supportive care. Erlotinib toxicity, as reported in these trials, seems to be modest, with the most prevalent adverse events being fatigue, acneiform rash and diarrhoea. However, recent pharmacovigilance reports, as well as sporadic case reports from the literature, raise concern of some serious adverse events, including pulmonary toxicity, sepsis and some rare cases of treatment-related deaths. In the current review, we present an evidence-based summary of the benefits and risks associated with erlotinib treatment in both advanced NSCLC and pancreatic cancer. Evidence for survival benefit in each of the drug's indications is provided, and treatment-related risks and costs are discussed. Finally, synthetic evaluation of the benefit-risk equilibrium is attempted, in order to help clinicians put this drug into perspective.

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