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Acquired Resistance of Lung Adenocarcinomas to Gefitinib or Erlotinib Is Associated with a Second Mutation in the EGFR Kinase Domain.

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In this study, the toxicity of palliative gefitinib was mild, although the folliculitis previously reported with gefitinib was more prevalent and florid than has been previously reported.

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In animal reproductive studies, oral administration of gefitinib from organogenesis through weaning resulted in fetotoxicity and neonatal death at doses below the recommended human dose.

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The following adverse reactions have been reported with IRESSA across NSCLC trials (Study 2, Study 3 and Study 4) and are not listed elsewhere in Section 6: nausea (18%), asthenia (17%), pyrexia (9%), alopecia (4.

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Tissue was not available from the other patients with a response to gefitinib, most commonly because diagnostic specimens were limited to needle aspirates.

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SOURCES: Canadian Medical Association Journal, news release, Jan. 10, 2011; Canadian Medical Association Journal, Jan.

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The preponderance of evidence indicates that postoperative cisplatin combination chemotherapy provides a significant survival advantage to patients with resected NSCLC with occult N2 disease discovered at surgery.

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In a subset analysis which included patients with EGFR-mutated disease (161 patients: 102 on erlotinib and 59 on placebo), DFS favored erlotinib in comparison with placebo.

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In addition, patients on afatinib had a significantly longer time on treatment, and risk of treatment failure was reduced by 27% versus gefitinib.

In patients without EGFR mutations for whom chemotherapy fails, erlotinib may be administered as a second-line agent.

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In a tumor with the 2240del18 mutation from a patient with nonsmall cell lung cancer who showed responsiveness to gefitinib with complete remission over a 2-year period, identified the development of a second mutation in EGFR, thr790 to met (T790M; ), responsible for secondary resistance to gefitinib.

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The alternate strategy of increasing the dose level in the wild-type EGFR group was ruled out as the doses of gefitinib would likely be toxic ().

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