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The magnitude of change considered to be clinically significant may need to be determined on a trial-by-trial basis since it may vary because of the patient population and the modality of treatment being studied.

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Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are effective for leptomeningeal metastasis from non-small cell lung cancer patients with sensitive EGFR mutation or other predictive factors of good response for EGFR TKI.

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Serum aminotransferase elevations above 5 times the upper limit of normal (if confirmed) should lead to dose interruption.

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This integrated mathematic modeling and experimental approach represents a new roadmap for the rational design of clinical trials that can also be applied to other cancer types treated with targeted therapy.

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During clinical trials, these side effects did subside with use.

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While the RADIANT trial was underway, another study had been designed with purpose to give answers about adjuvant treatment with erlotinib, particularly for patients who are positive for EGFR mutation.

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In this event, the tumor enrichment can be performed directly by the pathologist or by a trained technologist under guidance by the pathologist, in which case, the ideal region should be demarcated on the slide by a pathologist during their hematoxylin-eosin review of the case, with documentation of tumor content, and used as a reference for the tumor enrichment procedure.

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Phosphoinositide-3-kinase catalytic alpha and KRAS mutations are important predictors of resistance to therapy with epidermal growth factor receptor tyrosine kinase inhibitors in patients with advanced non-small cell lung cancer.

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As a result, lapatinib has been taken into clinical trials in melanoma, where patients with no more than two oncogenic somatic HER4 mutations will be offered lapatinib monotherapy (NCT01264081).

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Other class II activating mutations result in a glycine-719 (G719) change to serine, alanine or cysteine (4% of all EGFR TK activating mutations), and other missense mutations account for another 6% of EGFR mutations.

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Another important distinction between ALK FISH and EGFR mutation analysis is that FISH testing should ideally be performed on recently cut sections, although protocols can be adapted to older slides.

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