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Erlotinib in African Americans with advanced non-small cell lung cancer: a prospective randomized study with genetic and pharmacokinetic analyses.


ABSTRACT: Prospective studies on epidermal growth factor receptor (EGFR) inhibitors in African Americans with non-small cell lung cancer (NSCLC) have not previously been performed. In this phase II randomized study, 55 African Americans with NSCLC received 150?mg/day erlotinib or a body weight-adjusted dose with subsequent escalations to the maximum-allowable dose, 200?mg/day, to achieve rash. Erlotinib and OSI-420 exposures were lower than those observed in previous studies, consistent with CYP3A pharmacogenetics implying higher metabolic activity. Tumor genetics showed only two EGFR mutations, EGFR amplification in 17/47 samples, eight KRAS mutations, and five EML4-ALK translocations. Although absence of rash was associated with shorter time to progression (TTP), disease-control rate, TTP, and 1-year survival were not different between the two dose groups, indicating the dose-to-rash strategy failed to increase clinical benefit. Low incidence of toxicity and low erlotinib exposure suggest standardized and maximum-allowable dosing may be suboptimal in African Americans.

SUBMITTER: Phelps MA 

PROVIDER: S-EPMC4180036 | biostudies-literature | 2014 Aug

REPOSITORIES: biostudies-literature

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Erlotinib in African Americans with advanced non-small cell lung cancer: a prospective randomized study with genetic and pharmacokinetic analyses.

Phelps M A MA   Stinchcombe T E TE   Blachly J S JS   Zhao W W   Schaaf L J LJ   Starrett S L SL   Wei L L   Poi M M   Wang D D   Papp A A   Aimiuwu J J   Gao Y Y   Li J J   Otterson G A GA   Hicks W J WJ   Socinski M A MA   Villalona-Calero M A MA  

Clinical pharmacology and therapeutics 20140429 2


Prospective studies on epidermal growth factor receptor (EGFR) inhibitors in African Americans with non-small cell lung cancer (NSCLC) have not previously been performed. In this phase II randomized study, 55 African Americans with NSCLC received 150 mg/day erlotinib or a body weight-adjusted dose with subsequent escalations to the maximum-allowable dose, 200 mg/day, to achieve rash. Erlotinib and OSI-420 exposures were lower than those observed in previous studies, consistent with CYP3A pharmac  ...[more]

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