Abstract
Erlotinib (Tarceva) is a human epidermal growth factor receptor type 1/epidermal growth factor receptor (HER1/EGFR) tyrosine kinase inhibitor initially approved by the US Food and Drug Administration for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of at least one prior chemotherapy regimen. In this report, we present the pivotal study that led to the approval of erlotinib in combination with gemcitabine (Gemzar) in patients with locally advanced/metastatic chemonaive pancreatic cancer patients. The combination demonstrated a statistically significant increase in overall survival accompanied by an increase in toxicity. Physicians and patients now have a new option for the treatment of locally advanced/metastatic adenocarcinoma of the pancreas.
Publication types
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Clinical Trial, Phase III
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Randomized Controlled Trial
MeSH terms
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Adenocarcinoma / drug therapy*
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Adenocarcinoma / secondary*
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Adult
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Aged
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Aged, 80 and over
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Antimetabolites, Antineoplastic / administration & dosage
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Antimetabolites, Antineoplastic / adverse effects
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Antineoplastic Combined Chemotherapy Protocols / adverse effects
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
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Cohort Studies
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Deoxycytidine / administration & dosage
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Deoxycytidine / adverse effects
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Deoxycytidine / analogs & derivatives
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Double-Blind Method
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ErbB Receptors / antagonists & inhibitors
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Erlotinib Hydrochloride
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Female
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Gemcitabine
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Humans
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Male
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Middle Aged
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Pancreatic Neoplasms / drug therapy*
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Pancreatic Neoplasms / pathology
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Protein Kinase Inhibitors / administration & dosage
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Protein Kinase Inhibitors / adverse effects
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Quinazolines / administration & dosage
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Quinazolines / adverse effects
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Survival Analysis
Substances
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Antimetabolites, Antineoplastic
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Protein Kinase Inhibitors
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Quinazolines
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Deoxycytidine
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Erlotinib Hydrochloride
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ErbB Receptors
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Gemcitabine