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Erlotinib is effective in pancreatic cancer with epidermal growth factor receptor mutations : a randomized , open-label , prospective trial . OBJECTIVE To analyze the efficacy of gemcitabine with or without erlotinib for pancreatic cancer , and to determine the predictive role of epidermal growth factor receptor ( EGFR ) and KRAS mutations in these patients . METHODS This was a single-center , randomized , open-label , prospective trial . Eighty-eight chemotherapy-naïve metastatic pancreatic cancer patients were randomized for treatment with gemcitabine or gemcitabine plus erlotinib . EGFR and KRAS mutations were analyzed , respectively . The primary endpoint was the disease control rate . RESULTS Disease control rate ( 64 % vs. 25 % ; P < 0.001 ) , progression-free survival ( median 3.8 vs. 2.4 months ; P < 0.001 ) , and overall survival ( median 7.2 vs. 4.4 months ; P < 0.001 ) were better in the gemcitabine plus erlotinib group than in the gemcitabine alone group . In the gemcitabine plus erlotinib group , disease control ( 85 % vs. 33 % ; P = 0.001 ) , progression-free survival ( median 5.9 vs. 2.4 months ; P = 0.004 ) , and overall survival ( median 8.7 vs. 6.0 months ; P = 0.044 ) were better in patients with EGFR mutations than in those without EGFR mutations . KRAS mutation was not associated with treatment response or survival . CONCLUSIONS Gemcitabine plus erlotinib is more effective than gemcitabine alone for treating metastatic pancreatic cancer patients , especially those with EGFR mutations . ClinicalTrials.gov number , NCT01608841 .
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Intervention_Pharmacological
Erlotinib
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Intervention_Pharmacological
gemcitabine
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Intervention_Pharmacological
erlotinib
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Outcome_Other
the disease control rate
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Outcome_Other
RESULTS Disease control rate
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Outcome_Mortality
progression-free survival
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Outcome_Mortality
and overall survival
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Outcome_Other
disease control
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Outcome_Mortality
progression-free survival
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Outcome_Mortality
and overall survival
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Participant_Condition
pancreatic cancer with epidermal
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Participant_Sample-size
Eighty-eight
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Participant_Condition
chemotherapy-naïve metastatic pancreatic cancer patients
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Participant_Condition
gemcitabine or gemcitabine plus erlotinib
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Participant_Condition
patients with EGFR mutations than in those without EGFR mutations
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Participant_Condition
treating metastatic pancreatic cancer patients , especially those with EGFR mutations