title: Erlotinib is effective in pancreatic cancer with epidermal growth factor receptor mutations: a randomized, open-label, prospective trial.
abstract: 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.
authors.affiliation: Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.|National Yang-Ming University School of Medicine, Taipei, Taiwan.|Division of Gastroenterology, Department of Internal Medicine, Renai Branch, Taipei City Hospital, Taipei, Taiwan.
authors.forename: Jack P
authors.initials: JP
authors.lastname: Wang
authors.affiliation: Institute of Public Health, National Yang-Ming University, Taipei, Taiwan.|Department of Dermatology, Taipei Veterans General Hospital, Taipei, Taiwan.|Department of Dermatology, Heping Fuyou Branch, Taipei City Hospital, Taipei, Taiwan.
authors.forename: Chen-Yi
authors.initials: CY
authors.lastname: Wu
authors.affiliation: National Yang-Ming University School of Medicine, Taipei, Taiwan.|Department of Pathology, Taipei Veterans General Hospital, Taipei, Taiwan.
authors.forename: Yi-Cheng
authors.initials: YC
authors.lastname: Yeh
authors.affiliation: National Yang-Ming University School of Medicine, Taipei, Taiwan.|Division of General Surgery, Department of Surgery, Taipei Veterans General Hospital, Taipei, Taiwan.
authors.forename: Yi-Ming
authors.initials: YM
authors.lastname: Shyr
authors.affiliation: Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.|National Yang-Ming University School of Medicine, Taipei, Taiwan.
authors.forename: Ying-Ying
authors.initials: YY
authors.lastname: Wu
authors.affiliation: Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.|National Yang-Ming University School of Medicine, Taipei, Taiwan.|Department of Medicine, National Yang-Ming University Hospital, Yilan, Taiwan.|Division of Oncology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.
authors.forename: Chen-Yu
authors.initials: CY
authors.lastname: Kuo
authors.affiliation: Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.|National Yang-Ming University School of Medicine, Taipei, Taiwan.|Institute of Public Health, National Yang-Ming University, Taipei, Taiwan.|Division of Oncology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.
authors.forename: Yi-Ping
authors.initials: YP
authors.lastname: Hung
authors.affiliation: National Yang-Ming University School of Medicine, Taipei, Taiwan.|Division of Oncology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.
authors.forename: Ming-Huang
authors.initials: MH
authors.lastname: Chen
authors.affiliation: National Yang-Ming University School of Medicine, Taipei, Taiwan.|Department of Medical Research, Taipei Veterans General Hospital, Taipei, Taiwan.
authors.forename: Wei-Ping
authors.initials: WP
authors.lastname: Lee
authors.affiliation: Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.|National Yang-Ming University School of Medicine, Taipei, Taiwan.
authors.forename: Jiing-Chyuan
authors.initials: JC
authors.lastname: Luo
authors.affiliation: Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.|National Yang-Ming University School of Medicine, Taipei, Taiwan.|Department of Oncology Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.
authors.forename: Yee
authors.initials: Y
authors.lastname: Chao
authors.affiliation: Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.|National Yang-Ming University School of Medicine, Taipei, Taiwan.
authors.forename: Chung-Pin
authors.initials: CP
authors.lastname: Li
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D004252:DNA Mutational Analysis; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D066246:ErbB Receptors / Q000037:antagonists & inhibitors* / Q000235:genetics* / Q000378:metabolism; D000069347:Erlotinib Hydrochloride / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009154:Mutation; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000201:enzymology / Q000235:genetics / Q000401:mortality / Q000473:pathology; D011446:Prospective Studies; D047428:Protein Kinase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D016283:Proto-Oncogene Proteins p21(ras) / Q000235:genetics; D013624:Taiwan; D013997:Time Factors; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000970:Antineoplastic Agents; C117307:KRAS protein, human; D047428:Protein Kinase Inhibitors; D003841:Deoxycytidine; D000069347:Erlotinib Hydrochloride; C512478:EGFR protein, human; D066246:ErbB Receptors; D016283:Proto-Oncogene Proteins p21(ras); D000093542:Gemcitabine
keywords: adenocarcinoma; epidermal growth factor receptor; erlotinib; pancreas