title: A phase II trial of erlotinib in combination with gemcitabine and capecitabine in previously untreated metastatic/recurrent pancreatic cancer: combined analysis with translational research.
abstract: BACKGROUND
  To confirm the efficacy and toxicity of Erlotinib in combination with Gemcitabine and Capecitabine when used as a first-line therapy in metastatic/recurrent pancreatic cancer (PC).
  
  
  METHODS
  Locally advanced PC was excluded. Erlotinib was given at a dose of 100 mg daily from D1 to D28. 1000 mg/m(2) of gemcitabine was given on D1,8,15 and 1660 mg/m(2)/day of capecitabine was given from D1 to 21, repeated every 4 weeks. Response was assessed every 8 weeks.
  
  
  RESULTS
  A total of 47 patients were enrolled. Response rate and disease control rate was 32.6% (95% CI, 18.6-46.6%) and 83.7% (95% CI, 72.7-94.7%) respectively. The PFS was 6.5 months (95% CI, 3.4-9.7) and OS was 12.0 months (95% CI, 8.6-15.9). The Gr 3/4 toxicities were: neutropenia (6.8%), thrombocytopenia (3.2%), anemia (1.6%). nausea (1.6%), vomiting (1.6%), anorexia (5.3%), rash (2.4%). The EGFR expression was associated with shorter OS and ERCC2 expression was associated with longer PFS and OS. PFS and OS were not different according to K-RAS mutation or polymorphism of RRM1 and CDA.
  
  
  CONCLUSIONS
  Erlotinib, gemcitabine and capecitabine combination showed promising efficacy and good tolerability in metastatic PC. This efficacy was observed irrespective of K-RAS mutation, and EGFR expression was poor prognostic factor for OS.
authors.affiliation: Department of Internal Medicine, Seoul National University Hospital, 28 Yongondong, Chongno-gu, Seoul, 110-744, Korea.
authors.forename: Do-Youn
authors.initials: DY
authors.lastname: Oh
authors.forename: Keun Wook
authors.initials: KW
authors.lastname: Lee
authors.forename: Kyung-Hee
authors.initials: KH
authors.lastname: Lee
authors.forename: Chang-Hak
authors.initials: CH
authors.lastname: Sohn
authors.forename: Young Suk
authors.initials: YS
authors.lastname: Park
authors.forename: Dae Young
authors.initials: DY
authors.lastname: Zang
authors.forename: Hun-Mo
authors.initials: HM
authors.lastname: Ryoo
authors.forename: Hong-Suk
authors.initials: HS
authors.lastname: Song
authors.forename: Jin-Soo
authors.initials: JS
authors.lastname: Kim
authors.forename: Hye-Jin
authors.initials: HJ
authors.lastname: Kang
authors.forename: Bong-Seog
authors.initials: BS
authors.lastname: Kim
authors.forename: Yung-Jue
authors.initials: YJ
authors.lastname: Bang
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000235:genetics / Q000378:metabolism; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D066246:ErbB Receptors / Q000235:genetics* / Q000378:metabolism; D000069347:Erlotinib Hydrochloride; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D005784:Gene Amplification; D011905:Genes, ras / Q000235:genetics; D006801:Humans; D008297:Male; D008875:Middle Aged; D009154:Mutation; D009362:Neoplasm Metastasis; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000378:metabolism / Q000473:pathology; D020641:Polymorphism, Single Nucleotide; D011799:Quinazolines / Q000008:administration & dosage; D016896:Treatment Outcome; D051759:Xeroderma Pigmentosum Group D Protein / Q000378:metabolism*; D000093542:Gemcitabine
chemical_list: D014408:Biomarkers, Tumor; D011799:Quinazolines; D003841:Deoxycytidine; D000069287:Capecitabine; D000069347:Erlotinib Hydrochloride; C512478:EGFR protein, human; D066246:ErbB Receptors; D051759:Xeroderma Pigmentosum Group D Protein; C497292:ERCC2 protein, human; D005472:Fluorouracil; D000093542:Gemcitabine