title: ERCC1 Expression-Based Randomized Phase II Study of Gemcitabine/Cisplatin Versus Irinotecan/Cisplatin in Patients with Advanced Non-small Cell Lung Cancer.
abstract: OBJECTIVE
  We evaluated the clinical utility of excision repair cross-complementation group 1 (ERCC1) expression as a predictive biomarker for platinum-based chemotherapy in advanced non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Eligible patients were randomly assigned to the GP (gemcitabine 1,250 mg/m2on days 1 and 8, and cisplatin 75 mg/m2on day 1 every 3 weeks) or IP (irinotecan 65 mg/m2and cisplatin 30 mg/m2on days 1 and 8 every 3 weeks) arm. The primary goal of this study was to compare the response rate (RR) of the GP and IP arms according to the ERCC1 expression level.
  
  
  RESULTS
  A total of 279 patients were randomly assigned to the GP (n=139) and IP (n=140) arms, among which 63% were ERCC1-positive and 268 patients were assessable for the RR. The GP and IP arms did not differ significantly with respect to the RR (29.8% vs. 27.0%, respectively; p=0.082), median progression-free survival (PFS; 4.5 months vs. 3.9 months, respectively; p=0.117), and overall survival (OS; 16.5 months vs. 16.7 months, respectively; p=0.313). When comparing the efficacy between the ERCC1-positive and ERCC1-negative groups, there was no significant difference in the RR (GP, 28.2% vs. 32.6%, respectively, p=0.509; IP, 30.2% vs. 21.6%, respectively, p=0.536), median PFS (GP, 4.6 months vs. 5.0 months, respectively, p=0.506; IP, 3.9 months vs. 3.7 months, respectively, p=0.748), or median OS (GP, 18.6 months vs. 11.9 months, respectively, p=0.070; IP, 17.5 months vs. 14.0 months, respectively, p=0.821).
  
  
  CONCLUSIONS
  Immunohistochemical analysis of the ERCC1 expression level did not differentiate the efficacy of platinum-based chemotherapy in advanced NSCLC.
authors.affiliation: Center for Lung Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea.
authors.forename: Ji-Youn
authors.initials: JY
authors.lastname: Han
authors.affiliation: Center for Lung Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea.
authors.forename: Geon Kook
authors.initials: GK
authors.lastname: Lee
authors.affiliation: Center for Lung Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea.
authors.forename: Kun Young
authors.initials: KY
authors.lastname: Lim
authors.affiliation: Center for Lung Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea.
authors.forename: Young Ju
authors.initials: YJ
authors.lastname: Lee
authors.affiliation: Center for Lung Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea.
authors.forename: Byung Ho
authors.initials: BH
authors.lastname: Nam
authors.affiliation: Center for Lung Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea.
authors.forename: Jin Soo
authors.initials: JS
authors.lastname: Lee
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000077548:Anaplastic Lymphoma Kinase; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D014408:Biomarkers, Tumor; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000235:genetics* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D004268:DNA-Binding Proteins / Q000235:genetics*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004720:Endonucleases / Q000235:genetics*; D005260:Female; D015870:Gene Expression; D018773:Genes, erbB-1; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000235:genetics* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D016283:Proto-Oncogene Proteins p21(ras) / Q000235:genetics / Q000378:metabolism; D020794:Receptor Protein-Tyrosine Kinases / Q000235:genetics; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D014408:Biomarkers, Tumor; D004268:DNA-Binding Proteins; C117307:KRAS protein, human; D003841:Deoxycytidine; D000077146:Irinotecan; D000077548:Anaplastic Lymphoma Kinase; D020794:Receptor Protein-Tyrosine Kinases; C071447:ERCC1 protein, human; D004720:Endonucleases; D016283:Proto-Oncogene Proteins p21(ras); D002945:Cisplatin; D002166:Camptothecin; D000093542:Gemcitabine
keywords: ERCC1; Non-small-cell lung carcinoma; Platinum