title: A prospective study of biomarker-guided chemotherapy in patients with non-small cell lung cancer.
abstract: OBJECTIVE
  To assess the therapeutic value of biomarker-guided chemotherapy in patients with advanced non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Eighty-five NSCLC patients at stage IIIb or IV were divided into two groups based on the feasibility of biomarker analysis. Group A included patients with biomarker data (n = 41); Group B were patients without biomarker results (n = 44). Tumor samples obtained by fiberoptic bronchoscopy and computerized tomography-guided needle biopsy were analyzed by immunohistochemistry for intratumoral level of excision repair cross-complementing gene 1 (ERCC1), ribonucleotide reductase M1 (RRM1), and β-tubulin III. Chemotherapy regimens in Group A were determined according to the status of molecular signatures, whereas a standard gemcitabine plus cisplatin regimen was used for Group B. Tumor response, patient survival, and adverse effects were monitored for both groups.
  
  
  RESULTS
  The overall response rate, defined as complete response plus partial response, was 56.1% for Group A, significantly higher than that in Group B (31.8%; P = 0.024). The median progression-free survival (PFS) time was 5.2 months for Group A, significantly longer than that of Group B (4.1 months; P = 0.026). The 1-year survival rate of Group A was 65.9%, significantly higher than that of Group B (40.9%; P = 0.021), whereas the median overall survival times were 13.5 versus 12.5 months for Groups A and B, respectively (P = 0.483). The adverse effects in the two groups were essentially the same.
  
  
  CONCLUSIONS
  Biomarker-tailored chemotherapy based on ERCC1, RRM1, and β-tubulin III expression showed significantly increased response rate, median PFS time, and 1-year survival rate in patients with NSCLC.
authors.affiliation: Department of Pulmonary Medicine, Zhongda Hospital Affiliated to Southeast University, Dingjiaqiao No. 87, Nanjing, 210009, People's Republic of China.
authors.forename: Qiang
authors.initials: Q
authors.lastname: Zhang
authors.forename: Xiaoli
authors.initials: X
authors.lastname: Zhu
authors.forename: Li
authors.initials: L
authors.lastname: Zhang
authors.forename: Siqing
authors.initials: S
authors.lastname: Sun
authors.forename: Jing
authors.initials: J
authors.lastname: Huang
authors.forename: Yong
authors.initials: Y
authors.lastname: Lin
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D014408:Biomarkers, Tumor / Q000378:metabolism; D001999:Bronchoscopy / Q000379:methods; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D004268:DNA-Binding Proteins / Q000378:metabolism*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D018572:Disease-Free Survival; D004354:Drug Screening Assays, Antitumor; D004720:Endonucleases / Q000378:metabolism*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D061705:Image-Guided Biopsy / Q000379:methods; D007150:Immunohistochemistry; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D012262:Ribonucleoside Diphosphate Reductase; D014057:Tomography, X-Ray Computed / Q000379:methods; D016896:Treatment Outcome; D014404:Tubulin / Q000378:metabolism*; D025521:Tumor Suppressor Proteins / Q000378:metabolism*; D000093542:Gemcitabine
chemical_list: D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor; D004268:DNA-Binding Proteins; C498585:TUBB3 protein, human; D014404:Tubulin; D025521:Tumor Suppressor Proteins; D003841:Deoxycytidine; C475286:RRM1 protein, human; D012262:Ribonucleoside Diphosphate Reductase; C071447:ERCC1 protein, human; D004720:Endonucleases; D002945:Cisplatin; D000093542:Gemcitabine