title: Incorporating Erlotinib or Irinotecan Plus Cisplatin into Chemoradiotherapy for Stage III Non-small Cell Lung Cancer According to EGFR Mutation Status.
abstract: OBJECTIVE
  Concurrent chemoradiotherapy (CCRT) is the standard care for stage III non-small cell lung cancer (NSCLC) patients; however, a more effective regimen is needed to improve the outcome by better controlling occult metastases. We conducted two parallel randomized phase II studies to incorporate erlotinib or irinotecan-cisplatin (IP) into CCRT for stage III NSCLC depending on epidermal growth factor receptor (EGFR) mutation status.
  
  
  METHODS
  Patients with EGFR-mutant tumors were randomized to receive three cycles of erlotinib first and then either CCRT with erlotinib followed by erlotinib (arm A) or CCRT with IP only (arm B). Patients with EGFR unknown or wild-type tumors were randomized to receive either three cycles of IP before (arm C) or after CCRT with IP (arm D).
  
  
  RESULTS
  Seventy-three patients were screened and the study was closed early because of slow accrual after 59 patients were randomized. Overall, there were seven patients in arm A, five in arm B, 22 in arm C, and 25 in arm D. The response rate was 71.4% and 80.0% for arm A and B, and 70.0% and 73.9% for arm C and D. The median overall survival (OS) was 39.3 months versus 31.2 months for arm A and B (p=0.442), and 16.3 months versus 25.3 months for arm C and D (p=0.050). Patients with sensitive EGFR mutations had significantly longer OS than EGFR-wild patients (74.8 months vs. 25.3 months, p=0.034). There were no unexpected toxicities.
  
  
  CONCLUSIONS
  Combined-modality treatment by molecular diagnostics is feasible in stage III NSCLC. EGFR-mutant patients appear to be a distinct subset with longer survival.
authors.affiliation: Center for Lung Cancer, National Cancer Center, Goyang, Korea.
authors.forename: Youngjoo
authors.initials: Y
authors.lastname: Lee
authors.affiliation: Center for Lung Cancer, National Cancer Center, Goyang, Korea.
authors.forename: Ji-Youn
authors.initials: JY
authors.lastname: Han
authors.affiliation: Center for Proton Therapy, National Cancer Center, Goyang, Korea.
authors.forename: Sung Ho
authors.initials: SH
authors.lastname: Moon
authors.affiliation: Center for Clinical Trials, National Cancer Center, Goyang, Korea.
authors.forename: Byung-Ho
authors.initials: BH
authors.lastname: Nam
authors.affiliation: Center for Lung Cancer, National Cancer Center, Goyang, Korea.
authors.forename: Kun Young
authors.initials: KY
authors.lastname: Lim
authors.affiliation: Center for Lung Cancer, National Cancer Center, Goyang, Korea.
authors.forename: Geon Kook
authors.initials: GK
authors.lastname: Lee
authors.affiliation: Center for Lung Cancer, National Cancer Center, Goyang, Korea.
authors.forename: Heung Tae
authors.initials: HT
authors.lastname: Kim
authors.affiliation: Center for Lung Cancer, National Cancer Center, Goyang, Korea.
authors.forename: Tak
authors.initials: T
authors.lastname: Yun
authors.affiliation: Center for Lung Cancer, National Cancer Center, Goyang, Korea.
authors.forename: Hye Jin
authors.initials: HJ
authors.lastname: An
authors.affiliation: Center for Lung Cancer, National Cancer Center, Goyang, Korea.
authors.forename: Jin Soo
authors.initials: JS
authors.lastname: Lee
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; 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; D003131:Combined Modality Therapy; D004252:DNA Mutational Analysis; D066246:ErbB Receptors / Q000235:genetics*; D000069347:Erlotinib Hydrochloride / Q000008:administration & dosage; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000235:genetics* / Q000401:mortality / Q000473:pathology; D008297:Male; D009154:Mutation; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D016019:Survival Analysis; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D000077146:Irinotecan; D000069347:Erlotinib Hydrochloride; D066246:ErbB Receptors; D002945:Cisplatin; D002166:Camptothecin
keywords: Chemoradiotherapy; EGFR mutation; EGFR tyrosine kinase inhibitor; Non-small-cell lung carcinoma