title: Erlotinib as second-line treatment in patients with advanced non-small-cell lung cancer and asymptomatic brain metastases: a phase II study (CTONG-0803).
abstract: BACKGROUND
  This phase II, open-label study evaluated the efficacy and safety of erlotinib as second-line therapy in non-small-cell lung cancer (NSCLC) patients with brain metastases (BM).
  
  
  METHODS
  Forty-eight patients aged 18-75 years with Eastern Cooperative Oncology Group performance status 0-2, confirmed adenocarcinoma or activating epidermal growth factor receptor (EGFR) mutation-positive NSCLC, and asymptomatic BM without extracranial progressive disease after first-line platinum-doublet chemotherapy were recruited. Treatment comprised erlotinib 150 mg/day. The primary end point was progression-free survival (PFS) determined by RECIST.
  
  
  RESULTS
  The median PFS was 10.1 months [95% confidence interval (CI) 7.1-12.3] for intracranial progression and 9.7 months (95% CI 2.5-17.8) for intracranial and systemic progression. Patients with EGFR mutation-positive disease had significantly longer median PFS versus EGFR wild-type disease [15.2 months (95% CI 8.3-22.2) versus 4.4 months (95% CI 0.0-11.6); P = 0.02]. The median overall survival was 18.9 months (95% CI 14.4-23.4); 6-month and 1-year survival rates were 85% and 73%, respectively. Overall response rate was 58.3%. Most common adverse events were rash (77.1%), paronychia (20.8%), hyperbilirubinemia (16.7%), and diarrhea (14.6%); these were predominantly of grade 1/2.
  
  
  CONCLUSIONS
  Single-agent erlotinib was active and well tolerated in NSCLC patients with BM. Further studies are warranted.
authors.affiliation: Guangdong Lung Cancer Institute, Guangdong General Hospital and Guandong Academy of Medical Sciences, Guangzhou, China. syylwu@live.cn
authors.forename: Y-L
authors.initials: YL
authors.lastname: Wu
authors.forename: C
authors.initials: C
authors.lastname: Zhou
authors.forename: Y
authors.initials: Y
authors.lastname: Cheng
authors.forename: S
authors.initials: S
authors.lastname: Lu
authors.forename: G-Y
authors.initials: GY
authors.lastname: Chen
authors.forename: C
authors.initials: C
authors.lastname: Huang
authors.forename: Y-S
authors.initials: YS
authors.lastname: Huang
authors.forename: H-H
authors.initials: HH
authors.lastname: Yan
authors.forename: S
authors.initials: S
authors.lastname: Ren
authors.forename: Y
authors.initials: Y
authors.lastname: Liu
authors.forename: J-J
authors.initials: JJ
authors.lastname: Yang
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology / Q000556:secondary*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D064420:Drug-Related Side Effects and Adverse Reactions / Q000139:chemically induced / Q000473:pathology; D066246:ErbB Receptors / Q000235:genetics; D000069347:Erlotinib Hydrochloride; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011799:Quinazolines / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D011799:Quinazolines; D000069347:Erlotinib Hydrochloride; C512478:EGFR protein, human; D066246:ErbB Receptors