title: Intermittent chemotherapy and erlotinib for nonsmokers or light smokers with advanced adenocarcinoma of the lung: a phase II clinical trial.
abstract: BACKGROUND
  Intermittent application of chemotherapy and tyrosine kinase inhibitors may avoid antagonism between the two classes of drugs. This hypothesis was tested in a Phase II clinical trial.
  
  
  METHODS
  Eligible patients were nonsmokers or light smokers, chemo-naïve, with metastatic adenocarcinoma of the lung.
  
  
  METHODS
  4 to 6 cycles of gemcitabine 1250 mg/m(2) on days 1 and 4, cisplatin 75 mg/m(2) on day 2, and erlotnib 150 mg daily on days 5-15, followed by erlotinib as maintenance.
  
  
  RESULTS
  24 patients entered the trial. Four pts had grade 3 toxicity. Complete remission (CR) and partial remission (PR) were seen in 5 pts and 9 pts, respectively (response rate 58%). Median time to progression (TTP) was 13.4 months and median overall survival (OS) was 23 months. When compared to patients with negative or unknown status of EGFR mutations, 8 patients with EGFR gene activating mutations had significantly superior experience: 4 CR and 4 PR, with median TTP 21.5 months and OS 24.2 months (P < .05).
  
  
  CONCLUSIONS
  Intermittent schedule with gemcitabine, cisplatin and erlotinib has mild toxicity. For patients who are positive for EGFR gene activating mutations, this treatment offers excellent response rate, time to progression and survival.
authors.affiliation: Institute of Oncology, Ljubljana, Slovenia. matjaz.zwitter@guest.arnes.si
authors.forename: Matjaz
authors.initials: M
authors.lastname: Zwitter
authors.forename: Mirjana
authors.initials: M
authors.lastname: Rajer
authors.forename: Viljem
authors.initials: V
authors.lastname: Kovac
authors.forename: Izidor
authors.initials: I
authors.lastname: Kern
authors.forename: Martina
authors.initials: M
authors.lastname: Vrankar
authors.forename: Uros
authors.initials: U
authors.lastname: Smrdel
mesh_terms: D000230:Adenocarcinoma / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology*; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D001706:Biopsy; D003710:Demography; D018450:Disease Progression; D018572:Disease-Free Survival; D066246:ErbB Receptors / Q000235:genetics; D000069347:Erlotinib Hydrochloride; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009154:Mutation / Q000235:genetics; D009367:Neoplasm Staging; D011379:Prognosis; D011799:Quinazolines / Q000009:adverse effects / Q000627:therapeutic use*; D011859:Radiography; D011877:Radionuclide Imaging; D012907:Smoking; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; D000069347:Erlotinib Hydrochloride; D066246:ErbB Receptors