title: Serum albumin is a strong predictor of survival in patients with advanced-stage non-small cell lung cancer treated with erlotinib.
abstract: Molecular targeted therapy based on tyrosine kinase inhibitors (TKI), directed at epidermal growth factor receptor (EGFR) is one of the novel effective agents in management of advanced-stage of Non Small Cell Lung cancer (NSCLC). However several candidate predictors have been extensively studied, apart from activating EGFR gene mutations, no reliable biochemical or molecular predictors of response to erlotinib have been validated. The aim of our retrospective study was to evaluate the association of baseline serum albumin with outcomes in a large cohort of patients with advanced-stage NSCLC treated with erlotinib. Clinical data of 457 patients with locally-advanced (III B) or metastatic stage (IV) NSCLC treated with erlotinib were analysed. Serum samples were collected and the measurement was performed one day before the initiation of erlotinib treatment. Before the treatment initiation, low albumin was (<35 g/l) measured in 37 (8.1%) patients and normal albumin (≥ 35 g/l) was measured in 420 (91.9%). The median PFS and OS for patients with low serum albumin was 0.9 and 1.9 months compared to 1.9 and 11.4 months for patients with normal serum albumin (p=0.001 and p<0.001). The multivariate Cox proportional hazards model revealed that EGFR mutation status (HR=2.50; CI: 1.59-3.92; p<0.001) and pretreatment serum albumin (HR=1.73; CI: 1.21-2.47; p=0.003) were significant independent predictive factors for PFS, whereas EGFR mutation status (HR=3.14; CI: 1.70-5.81; p<0.001), stage (HR=1.48; CI: 1.09-2.02; p=0.013), ECOG PS (HR=1.77; CI: 1.37-2.29; p<0.001) and pretreatment serum albumin (HR=4.60; CI: 2.98-7.10; p<0.001) were significant independent predictive factors for OS. In conclusion, the results of present retrospective study indicate that pretreatment hypoalbuminemia is associated with poor outcome of NSCLC patients treated with erlotinib. Based on these results, measuement of serum albumin is an objective laboratory method feasible for estimation of prognosis of patients with advanced-stage NSCLC.
authors.forename: O
authors.initials: O
authors.lastname: Fiala
authors.forename: M
authors.initials: M
authors.lastname: Pesek
authors.forename: J
authors.initials: J
authors.lastname: Finek
authors.forename: J
authors.initials: J
authors.lastname: Racek
authors.forename: M
authors.initials: M
authors.lastname: Minarik
authors.forename: L
authors.initials: L
authors.lastname: Benesova
authors.forename: Z
authors.initials: Z
authors.lastname: Bortlicek
authors.forename: O
authors.initials: O
authors.lastname: Sorejs
authors.forename: R
authors.initials: R
authors.lastname: Kucera
authors.forename: O
authors.initials: O
authors.lastname: Topolcan
mesh_terms: D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000097:blood* / Q000188:drug therapy* / Q000473:pathology; D015331:Cohort Studies; D066246:ErbB Receptors / Q000037:antagonists & inhibitors; D000069347:Erlotinib Hydrochloride / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D034141:Hypoalbuminemia / Q000097:blood; D008175:Lung Neoplasms / Q000097:blood* / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D009367:Neoplasm Staging; D011237:Predictive Value of Tests; D000077982:Progression-Free Survival; D016016:Proportional Hazards Models; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use; D012189:Retrospective Studies; D012709:Serum Albumin / Q000378:metabolism*; D016896:Treatment Outcome
chemical_list: D047428:Protein Kinase Inhibitors; D012709:Serum Albumin; D000069347:Erlotinib Hydrochloride; C512478:EGFR protein, human; D066246:ErbB Receptors
keywords: EGFR-TKI; NSCLC; albumin; biomarker.; erlotinib; lung cancer; prediction