title: Identifying the target NSCLC patient for maintenance therapy: an analysis from a placebo-controlled, phase III trial of maintenance pemetrexed (H3E-MC-JMEN).
abstract: BACKGROUND
  This was a post hoc analysis of patients with non-squamous histology from a phase III maintenance pemetrexed study in advanced non-small cell lung cancer (NSCLC).
  
  
  METHODS
  The six symptom items' [average symptom burden index (ASBI)] mean at baseline was calculated using the lung cancer symptom scale (LCSS). Low and high symptom burden (LSB, ASBI < 25; HSB, ASBI ≥ 25) and performance status (PS: 0, 1) subgroups were analyzed for treatment effect on progression-free survival (PFS) and overall survival (OS) using the Cox proportional hazard models adjusted for demographic/clinical factors.
  
  
  RESULTS
  Significantly longer PFS and OS for pemetrexed versus placebo occurred in LSB patients [PFS: median 5.1 versus 2.4 months, hazard ratio (HR) 0.49, P < 0.0001; OS: median 17.5 versus 11.0 months, HR 0.63, P = 0.0012] and PS 0 patients (PFS: median 5.5 versus 1.7 months, HR 0.36, P < 0.0001; OS: median 17.7 versus 10.3 months, HR 0.54, P = 0.0019). Significantly longer PFS, but not OS, occurred in HSB patients (median 3.7 versus 2.8 months, HR 0.50, P = 0.0033) and PS 1 patients (median 4.4 versus 2.8 months, HR 0.60, P = 0.0002).
  
  
  CONCLUSIONS
  ASBI and PS are associated with survival for non-squamous NSCLC patients, suggesting that maintenance pemetrexed is useful for LSB or PS 0 patients following induction.
authors.affiliation: Eli Lilly and Company, Indianapolis, IN 46285, USA. obasaju_coleman_k@lilly.com
authors.forename: C
authors.initials: C
authors.lastname: Obasaju
authors.forename: L
authors.initials: L
authors.lastname: Bowman
authors.forename: P
authors.initials: P
authors.lastname: Wang
authors.forename: W
authors.initials: W
authors.lastname: Shen
authors.forename: K B
authors.initials: KB
authors.lastname: Winfree
authors.forename: E N
authors.initials: EN
authors.lastname: Smyth
authors.forename: M E
authors.initials: ME
authors.lastname: Boye
authors.forename: W
authors.initials: W
authors.lastname: John
authors.forename: T
authors.initials: T
authors.lastname: Brodowicz
authors.forename: C P
authors.initials: CP
authors.lastname: Belani
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis / Q000188:drug therapy*; D016503:Drug Delivery Systems / Q000379:methods*; D005260:Female; D005971:Glutamates / Q000008:administration & dosage*; D006147:Guanine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis / Q000188:drug therapy*; D060046:Maintenance Chemotherapy / Q000379:methods*; D008297:Male; D008875:Middle Aged; D000068437:Pemetrexed; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D005971:Glutamates; D000068437:Pemetrexed; D006147:Guanine
keywords: lung cancer symptom scale; maintenance therapy; non-squamous NSCLC; patient-reported symptoms; pemetrexed; survival
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