title: Pemetrexed therapy in elderly patients with good performance status: analysis of two phase III trials of patients with nonsquamous non-small-cell lung cancer.
abstract: BACKGROUND
  A widely held misperception contends that all elderly patients, even those with good performance status (PS 0-1), are unable to tolerate aggressive chemotherapy. The objective of these analyses was to evaluate the survival and safety of treatment with pemetrexed in elderly patients with nonsquamous non-small-cell lung cancer (NSCLC) and PS 0-1.
  
  
  METHODS
  Two randomized studies, 1 reporting the activity of pemetrexed in combination with cisplatin vs. cisplatin and gemcitabine in chemotherapy-naive patients (N = 1725) and another comparing single-agent pemetrexed with placebo in the maintenance setting (N = 663) were retrospectively considered. Data from patients with nonsquamous advanced NSCLC with PS 0-1 in these studies were evaluated in 2 separate dichotomous analyses (< 65 years and ≥ 65 years and < 70 years and ≥ 70). Cox proportional hazard models were used to estimate covariate-adjusted between-arm hazard ratios (HRs) with 95% confidence intervals for each age group.
  
  
  RESULTS
  In the first-line study, 32.7% of the 1252 patients with nonsquamous NSCLC were ≥ 65 years and 12.8% were ≥ 70 years old. In the maintenance study, 33.1% of the 481 patients with nonsquamous NSCLC were ≥ 65 years and 16.0% were ≥ 70 years old. In both studies, the adjusted HRs for overall survival (range, 0.62-0.89) favored pemetrexed and were similar between the older and younger age groups. Dose intensity delivered and toxicities observed for patients treated with pemetrexed were manageable and similar between the older and younger age groups.
  
  
  CONCLUSIONS
  For elderly patients with nonsquamous advanced NSCLC and PS 0-1, pemetrexed therapy, with its favorable toxicity profile, is a viable option, either in combination with cisplatin in the first-line setting or as maintenance therapy after initial chemotherapy.
authors.affiliation: Division of Medical Oncology, S.G. Moscati Hospital, Avellino, Italy. cgridelli@libero.it
authors.forename: Cesare
authors.initials: C
authors.lastname: Gridelli
authors.forename: Thomas
authors.initials: T
authors.lastname: Brodowicz
authors.forename: Corey J
authors.initials: CJ
authors.lastname: Langer
authors.forename: Patrick
authors.initials: P
authors.lastname: Peterson
authors.forename: Mominul
authors.initials: M
authors.lastname: Islam
authors.forename: Susan C
authors.initials: SC
authors.lastname: Guba
authors.forename: Patti
authors.initials: P
authors.lastname: Moore
authors.forename: Carla M
authors.initials: CM
authors.lastname: Visseren-Grul
authors.forename: Giorgio
authors.initials: G
authors.lastname: Scagliotti
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D005971:Glutamates / Q000008:administration & dosage; D006147:Guanine / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D000068437:Pemetrexed; D011379:Prognosis; D012189:Retrospective Studies; D015996:Survival Rate
chemical_list: D005971:Glutamates; D000068437:Pemetrexed; D006147:Guanine; D002945:Cisplatin