title: Impact of pretreatment factors on adverse events: a pooled analysis of North Central Cancer Treatment Group advanced stage non-small cell lung cancer trials.
abstract: BACKGROUND
  This pooled analysis was performed to examine the impact of pretreatment factors on severe (grade 3 or higher) adverse events (AE) in patients with advanced stage non-small cell lung cancer (NSCLC).
  
  
  METHODS
  A pooled data set of 1053 participants from nine North Central Cancer Treatment Group clinical trials was used. Age, gender, performance status, tumor stage, body mass index, serum creatinine levels, hemoglobin levels, white blood cell counts, and platelet counts were evaluated univariately and multivariately using logistic regression. The magnitude of the effects of the pretreatment factors after adjusting for type of chemotherapy agent (platinum versus no platinum) was explored in the final multivariate model.
  
  
  RESULTS
  Women and older participants had a significantly greater risk for experiencing severe hematologic and non-hematologic AE. Participants with performance status >0 had an increased risk for severe non-hematologic AE. For every one unit (10/L) increase in pretreatment white blood cell count, there was an 11% reduction in the odds of experiencing a severe hematologic AE. The magnitude of these effects on the end points remained similar after adjusting for type of chemotherapy agent.
  
  
  CONCLUSIONS
  Pretreatment factors of gender, age, performance status, and hematologic parameters were significant predictors of severe AE among patients with advanced stage NSCLC. This suggests the need to control or adjust for factors that predispose patients to an increased risk of severe AE. These findings can aid in tailoring therapy to individual patients and in the proper design of future clinical trials.
authors.affiliation: Mayo Clinic and Mayo Foundation, Rochester, Minnesota 55905, USA. mandrekar.sumithra@mayo.edu
authors.forename: Sumithra J
authors.initials: SJ
authors.lastname: Mandrekar
authors.forename: Donald W
authors.initials: DW
authors.lastname: Northfelt
authors.forename: Steven E
authors.initials: SE
authors.lastname: Schild
authors.forename: Nathan R
authors.initials: NR
authors.lastname: Foster
authors.forename: Brian
authors.initials: B
authors.lastname: Bot
authors.forename: Randolph S
authors.initials: RS
authors.lastname: Marks
authors.forename: James A
authors.initials: JA
authors.lastname: Mailliard
authors.forename: James E
authors.initials: JE
authors.lastname: Krook
authors.forename: Andrew W
authors.initials: AW
authors.lastname: Maksymiuk
authors.forename: Alex A
authors.initials: AA
authors.lastname: Adjei
authors.forename: James R
authors.initials: JR
authors.lastname: Jett
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D002986:Clinical Trials as Topic; D015897:Comorbidity; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D006801:Humans; D016015:Logistic Models; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D008297:Male; D008350:Manitoba; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D015999:Multivariate Analysis; D009367:Neoplasm Staging; D011237:Predictive Value of Tests; D011379:Prognosis; D012042:Registries; D018570:Risk Assessment; D012737:Sex Factors; D016019:Survival Analysis