title: Prospective observational comparison of clinical outcomes between african-american and caucasian patients receiving second-line treatment with pemetrexed for advanced non-small-cell lung cancer.
abstract: BACKGROUND
  This prospective observational study evaluated the effect of race on disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) in patients with NSCLC treated with second-line pemetrexed.
  
  
  METHODS
  Eligibility criteria included stage IIIB or IV NSCLC patients receiving single-agent pemetrexed for second-line therapy in routine clinical practice. Noninferiority was evaluated using logistic regression analysis of DCR, controlling for predefined covariates. Noninferiority was considered if the upper 95% confidence bound on the adjusted odds ratio (OR) for Caucasian vs. African-American individuals was less than 1.78, corresponding to a difference in proportion of 14% assuming Caucasian individuals to have a DCR of approximately 50%. The bound was chosen to be half of the anticipated difference between treatment and no second-line treatment. PFS and OS were estimated using the Kaplan-Meier method. Tools were used to measure functional status and symptom burden.
  
  
  RESULTS
  The unadjusted DCR was 43.7% (117/268) for Caucasian and 45.0% (27/60) for African-American individuals (unadjusted OR, 0.95; 95% confidence interval [CI], 0.54-1.66). The adjusted OR in the final logistic regression model was 0.82 (95% CI, 0.43-1.58). This upper 95% confidence bound was within the prespecified acceptable bound of 1.78. Median PFS times (months) were 2.7 (95% CI, 2.4-3.4) for Caucasian and 3.0 (95% CI, 2.3-4.7) for African-American individuals (P = .91). Median OS times (months) were 6.7 (95% CI, 5.7-7.9) for Caucasian and 6.9 (95% CI, 4.5-8.9) for African-American individuals (P = .92). Baseline and functional status after baseline assessment and mean symptom burden did not differ substantially among races.
  
  
  CONCLUSIONS
  African-American race was not considered to be a significant predictor of disease control after second-line treatment with pemetrexed.
authors.affiliation: Lilly USA, LLC, Indianapolis, IN. Electronic address: pennella_eduardo@lilly.com.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Pennella
authors.forename: Coleman K
authors.initials: CK
authors.lastname: Obasaju
authors.forename: Gerhardt
authors.initials: G
authors.lastname: Pohl
authors.forename: Gerson
authors.initials: G
authors.lastname: Peltz
authors.forename: Allicia C
authors.initials: AC
authors.lastname: Girvan
authors.forename: Katherine B
authors.initials: KB
authors.lastname: Winfree
authors.forename: Betzaida
authors.initials: B
authors.lastname: Martinez
authors.forename: Martin
authors.initials: M
authors.lastname: Marciniak
authors.forename: Mark S
authors.initials: MS
authors.lastname: Walker
authors.forename: Edward
authors.initials: E
authors.lastname: Stepanski
authors.forename: Lee S
authors.initials: LS
authors.lastname: Schwartzberg
authors.forename: Alex
authors.initials: A
authors.lastname: Adjei
mesh_terms: D000328:Adult; D001741:Black or African American; D000368:Aged; D000369:Aged, 80 and over; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000208:ethnology* / Q000401:mortality; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D005971:Glutamates / Q000008:administration & dosage*; D006147:Guanine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000208:ethnology* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D000068437:Pemetrexed; D011446:Prospective Studies; D016896:Treatment Outcome; D044465:White People
chemical_list: D005971:Glutamates; D000068437:Pemetrexed; D006147:Guanine
keywords: Ethnicity; Nonsquamous NSCLC; Observational study; Pemetrexed; Symptoms