title: Impact of hemoglobin levels on outcomes of adjuvant chemotherapy in resected non-small cell lung cancer: the JBR.10 trial experience.
abstract: BACKGROUND
  Cisplatin-induced anemia may correlate with adverse events, poor quality of life (QoL), decreased adjuvant chemotherapy (ACT) dose intensity, shorter relapse-free survival (RFS) or overall survival (OS).
  
  
  METHODS
  The JBR.10 trial demonstrated significantly longer survival with adjuvant cisplatin and vinorelbine (n=242) compared to observation (n=240) in patients with resected NSCLC [Winton T, Livingston R, Johnson D, Rigas J, Johnston M, Butts C, et al. Vinorelbine plus cisplatin vs. observation in resected non-small-cell lung cancer. N Engl J Med 2005;352(25):2640-2]. This exploratory analysis evaluates the predictive value of baseline (in all patients) and during-treatment (in ACT arm only) hemoglobin (Hb) levels on OS and RFS when adjusted for prognostic factors. Baseline (in all patients) and during treatment (in ACT arm only) Hb levels were also correlated with adverse events, QoL, morbidity and ACT dose intensity.
  
  
  RESULTS
  Baseline Hb did not predict RFS or OS. However, there was a trend to shorter OS (p=0.1) when baseline Hb was <120g/L. Lower baseline Hb predicted increased hospitalization (p=0.04) and worse QoL (SOB item, p=0.03) but had no impact on adverse events or dose intensity. There was a trend to longer RFS (p=0.08) in patients with lower nadir during-treatment Hb and to longer OS (p=0.06) and RFS (p=0.08) in patients with maximum during-treatment Hb drop >30% that was not maintained when ACT dose intensity was included in the model. Maximum during-treatment Hb drop >30% correlated with increased lethargy (p=0.003) and worse QoL (fatigue item, p=0.07).
  
  
  CONCLUSIONS
  Lower baseline and during-treatment Hb levels seem associated with poorer QoL, fatigue and increased hospitalization. There is a trend for shorter OS in patients with lower baseline Hb levels.
authors.affiliation: National Cancer Institute of Canada Clinical Trials Group, Kingston, Ont., Canada. igauthier@ottawahospital.on.ca <igauthier@ottawahospital.on.ca>
authors.forename: I
authors.initials: I
authors.lastname: Gauthier
authors.forename: K
authors.initials: K
authors.lastname: Ding
authors.forename: T
authors.initials: T
authors.lastname: Winton
authors.forename: F A
authors.initials: FA
authors.lastname: Shepherd
authors.forename: R
authors.initials: R
authors.lastname: Livingston
authors.forename: D H
authors.initials: DH
authors.lastname: Johnson
authors.forename: J R
authors.initials: JR
authors.lastname: Rigas
authors.forename: M
authors.initials: M
authors.lastname: Whitehead
authors.forename: B
authors.initials: B
authors.lastname: Graham
authors.forename: L
authors.initials: L
authors.lastname: Seymour
mesh_terms: D000740:Anemia / Q000139:chemically induced; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000097:blood / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006454:Hemoglobins / Q000032:analysis* / Q000187:drug effects; D006801:Humans; D008175:Lung Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology; D011379:Prognosis; D016016:Proportional Hazards Models; D016019:Survival Analysis; D014747:Vinblastine / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D000970:Antineoplastic Agents; D006454:Hemoglobins; D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine