title: Expectations of serious adverse events at the end of life of patients with acute myeloid leukemia who receive salvage therapy.
abstract: BACKGROUND
  Patients with AML and refractory disease receive investigational therapies within 2 months of their death. The attribution of serious AEs in this phase to disease progression vs. drug toxicity is tenuous. We aimed to determine the incidence of serious AEs in the last 2 weeks of life of patients with refractory-relapsed AML undergoing salvage therapy (ST).
  
  
  METHODS
  Adults who received ST from September 2010 to December 2011 were evaluated. Data collected included incidence of serious AEs, type of ST, medical complications, length of hospital stay, and Intensive Care Unit stays, organ dysfunctions, and use of life support therapies.
  
  
  RESULTS
  A total of 122 patients received ST. Most 64 patients (52%) received intensive chemotherapy; 39 patients (32%) had single investigational drug therapies, and 19 patients (16%) received therapy with hypomethylating agents. Common complications were pneumonia (82%), disseminated intravascular coagulopathy 72 patients (59%), and septic shock 60 patients (49%). Notable complications included: acute respiratory failure justifying invasive mechanical ventilation in 60 patients (42%), renal failure requiring dialysis in 33 patients (27%), atrial fibrillation in 37 patients (30%), and prolonged prothrombin time (grade 3) in 68 patients (56%). There was no difference in the incidence of these complications by type of ST.
  
  
  CONCLUSIONS
  Baseline expectations of serious AEs at the end of life of patients with AML undergoing ST were established. The AE profiles of new investigational interventions or therapies could be compared with what would be expected in such circumstances from the combined effect of disease progression, expected complications of the AML therapy, and therapies delivered in previous historical contexts.
authors.affiliation: Department of Leukemia, The University of Texas M.D. Anderson Cancer Center, Houston, TX. Electronic address: mcardena@mdanderson.org.
authors.forename: Marylou
authors.initials: M
authors.lastname: Cardenas-Turanzas
authors.forename: Farhad
authors.initials: F
authors.lastname: Ravandi-Kashani
authors.forename: Jorge E
authors.initials: JE
authors.lastname: Cortes
authors.forename: Elias
authors.initials: E
authors.lastname: Jabbour
authors.forename: Stefan
authors.initials: S
authors.lastname: Faderl
authors.forename: Sherry A
authors.initials: SA
authors.lastname: Pierce
authors.forename: Hagop
authors.initials: H
authors.lastname: Kantarjian
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D016879:Salvage Therapy / Q000009:adverse effects*; D012720:Severity of Illness Index; D013727:Terminal Care; D019452:Terminally Ill; D055815:Young Adult
keywords: Adverse effects; Cancer chemotherapy agents; Drug toxicities; Leukemias; Terminally ill