title: Body composition and survival in the early clinical trials setting.
abstract: OBJECTIVE
  Delineate the relationships between body composition parameters, 90-day mortality and overall survival, and correlate them with known prognostic factors in an early clinical trials clinic.
  
  
  METHODS
  We studied 306 consecutive patients with various tumours; body composition was analysed by computerised tomography images. Survival was measured from the first clinic visit, at 90-day period and until death/last follow-up visit.
  
  
  RESULTS
  Median patient age was 56 years; 159 patients were men. Ninety-day mortality rate was 12%. Median overall survival was 9 months. In multivariate analyses, high MD Anderson Cancer Center (MDACC) score (p < 0.0001) [lactate dehydrogenase (LDH) > normal, albumin < normal, Eastern Cooperative Oncology Group (ECOG) performance status > 1, metastatic sites > 2, gastrointestinal (GI) tumours], low skeletal muscle index (SMI) (p = 0.0406) and male gender (p = 0.0077) were independent predictors of poor survival. If Royal Marsden Hospital (RMH) score (LDH > normal, albumin<normal, metastatic sites > 2) was used in lieu of MDACC score, it was also significant (p = 0.0003). Including SMI and gender in the MDACC or RMH score improved the accuracy of the original model (p = 0.006 and p = 0.0037, respectively).
  
  
  CONCLUSIONS
  Patients with low SMI have shorter survival. Gender and SMI strengthens the accuracy of MDACC or RMH scores as prognostic tools. Prospective validation of these findings is warranted.
authors.affiliation: Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: hveasey@gmail.com.
authors.forename: H
authors.initials: H
authors.lastname: Veasey Rodrigues
authors.forename: V E
authors.initials: VE
authors.lastname: Baracos
authors.forename: J J
authors.initials: JJ
authors.lastname: Wheler
authors.forename: H A
authors.initials: HA
authors.lastname: Parsons
authors.forename: D S
authors.initials: DS
authors.lastname: Hong
authors.forename: A
authors.initials: A
authors.lastname: Naing
authors.forename: S
authors.initials: S
authors.lastname: Fu
authors.forename: G
authors.initials: G
authors.lastname: Falchoock
authors.forename: A M
authors.initials: AM
authors.lastname: Tsimberidou
authors.forename: S
authors.initials: S
authors.lastname: Piha-Paul
authors.forename: G
authors.initials: G
authors.lastname: Chisholm
authors.forename: R
authors.initials: R
authors.lastname: Kurzrock
mesh_terms: D001823:Body Composition; D017321:Clinical Trials, Phase I as Topic / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000401:mortality* / Q000473:pathology; D016019:Survival Analysis; D016896:Treatment Outcome
keywords: Body composition; Phase I clinical trial; Prognostic score; Sarcopenia