title: Body composition, symptoms, and survival in advanced cancer patients referred to a phase I service.
abstract: BACKGROUND
  Body weight and body composition are relevant to the outcomes of cancer and antineoplastic therapy. However, their role in Phase I clinical trial patients is unknown.
  
  
  METHODS
  We reviewed symptom burden, body composition, and survival in 104 patients with advanced cancer referred to a Phase I oncology service. Symptom burden was analyzed using the MD Anderson Symptom Assessment Inventory(MDASI); body composition was evaluated utilizing computerized tomography(CT) images. A body mass index (BMI)≥25 kg/m² was considered overweight. Sarcopenia, severe muscle depletion, was assessed using CT-based criteria.
  
  
  RESULTS
  Most patients were overweight (n = 65, 63%); 53 patients were sarcopenic (51%), including 79% of patients with a BMI<25 kg/m² and 34% of those with BMI≥25 kg/m². Sarcopenic patients were older and less frequently African-American. Symptom burden did not differ among patients classified according to BMI and presence of sarcopenia. Median (95% confidence interval) survival (days) varied according to body composition: 215 (71-358) (BMI<25 kg/m²; sarcopenic), 271 (99-443) (BMI<25 kg/m²; non-sarcopenic), 484 (286-681) (BMI≥25 kg/m²; sarcopenic); 501 d (309-693) (BMI≥25 kg/m²; non-sarcopenic). Higher muscle index and gastrointestinal cancer diagnosis predicted longer survival in multivariate analysis after controlling for age, gender, performance status, and fat index.
  
  
  CONCLUSIONS
  Patients referred to a Phase I clinic had a high frequency of sarcopenia and a BMI≥25 kg/m², independent of symptom burden. Body composition variables were predictive of clinically relevant survival differences, which is potentially important in developing Phase I studies.
authors.affiliation: Department of Investigational Cancer Therapeutics (A Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.
authors.forename: Henrique A
authors.initials: HA
authors.lastname: Parsons
authors.forename: Vickie E
authors.initials: VE
authors.lastname: Baracos
authors.forename: Navjot
authors.initials: N
authors.lastname: Dhillon
authors.forename: David S
authors.initials: DS
authors.lastname: Hong
authors.forename: Razelle
authors.initials: R
authors.lastname: Kurzrock
mesh_terms: D001823:Body Composition; D017321:Clinical Trials, Phase I as Topic / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009367:Neoplasm Staging; D009369:Neoplasms / Q000473:pathology* / Q000503:physiopathology*; D012017:Referral and Consultation; D016019:Survival Analysis