Body composition and survival in the early clinical trials setting

Abstract

Purpose: 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.

Patients and 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).

Conclusion: 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.

Keywords: Body composition; Phase I clinical trial; Prognostic score; Sarcopenia.