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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/m 2  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/m 2  and 34% of those with BMI≥25 kg/m 2 . 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/m 2 ; sarcopenic), 271 (99–443) (BMI<25 kg/m 2 ; non-sarcopenic), 484 (286–681) (BMI≥25 kg/m 2 ; sarcopenic); 501 d (309–693) (BMI≥25 kg/m 2 ; 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/m 2 , independent of symptom burden. Body composition variables were predictive of clinically relevant survival differences, which is potentially important in developing Phase I studies.

Body Composition, Symptoms, and Survival in Advanced Cancer Patients Referred to a Phase I Service