Validation of the royal marsden hospital prognostic score in patients treated in the phase I clinical trials program at the MD Anderson Cancer Center

Abstract

The authors validated the Royal Marsden Hospital (RMH) prognostic score in patients with advanced lung, pancreatic, and head and neck cancers who were enrolled on phase 1 trials in the MD Anderson Cancer Center Phase I Clinical Trials Program. The RMH score uses albumin (≥3.5 g/dL vs <3.5 g/dL), lactate dehydrogenase (less than or equal to the upper limit of normal [≤ULN] vs >ULN), and the number of metastatic sites (≤2 sites vs ≥3 sites) to predict patient survival in phase 1 trials. The authors of this report retrospectively reviewed the outcomes of 229 consecutive patients with lung, pancreatic, and head and neck tumors who were treated on 57 phase 1 trials. Two hundred twenty-nine consecutive patients with lung cancer (N = 85), pancreatic cancer (N = 83), and head and neck tumors (N = 61) were treated. The median patient age was 60 years (range, 26-85 years), and 63% of the patients were men. Patients with a good RMH prognostic score (0-1) at baseline had a longer median survival than patients with a poor prognostic score (2-3; 33.9 weeks vs 21.1 weeks; P < .0001). The RMH score was an independent variable that predicted survival in multivariate analysis. Other independent variables that predicted better survival were hemoglobin level (≥10.5 g/dL), Eastern Cooperative Oncology Group performance status (0-1), and tumor type. Patients who were treated on first-in-human trials did not fare worse compared with those who were not treated on first-in-human trials. For patients with lung, pancreatic, and head and neck tumors who were treated on phase 1 trials, survival was predicted accurately by the RMH prognostic score.