title: 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: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, Texas 77030, USA. igarrid1@gmail.com
authors.forename: Ignacio
authors.initials: I
authors.lastname: Garrido-Laguna
authors.forename: Filip
authors.initials: F
authors.lastname: Janku
authors.forename: Christos
authors.initials: C
authors.lastname: Vaklavas
authors.forename: Gerald S
authors.initials: GS
authors.lastname: Falchook
authors.forename: Siqing
authors.initials: S
authors.lastname: Fu
authors.forename: David S
authors.initials: DS
authors.lastname: Hong
authors.forename: Aung
authors.initials: A
authors.lastname: Naing
authors.forename: Apostolia M
authors.initials: AM
authors.lastname: Tsimberidou
authors.forename: Sijin
authors.initials: S
authors.lastname: Wen
authors.forename: Razelle
authors.initials: R
authors.lastname: Kurzrock
mesh_terms: D000230:Adenocarcinoma / Q000175:diagnosis / Q000401:mortality / Q000473:pathology / Q000628:therapy; D000077192:Adenocarcinoma of Lung; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002173:Cancer Care Facilities; D002277:Carcinoma / Q000175:diagnosis / Q000401:mortality / Q000473:pathology / Q000628:therapy; D002294:Carcinoma, Squamous Cell / Q000175:diagnosis* / Q000401:mortality / Q000473:pathology* / Q000628:therapy; D017321:Clinical Trials, Phase I as Topic / Q000379:methods; D005260:Female; D006258:Head and Neck Neoplasms / Q000175:diagnosis* / Q000401:mortality / Q000473:pathology* / Q000628:therapy; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis / Q000401:mortality / Q000473:pathology / Q000628:therapy; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010190:Pancreatic Neoplasms / Q000175:diagnosis / Q000401:mortality / Q000473:pathology / Q000628:therapy; D011379:Prognosis; D012107:Research Design; D012189:Retrospective Studies; D000077195:Squamous Cell Carcinoma of Head and Neck; D013781:Texas; D016896:Treatment Outcome