title: A new, simple and objective prognostic score for phase I cancer patients.
abstract: OBJECTIVE
  To ensure safety and optimise efficacy, careful patient selection for participation in oncologic phase I trials is warranted. Therefore, we did a validation study on existing phase I prognostic scores, and subsequently aimed to make an even more simple prognostic score.
  
  
  METHODS
  We retrospectively analysed characteristics and clinical outcome of 122 patients who participated in eight different phase I studies in our centre. A literature search was performed for existing prognostic scores which were validated in our dataset. Additionally, a simple prognostic score able to predict overall survival (OS), progression free survival (PFS), 90-d mortality and duration of participation was developed.
  
  
  RESULTS
  In our population the median OS was 31 (range 4-241) weeks, median PFS was 10 (range 3-119) weeks. Thirteen patients (11%) died within 90-d and median participation duration was 11 (range 1-119) weeks. Two out of five existing prognostic scores could be validated in this dataset for OS. Based on multivariate analyses a new, objective and simple score, consisting of LDH, sodium and haemoglobin, was tested. High score (2-3 points) compared to low score (0-1) significantly predicted OS (HR 1.878, p = 0.003), PFS (HR 1.156, p = 0.038), participation duration (HR 1.858, p = 0.004) and 90-d mortality (OR 4.200, p = 0.022).
  
  
  CONCLUSIONS
  We propose a new prognostic model, using LDH, sodium and haemoglobin, helpful to predict OS, PFS, participation duration and 90-d mortality. Larger multicentre studies are needed to validate this score.
authors.affiliation: Department of Medical Oncology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.
authors.forename: L M
authors.initials: LM
authors.lastname: Füssenich
authors.forename: I M E
authors.initials: IM
authors.lastname: Desar
authors.forename: M E W J
authors.initials: ME
authors.lastname: Peters
authors.forename: S
authors.initials: S
authors.lastname: Teerenstra
authors.forename: W T A
authors.initials: WT
authors.lastname: van der Graaf
authors.forename: J N H
authors.initials: JN
authors.lastname: Timmer-Bonte
authors.forename: C M L
authors.initials: CM
authors.lastname: van Herpen
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017321:Clinical Trials, Phase I as Topic / Q000379:methods*; D018572:Disease-Free Survival; D005260:Female; D006454:Hemoglobins / Q000096:biosynthesis; D006801:Humans; D008297:Male; D008495:Medical Oncology / Q000379:methods / Q000592:standards*; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D015999:Multivariate Analysis; D011379:Prognosis; D012189:Retrospective Studies; D012964:Sodium / Q000097:blood; D016896:Treatment Outcome
chemical_list: D006454:Hemoglobins; D012964:Sodium