title: Prospective validation of a prognostic score to improve patient selection for oncology phase I trials.
abstract: OBJECTIVE
  With the aim of improving patient selection for phase I trials, we previously performed a retrospective analysis of 212 phase I oncology patients where we were able to develop a prognostic score predicting overall survival (OS). This prospective study was performed to test the validity of the prognostic score.
  
  
  METHODS
  On the basis of our retrospective multivariate analysis, three factors were associated with poor survival (albumin < 35 g/L, lactate dehydrogenase [LDH] > upper limit of normal [ULN], and > two sites of metastases). We integrated these into a prognostic score ranging from 0 to 3 and analyzed this score in a prospectively selected cohort of 78 patients enrolled onto phase I trials.
  
  
  RESULTS
  All patients had progressive disease before study entry. The median age was 56 years (range, 18 to 79 years). After a median follow-up time of 27.3 weeks, patients with a prognostic score of 0 to 1 (n = 43) had superior OS (33.0 weeks; 95% CI, 24 to 42 weeks) compared with patients with a score of 2 to 3 (n = 35; 15.7 weeks; 95% CI, 11 to 21 weeks). Our multivariate analysis confirmed that our prognostic score was an independent marker for OS, with a hazard ratio of 1.4 (95% CI, 1.02 to 1.9; P = .036).
  
  
  CONCLUSIONS
  This is the first prospective analysis confirming that a prognostic score based on objective markers, including albumin less than 35 g/L, LDH more than ULN, and more than two sites of metastasis, is a helpful tool in the process of patient selection for phase I trial entry.
authors.affiliation: Royal Marsden Hospital and Institute of Cancer Research, Drug Development Unit, Sutton, UK.
authors.forename: Hendrik-Tobias
authors.initials: HT
authors.lastname: Arkenau
authors.forename: Jorge
authors.initials: J
authors.lastname: Barriuso
authors.forename: David
authors.initials: D
authors.lastname: Olmos
authors.forename: Joo Ern
authors.initials: JE
authors.lastname: Ang
authors.forename: Johann
authors.initials: J
authors.lastname: de Bono
authors.forename: Ian
authors.initials: I
authors.lastname: Judson
authors.forename: Stan
authors.initials: S
authors.lastname: Kaye