title: Survival of 1,181 patients in a phase I clinic: the MD Anderson Clinical Center for targeted therapy experience.
abstract: OBJECTIVE
  To determine whether the Royal Marsden Hospital (RMH; London, UK) prognostic score for phase I patients can be validated in a large group of individuals seen in a different center and whether other prognostic variables are also relevant, we present an analysis of 1,181 patients treated in the MD Anderson Cancer Center (MDACC; Houston, TX) phase I clinic.
  
  
  METHODS
  Medical records of 1,181 consecutive patients who were treated on at least one trial in the phase I clinic were reviewed.
  
  
  RESULTS
  The median age was 58 years and 50% were women. The median number of prior therapies was four and median survival 10 months [95% confidence interval (CI), 9.1-10.9 months]. Independent factors that predicted shorter survival in a multivariate Cox model and could be internally validated included RMH score of >1 (P < 0.0001; albumin <3.5 g/dL; lactate dehydrogenase >upper limit of normal, and >two sites of metastases), gastrointestinal tumor type (P < 0.0001), and Eastern Cooperative Oncology Group performance status ≥ 1 (P = 0.0004). The median survival was 24.0, 15.2, 8.4, 6.2, and 4.1 months for patients with 0, 1, 2, 3, and 4 or 5 of the above risk factors, respectively.
  
  
  CONCLUSIONS
  The RMH score was validated in a large group of patients at MDACC. Internal validation of the independent prognostic factors for survival led to the development of the MDACC prognostic score, a modification of the RMH score that strengthens it.
authors.affiliation: Department of Investigational Cancer Therapeutics, Phase I Clinical Trials Program, Biostatistics, and Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas 77030, USA. jjwheler@mdanderson.com
authors.forename: Jennifer
authors.initials: J
authors.lastname: Wheler
authors.forename: Apostolia M
authors.initials: AM
authors.lastname: Tsimberidou
authors.forename: David
authors.initials: D
authors.lastname: Hong
authors.forename: Aung
authors.initials: A
authors.lastname: Naing
authors.forename: Gerald
authors.initials: G
authors.lastname: Falchook
authors.forename: Sarina
authors.initials: S
authors.lastname: Piha-Paul
authors.forename: Siqing
authors.initials: S
authors.lastname: Fu
authors.forename: Stacy
authors.initials: S
authors.lastname: Moulder
authors.forename: Bettzy
authors.initials: B
authors.lastname: Stephen
authors.forename: Sijin
authors.initials: S
authors.lastname: Wen
authors.forename: Razelle
authors.initials: R
authors.lastname: Kurzrock
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D017321:Clinical Trials, Phase I as Topic / Q000379:methods*; D005260:Female; D005770:Gastrointestinal Neoplasms / Q000188:drug therapy; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D009362:Neoplasm Metastasis; D009369:Neoplasms / Q000188:drug therapy*; D011379:Prognosis; D012307:Risk Factors; D015996:Survival Rate; D016896:Treatment Outcome; D055815:Young Adult