title: Participation of patients with gynecological cancer in phase I clinical trials: two years experience in a major cancer center.
abstract: OBJECTIVE
  This study aims at analyzing the clinico-demographic features that influence the recruitment of gynecological cancer (GC) patients to phase I trials. The possible clinical benefit to patients resulting from the participation in these trials has been also investigated.
  
  
  METHODS
  We performed a retrospective analysis of GC patients referred to the Phase I Unit of the Royal Marsden Hospital in Sutton (Surrey, UK), over 2 years.
  
  
  RESULTS
  Overall 68 GC patients were referred, and subsequently 32 (47.1%) enrolled. The percentage of patients enrolled increased as the distance to travel between the patient's residence and the hospital shortened (8.3% through 47.8% to 60.8%, for travel time >2, 1-2 or < or =1 h, respectively; p=0.008). Better performance status (PS) was found to be associated with higher enrollment rate with percentages increasing from 0 through 51.2 to 58.8 in cases with PS> or =2, PS=1, PS=0, respectively (p=0.015). Among the biochemical parameters, only hepatobiliary dysfunction was found to be associated with lower enrollment (p=0.012). Minimal response/disease stabilization was observed in 11 patients (34.4%). An increased median survival following the first visit was observed in patients enrolled compared to those not enrolled (8 versus 4 months, respectively, p=0.0055). In the multivariate analysis, only PS and enrollment in trials retained an independent prognostic role (p=0.031 and p=0.040, respectively).
  
  
  CONCLUSIONS
  This study, suggesting liver function and PS as important factors influencing the recruitment of GC patients to phase I trials could guide referral of patients to phase I Units. Moreover, the practical limitations imposed by long distance travel, together with the potential clinical benefit due to the participation to these trials, should encourage more investigators to develop phase I units in major cancer centers.
authors.affiliation: Gynecologic Oncology Unit, Catholic University of Campobasso, Italy; Gynecologic Oncology Unit, Catholic University of Rome, Italy. francescolegge@libero.it
authors.forename: F
authors.initials: F
authors.lastname: Legge
authors.forename: D
authors.initials: D
authors.lastname: Eaton
authors.forename: R
authors.initials: R
authors.lastname: Molife
authors.forename: G
authors.initials: G
authors.lastname: Ferrandina
authors.forename: I
authors.initials: I
authors.lastname: Judson
authors.forename: J
authors.initials: J
authors.lastname: de Bono
authors.forename: S
authors.initials: S
authors.lastname: Kaye
mesh_terms: D000328:Adult; D000368:Aged; D017321:Clinical Trials, Phase I as Topic / Q000379:methods*; D005260:Female; D005833:Genital Neoplasms, Female / Q000188:drug therapy*; D006801:Humans; D008875:Middle Aged; D015999:Multivariate Analysis; D010349:Patient Compliance; D018579:Patient Selection; D035842:Research Subjects; D012189:Retrospective Studies