Participation of patients with gynecological cancer in phase I clinical trials: Two years experience in a major cancer center

Objectives.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 ≤ 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 ≥ 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.