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Gynecol Oncol. 2007 Mar;104(3):551-6. Epub 2006 Oct 24.

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

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  • 1Gynecologic Oncology Unit, Catholic University of Campobasso, Italy; Gynecologic Oncology Unit, Catholic University of Rome, Italy. francescolegge@libero.it



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.


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.


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).


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.

[PubMed - indexed for MEDLINE]
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