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Abstract
Highlights
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- Patients enrolled on phase I clinical trials fare at least as well as they do on phase II trials.
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- Repeated anti-angiogenic exposure on phase I clinical trials does not alter 6 month PFS.
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- Tissue specific targeted agents do not perform better than non-tissue specific agents.
Abstract
Objectives
Previous
reviews of phase I clinical trials report limited response rates.
Development of novel biologic agents and trials designs have increased
these rates. A contemporary appraisal of phase I clinical trials in
gynecologic malignancies could help validate these findings.
Methods
Retrospectively
reviewed records for 410 patients with gynecologic malignancies treated
in a phase I unit, January 1999 to October 2012. Patient
characteristics and treatment outcomes were abstracted and analyzed.
Results
Patients
enrolled in 43 different phase I trials, 17 phase Ia, 17 phase Ib dose
escalation and 9 dose expansion. 9 trials (21%) investigated unique
cytotoxic delivery methods, 15 (35%) conventional cytotoxic plus novel
agents and 19 (44%) novel agents alone. For patients treated in the
first-line setting, 90 (74.4%) achieved CR, 20 (16.5%) PR, 9 (7.4%) SD
and 2 (1.7%) PD, yielding overall response rate 90.9%. In patients
treated for recurrent disease, 2 (1.6%) achieved CR, 11 (8.9%) PR, 57
(46.0%) SD and 54 (43.5%) PD, yielding response rate 11% and overall
clinical benefit rate 57%. Response rate for molecular targeted
therapies was 11.5% with overall clinical benefit rate 46.2%. Patients
with prior anti-angiogenic exposure had comparable median PFS to those
who had not been previously exposed (3.5 vs. 4.0 months, p = 0.29).
Conclusions
Results
support referral of gynecologic cancer patients for phase I clinical
trials. Patients with advanced, heavily pretreated disease fare at least
as well as they do on phase II trials and a proportion of them can
attain an objective response or stabilization of their disease.
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