Skip Navigation LinksHome > November 2011 - Volume 21 - Issue 8 > Phase 2 Trial of Nonpegylated Doxorubicin (Myocet) as Second...
International Journal of Gynecological Cancer:
doi: 10.1097/IGC.0b013e31822d754e
Uterine Cancer

Phase 2 Trial of Nonpegylated Doxorubicin (Myocet) as Second-Line Treatment in Advanced or Recurrent Endometrial Cancer

Di Legge, Alessia MD; Trivellizzi, Ilaria Nausica MD; Moruzzi, Maria Cristina MD; Pesce, Adele MD; Scambia, Giovanni MD; Lorusso, Domenica MD

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Abstract

Background: Advanced or recurrent endometrial cancer is associated with a poor prognosis, and results obtained with systemic therapy are far from being impressive. Myocet is an interesting formulation of citrate conjugated doxorubicin encapsulated in nonpegylated liposomes. This phase 2 study was designed to evaluate the objective response rate and the toxicity profile of Myocet in women with advanced or recurrent endometrial cancer.

Methods: Patients with diagnosis of advanced or recurrent endometrial cancer failing 1 previous carboplatin-paclitaxel chemotherapy were enrolled. Myocet was administered at the dose of 60 mg/m2 intravenously on day 1 every 4 weeks.

Results: Eighteen patients were enrolled in our institution from September 2007 to January 2010. No complete or partial response was observed. Stable disease was registered in 5 patients (27.5%). Median time to progression was 9 weeks. Median time to death was 24 weeks. Grade 3/4 anemia was reported in 2 patients (11%). Grade 3/4 neutropenia was observed in 16.5% and 44% of patients, respectively. The major nonhematologic toxicities (grades 3/4) were fatigue (22%), nausea, and vomiting (5.5%).

Conclusions: Myocet presents no activity, and only few stabilizations of disease of limited duration in this recurrent endometrial carcinoma population previously treated with platinum-taxane chemotherapy are reported.

Copyright © 2011 by IGCS and ESGO

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