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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

International Journal of Gynecological Cancer: November 2011 - Volume 21 - Issue 8 - pp 1446-1451
doi: 10.1097/IGC.0b013e31822d754e
Uterine Cancer

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.

Division of Gynecologic Oncology, Catholic University of the Sacred Heart, Rome, Italy.

Received March 31, 2011, and in revised form June 28, 2011.

Accepted for publication July 12, 2011.

Address correspondence and reprint requests to Domenica Lorusso, MD, Department of Gynecologic Oncology, Catholic University of the Sacred Heart, Largo Agostino Gemelli 8, IT-00168 Rome, Italy. E-mail:

The authors have no conflicts of interest to declare.

Copyright © 2011 by IGCS and ESGO