Phase 2 trial of nonpegylated doxorubicin (Myocet) as second-line treatment in advanced or recurrent endometrial cancer

Int J Gynecol Cancer. 2011 Nov;21(8):1446-51. doi: 10.1097/IGC.0b013e31822d754e.

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/m 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.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Aged
  • Aged, 80 and over
  • Antibiotics, Antineoplastic / therapeutic use*
  • Antibiotics, Antineoplastic / toxicity
  • Carcinoma / drug therapy*
  • Doxorubicin / therapeutic use*
  • Doxorubicin / toxicity
  • Endometrial Neoplasms / drug therapy*
  • Female
  • Humans
  • Middle Aged
  • Neoplasm Recurrence, Local / drug therapy*
  • Treatment Failure

Substances

  • Antibiotics, Antineoplastic
  • Doxorubicin