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

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.

• Authors: Alessia Di Legge, Ilaria Nausica Trivellizzi, Maria Cristina Moruzzi, Adele Pesce, Giovanni Scambia, Domenica Lorusso
• Journal: International journal of gynecological cancer : official journal of the International Gynecological Cancer Society (Int J Gynecol Cancer) Vol. 21 Issue 8 Pg. 1446-51 (Nov 2011) ISSN: 1525-1438 [Electronic] England
• PMID: 22027749 (Publication Type: Clinical Trial, Phase II, Journal Article)

Chemical References

• Antibiotics, Antineoplastic
• Doxorubicin

Topics

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