Phase 2 trial of nonpegylated doxorubicin (Myocet) as second-line treatment in advanced or recurrent endometrial 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/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.
Division of Gynecologic Oncology, Catholic University of the Sacred Heart, Rome, Italy.
Alessia
A
Di Legge
Ilaria Nausica
IN
Trivellizzi
Maria Cristina
MC
Moruzzi
Adele
A
Pesce
Giovanni
G
Scambia
Domenica
D
Lorusso
D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use* / Q000633:toxicity; D002277:Carcinoma / Q000188:drug therapy*; D004317:Doxorubicin / Q000627:therapeutic use* / Q000633:toxicity; D016889:Endometrial Neoplasms / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D017211:Treatment Failure
D000903:Antibiotics, Antineoplastic; D004317:Doxorubicin