Pegylated liposomal doxorubicin for platinum-resistant or refractory Müllerian carcinoma (epithelial ovarian carcinoma, primary carcinoma of Fallopian tube and peritoneal carcinoma): A single-institutional experience

Abstract

Abstract. The aim of the present study was to evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD) in patients with Müllerian carcinoma treated at our hospital. Nineteen patients with platinum-resistant Müllerian carcinoma were treated with intravenous PLD 50 mg/m 2 every 4 weeks. Tumor response was assessed by MRI following every 2-3 cycles of treatment. The severity of adverse events was assessed according to the Common Terminology Criteria for Adverse Events (v3.0). The best overall responses in the 19 patients were identified as 5 partial responses (PR), 6 stable diseases (SD) and 8 progressive diseases (PD). Response rate was 26.3%. The proportion of patients with CR, PR or SD was 57.9%. The median time to progression was 188.0 days. The median survival time was 381.0 days. Toxicity grades were identified as one grade III hand-foot syndrome, two grade III neutropenia, one grade IV hand-foot syndrome, one grade IV stomatitis and one grade IV neutropenia. The present study confirmed that PLD is an effective drug when administered as a salvage therapy for the treatment of Müllerian carcinoma and is associated with a reduced toxicity profile compared with current therapeutic options.

Outcomes analysis of an alternative formulation of PEGylated liposomal doxorubicin in recurrent epithelial ovarian carcinoma during the drug shortage era

“…First, our population of patients was more heavily pretreated, receiving a median of three prior chemotherapeutic regimens compared with two prior lines of therapy in the studies by Chou et al14 and Fukuda et al15 Second, the patients in our study received a lower average dose of Lipo-Dox, ie, 40 mg/m,2 compared with 45 mg/m 2 in the Japanese study and 50 mg/m 2 in the Taiwanese study. Despite these limitations and the selection bias inherent in retrospective studies, these results raise the question as to whether this formulation of PLD has equivalent efficacy in a North American population when compared with Asian populations, or when compared with Doxil.…”

“…Six additional patients had stable disease indicating a disease control rate of 58.9%. Median progression-free survival and overall survival were 188 days and 381 days, respectively 15. Lipo-Dox was prospectively evaluated in a Phase II trial of 29 patients with platinum-resistant or refractory EOC in Taiwan.…”

“…Median progression-free survival and overall survival were 188 days and 381 days, respectively. 15 Lipo-Dox was prospectively evaluated in a Phase II trial of 29 patients with platinum-resistant or refractory EOC in Taiwan. The overall response rate was 23.1%, with one complete response, five partial responses, and nine patients with stable disease.…”

A tale of the two PEGylated liposomal doxorubicins

“…Berger et al incorrectly referenced two Asian ovarian cancer trials for efficacy and survival data for Lipodox, and we need to set the record straight that the Taiwanese trial used TTY Biopharm Lipo-Dox, 4 and that the Japanese trial most likely used the originator Doxil. 5 Another smaller study using single-agent TTY Biopharm Lipo-Dox in patients with ovarian cancer refractory to both cisplatin and paclitaxel produced efficacy similar to that reported by Chou et al 6 but with no serious toxicity because of a slightly lower dose (see Table 1 ).…”