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A tale of the two PEGylated liposomal doxorubicins

Authors Chou H, Lin H, Liu J

Received 11 December 2014

Accepted for publication 13 February 2015

Published 13 July 2015 Volume 2015:8 Pages 1719—1720

DOI https://doi.org/10.2147/OTT.S79089

Checked for plagiarism Yes

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Hunghsueh Chou,1,4 Hao Lin,2,4 Jacqueline M Liu3

1Department of Obstetrics and Gynecology, Linkou Chang Gung Memorial Hospital, Linkou, Taiwan; 2Department of Obstetrics and Gynecology, Kaohsiung Chang Gung Memorial Hospital, Linkou, Taiwan; 3TTY Oncology Translational Research Center, TTY Biopharm, Taipei, Taiwan; 4Chang Gung University College of Medicine, Linkou, Taiwan

We are writing this letter in response to the article "Outcomes analysis of an alternative formulation of PEGylated liposomal doxorubicin in recurrent epithelial ovarian carcinoma during the drug shortage era" by Berger et al and published in August 2014.1 This paper is one of the earliest reports of the outcome of using Lipodox® available in the Western medical literature.

View original paper by Berger et al

Corrigendum for this article has been published

Dear editor

We are writing this letter in response to the article “Outcomes analysis of an alternative formulation of PEGylated liposomal doxorubicin in recurrent epithelial ovarian carcinoma during the drug shortage era” by Berger et al and published in August 2014.1 This paper is one of the earliest reports of the outcome of using Lipodox® available in the Western medical literature.

There are two PEGylated liposomal doxorubicin formulations, with the brand names Lipodox and Lipo-Dox®. Lipodox is manufactured by Sun Pharma and has been approved by the US Food and Drug Administration as a generic of Doxil® since February 4, 2013.2 Lipo-Dox is manufactured by TTY Biopharm, and has a lipid formulation different to that of Doxil and has a longer half-life;3 it has been sold in Taiwan and many Asian countries since 1998, and is probably the alternative formulation referenced in the paper by Berger et al.1

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 al6 but with no serious toxicity because of a slightly lower dose (see Table 1).

Table 1 Clinical trials reporting single-agent liposomal doxorubicin therapy for refractory ovarian cancer, with dosage, response, survival, and toxicity information
Abbreviations: CR, complete response; PR, partial response; ORR, overall response rate; PFS, progression-free survival; OS, overall survival; NR, not reached; CDDP, diamminedichloroplatinum(II).

Disclosure

The authors report no conflicts of interest in this communication.


References

1.

Berger JL, Smith AL, Zorn KK, et al. Outcomes analysis of an alternative formulation of PEGylated liposomal doxorubicin in recurrent epithelial ovarian carcinoma during the drug shortage era. Onco Targets Ther. 2014;7:1409–1413.

2.

US Food and Drug Administration. FDA approval of generic version of cancer drug Doxil is expected to help resolve shortage. Available from: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm337872.htm. Accessed February 13, 2015.

3.

Hong RL, Tseng YL. Phase I and pharmacokinetic study of a stable, polyethylene-glycolated liposomal doxorubicin in patients with solid tumors. Cancer. 2001;91(9):1826–1833.

4.

Chou HH, Wang KL, Chen CA, et al. Pegylated liposomal doxorubicin (Lipo-Dox) for platinum-resistant or refractory epithelial ovarian carcinoma: a Taiwanese Gynecologic Oncology Group study with long term follow up. Gynecol Oncol. 2006;101(3):423–428.

5.

Fukada T, Wumi T, Teramae M, et al. PEGylated liposomal doxorubicin for platinum-resistant or refractory Mullerian carcinoma: a single institution experience. Oncol Lett. 2013;5(1):35–38.

6.

Lin H, Tseng CW, Chang HY, et al. Evaluation of PEGylated liposomal doxorubicin in the treatment of both platinum and paclitaxel-refractory epithelial ovarian cancer. Taiwanese J Obstet Gynecol. 2004;43:140–143.

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