Authors' objectives:

This report is intended to assess the available evidence on the usefulness of liposomal doxorubicin for most common clinical uses.

Authors' results and conclusions: I- Pegylated Liposomal Doxorubicin and Non-Pegylated Liposomal Doxorubicin for the Treatment of Metastatic Breast Cancer Two randomized clinical trials (RCTs) which included 224 and 509 treatment-naive metastatic breast cancer patients who were randomized to receive either pegylated liposomal doxorubicin or conventional doxorubicin, found that the response rate, time to disease progression and median survival were similar for both groups. Cardiotoxicity was most commonly observed in the conventional doxorubicin group (approximately 25 vs. 10%). Another RCT randomized 160 treatment-naive metastatic breast cancer patients to receive cyclophosphamide in combination with non-pegylated liposomal doxorubicin or epirubicin (another anthracycline). The rate of total response and median survival was similar for both groups. Median time to disease progression was shorter for the liposomal group (5.6 versus 7.7 months; p=0.02). Cardiotoxicity was similar and low in both groups (11.84% and 10.26%). One RCT randomized 301 metastatic breast cancer patients who had failed a first or second line regimen with taxanes to receive pegylated liposomal doxorubicin or two control groups: vinorelbine or mytomicine C with vinblastine. Survival rate and progression-free survival was similar in the liposomal doxorubicin and the control groups when jointly analyzed. II- Pegylated Liposomal Doxorubicin for the Treatment of Multiple Myeloma Two RCTs which randomized 259 and 192 patients to receive vincristine + dexamethasone + conventional (VAD) or liposomal (VADlip) doxorubicin were found. The rate of objective response, disease-free survival and overall survival were similar for both groups. Alopecia was most frequent in the VAD group and Hand-Food erythrodysesthesia, in the VADlip group. III- Pegylated Liposomal Doxorubicin for the Treatment HIV (Human Immunodeficiency Virus) Related to Kaposi Sarcoma Only two clinical trials which compared liposomal doxorubicin with standard treatments and one Cochrane revision of both were found. They included 499 patients with mucocutaneous or extensive visceral involvement and a CD4 count lower than 200 who were assigned to liposomal doxorubicin or bleomicine and vincristine (plus conventional doxorubicin in one of the studies). There were no significant differences in death risk among the different treatments. The response for the liposomal group was higher than the control, RR 2.16; (95% CI: 1.68 to 2.78). There were fewer treatment discontinuations in the liposomal group, RR 0.57; (95% CI: 0.48 to 0.68), but more cases of opportunistic infections, RR 1.42; (95% CI: 1.12 to 1.80). IV- Pegylated Liposomal Doxorubicin for the treatment of Advance Ovarian Cancer (New Indication) Its use was assessed as second line treatment in three RCTs which compared this drug against topotecan and paclitaxel. The RCT that evaluated the use of liposomal doxorubicin vs. topotecan and the one that evaluated it against paclitaxel reported that disease-free survival rates, total response rate and survival were similar for both groups. Another RCT compared the use of paclitaxel versus liposomal doxorubicin in combination with cyclophosphamide and cisplatin: a better survival rate was found in the combination group. NICE (National Institute of Clinical Excellence) of United Kingdom, recommends liposomal doxorubicin as an option in second line treatments (or after) for those women with advanced ovarian cancer partially sensitive, resistant or refractory to platinum, or for those who are allergic to platinum-based agents.

Authors' recommendations: Liposomal doxorubicin has demonstrated to be as effective as conventional doxorubicin. In pathologies where high doses are required (especially breast cancer), liposomal doxorubicin can be a good alternative because it presents a lower incidence of cardiotoxicity, although it has a greater incidence of erythrodysesthesia and stomatitis. Liposomal doxorubicin seems to achieve a higher response rate and cause a similar number of adverse events compared with standard treatments, when used in advanced Kaposi sarcoma. For advanced ovarian cancer, liposomal doxorubicin is an option as second line therapy or after.

Authors' methods: Overview

Project Status: Completed

URL for project: http://www.iecs.org.ar/

Year Published: 2006

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Argentina

Organisation Name: Institute for Clinical Effectiveness and Health Policy

Contact Address: Dr. Emilio Ravignani 2024, Buenos Aires - Argentina, C1414 CABA

Contact Name: info@iecs.org.ar

Contact Email: info@iecs.org.ar

Copyright: Institute for Clinical Effectiveness and Health Policy (IECS)