A randomized phase III study evaluating pegylated liposomal doxorubicin versus capecitabine as first-line therapy for metastatic breast cancer : results of the PELICAN study

  • Purpose: The PELICAN trial evaluates for the first time efficacy and safety of pegylated liposomal doxorubicin (PLD) versus capecitabine as first-line treatment of metastatic breast cancer (MBC). Methods: This randomized, phase III, open-label, multicenter trial enrolled first-line MBC patients who were ineligible for endocrine or trastuzumab therapy. Cumulative adjuvant anthracyclines of 360 mg/m2 doxorubicin or equivalent were allowed. Left ventricular ejection fraction of >50 % was required. Patients received PLD 50 mg/m2 every 28 days or capecitabine 1250 mg/m2 twice daily for 14 days every 21 days. The primary endpoint was time-to-disease progression (TTP). Results: 210 patients were randomized (n = 105, PLD and n = 105, capecitabine). Adjuvant anthracyclines were given to 37 % (PLD) and 36 % (capecitabine) of patients. No significant difference was observed in TTP [HR = 1.21 (95 % confidence interval, 0.838–1.750)]. Median TTP was 6.0 months for both PLD and capecitabine. Comparing patients with or without prior anthracyclines, no significant difference in TTP was observed in the PLD arm (log-rank P = 0.64). For PLD versus capecitabine, respectively, overall survival (median, 23.3 months vs. 26.8 months) and time-to-treatment failure (median, 4.6 months vs. 3.7 months) were not statistically significantly different. Compared to PLD, patients on capecitabine experienced more serious adverse events (P = 0.015) and more cardiac events among patients who had prior anthracycline exposure (18 vs. 8 %; P = 0.31). Conclusion: Both PLD and capecitabine are effective first-line agents for MBC.

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Author:Nadia HarbeckORCiDGND, Steffen Saupe, Elke Jäger, Marcus Schmidt, Rolf Kreienberg, Lothar Müller, Burkhard Otremba, Dirk Waldenmaier, Julia Dorn, Mathias Warm, Michael Scholz, Michael UntchORCiDGND, Maike de Wit, Jana Barinoff, Hans-Joachim LückORCiDGND, Philipp HarterORCiDGND, Doris Augustin, Paul Harnett, Matthias Wilhelm BeckmannORCiDGND, Salah-Eddin al- BatranORCiDGND
URN:urn:nbn:de:hebis:30:3-452287
DOI:https://doi.org/10.1007/s10549-016-4033-3
ISSN:0167-6806
ISSN:1573-7217
Pubmed Id:https://pubmed.ncbi.nlm.nih.gov/27798749
Parent Title (English):Breast cancer research and treatment
Publisher:Springer Science + Business Media B.V.
Place of publication:Dordrecht [u. a.]
Document Type:Article
Language:English
Year of Completion:2016
Date of first Publication:2016/10/31
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Creating Corporation:PELICAN Investigators
Release Date:2017/12/12
Tag:Capecitabine; Metastatic breast cancer; PELICAN; Pegylated liposomal doxorubicin
Volume:161
Issue:1
Page Number:10
First Page:63
Last Page:72
Note:
Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://crea tivecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
HeBIS-PPN:428681921
Institutes:Medizin / Medizin
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Sammlungen:Universitätspublikationen
Licence (German):License LogoCreative Commons - Namensnennung 4.0