TY  - JOUR
A1  - Harbeck, Nadia
A1  - Saupe, Steffen
A1  - Jäger, Elke
A1  - Schmidt, Marcus
A1  - Kreienberg, Rolf
A1  - Müller, Lothar
A1  - Otremba, Burkhard
A1  - Waldenmaier, Dirk
A1  - Dorn, Julia
A1  - Warm, Mathias
A1  - Scholz, Michael
A1  - Untch, Michael
A1  - Wit, Maike de
A1  - Barinoff, Jana
A1  - Lück, Hans-Joachim
A1  - Harter, Philipp
A1  - Augustin, Doris
A1  - Harnett, Paul
A1  - Beckmann, Matthias Wilhelm
A1  - Batran, Salah-Eddin al-
T1  - A randomized phase III study evaluating pegylated liposomal doxorubicin versus capecitabine as first-line therapy for metastatic breast cancer : results of the PELICAN study
T2  - Breast cancer research and treatment
N2  - 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.
KW  - Pegylated liposomal doxorubicin
KW  - Capecitabine
KW  - Metastatic breast cancer
KW  - PELICAN
Y1  - 2016
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/45228
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-452287
SN  - 0167-6806
SN  - 1573-7217
N1  - 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.
VL  - 161
IS  - 1
SP  - 63
EP  - 72
PB  - Springer Science + Business Media B.V.
CY  - Dordrecht [u. a.]
ER  -