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

Harbeck N, Saupe S, Jaeger E, Schmidt M, Kreienberg R, Mueller L, Otremba BJ, Waldenmaier D, Dorn J, Warm M, Scholz M, Untch M, De Wit M, Barinoff J, Lueck HJ, Harter P, Augustin D, Harnett P, Beckmann M, Al-Batran SE (2017)

Publication Type: Journal article

Publication year: 2017

Journal

Breast Cancer Research and Treatment Springer Verlag (Germany)

Book Volume: 161

Pages Range: 63-72

Journal Issue: 1

DOI: 10.1007/s10549-016-4033-3

Abstract

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.

Authors with CRIS profile

Matthias Beckmann Lehrstuhl für Geburtshilfe und Frauenheilkunde

Involved external institutions

Donau Isar Klinikum DE Germany (DE) Crown Princess Mary Cancer Centre AU Australia (AU) Kliniken Essen-Mitte DE Germany (DE) Johannes Gutenberg-Universität Mainz (JGU) DE Germany (DE) HELIOS Kliniken DE Germany (DE) Krankenhaus Köln-Holweide DE Germany (DE) Technische Universität München (TUM) DE Germany (DE) Trium Analysis Online GmbH DE Germany (DE) Krankenhaus Nordwest DE Germany (DE) Ludwig-Maximilians-Universität (LMU) DE Germany (DE) Universitätsklinikum Ulm DE Germany (DE) Vivantes - Netzwerk für Gesundheit GmbH DE Germany (DE) Merck KGaA DE Germany (DE)

How to cite

APA:

Harbeck, N., Saupe, S., Jaeger, E., Schmidt, M., Kreienberg, R., Mueller, L.,... Al-Batran, S.-E. (2017). A randomized phase III study evaluating pegylated liposomal doxorubicin versus capecitabine as first-line therapy for metastatic breast cancer: results of the PELICAN study. Breast Cancer Research and Treatment, 161(1), 63-72. https://doi.org/10.1007/s10549-016-4033-3

MLA:

Harbeck, Nadia, et al. "A randomized phase III study evaluating pegylated liposomal doxorubicin versus capecitabine as first-line therapy for metastatic breast cancer: results of the PELICAN study." Breast Cancer Research and Treatment 161.1 (2017): 63-72.

BibTeX: Download