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

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: Nadia Harbeck, Steffen Saupe, Elke Jäger, Marcus Schmidt, Rolf Kreienberg, Lothar Müller, Burkhard Joerg Otremba, Dirk Waldenmaier, Julia Dorn, Mathias Warm, Michael Scholz, Michael Untch, Maike de Wit, Jana Barinoff, Hans-Joachim Lück, Philipp Harter, Doris Augustin, Paul Harnett, Matthias W Beckmann, Salah-Eddin Al-Batran, PELICAN Investigators
• Journal: Breast cancer research and treatment (Breast Cancer Res Treat) Vol. 161 Issue 1 Pg. 63-72 (01 2017) ISSN: 1573-7217 [Electronic] Netherlands
• PMID: 27798749 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antimetabolites, Antineoplastic
• liposomal doxorubicin
• Polyethylene Glycols
• Capecitabine
• Doxorubicin

Topics

• Adult
• Aged
• Aged, 80 and over
• Antimetabolites, Antineoplastic (administration & dosage, adverse effects, therapeutic use)
• Breast Neoplasms (drug therapy, mortality, pathology)
• Capecitabine (administration & dosage, adverse effects, therapeutic use)
• Disease Progression
• Doxorubicin (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Female
• Humans
• Middle Aged
• Neoplasm Metastasis
• Neoplasm Staging
• Polyethylene Glycols (administration & dosage, adverse effects, therapeutic use)
• Quality of Life
• Risk Factors
• Survival Analysis
• Treatment Outcome
• Young Adult