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

作者：Harbeck Nadia; Saupe Steffen; Jaeger Elke; Schmidt Marcus; Kreienberg Rolf; Mueller Lothar; Otremba Burkhard Joerg; Waldenmaier Dirk; Dorn Julia; Warm Mathias; Scholz Michael; Untch Michael; de Wit Maike; Barinoff Jana; Lueck Hans Joachim; Harter Philipp; Augustin Doris; Harnett Paul; Beckmann Matthias W; Al Batran Salah Eddin

来源：Breast Cancer Research and Treatment, 2017, 161(1): 63-72.

DOI：10.1007/s10549-016-4033-3

• Pegylated liposomal doxorubicin
• Capecitabine
• Metastatic breast cancer
• PELICAN

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).
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/m(2) doxorubicin or equivalent were allowed. Left ventricular ejection fraction of > 50 % was required. Patients received PLD 50 mg/m(2) every 28 days or capecitabine 1250 mg/m(2) twice daily for 14 days every 21 days. The primary endpoint was time-to-disease progression (TTP).
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).
Both PLD and capecitabine are effective first-line agents for MBC.

• 出版日期2017-1