Abstract
PurposeThe 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).MethodsThis 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).Results210 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).ConclusionBoth PLD and capecitabine are effective first-line agents for MBC.
Highlights
Metastatic breast cancer (MBC), though not considered curable by today’s therapies, deserves effective treatment
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)
The PELICAN trial evaluated for the first time the first-line efficacy of PLD and capecitabine in a randomized setting for all patients
Summary
Metastatic breast cancer (MBC), though not considered curable by today’s therapies, deserves effective treatment. In studies that have demonstrated a statistically significant survival benefit for combination therapy, tolerability must be considered and toxicity is often prohibitive in this palliative setting [4]. In particular in the current clinical setting of anthracycline and taxane pre-treatment in the adjuvant setting, are pegylated liposomal doxorubicin (PLD) and capecitabine. Both have demonstrated single-agent efficacy in MBC, are supported by established guidelines, and are relatively well tolerated [5,6,7,8,9,10,11]
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