A randomized phase III study evaluating pegylated liposomal doxorubicin (PLD) versus capecitabine (CAP) as first-line therapy for metastatic breast cancer (MBC): Results of the PELICAN study.

1022 Background: PLD and CAP have significant antitumor activity in a wide range of solid tumors including MBC. The PELICAN trial was designed to compare efficacy and safety of first-line PLD vs. CAP in MBC. Methods: Patients (pts) with MBC were stratified by age and prior adjuvant anthracycline (A), and randomized to receive either PLD (50 mg/m2 every 28 days) or CAP (1,250 mg/m2 BID x 14 days every 21 days) as first-line therapy until disease progression or unacceptable toxicity. Primary objective was to compare the time to disease progression (TTP). Results: 210 pts (PLD: 105; CAP: 105) were randomized. Median age was 62 (22–85) years; most pts had an ECOG of 0 (51%) or 1 (43%). Prior adjuvant anthracycline was documented in 37% of pts. Pts received a median of 5 cycles of PLD and 5 cycles of CAP. Median TTP was comparable in both arms (6.7 mo with PLD vs. 7.1 mo with CAP, p > 0.3460), as was the overall survival (OS), with 1-year survival rates being 82% and 75% with PLD and CAP, respectively. The ove...