Interim safety analysis of a randomized phase III study evaluating pegylated liposomal doxorubicin (PLD) versus capecitabine as first-line chemotherapy for metastatic breast cancer (MBC): The PELICAN study

12010 Background: MBC is still an incurable disease. Effective single agent chemotherapy is increasingly used in the frontline setting to lower toxicity and maintain patient’s quality of life (QoL). The phase III PELICAN trial was designed to evaluate efficacy and safety of first-line PLD (50 mg/m2, q28 days) vs. capecitabine (1,250 mg/m2 BID×14 days, q21 days) as approved dose for both agents. Methods: Pts with MBC were eligible. They received either PLD 50 mg/m2 iv every 28 days or capecitabine 1,250 mg/m2 orally twice daily for 14 days followed by a 7-day rest period (qd21) as a first line treatment. Toxicity was evaluated continuously, efficacy and quality of life every 3 months; cycles were repeated until disease progression or unacceptable toxicity. Results: The PELICAN trial is actively enrolling pts. 79 pts (PLD n= 40; capecitabine n=39) were analyzed for safety. Median age was 61 years (range, 35–80. Pts received a median of 4 cycles (1–20). Both drugs were associated with comparable rates of gra...