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.

Abstract

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 overall response rate was 24% with PLD and 26% with CAP. In the planned subgroup analyses, adjuvant A-pretreatment had a negative impact on TTP in the CAP group (4.8 mo with prior A vs. 9.0 mo without; p > 0.0098) but not in the PLD-group (5.9 mo with prior A vs. 6.9 mo without; p > 0.5584). Significantly more patients in the CAP group experienced grade 3/4 diarrhea (12% vs. 0%, p > 0.0002) and grade 3/4 thromboembolic events (10% vs. 2%, p > 0.0333) than in the PLD group. Hand-foot-syndrome was not significantly different between groups (PLD 36% vs. CAP 25%, respectively; p > 0.1352). Cardiac events were reported with 9% in the PLD group and 12% in the CAP group (p > 0.4999). Conclusions: First-line chemotherapy of MBC patients in the randomized phase III PELICAN trial using PLD or CAP showed to be similarly effective with respect to TTP. However, the PLD arm showed a better tolerability profile, which may also allow more treatment options for subsequent therapy. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Essex Pharma Essex Pharma, Schering-Plough Schering-Plough