If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Pegylated Liposomal Doxorubicin May Be a First-Line Alternative to Capecitabine in Metastatic Breast Cancer: Presented at ASCO By Brian Hoyle CHICAGO -- June 6, 2010 -- The use of pegylated liposomes in the delivery of doxorubicin is similarly effective as capecitabine (CAP) in the first-line chemotherapy of metastatic breast cancer, and is better tolerated, thus presenting another treatment option for this patient population, researchers said here at the 2010 Annual Meeting of the American Society for Clinical Oncology (ASCO). The results of the randomised, phase 3 Pegylated Liposomal Doxorubicin Versus Capecitabine as First-Line Chemotherapy for Metastatic Breast Cancer (PELICAN) trial were presented by Elke Jäger, MD, Department of Hematology and Oncology, Krankenhaus Nordwest, Frankfurt, Germany, during a poster presentation here on June 5. The encapsulation of drugs within a sphere formed of liposomes can be a useful means of protecting and delivering a potent dose of the particular drug to the body target, especially when the liposomes are made more resilient by the incorporation of molecules of polyethylene glycol. These so-called pegylated liposomes have shown potent antitumour activity in a variety of solid tumours including metastatic breast cancer. The PELICAN trial was undertaken to compare the efficacy and patient safety of pegylated liposomal doxorubicin (PLD) and capecitabine as the go-to agents in the treatment of metastatic breast cancer. A total of 210 patients aged 22 to 85 years with metastatic breast cancer were stratified according to their age and prior treatment with an anthracycline. They were randomised to receive either PLD 50 mg/m2 every 28 days (n = 105) or capecitabine 1,250 mg/m2 BID for 14 days every 21 days (n = 105) as first-line therapy until disease progression was evident or unacceptable toxicity developed. Primary objective was the time to disease progression (TTP). Secondary objectives included response rates, overall survival (OS), quality of life, safety, and time to treatment failure. Most patients had an Eastern Cooperative Oncology Group performance status of 0 or 1. Anthracyclines had previously been used in 37% of PLD-treated patients and 36% of capecitabine-treated patients. Nearly all patients were postmenopausal (83% of PLD, 85% of capecitabine) and the site of metastasis was both visceral and nonvisceral in 56% of PLD patients and 64% of capecitabine patients. Both patient groups received a median of 5 cycles of therapy. The median TTP was comparable for both the PLD- (6.7 months) and capecitabine-treated (7.1 months) patients in both arms (P = .3460). One-year OS was also similar with a rate of 82% and 75% for PLD and capecitabine groups, respectively. The overall response rate was 24% for the PLD group and 26% for the capecitabine group. In patients who had previously been treated with an anthracycline, this treatment shortened the TTP in the capecitabine group of patients (TTP of 4.8 and 9.0 months with or without previous anthracycline treatment, respectively; P = .0098), whereas no effect was evident in the PLD group of patients (TTP of 5.9 and 6.9 months with or without previous anthracycline treatment, respectively; P = .5584). In terms of adverse events, grade 3/4 diarrhoea was experienced by 12% of capecitabine-treated patients and none of the PLD-treated patients (P = .0002) and grade 3/4 thromboembolic events were experienced by 10% of capecitabine-treated patients and 2% of PLD-treated patients (P = .0333). Hand-foot-syndrome was not significantly different between PLD- and CAP-treated patients (36% and 25%, respectively; P = .1352). All grades of cardiac events were reported with 9% and 12% of PLD and capecitabine patients, respectively (P = .4999). PLD treatment was associated with increased frequencies of leucopenia (35% in PLD, 16% in CAP; P = .0025) and mucositis (57% in PLD, 29% in CAP; P < .0001). Overall, the number of serious adverse events was less in the PLD arm (58 vs 115), as was the number of patients with serious adverse events (30 vs 48). "Pegylated liposomal doxorubicin may be better tolerated by patients with metastatic breast cancer than capecitabine. Given the similar efficacies between the drugs; this liposome strategy may be promising," said Dr. Jäger. Funding for this study was provided by Schering-Plough, sanofi-aventis, Pfizer, and Roche. [Presentation title: 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]
|
