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Randomized Phase III Trial of Pegylated Liposomal Doxorubicin Versus Vinorelbine or Mitomycin C Plus Vinblastine in Women With Taxane-Refractory Advanced Breast Cancer

From US Oncology Inc, Cancer Care Associates, Tulsa, OK; US Oncology, Dallas, TX; University Hospital of Heraklion, Heraklion, Crete, Greece; Cross Cancer Institute, Edmonton, Alberta, Canada; Centro Medico Nacional ISSSTE, Mexico, D.F. Mexico; Hospital Clinico Universitario, Valencia, Spain; Aventura Concorde Center II, Aventura, FL; Department of Gynecology and Obstetrics, Johann Wolfgang Goethe-University, Frankfurt, Germany; University of California San Francisco, San Francisco, CA; Schering-Plough Research Institute, Kenilworth, NJ.

Address reprint requests to Alan M. Keller, MD, US Oncology Inc, Cancer Care Associates, 6151 S Yale, Tulsa, OK 74136, e-mail: alan.keller2{at}usoncology.com

PURPOSE: To compare the efficacy of pegylated liposomal doxorubicin (PLD) with that of a common salvage regimen (comparator) in patients with taxane-refractory advanced breast cancer.

PATIENTS AND METHODS: Following failure of a first- or second-line taxane-containing regimen for metastatic disease, 301 women were randomly assigned to receive PLD (50 mg/m² every 28 days); or comparator-vinorelbine (30 mg/m² weekly) or mitomycin C (10 mg/m² day 1 and every 28 days) plus vinblastine (5 mg/m² day 1, day 14, day 28, and day 42) every 6 to 8 weeks. Patients were stratified before random assignment based on number of previous chemotherapy regimens for metastatic disease and presence of bone metastases only.

RESULTS: Progression-free survival (PFS) and overall survival (OS) were similar for PLD and comparator (PFS: hazard ratio [HR], 1.26; 95% CI, 0.98 to 1.62; P = .11; median, 2.9 months [PLD] and 2.5 months [comparator]; OS: HR, 1.05; 95% CI, 0.82 to 1.33; P = .71; median, 11.0 months [PLD] and 9.0 months [comparator]). In anthracycline-naïve patients, PFS was somewhat longer with PLD, relative to the comparator (n = 44; median PFS, 5.8 v 2.1 months; HR, 2.40; 95% CI, 1.16 to 4.95; P = .01). Most frequently reported adverse events were nausea (23% to 31%), vomiting (17% to 20%), and fatigue (9% to 20%) and were similar among treatment groups. PLD-treated patients experienced more palmar-plantar erythrodysesthesia (37%; 18% grade 3, 1 patient grade 4) and stomatitis (22%; 5% grades 3/4). Neuropathy (11%), constipation (16%), and neutropenia (14%) were more common with vinorelbine. Alopecia was low in both the PLD and vinorelbine groups (3% and 5%).

CONCLUSION: PLD has efficacy comparable to that of common salvage regimens in patients with taxane-refractory metastatic breast cancer, thereby representing a useful therapeutic option.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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