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Pegylated liposomal doxorubicin in combination with vinorelbine as salvage treatment in pretreated patients with advanced breast cancer: a multicentre phase II study.

Ardavanis A, Mavroudis D, Kalbakis K, Malamos N, Syrigos K, Vamvakas L, Kotsakis A, Kentepozidis N, Kouroussis C, Agelaki S, Georgoulias V,

Department of Medical Oncology, University General Hospital of Heraklion, PO BOX 1352, 71110, Heraklion, Crete, Greece.

PURPOSE: To investigate the activity and tolerance of pegylated liposomal doxorubicin in combination with vinorelbine in pretreated patients with metastatic breast cancer. PATIENTS AND TREATMENT: Thirty-six women with metastatic breast cancer were enrolled. The median age was 64 years, 80% of the patients had a performance status of 0-1, 30 (83%) had visceral disease and 83% had received prior taxanes while 50% anthracyclines. Treatment consisted of pegylated liposomal doxorubicin (40 mg/m2 on day 1) and vinorelbine (25 mg/m2 on days 1 and 15) every 4 weeks. RESULTS: In an intention-to-treat analysis 2 (6%) complete and 12 (33%) partial responses were observed (overall response rate 39%; 95% CI: 23-54.8%); 8 (22%) and 14 (39%) patients experienced stable and progressive disease, respectively. The median TTP was 6.5 months and the median survival time 14.2 months. The 1-year survival rate was 54.1%. Grade 3 and 4 neutropenia occurred in 21 (58%) patients, grade 3-4 anemia in four (11%) and grade 4 thrombocytopenia in one (3%). Two (6%) patients developed febrile neutropenia. Non-hematologic toxicity was mild and easily manageable. There was no clinically important cardiac toxicity or treatment-related deaths. CONCLUSIONS: The combination of pegylated liposomal doxorubicin and vinorelbine is an active and well tolerated salvage regimen in patients with metastatic breast cancer which merits further evaluation.

Published 5 September 2006 in Cancer Chemother Pharmacol, 58(6): 742-8.
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