title: Pegylated liposomal doxorubicin in combination with vinorelbine as salvage treatment in pretreated patients with advanced breast cancer: a multicentre phase II study.
abstract: OBJECTIVE
  To investigate the activity and tolerance of pegylated liposomal doxorubicin in combination with vinorelbine in pretreated patients with metastatic breast cancer.
  
  
  METHODS
  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.
authors.affiliation: Department of Medical Oncology, University General Hospital of Heraklion, PO BOX 1352, 71110, Heraklion, Crete, Greece.
authors.forename: Alexandros
authors.initials: A
authors.lastname: Ardavanis
authors.forename: Dimitris
authors.initials: D
authors.lastname: Mavroudis
authors.forename: Kostas
authors.initials: K
authors.lastname: Kalbakis
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Malamos
authors.forename: Kostas
authors.initials: K
authors.lastname: Syrigos
authors.forename: Lambros
authors.initials: L
authors.lastname: Vamvakas
authors.forename: Athanasios
authors.initials: A
authors.lastname: Kotsakis
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Kentepozidis
authors.forename: Charalambos
authors.initials: C
authors.lastname: Kouroussis
authors.forename: Sophia
authors.initials: S
authors.lastname: Agelaki
authors.forename: Vassilis
authors.initials: V
authors.lastname: Georgoulias
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009503:Neutropenia / Q000139:chemically induced; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects; D016879:Salvage Therapy / Q000379:methods*; D016019:Survival Analysis; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D014747:Vinblastine; D004317:Doxorubicin; D000077235:Vinorelbine