Pegylated liposomal doxorubicin in combination with vinorelbine as salvage treatment in pretreated patients with advanced breast cancer: a multicentre phase II study.
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.
Ardavanis
Alexandros
A
Department of Medical Oncology, University General Hospital of Heraklion, PO BOX 1352, 71110, Heraklion, Crete, Greece.
Mavroudis
Dimitris
D
Kalbakis
Kostas
K
Malamos
Nikolaos
N
Syrigos
Kostas
K
Vamvakas
Lambros
L
Kotsakis
Athanasios
A
Kentepozidis
Nikolaos
N
Kouroussis
Charalambos
C
Agelaki
Sophia
S
Georgoulias
Vassilis
V
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
C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D014747:Vinblastine; D004317:Doxorubicin; D000077235:Vinorelbine