title: Phase II study of pegylated liposomal doxorubicin plus vinorelbine in breast cancer with previous anthracycline exposure.
abstract: Thirty-five patients with metastatic breast cancer (MBC) entered a phase II study of pegylated liposomal doxorubicin 35 mg/m2 intravenously (i.v.) on day 1 plus vinorelbine 30 mg/m2 i.v. on day 1 every 4 weeks. Patients were required to have measurable disease, previous chemotherapy with an anthracycline-containing regimen, and a normal left ventricular ejection fraction (LVEF). Thirty-four patients were assessable for response and toxicity. The overall response rate (on an intent-to-treat basis) was 35% (12 of 34; 95% CI, 20%-54%). One complete response and 11 partial responses were noted. In addition, 14 patients (41%) had stable disease of > 4 months duration, and 7 patients (20.5%) had disease progression. The response rates to the combination when it was used as first- and second-line chemotherapy were 31% (4 of 13) and 38% (8 of 21), respectively. Median time to disease progression was 7 months (range, 1-35 months) and median overall survival was 13 months (range, 2 to > 62 months). Neutropenia was the most frequent toxicity (grade 4 in 44% of patients and 19% of cycles), but neutropenic fever was seen in only 3 cases. No septic deaths occurred. Nonhematologic grade 3 side effects included skin toxicity (palmar-plantar erythrodysesthesia syndrome, 6%) and mucositis (15%). Late alopecia was seen in 53% of patients (grade 1 in 41%, and grade 2 in 12%). The median LVEFs were 64% (range, 50%-81%) at baseline and 62% (range, 37%-70%) after treatment. Three patients presented an LVEF decrease to < 50%; however, no clinical heart failure was noted, and 2 of these patients recovered normal values after cessation of therapy. The combination of pegylated liposomal doxorubicin and vinorelbine can be safely administered to patients with anthracycline-pretreated MBC and is active in this population.
authors.affiliation: Medical Oncology Service, Hospital Universitario San Carlos, Madrid, Spain. mmartin@geicam.org
authors.forename: Miguel
authors.initials: M
authors.lastname: Martin
authors.forename: Jesus
authors.initials: J
authors.lastname: García-Donas
authors.forename: Antonio
authors.initials: A
authors.lastname: Casado
authors.forename: Isabel
authors.initials: I
authors.lastname: de la Gándara
authors.forename: Pedro
authors.initials: P
authors.lastname: Pérez-Segura
authors.forename: Jose-Angel
authors.initials: JA
authors.lastname: García-Saenz
authors.forename: Gabriel
authors.initials: G
authors.lastname: Ibáñez
authors.forename: Belen
authors.initials: B
authors.lastname: Loboff
authors.forename: Gemma
authors.initials: G
authors.lastname: García-Ledo
authors.forename: Fernando
authors.initials: F
authors.lastname: Moreno
authors.forename: Enrique
authors.initials: E
authors.lastname: Grande
authors.forename: Eduardo
authors.initials: E
authors.lastname: Diaz-Rubio
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D018943:Anthracyclines / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009503:Neutropenia / Q000139:chemically induced; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D018943:Anthracyclines; D004317:Doxorubicin