title: Safety and efficacy study of metronomic vinorelbine, cyclophosphamide plus capecitabine in metastatic breast cancer: A phase II trial.
abstract: In a phase II study we assessed the safety and efficacy of metronomic oral chemotherapy with vinorelbine, cyclophosphamide capecitabine in patients with metastatic breast cancer, either as first-line (naïve group) or second-line or greater therapy (pre-treated group). Eligible patients had histologically or cytologically proven, hormone-receptor positive metastatic breast cancer. The primary end point was median time to progression (TTP). A total of 43 patients in the naïve group and 65 in the pre-treated group were enrolled. The median TTP was 25.1 months in the naïve group and 11.2 months in the pre-treated group. The most frequently reported grade 2 treatment-related adverse events were leukopenia and hand and foot syndrome. Metronomic combination of cyclophosphamide, capecitabine and vinorelbine showed significant activity and good tolerability in patients hormonal receptor positive, metastatic breast cancer patients.
authors.affiliation: Division of Medical Senology, European Institute of Oncology, 20141 Milan, Italy.
authors.forename: Emilia
authors.initials: E
authors.lastname: Montagna
authors.affiliation: Division of Medical Senology, European Institute of Oncology, 20141 Milan, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: Palazzo
authors.affiliation: Division of Epidemiology and Biostatistics, European Institute of Oncology, 20141 Milan, Italy.
authors.forename: Patrick
authors.initials: P
authors.lastname: Maisonneuve
authors.affiliation: Division of Medical Senology, European Institute of Oncology, 20141 Milan, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Cancello
authors.affiliation: Division of Medical Senology, European Institute of Oncology, 20141 Milan, Italy.
authors.forename: Monica
authors.initials: M
authors.lastname: Iorfida
authors.affiliation: Division of Medical Senology, European Institute of Oncology, 20141 Milan, Italy.
authors.forename: Angela
authors.initials: A
authors.lastname: Sciandivasci
authors.affiliation: Division of Early Drugs Development, European Institute of Oncology, 20141 Milan, Italy.
authors.forename: Angela
authors.initials: A
authors.lastname: Esposito
authors.affiliation: Division of Medical Senology, European Institute of Oncology, 20141 Milan, Italy.
authors.forename: Anna
authors.initials: A
authors.lastname: Cardillo
authors.affiliation: Division of Medical Senology, European Institute of Oncology, 20141 Milan, Italy.
authors.forename: Manuelita
authors.initials: M
authors.lastname: Mazza
authors.affiliation: Division of Medical Senology, European Institute of Oncology, 20141 Milan, Italy.
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Munzone
authors.affiliation: Palliative Care, Sassari, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: Lai
authors.affiliation: Department of Medicine, European Institute of Oncology, 20141 Milan, Italy.
authors.forename: Aron
authors.initials: A
authors.lastname: Goldhirsch
authors.affiliation: Division of Medical Senology, European Institute of Oncology, 20141 Milan, Italy. Electronic address: marco.colleoni@ieo.it.
authors.forename: Marco
authors.initials: M
authors.lastname: Colleoni
mesh_terms: D059250:Administration, Metronomic; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000069287:Capecitabine / Q000008:administration & dosage* / Q000009:adverse effects; D003520:Cyclophosphamide / Q000008:administration & dosage* / Q000009:adverse effects; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D015999:Multivariate Analysis; D009362:Neoplasm Metastasis; D016016:Proportional Hazards Models; D013997:Time Factors; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D000069287:Capecitabine; D003520:Cyclophosphamide; D000077235:Vinorelbine
keywords: Breast cancer; Metronomic; Vinorelbine