title: Intravenous versus oral vinorelbine plus capecitabine as second-line treatment in advanced breast cancer patients. A retrospective comparison of two consecutive phase II studies.
abstract: Vinorelbine (i.v.) plus capecitabine (oral) combination therapy is active in anthracycline/taxane pretreated patients with metastatic breast cancer. Availability of oral vinorelbine provides this combination in an all-oral formulation. Two consecutive phase II trials differing only in vinorelbine administration routes evaluated their respective activities and tolerabilities in this population. In the i.v. group (n = 38) disease control was 61% (37% PR, 24% SD), median TTP 6.8 months and median survival 11.3 months. In the oral group (n = 38) disease control was 77% (5.4% CR, 34% PR, 38% SD), median TTP 7 months and median survival 10 months. G3-G4 neutropenia was more common in the oral group (p < 0.05); G2-G3 anaemia [5] and G3 thrombocytopenia [1] were observed only in the oral group. Although the comparison between the two regimens was not randomized, the results observed in these two consecutive phase II studies may suggest that oral and iv vinorelbine, in combination with capecitabine, can achieve similar responses in patients with metastatic breast cancer refractory to anthra-taxane combinations.
authors.affiliation: Medical Oncology Unit, Vito Fazzi Hospital, Lecce, Italy. vitolorusso@inwind.it
authors.forename: Vito
authors.initials: V
authors.lastname: Lorusso
authors.forename: Saverio
authors.initials: S
authors.lastname: Cinieri
authors.forename: Marianna
authors.initials: M
authors.lastname: Giampaglia
authors.forename: Mariangela
authors.initials: M
authors.lastname: Ciccarese
authors.forename: Andrea
authors.initials: A
authors.lastname: Tinelli
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Chiuri
authors.forename: Corrado
authors.initials: C
authors.lastname: Manca
authors.forename: Nicola
authors.initials: N
authors.lastname: Silvestris
authors.forename: Giampiero
authors.initials: G
authors.lastname: Gasparini
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Colucci
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D000069287:Capecitabine; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004359:Drug Therapy, Combination; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D000970:Antineoplastic Agents; D003841:Deoxycytidine; D014747:Vinblastine; D000069287:Capecitabine; D000077235:Vinorelbine; D005472:Fluorouracil