title: Phase II study of capecitabine in combination with paclitaxel in patients with anthracycline-pretreated advanced/metastatic breast cancer.
abstract: The addition of oral capecitabine to docetaxel improves response rate, time to progression (TTP) and overall survival in anthracycline-pretreated metastatic breast cancer (MBC). This phase II study evaluates the efficacy and safety of a 21-day cycle of oral capecitabine (1000 mg m(-2) twice daily, days 1-14) plus i.v. paclitaxel (175 mg m(-2), day 1) in anthracycline-pretreated advanced/MBC. In all, 73 patients were enrolled at 13 Swedish and Spanish centres. The objective response rate was 52% (95% confidence interval (CI): 40-63%) in the intent-to-treat population, including complete responses in 11%. Disease was stabilised in a further 29%. The median time to disease progression (TTP) was 8.1 months and the median overall survival was 16.5 months. The combination was generally well tolerated with a predictable safety profile. The most common treatment-related nonhaematological adverse events were hand-foot syndrome (42%), alopecia (30%) and diarrhoea (26%). The only treatment-related Grade 3/4 adverse events occurring in >5% of patients were alopecia (22%) and hand-foot syndrome (11%). Grade 3/4 neutropenia and lymphocytopenia were reported in 12 and 14% of patients, respectively. Capecitabine plus paclitaxel is highly active with a favourable safety profile in anthracycline-pretreated MBC.
authors.affiliation: Hospital Universitario, Campus de Ofra, La Laguna, Tenerife E-38320, Spain. nbatista@ull.es
authors.forename: N
authors.initials: N
authors.lastname: Batista
authors.forename: G
authors.initials: G
authors.lastname: Perez-Manga
authors.forename: M
authors.initials: M
authors.lastname: Constenla
authors.forename: A
authors.initials: A
authors.lastname: Ruiz
authors.forename: F
authors.initials: F
authors.lastname: Carabantes
authors.forename: J
authors.initials: J
authors.lastname: Castellanos
authors.forename: M
authors.initials: M
authors.lastname: Gonzalez Barón
authors.forename: K
authors.initials: K
authors.lastname: Villman
authors.forename: M
authors.initials: M
authors.lastname: Söderberg
authors.forename: J
authors.initials: J
authors.lastname: Ahlgren
authors.forename: J
authors.initials: J
authors.lastname: Casinello
authors.forename: P
authors.initials: P
authors.lastname: Regueiro
authors.forename: A
authors.initials: A
authors.lastname: Murias
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D018450:Disease Progression; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D006801:Humans; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D018943:Anthracyclines; D000970:Antineoplastic Agents; D003841:Deoxycytidine; D000069287:Capecitabine; D017239:Paclitaxel; D005472:Fluorouracil