Phase II study of capecitabine in combination with paclitaxel in patients with anthracycline-pretreated advanced/metastatic breast cancer.

• 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.

Nyckelord

Adolescent

Adult

Aged

Anthracyclines/therapeutic use

Antineoplastic Agents/therapeutic use

Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use

Breast Neoplasms/*drug therapy/mortality

Deoxycytidine/administration & dosage/adverse effects/*analogs & derivatives

Disease Progression

Female

Humans

Maximum Tolerated Dose

Middle Aged

Paclitaxel/administration & dosage/adverse effects

Survival Rate

Treatment Outcome

Publikations- och innehållstyp

ref (ämneskategori)

art (ämneskategori)