Phase II study of capecitabine in combination with paclitaxel in patients with anthracycline-pretreated advanced/metastatic breast cancer.
2004 (English)In: Br J Cancer, ISSN 0007-0920, Vol. 90, no 9, 1740-6 p.Article in journal (Refereed) Published
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.
Place, publisher, year, edition, pages
2004. Vol. 90, no 9, 1740-6 p.
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
IdentifiersURN: urn:nbn:se:uu:diva-81295PubMedID: 15150624OAI: oai:DiVA.org:uu-81295DiVA: diva2:109210