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

被引:0
|
作者
N Batista
G Perez-Manga
M Constenla
A Ruiz
F Carabantes
J Castellanos
M Gonzalez Barón
K Villman
M Söderberg
J Ahlgren
J Casinello
P Regueiro
A Murias
机构
[1] Hospital Universitario,
[2] Campus de Ofra,undefined
[3] La Laguna,undefined
[4] Hospital Gregorio Marañón,undefined
[5] Hospital Montecelo,undefined
[6] IVO,undefined
[7] Hospital Carlos Haya,undefined
[8] Hospital Xeral Cies,undefined
[9] Hospital La Paz,undefined
[10] Orebro University Hospital,undefined
[11] Central Hospital of Karlstad,undefined
[12] Academic Hospital,undefined
[13] Hospital General,undefined
[14] F. Hoffmann-La Roche,undefined
[15] Hospital Insular,undefined
来源
British Journal of Cancer | 2004年 / 90卷
关键词
capecitabine; paclitaxel; anthracycline; breast cancer; fluoropyrimidines; oral;
D O I
暂无
中图分类号
学科分类号
摘要
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.
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页码:1740 / 1746
页数:6
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