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

Batista, N (author)
Perez-Manga, G (author)
Constenla, M (author)
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Ruiz, A (author)
Carabantes, F (author)
Castellanos, J (author)
Gonzalez Baron, M (author)
Villman, K (author)
Söderberg, M (author)
Ahlgren, J (author)
Uppsala universitet,Institutionen för onkologi, radiologi och klinisk immunologi,Centrum för klinisk forskning, Gävleborg
Casinello, J (author)
Regueiro, P (author)
Murias, A (author)
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 (creator_code:org_t)
2004
2004
English.
In: Br J Cancer. - 0007-0920. ; 90:9, s. 1740-6
  • Journal article (peer-reviewed)
Abstract Subject headings
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  • 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.

Keyword

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

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