Phase II study of capecitabine in combination with paclitaxel in patients with anthracycline-pretreated advanced/metastatic breast cancer
| Autor: | F Carabantes, A Murias, Manuel Constenla, P Regueiro, G Perez-Manga, M Söderberg, J Castellanos, Anna Ruiz, Kenneth Villman, M. González Barón, J Casinello, N Batista, J Ahlgren |
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| Rok vydání: | 2004 |
| Předmět: |
Adult
Oncology Cancer Research medicine.medical_specialty Adolescent Maximum Tolerated Dose Paclitaxel Population Antineoplastic Agents Breast Neoplasms Neutropenia anthracycline fluoropyrimidines Deoxycytidine Capecitabine Clinical oral breast cancer Breast cancer Internal medicine Antineoplastic Combined Chemotherapy Protocols Humans Medicine Anthracyclines education Survival rate Aged education.field_of_study business.industry capecitabine Middle Aged medicine.disease Metastatic breast cancer Survival Rate Treatment Outcome Docetaxel Fluorouracil Disease Progression Female business medicine.drug |
| Zdroj: | British Journal of Cancer |
| ISSN: | 1532-1827 0007-0920 |
| DOI: | 10.1038/sj.bjc.6601784 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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