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

• Published in: British journal of cancer 2004-05, Vol.90 (9), p.1740-1746
• Main Authors: Batista, N, Perez-Manga, G, Constenla, M, Ruiz, A, Carabantes, F, Castellanos, J, Gonzalez Barón, M, Villman, K, Söderberg, M, Ahlgren, J, Casinello, J, Regueiro, P, Murias, A
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Anthracyclines - therapeutic use; Antineoplastic Agents - therapeutic use; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Antineoplastic Combined Chemotherapy Protocols/adverse effects/therapeutic use; Biological and medical sciences; Biomedical and Life Sciences; Biomedicine; Breast Neoplasms - drug therapy; Breast Neoplasms - mortality; Breast Neoplasms/drug therapy/mortality; Cancer Research; Capecitabine; Clinical; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Deoxycytidine/administration & dosage/adverse effects/analogs & derivatives; Disease Progression; Drug Resistance; Epidemiology; Female; Fluorouracil - analogs & derivatives; Gynecology. Andrology. Obstetrics; Humans; Mammary gland diseases; Maximum Tolerated Dose; Medical sciences; Middle Aged; Molecular Medicine; Oncology; Paclitaxel - administration & dosage; Paclitaxel - adverse effects; Paclitaxel/administration & dosage/adverse effects; Survival Rate; Treatment Outcome; Tumors
• ISSN: 0007-0920; 1532-1827
• DOI: 10.1038/sj.bjc.6601784

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.