E M Ciruelos1, J Cortés2, H Cortés-Funes3, J I Mayordomo4, B Bermejo5, B Ojeda6, E García7, C A Rodríguez8, M Muñoz9, P Gómez2, L Manso3, R Andrés4, A Lluch5, C Saura2, C Mendiola3, J Baselga2. 1. Medical Oncology Department, University Hospital 12 de Octubre, Madrid. Electronic address: eciruelos@hotmail.com. 2. Medical Oncology Division, Hospital Vall d'Hebron, Barcelona. 3. Medical Oncology Department, University Hospital 12 de Octubre, Madrid. 4. Medical Oncology Division, Hospital Clínico de Zaragoza, Zaragoza. 5. Medical Oncology Division, Hospital Clínico de Valencia, Valencia. 6. Medical Oncology Division, Hospital de Sant Pau, Barcelona. 7. Medical Oncology Division, Hospital Morales Meseguer, Murcia. 8. Medical Oncology Division, Hospital Clínico de Salamanca, Salamanca. 9. Medical Oncology Division, Hospital Clínico de Barcelona, Barcelona, Spain.
Abstract
BACKGROUND: On the basis of clinical activity of capecitabine and gemcitabine for metastatic breast cancer, we carried out a multicenter phase II clinical trial on the combination of these two agents in advanced anthracycline-pretreated breast cancer patients. Main objectives were to assess its efficacy and safety profile. PATIENTS AND METHODS: Seventy-six anthracycline-pretreated breast cancer patients were evaluated and were stratified according to previous treatment of advanced disease (group-1: not previously treated and group-2: previously treated). Study treatment consisted of gemcitabine 1000 mg/m(2), i.v., as 30 min-infusion, days 1 and 8 every 21 days, plus oral capecitabine 830 mg/m(2) b.i.d., days 1-14 every 21 days. RESULTS:Overall response rate was 61% for group-1, 48.5% for group-2 and 55.2% for the whole population. Clinical benefit rate was 73% for group-1, 80% for patients in group-2 and 76% for all patients. Median time to progression was 13.0 months for group-1, 8.2 months for group-2 and 11.1 months for the whole population. Most frequent grade 3-4 observed toxic effects per patient were neutropenia (60%), asymptomatic liver toxicity (13.5%), asthenia (14%) and hand-foot syndrome (16%). Only one patient presented febrile neutropenia. No treatment-related deaths occurred. CONCLUSION: Combination of gemcitabine and capecitabine is an active and safe regimen in anthracycline-pretreated breast cancer patients.
RCT Entities:
BACKGROUND: On the basis of clinical activity of capecitabine and gemcitabine for metastatic breast cancer, we carried out a multicenter phase II clinical trial on the combination of these two agents in advanced anthracycline-pretreated breast cancerpatients. Main objectives were to assess its efficacy and safety profile. PATIENTS AND METHODS: Seventy-six anthracycline-pretreated breast cancerpatients were evaluated and were stratified according to previous treatment of advanced disease (group-1: not previously treated and group-2: previously treated). Study treatment consisted of gemcitabine 1000 mg/m(2), i.v., as 30 min-infusion, days 1 and 8 every 21 days, plus oral capecitabine 830 mg/m(2) b.i.d., days 1-14 every 21 days. RESULTS: Overall response rate was 61% for group-1, 48.5% for group-2 and 55.2% for the whole population. Clinical benefit rate was 73% for group-1, 80% for patients in group-2 and 76% for all patients. Median time to progression was 13.0 months for group-1, 8.2 months for group-2 and 11.1 months for the whole population. Most frequent grade 3-4 observed toxic effects per patient were neutropenia (60%), asymptomatic liver toxicity (13.5%), asthenia (14%) and hand-foot syndrome (16%). Only one patient presented febrile neutropenia. No treatment-related deaths occurred. CONCLUSION: Combination of gemcitabine and capecitabine is an active and safe regimen in anthracycline-pretreated breast cancerpatients.
Authors: S-E Al-Batran; M Güntner; C Pauligk; M Scholz; R Chen; B Beiss; S Stopatschinskaja; W Lerbs; N Harbeck; E Jäger Journal: Br J Cancer Date: 2010-10-26 Impact factor: 7.640
Authors: H J Stemmler; D diGioia; W Freier; H W Tessen; G Gitsch; W Jonat; W Brugger; E Kettner; W Abenhardt; H Tesch; H J Hurtz; S Rösel; O Brudler; V Heinemann Journal: Br J Cancer Date: 2011-03-15 Impact factor: 7.640