BACKGROUND: A retrospective source review identifying predictive factors and assessing safety and efficacy in pretreated metastatic breast cancer (MBC) patients treated with capecitabine in a French compassionate-use program. PATIENTS AND METHODS: 197 patients received capecitabine at an initial total dose 0.25-3.0 g/m2/day, twice daily for 14 consecutive days, every 3 weeks. RESULTS: Median patient age was 56 years (range, 31-88), 19% had performance status (PS) 3-4. Prior palliative and adjuvant treatment was reported in 96 and 61% of patients respectively. Best overall response rate (ORR) was 15% (95% confidence interval [CI], 11-21%) and 49% had benefit (CR, PR or SD). Median time to progression (TTP) and overall survival were 4.8 and 14.7 months, respectively. Median TTP in responders was 8.9 months (95%CI 6.1-11.7). Grade 3/4 neutropenia and grade 3 thrombocytopenia occurred in 8 and 3% of patients respectively. Hand-foot syndrome (grade 3/4 in 16% of patients), diarrhea, stomatitis and asthenia were prevalent. Multivariate analysis showed ORR was significantly influenced by PS > or = 2 (p = 0.004), time from metastases diagnosis to capecitabine treatment (p = 0.015) and presence of liver metastases at inclusion (p = 0.047). Abnormal liver function tests at baseline were associated with severe thrombocytopenia and anemia. Four treatment-related deaths occurred. CONCLUSION: Capecitabine is active in heavily pretreated MBC patients and has a favorable toxicity profile with the added advantage of being an oral drug administered in an outpatient setting.
BACKGROUND: A retrospective source review identifying predictive factors and assessing safety and efficacy in pretreated metastatic breast cancer (MBC) patients treated with capecitabine in a French compassionate-use program. PATIENTS AND METHODS: 197 patients received capecitabine at an initial total dose 0.25-3.0 g/m2/day, twice daily for 14 consecutive days, every 3 weeks. RESULTS: Median patient age was 56 years (range, 31-88), 19% had performance status (PS) 3-4. Prior palliative and adjuvant treatment was reported in 96 and 61% of patients respectively. Best overall response rate (ORR) was 15% (95% confidence interval [CI], 11-21%) and 49% had benefit (CR, PR or SD). Median time to progression (TTP) and overall survival were 4.8 and 14.7 months, respectively. Median TTP in responders was 8.9 months (95%CI 6.1-11.7). Grade 3/4 neutropenia and grade 3 thrombocytopenia occurred in 8 and 3% of patients respectively. Hand-foot syndrome (grade 3/4 in 16% of patients), diarrhea, stomatitis and asthenia were prevalent. Multivariate analysis showed ORR was significantly influenced by PS > or = 2 (p = 0.004), time from metastases diagnosis to capecitabine treatment (p = 0.015) and presence of liver metastases at inclusion (p = 0.047). Abnormal liver function tests at baseline were associated with severe thrombocytopenia and anemia. Four treatment-related deaths occurred. CONCLUSION:Capecitabine is active in heavily pretreated MBCpatients and has a favorable toxicity profile with the added advantage of being an oral drug administered in an outpatient setting.
Authors: Juan Bayo; María Lomas; Javier Salvador; Alberto Moreno; Manuel Ruiz; Alberto Rodríguez; José Fuentes; Ana Fernández-Freire; Reyes Bernabé; Andrea Fernández Journal: Clin Transl Oncol Date: 2008-12 Impact factor: 3.405
Authors: Olukayode A Arowolo; Uchenna O Njiaju; Temidayo O Ogundiran; Oyewale Abidoye; Olukayode O Lawal; Millicent Obajimi; Adebayo V Adetiloye; Hae K Im; Akinbolaji A Akinkuolie; Abideen Oluwasola; Kayode Adelusola; Adesunkanmi A Kayode; Augustine E Agbakwuru; Helen Oduntan; Chinedum P Babalola; Gini Fleming; Olusola C Olopade; Adeyinka Gladys Falusi; Muheez A Durosinmi; Olufunmilayo I Olopade Journal: Breast J Date: 2013-07-19 Impact factor: 2.431