Academic Journal
Randomized, open-label, phase II trial of oral capecitabine (Xeloda(R)) vs. a reference arm of intravenous CMF (cyclophosphamide, methotrexate and 5-fluorouracil) as first-line therapy for advanced/metastatic breast cancer
| العنوان: | Randomized, open-label, phase II trial of oral capecitabine (Xeloda(R)) vs. a reference arm of intravenous CMF (cyclophosphamide, methotrexate and 5-fluorouracil) as first-line therapy for advanced/metastatic breast cancer |
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| المؤلفون: | O'Shaughnessy, J. A., Blum, J., Moiseyenko, V., Jones, S. E., Miles, D., Bell, D., Rosso, R., Mauriac, L., Osterwalder, B., Burger, H.-U., Laws, S. |
| بيانات النشر: | Oxford University Press |
| سنة النشر: | 2001 |
| المجموعة: | HighWire Press (Stanford University) |
| مصطلحات موضوعية: | Original articles |
| الوصف: | Background Oral capecitabine was evaluated in terms of overall response rate, safety, and tolerability as first-line therapy in women aged ≥55 years with advanced/metastatic breast cancer Patients and methods Ninety-five patients were randomized (2: 1) to either intermittent oral capecitabine 1255 mg/m2 twice daily (two weeks' treatment followed by a one-week rest period) or intravenous CMF (cyclophosphamide, methotrexate, 5-fluorouracil [5-FU]) administered every three weeks Results . The overall response rate in the capecitabine group was 30% (95% confidence interval (95% CI) 19%–43%), including three complete responses (5%) The response rate observed in the CMF group was 16% (95% CI 5%–33%), with no complete responses Median time to disease progression was 4 1 months with capecitabine and 30 months with CMF Survival was similar in the two treatment groups (median 19.6 months with capecitabine, 17 2 months with CMF) The safety profiles were different for capecitabine and CMF However, both regimens were generally well tolerated and treatment interruption and/or dose modification was effective in managing toxicities associated with capecitabine Alopecia and myelosuppression were rare in patients receiving capecitabine while diarrhea and hand-foot syndrome were more common Treatment interruption and/or individual dose adjustment of capecitabine was required in 34% of patients and was generally effective in managing adverse events. Treatment was stopped owing to toxicity in 16% of patients in the capecitabine arm. The incidence of deaths during or within 28 days of stopping study treatment was 8% and 6% in the capecitabine and CMF arms, respectively Conclusions An oral, twice-daily regimen of capecitabine is effective and well tolerated when used as first-line chemotherapy in older patients (≥55 years) with advanced/meta-static breast cancer, and is suitable for outpatient therapy |
| نوع الوثيقة: | text |
| وصف الملف: | text/html |
| اللغة: | English |
| Relation: | http://annonc.oxfordjournals.org/cgi/content/short/12/9/1247; http://dx.doi.org/10.1023/A:1012281104865 |
| DOI: | 10.1023/A:1012281104865 |
| الاتاحة: | http://annonc.oxfordjournals.org/cgi/content/short/12/9/1247 https://doi.org/10.1023/A:1012281104865 |
| Rights: | Copyright (C) 2001, European Society for Medical Oncology |
| رقم الانضمام: | edsbas.FE648993 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1023/A:1012281104865 |
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