First-line therapy with moderate dose capecitabine in metastatic breast cancer is safe and active: results of the MONICA trial
BACKGROUND: To determine activity and safety of capecitabine at a moderate dose of 2000 mg/m(2) as first-line therapy for metastatic breast cancer. - METHODS: In this prospective phase II trial, patients with HER2-negative metastatic breast cancer received first-line capecitabine 2000 mg/m(2) on day...
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| Hauptverfasser: | , , , , , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
2010 Aug 24
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| In: |
European journal of cancer
Year: 2010, Jahrgang: 46, Heft: 18, Pages: 3184-3191 |
| ISSN: | 1879-0852 |
| Online-Zugang: |
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| Verfasserangaben: | M. Kaufmann, N. Maass, S.D. Costa, A. Schneeweiss, S. Loibl, M. W. Sütterlin, I. Schrader, B. Gerber, W. Bauer, W. Wiest, O. Tomé, A. Distelrath, V. Hagen, A. Kleine-Tebbe, E. Ruckhaeberle, K. Mehta, G. von Minckwitz, for the GBG-39 trialists |
MARC
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| 245 | 1 | 0 | |a First-line therapy with moderate dose capecitabine in metastatic breast cancer is safe and active |b results of the MONICA trial |c M. Kaufmann, N. Maass, S.D. Costa, A. Schneeweiss, S. Loibl, M. W. Sütterlin, I. Schrader, B. Gerber, W. Bauer, W. Wiest, O. Tomé, A. Distelrath, V. Hagen, A. Kleine-Tebbe, E. Ruckhaeberle, K. Mehta, G. von Minckwitz, for the GBG-39 trialists |
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| 520 | |a BACKGROUND: To determine activity and safety of capecitabine at a moderate dose of 2000 mg/m(2) as first-line therapy for metastatic breast cancer. - METHODS: In this prospective phase II trial, patients with HER2-negative metastatic breast cancer received first-line capecitabine 2000 mg/m(2) on days 1-14 every 3 weeks. The primary aim was to exclude a time to progression (TTP) <6 months. Secondary end-points were overall response rate, overall survival (OS), toxicity and quality of life. - RESULTS: Median age of the 161 included patients was 65 years. Median TTP and OS were 7.3 months [95% (confidence interval) CI: 6.2-8.4] and 17.1 months (95% CI: 14.0-20.3), respectively. An overall response rate of 26.1%, including 13 complete remissions was observed. Patients developing grade I-III hand-foot syndrome had a significantly longer TTP and OS and patients >65 years also achieved a significantly longer TTP. Haematological grade I-IV toxicities were leucopenia (64.0%), anaemia (50.9%) and thrombocytopenia (28.0%). Relevant non-haematological toxicities were hand-food-syndrome (37.3%), fatigue (34.2%), nausea (29.8%) and diarrhoea (20.5%). Quality of life assessment revealed an improved emotional function, but worsening of nausea and vomiting from cycle 1-10. - CONCLUSIONS: Capecitabine at a dose of 2000 mg/m(2) is active and safe as first-line treatment of patients with metastatic breast cancer. | ||
| 650 | 4 | |a Adult | |
| 650 | 4 | |a Aged | |
| 650 | 4 | |a Aged, 80 and over | |
| 650 | 4 | |a Antimetabolites, Antineoplastic | |
| 650 | 4 | |a Breast Neoplasms | |
| 650 | 4 | |a Breast Neoplasms, Male | |
| 650 | 4 | |a Capecitabine | |
| 650 | 4 | |a Deoxycytidine | |
| 650 | 4 | |a Disease Progression | |
| 650 | 4 | |a Disease-Free Survival | |
| 650 | 4 | |a Female | |
| 650 | 4 | |a Fluorouracil | |
| 650 | 4 | |a Humans | |
| 650 | 4 | |a Male | |
| 650 | 4 | |a Middle Aged | |
| 650 | 4 | |a Neoplasm Metastasis | |
| 650 | 4 | |a Prospective Studies | |
| 650 | 4 | |a Quality of Life | |
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