First-line therapy with moderate dose capecitabine in metastatic breast cancer is safe and active : results of the MONICA trial / 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
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..
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2010 Aug 24 2010 |
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| Erschienen: |
2010 Aug 24 |
| Weitere Ausgaben: |
Erscheint auch als Druck-Ausgabe: First-line therapy with moderate dose capecitabine in metastatic breast cancer is safe and active |
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| Enthalten in: |
Zur Gesamtaufnahme - volume:46 |
| Enthalten in: |
European journal of cancer - 46(2010), 18, Seite 3184-3191 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Kaufmann, Manfred, 1946- [VerfasserIn] |
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| Anmerkungen: |
Gesehen am 20.08.2020 |
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| Umfang: |
8 |
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| doi: |
10.1016/j.ejca.2010.07.009 |
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| funding: |
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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. | ||
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