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First-line therapy with moderate dose capecitabine in metastatic breast cancer is safe and active: results of the MONICA trial

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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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Main Authors: Kaufmann, Manfred (Author) , Maass, Nicolai (Author) , Costa, Serban-Dan (Author) , Schneeweiss, Andreas (Author) , Loibl, Sibylle (Author) , Sütterlin, Marc (Author) , Schrader, Iris (Author) , Gerber, Bernd (Author) , Bauer, Wolfgang (Author) , Wiest, Wolfgang (Author) , Tomé, Oliver (Author) , Distelrath, Andrea (Author) , Hagen, Volker (Author) , Kleine-Tebbe, Anke (Author) , Ruckhäberle, Eugen (Author) , Mehta, Keyur (Author) , Minckwitz, Gunter von (Author)
Format: Article (Journal)
Language:English
Published: 2010 Aug 24
In: European journal of cancer
Year: 2010, Volume: 46, Issue: 18, Pages: 3184-3191
ISSN:1879-0852
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Author Notes: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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Summary: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.
Item Description:Gesehen am 20.08.2020
Physical Description:Online Resource
ISSN:1879-0852

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