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: Kaufmann, Manfred (VerfasserIn) , Maass, Nicolai (VerfasserIn) , Costa, Serban-Dan (VerfasserIn) , Schneeweiss, Andreas (VerfasserIn) , Loibl, Sibylle (VerfasserIn) , Sütterlin, Marc (VerfasserIn) , Schrader, Iris (VerfasserIn) , Gerber, Bernd (VerfasserIn) , Bauer, Wolfgang (VerfasserIn) , Wiest, Wolfgang (VerfasserIn) , Tomé, Oliver (VerfasserIn) , Distelrath, Andrea (VerfasserIn) , Hagen, Volker (VerfasserIn) , Kleine-Tebbe, Anke (VerfasserIn) , Ruckhäberle, Eugen (VerfasserIn) , Mehta, Keyur (VerfasserIn) , Minckwitz, Gunter von (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: 2010 Aug 24
In: European journal of cancer
Year: 2010, Jahrgang: 46, Heft: 18, Pages: 3184-3191
ISSN:1879-0852
Online-Zugang: Volltext
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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