First-line therapy with moderate dose capecitabine in metastatic breast cancer is safe and active

• Verfasst von: Kaufmann, Manfred [VerfasserIn]
• Verfasst von: Maass, Nicolai [VerfasserIn]
• Verfasst von: Costa, Serban-Dan [VerfasserIn]
• Verfasst von: Schneeweiss, Andreas [VerfasserIn]
• Verfasst von: Loibl, Sibylle [VerfasserIn]
• Verfasst von: Sütterlin, Marc [VerfasserIn]
• Verfasst von: Schrader, Iris [VerfasserIn]
• Verfasst von: Gerber, Bernd [VerfasserIn]
• Verfasst von: Bauer, Wolfgang [VerfasserIn]
• Verfasst von: Wiest, Wolfgang [VerfasserIn]
• Verfasst von: Tomé, Oliver [VerfasserIn]
• Verfasst von: Distelrath, Andrea [VerfasserIn]
• Verfasst von: Hagen, Volker [VerfasserIn]
• Verfasst von: Kleine-Tebbe, Anke [VerfasserIn]
• Verfasst von: Ruckhäberle, Eugen [VerfasserIn]
• Verfasst von: Mehta, Keyur [VerfasserIn]
• Verfasst von: Minckwitz, Gunter von [VerfasserIn]
• Titel: First-line therapy with moderate dose capecitabine in metastatic breast cancer is safe and active
• Titelzusatz: results of the MONICA trial
• Verf.angabe: 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
• E-Jahr: 2010
• Jahr: 2010 Aug 24
• Umfang: 8 S.
• Fussnoten: Gesehen am 20.08.2020
• Titel Quelle: Enthalten in: European journal of cancer
• Ort Quelle: Amsterdam [u.a.] : Elsevier, 1992
• Jahr Quelle: 2010
• Band/Heft Quelle: 46(2010), 18, Seite 3184-3191
• ISSN Quelle: 1879-0852
• DOI: doi:10.1016/j.ejca.2010.07.009
• Datenträger: Online-Ressource
• Sprache: eng
• Bibliogr. Hinweis: Erscheint auch als : Druck-Ausgabe: Kaufmann, Manfred, 1946 - : First-line therapy with moderate dose capecitabine in metastatic breast cancer is safe and active. - 2010
• Sach-SW: Adult
• Sach-SW: Aged
• Sach-SW: Aged, 80 and over
• Sach-SW: Antimetabolites, Antineoplastic
• Sach-SW: Breast Neoplasms
• Sach-SW: Breast Neoplasms, Male
• Sach-SW: Capecitabine
• Sach-SW: Deoxycytidine
• Sach-SW: Disease Progression
• Sach-SW: Disease-Free Survival
• Sach-SW: Female
• Sach-SW: Fluorouracil
• Sach-SW: Humans
• Sach-SW: Male
• Sach-SW: Middle Aged
• Sach-SW: Neoplasm Metastasis
• Sach-SW: Prospective Studies
• Sach-SW: Quality of Life
• K10plus-PPN: 1727525000

Abstract

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.