Randomized, open-label, phase II trial of oral capecitabine (Xeloda®) vs. a reference arm of intravenous CMF (cyclophosphamide, methotrexate and 5-fluorouracil) as first-line therapy for advanced/metastatic breast cancer

• Published in: Annals of oncology Vol. 12; no. 9; pp. 1247 - 1254
• Main Authors: O'Shaughnessy, J. A., Blum, J., Moiseyenko, V., Jones, S. E., Miles, D., Bell, D., Rosso, R., Mauriac, L., Osterwalder, B., Burger, H.-U., Laws, S.
• Format: Journal Article
• Language: English; Russian
• Published: Oxford Oxford University Press 01.09.2001
• Subjects: Administration, Oral; Aged; Aged, 80 and over; Antimetabolites, Antineoplastic - administration & dosage; Antimetabolites, Antineoplastic - adverse effects; Antimetabolites, Antineoplastic - pharmacology; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; breast cancer; Breast Neoplasms - drug therapy; Breast Neoplasms - pathology; Capecitabine; CMF; Cyclophosphamide - administration & dosage; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Deoxycytidine - pharmacology; Diarrhea - chemically induced; Disease Progression; Female; first-line; Fluorouracil - administration & dosage; Humans; Infusions, Intravenous; Methotrexate - administration & dosage; Middle Aged; Neoplasm Metastasis; oral fluoropyrimidine; Peripheral Nervous System Diseases - chemically induced; Survival Analysis; Treatment Outcome
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1023/A:1012281104865

Summary Background Oral capecitabine was evaluated in terms of overall response rate, safety, and tolerability as first-line therapy in women aged ≥55 years with advanced/metastatic breast cancer Patients and methods Ninety-five patients were randomized (2: 1) to either intermittent oral capecitabine 1255 mg/m2 twice daily (two weeks' treatment followed by a one-week rest period) or intravenous CMF (cyclophosphamide, methotrexate, 5-fluorouracil [5-FU]) administered every three weeks Results. The overall response rate in the capecitabine group was 30% (95% confidence interval (95% CI) 19%–43%), including three complete responses (5%) The response rate observed in the CMF group was 16% (95% CI 5%–33%), with no complete responses Median time to disease progression was 4 1 months with capecitabine and 30 months with CMF Survival was similar in the two treatment groups (median 19.6 months with capecitabine, 17 2 months with CMF) The safety profiles were different for capecitabine and CMF However, both regimens were generally well tolerated and treatment interruption and/or dose modification was effective in managing toxicities associated with capecitabine Alopecia and myelosuppression were rare in patients receiving capecitabine while diarrhea and hand-foot syndrome were more common Treatment interruption and/or individual dose adjustment of capecitabine was required in 34% of patients and was generally effective in managing adverse events. Treatment was stopped owing to toxicity in 16% of patients in the capecitabine arm. The incidence of deaths during or within 28 days of stopping study treatment was 8% and 6% in the capecitabine and CMF arms, respectively Conclusions An oral, twice-daily regimen of capecitabine is effective and well tolerated when used as first-line chemotherapy in older patients (≥55 years) with advanced/meta-static breast cancer, and is suitable for outpatient therapy