- Title
- Capecitabine versus classical cyclophosphamide, methotrexate, and fluorouracil as first-line chemotherapy for advanced breast cancer
- Creator
- Stockler, Martin R.; Harvey, Vernon J.; Gainford, M. Corona; Fong, Akiko; Paksec, Lisa; Sourjina, Tatiana; Zannino, Diana; Gebski, Val; Simes, R. John; Forbes, John F.; Coates, Alan S.; Francis, Prudence A.; Byrne, Michael J.; Ackland, Stephen P.; Fitzharris, Bernie; Van Hazel , Guy; Wilcken, Nicholas R. C.; Grimison, Peter S.; Nowak, Anna K.
- Relation
- Journal of Clinical Oncology Vol. 29, Issue 34, p. 4498-4504
- Publisher Link
- http://dx.doi.org/10.1200/jco.2010.33.9101
- Publisher
- American Society of Clinical Oncology
- Resource Type
- journal article
- Date
- 2011
- Description
- Purpose: We compared oral capecitabine, administered intermittently or continuously, versus classical cyclophosphamide, methotrexate, and fluorouracil (CMF) as first-line chemotherapy for women with advanced breast cancer unsuited to more intensive regimens. Patients and Methods: Three hundred twenty-three eligible women were randomly assigned to capecitabine administered intermittently (1,000 mg/m2 twice daily for 14 of every 21 days; n = 107) or continuously (650 mg/m2 twice daily for 21 of every 21 days; n = 107), or to classical CMF (oral cyclophosphamide 100 mg/m2 days 1 to 14 with intravenous methotrexate 40 mg/m2 and fluorouracil 600 mg/m2 on days 1 and 8 every 28 days; n = 109). The primary end point was quality-adjusted progression-free survival (PFS); secondary end points included PFS, overall survival (OS), objective tumor response, and adverse events. Intermittent and continuous capecitabine were to be compared first and, if similar (P > .05), combined for definitive comparisons versus CMF. Results: Quality-adjusted PFS (P = .2), objective tumor response rate (20%; P = .8), and PFS (median, 6 months; hazard ratio [HR], 0.86; 95% CI, 0.67 to 1.10; P = .2) were similar in women assigned capecitabine versus CMF. OS was longer in women assigned capecitabine rather than CMF (median, 22 v 18 months; HR, 0.72; 95% CI, 0.55 to 0.94; P = .02). Febrile neutropenia, infection, stomatitis, and serious adverse events were more common with CMF; hand-foot syndrome was more common with capecitabine. Conclusion: Capecitabine improved OS by being similarly active, less toxic, and more tolerable than CMF. Capecitabine is a good first-line chemotherapy option for women with advanced breast cancer who are unsuited to more intensive regimens.
- Subject
- capecitabine; cyclophosphamide; methotrexate; fluorouracil; chemotherapy; breast cancer
- Identifier
- http://hdl.handle.net/1959.13/1036415
- Identifier
- uon:13278
- Identifier
- ISSN:0732-183X
- Language
- eng
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