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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/m(2) twice daily for 14 of every 21 days; n = 107) or continuously (650 mg/m(2) twice daily for 21 of every 21 days; n = 107), or to classical CMF (oral cyclophosphamide 100 mg/m(2) days 1 to 14 with intravenous methotrexate 40 mg/m(2) and fluorouracil 600 mg/m(2) 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.

Purpose: Many women who have had adjuvant chemotherapy for early breast cancer judge small benefits sufficient to make it worthwhile despite significant side effects and inconvenience. The rationality of these preferences has been questioned. We sought to better understand such preferences by assessing associations between preferences and psychosocial factors, and by asking women who judged negligible benefits sufficient to explain why., Methods: We recruited 83 consecutive consenting women who had completed adjuvant chemotherapy for early breast cancer 3-34 months earlier. Preferences were elicited during a structured, scripted interview using four sets of validated, hypothetical trade-off scenarios about the possible benefits of adjuvant chemotherapy on survival times (5 and 15 years) and rates (65 and 85% at 5 years). Women completed questionnaires measuring anxiety, depression, optimism, quality and quantity of social support, and illness perceptions., Results: More than half the women judged benefits of 1 day or 0.1% sufficient to make adjuvant chemotherapy worthwhile. The most important factors in multivariable models were whether the woman had dependants and number of non-specific symptoms attributed to breast cancer and adjuvant chemotherapy since completing treatment. The proportion of variance explained was modest. Preferences were not associated with: scores for anxiety, optimism, and perceived quality and quantity of social support. Explanations for judging negligible benefits sufficient included minimising regret, parenting concerns, doubts about the information provided and feeling that they had no choice., Conclusions: Preferences were highly variable and influenced by women's unique circumstances and attitudes, but not by their anxiety or optimism scores., (Copyright 2006 John Wiley & Sons, Ltd.)

The use of taxanes in early breast cancer is increasing. However, there are few mature studies of taxanes in this setting, and their role is uncertain. Our systematic review of randomised trials of adjuvant or neoadjuvant systemic therapy identified ten reported trials comparing a taxane-containing group with a non-taxane-containing control group in women with early breast cancer. Four of five neoadjuvant trials showed higher rates of complete response with taxanes, although differences were not significant. All five adjuvant trials showed improvements in disease-free survival with taxanes, and these improvements were significant in three trials and independent of oestrogen-receptor status. Two trials showed a significant improvement in overall survival. These results support the use of adjuvant taxanes in women with early breast cancer and involved lymph nodes. Longer follow-up of these trials and results from continuing trials are needed to clarify the best use of taxanes in early breast cancer.