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Adding Capecitabine to Breast Cancer Regimen Improves Recurrence-Free Survival, Increases Adverse Events

NEW YORK -- November 10, 2009 -- Addition of capecitabine to a standard chemotherapy regimen for breast cancer improves recurrence-free survival. However, increased adverse events mean treatment with capecitabine is frequently discontinued, according to a study published online first and in the December edition of The Lancet Oncology.

Heikki Joensuu, MD, Helsinki University Central Hospital, Helsinki, Finland, and colleagues conducted a randomised controlled trial in 1,500 women with moderate-to-high risk early breast cancer. The women were assigned to receive either 3 cycles of capecitabine and docetaxel followed by 3 cycles of cyclophosphamide, epirubicin, and capecitabine (capecitabine group; n = 753), or to 3 cycles of docetaxel followed by 3 cycles of cyclophosphamide, epirubicin, and fluorouracil (control group; n = 747).

The primary endpoint was recurrence-free survival. In this study, the authors carried out a planned interim analysis after 3 years' median follow-up.

The team found that recurrence-free survival at 3 years was better with the capecitabine regimen than with control (93% vs 89%). The capecitabine regimen was associated with more cases of grade 3 or 4 diarrhoea (6% vs 3%) and hand-foot syndrome (11% vs <1%) and the control regimen with more occurrences of grade 3 or 4 neutropenia (98% vs 86%) and febrile neutropenia (9% vs 4%). More patients discontinued planned treatment in the capecitabine group (24% vs 3% in the control arm).

"The capecitabine-containing chemotherapy regimen reduced breast cancer recurrence compared with a control schedule of standard agents," the authors wrote. "Capecitabine administration was frequently discontinued because of adverse effects... Our results suggest that integration of capecitabine upfront with potentially synergistic chemotherapeutic agents and into several cycles might be an effective treatment strategy."

"Integration of capecitabine was associated with frequent discontinuation of planned chemotherapy, but most patients could tolerate all 6 scheduled cycles," they concluded. "Studies that focus on further refinement of the current chemotherapy regimen are warranted."

In an accompanying comment, Ruth M. O'Regan. Emory Winship Cancer Institute, Atlanta, Georgia, said: "Although the findings of this trial are not practice-changing, they are intriguing and could merit further assessment in a larger trial. However, the significant toxicity noted with the addition of capecitabine to the taxane-anthracycline backbone dampens enthusiasm for further studies of this approach. More importantly, it is imperative that we take a more rational approach to the treatment of early-stage breast cancer by tailoring our treatment approaches to molecular phenotypes."

SOURCE: The Lancet Oncology

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