Among women aged 65 or older with operable breast cancer, risk of recurrence and risk of death were higher among those treated with Xeloda® (capecitabine) monotherapy than among those treated with AC or CMF chemotherapy. These were the results of the CALGB/CTSU 49907 trial, presented at the 2008 annual meeting of the American Society of Clinical Oncology (ASCO).

Xeloda is an active agent for the treatment of breast cancer and has the advantage of being administered orally. However, this agent has not been evaluated in the adjuvant setting. Prompted by the relative lack of information about the effects of adjuvant chemotherapy in older breast cancer patients, the CALGB/CTSU 49907 trial compared standard chemotherapy to Xeloda monotherapy in breast cancer patients aged 65 or older.

Study participants were randomized to receive either Xeloda or standard chemotherapy. Those who were randomized to standard chemotherapy received either AC (doxorubicin/cyclophosphamide) or CMF (cyclophosphamide/methotrexate/fluorouracil), based on the choice of their physician.

The study stopped enrollment after the first 633 patients, when it became apparent that Xeloda was unlikely to prove equivalent to standard chemotherapy. Sixty-one percent of patients were age 70 or older, 69% were node-positive, and 66% were hormone receptor-positive. Patients have now been followed for over two years.

• Risk of recurrence and risk of death were roughly two times higher in the Xeloda group than in the standard chemotherapy group.
• In an unplanned subset analysis of women with hormone receptor-negative breast cancer, risk of recurrence and risk of death were five to six times higher in the Xeloda group than in the standard chemotherapy group.

Comments: This study indicates that compared with AC or CMF, Xeloda monotherapy results in a higher risk of recurrence and worse survival among older women with early breast cancer. The benefit of AC or CMF over Xeloda was particularly apparent among women with hormone receptor-negative breast cancer.

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Reference: Muss HB, Berry DL, Cirrincione C et al. Standard chemotherapy (CMF or AC) versus capecitabine in early-stage breast cancer (BC) patients aged 65 and older: Results of CALGB/CTSU 49907. Proceedings from the 44th annual meeting of the American Society of Clinical Oncology. Chicago, IL. 2008. Abstract #507.