1. Home>
2. Specialties>
3. Oncology and Hematology>
4. Summary and Comment

Adjuvant Chemotherapy in Older Patients with Breast Cancer

Capecitabine was inferior to standard chemotherapy.

Older breast cancer patients who have concurrent illnesses and declining performance status can experience greater toxicity from adjuvant chemotherapy than younger patients. Might a more "user-friendly" chemotherapy program be as effective as conventional adjuvant chemotherapy? To answer this question, investigators conducted an industry-supported, prospective randomized trial of the oral fluorouracil prodrug capecitabine (Xeloda) in patients with early-stage breast cancer (stage I–III; age, 65).

Patients were randomly assigned to 6 cycles of capecitabine (2 g/m² daily for 14 consecutive days every 3 weeks) or to one of two standard chemotherapy regimens (6 cycles of cyclophosphamide, methotrexate, and 5-fluorouracil or 4 cycles of doxorubicin and cyclophosphamide). The trial allowed for dose escalation of capecitabine to 2.5 g/m² daily; however, this strategy was abandoned because of unacceptable toxicity. The primary endpoint was relapse-free survival.

After 600 patients were enrolled, enrollment was discontinued because capecitabine was deemed highly likely to be inferior to standard adjuvant chemotherapy. At median follow-up of 2.4 years, rates of relapse and death were nearly twice as high in the capecitabine group as in either standard chemotherapy group. Estimates of 3-year survival rates were higher for those who received standard chemotherapy than for those who received capecitabine (85% vs. 68%). Two patients who received capecitabine died of treatment-related side effects.

Comment: Current data support the use of standard adjuvant chemotherapy regimens for treating older women who have early-stage breast cancer. Ad hoc treatment programs, which might be less effective, also could be associated with unexpected toxicities.

— William J. Gradishar, MD

Published in Journal Watch Oncology and Hematology May 13, 2009

Citation(s):

Muss HB et al. Adjuvant chemotherapy in older women with early-stage breast cancer. N Engl J Med 2009 May 14; 360:2055.

• Original article (Subscription may be required)
• Medline abstract (Free)