The addition of capecitabine to a chemotherapy regimen
containing standard agents reduced the incidence of breast cancer recurrence
but yielded a higher rate of discontinuance because of adverse effects.
Researchers conducted an open-label trial in which 1,500
women with axillary node–positive or high-risk node-negative breast cancer
were randomly assigned to three cycles of capecitabine (Xeloda, Hoffmann La
Roche) and docetaxel followed by three cycles of cyclophosphamide, epirubicin
and capecitabine (n=753) or to three cycles of docetaxel followed by three
cycles of cyclophosphamide, epirubicin and fluorouracil (n=747). The
researchers excluded two patients from each group after they withdrew consent
or because of distant metastases.
Median follow-up was 35 months. Three-year
recurrence-free survival was 93% for patients assigned to the capecitabine
regimen vs. 89% for those assigned to standard agents only (P=.020).
Patients assigned to the capecitabine regimen experienced more cases of grade-3
or -4 diarrhea (6% vs. 3%) and hand–foot syndrome (11% vs. <1%).
Patients assigned to the standard-agent regimen reported more cases of grade-3
or -4 neutropenia (98% vs. 86%) and febrile neutropenia (9% vs. 4%).
Twenty-four percent of patients in the capecitabine
group discontinued treatment compared with 3% of patients in the standard-agent
regimen group. Four patients assigned to the capecitabine regimen and two
assigned to the standard-agent regimen died from causes that the researchers
said were potentially treatment related.
In an accompanying “Reflection and Reaction”
piece, Ruth M. O’Regan, MD, of the department of hematology and
medical oncology at Emory Winship Cancer Institute in Atlanta, said these
findings are not practice changing but 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,” O’Regan added.
“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.”
Joensuu H. Lancet Oncol.
2009;doi:10.1016/S1470-2045(09)70307-9.
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