medwireNews: Adjuvant treatment with a capecitabine-containing chemotherapy regimen could improve the overall survival (OS) of patients with early breast cancer, suggest long-term follow-up data from the phase 3 FinXX trial.
After a median 15 years of follow-up, the OS rate was 77.6% for the 751 patients with axillary node-positive or high-risk node-negative disease who were randomly assigned to receive three cycles of docetaxel plus capecitabine followed by three cycles of cyclophosphamide, epirubicin, and capecitabine.
This was significantly higher than the 73.3% rate observed among the 744 participants who instead received three cycles of docetaxel followed by three cycles of cyclophosphamide, epirubicin, and fluorouracil, and equated to a “statistically significant, but modest” 19% reduction in the risk for death with capecitabine, report the researchers.
They continue: “The earlier analyses of FinXX on the basis of a median follow-up time of about 5 years and 10 years did not find integration of capecitabine with standard chemotherapy to prolong OS statistically significantly, although the HRs [hazard ratios] for OS (0.73 and 0.84, respectively) do not differ markedly from the HR found in the current analysis (0.81).
“This suggests that the study, powered for [recurrence-free survival], did not have sufficient power for assessing OS in the previous analyses with shorter follow-up times, leading to a premature conclusion that addition of capecitabine does not prolong OS.”
Predefined exploratory subgroup analyses showed that the greatest OS benefit with capecitabine-containing treatment was derived by patients with estrogen receptor-, HER2-, or triple-negative disease, with respective HRs for death of 0.67, 0.79, and 0.59 relative to the control regimen.
“[B]ut the subgroup analyses need to be interpreted with caution,” note Heikki Joensuu (Helsinki University Hospital and University of Helsinki, Finland) and co-investigators in the Journal of Clinical Oncology.
The team says in conclusion that “adjuvant capecitabine-containing chemotherapy could be considered as an option for some patients with early breast cancer.”
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