For patients with early-stage breast cancer, the addition of zoledronic acid to standard adjuvant therapy does not offer any benefit for disease-free or overall survival, according to a study published in the New England Journal of Medicine to coincide with presentation at the 2011 European Multidisciplinary Cancer Congress, held from Sept. 23 to 27 in Stockholm, Sweden.
Robert E. Coleman, M.B., B.S., M.D, from the University of Sheffield in the United Kingdom, and colleagues investigated whether zoledronic acid treatment in addition to standard adjuvant therapy improves disease outcomes in patients with early-stage breast cancer. A total of 3,360 patients were randomly assigned to receive standard adjuvant systemic therapy with or without zoledronic acid. Zoledronic acid was administered for six doses every three to four weeks, then every three to six months, to complete five years of treatment. The primary end point was disease-free survival, measured during a median follow-up of 59 months.
The investigators found there was no significant difference in the disease-free survival between the groups (77 percent in each group). Disease recurrence or death was observed in 377 and 375 patients in the zoledronic acid and control groups, respectively. The number of deaths was similar in the two groups: 243 and 276 patients in the zoledronic acid and control groups, respectively, with an overall survival rate of 85.4 and 83.1 percent, respectively.
"Our findings do not support the routine use of zoledronic acid as adjuvant therapy in unselected patients with early-stage breast cancer," the authors write.
The study was funded by Novartis Pharmaceuticals.
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