WEDNESDAY, Dec. 7 (HealthDay News) -- Patients with early breast cancer who receive six cycles of standard chemotherapy every two weeks have similar 10-year outcomes to patients who have standard therapy every three weeks, according to the results of a large Italian study published in the Dec. 7 issue of the Journal of the National Cancer Institute.
Marco Venturini, M.D., of the National Cancer Research Institute in Genoa, Italy, and colleagues randomized 1,214 women newly diagnosed with breast cancer to either a regimen of fluorouracil, epirubicin and cyclophosphamide delivered every three weeks (FEC21) or the same regimen plus filgrastim delivered every two weeks (FEC14). Women in both arms of the study underwent six cycles of chemotherapy.
Women in the FEC14 arm had fewer dose reductions or treatment drop-outs (26%) than those receiving FEC21 (33%), despite slightly higher overall toxicity with the dose-dense approach of FEC14. Side effects included asthenia (36%, FEC14; 29%, FEC21), bone pain (33%, FEC14; 4%, FEC21), anemia (38%, FEC14; 19%, FEC21) and thrombocytopenia (8%, FEC14; 2%, FEC21). However, leukopenia occurred in only 12% with FEC14 versus 45% with FEC21. After 10.4 years of follow-up, the hazard of death was 0.87 and recurrence was 0.88, a statistically insignificant difference favoring FEC14 over FEC21.
Despite the lack of survival benefit, dose-dense chemotherapy increases survival for some patients, probably dependent on tumor type, according to editorialists at Dana-Farber Cancer Institute in Boston. More study is needed to determine which patients benefit the most. "If we attempt to apply a single treatment approach across all patients and tumor subtypes, we risk missing a large benefit among a small subset of patients," they write.
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