LENOGRASTIM PREVENTS MORBIDITY FROM INTENSIVE INDUCTION CHEMOTHERAPY IN THE TREATMENT OF INFLAMMATORY BREAST-CANCER

Purpose: To compare the efficacy and safety of recombinant human granu locyte colony-stimulating factor (rHuG-CSF) versus its inert vehicle i n patients with unilateral nonmetastatic inflammatory breast cancer tr eated with fluorourocil, epirubicin, and cyclophosphamide high dose (F EC-HD) neoadjuvant chemotherapy.Patients and Methods: One hundred twen ty patients have been enrolled by nine French centers in this double-b lind, parallel-group, vehicle-controlled study to compare at each cycl e subcutaneous lenograstim (5 mu g/kg/d) with placebo given from day 6 to day 15 after the induction chemotherapy (day 1 to day 4, fluoroura cil 750 mg/m(2) continuous intravenous [IV] infusion; day 2 to day 4, epirubicin 35 mg/m(2) and cyclophosphamide 400 mg/m(2) both IV push), Four cycles were planned every 3 weeks before locoregional treatment. patients with febrile neutropenia remained blinded for the subsequent cycles. Results: Lenograstim significantly reduced the duration of neu tropenia at less than 0.5 x 10(9)/L and less than 1 x 10(9)/L. to a me dian duration of 2 and 3 days, respectively, as compared with 5 and 7 days in the placebo group. This translated into a statistically signif icant reduced incidence of microbiologically documented infections, an d a decreased need for rehospitalizations for infectious events and an tibiotic use. Clinical objective tumor response rate observed after fo ur cycles wets 89.6% and 93%, respectively, in the placebo and treated groups. Mild transient bone and injection-site pain, myelemia, and hy perleukocytosis were the most frequently reported adverse events assoc iated with lenograstim. Conclusion: Lenograstim is safe and effective to reduce morbidity associated with FEC-HD neoadjuvant chemotherapy in inflammatory breast cancer, Response rate is not effected.