Lenograstim prevents morbidity from intensive induction chemotherapy in the treatment of inflammatory breast cancer.

Abstract

PURPOSE:

To compare the efficacy and safety of recombinant human granulocyte colony-stimulating factor (rHuG-CSF) versus its inert vehicle in patients with unilateral nonmetastatic inflammatory breast cancer treated with fluorouracil, epirubicin, and cyclophosphamide high-dose (FEC-HD) neoadjuvant chemotherapy.

PATIENTS AND METHODS:

One hundred twenty patients have been enrolled by nine French centers in this double-blind, parallel-group, vehicle-controlled study to compare at each cycle subcutaneous lenograstim (5 micrograms/kg/d) with placebo given from day 6 to day 15 after the induction chemotherapy (day 1 to day 4, fluorouracil 750 mg/m2 continuous intravenous [IV] infusion; day 2 to day 4, epirubicin 35 mg/m2 and cyclophosphamide 400 mg/m2 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 neutropenia at less than 0.5 x 10(9)/L and less than 1 x 10(9)/L to a median duration of 2 and 3 days, respectively, as compared with 5 and 7 days in the placebo group. This translated into a statistically significant reduced incidence of microbiologically documented infections, and a decreased need for rehospitalizations for infectious events and antibiotic use. Clinical objective tumor response rate observed after four cycles was 89.6% and 93%, respectively, in the placebo and treated groups. Mild transient bone and injection-site pain, myelemia, and hyperleukocytosis were the most frequently reported adverse events associated 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 affected.

• Authors: B Chevallier, P Chollet, Y Merrouche, H Roche, P Fumoleau, P Kerbrat, J Y Genot, P Fargeot, J P Olivier, C Fizames
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 13 Issue 7 Pg. 1564-71 (Jul 1995) ISSN: 0732-183X [Print] United States
• PMID: 7541448 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Pharmaceutical Vehicles
• Recombinant Proteins
• Granulocyte Colony-Stimulating Factor
• Epirubicin
• Lenograstim
• Cyclophosphamide
• Fluorouracil

Topics

• Adenocarcinoma (drug therapy, mortality)
• Adult
• Antineoplastic Combined Chemotherapy Protocols (adverse effects)
• Breast Neoplasms (drug therapy, mortality)
• Cyclophosphamide (adverse effects)
• Double-Blind Method
• Epirubicin (adverse effects)
• Female
• Fluorouracil (adverse effects)
• Granulocyte Colony-Stimulating Factor (therapeutic use)
• Humans
• Infections (epidemiology)
• Lenograstim
• Middle Aged
• Neutropenia (chemically induced, prevention & control)
• Pharmaceutical Vehicles
• Recombinant Proteins (therapeutic use)
• Thrombocytopenia (chemically induced, therapy)