title: Folinic acid, 5-fluorouracil bolus and infusion and mitoxantrone with or without cyclophosphamide in metastatic breast cancer.
abstract: 60 patients with metastatic breast cancer were entered in a phase II study using folinic acid, 5-fluorouracil bolus and infusion and mitoxantrone with or without cyclophosphamide. 47 had measurable visceral metastases and 13 had exclusively bone metastases. 36 had received previous adjuvant or metastatic treatment (33/36 with anthracycline-based regimens). Overall response rate in visceral metastatic patients was 57.1% [95% confidence interval (CI) 35.4-78.8%]; 45.5% and 70% in previously and non-previously treated patients, respectively; duration of response was 9 and 13 months, respectively. 10 out 13 patients with exclusive bone metastases improved for a median time of 18 months. Median survival was 22 months for the 60 patients; 18 and 31 months for previously and non-previously treated patients, respectively. Cyclophosphamide was scheduled only in the absence of nadir grade 4 neutropenia. However, this toxicity occurred in the first 7 patients. For this reason, we chose to avoid cyclophosphamide in patients over 60 years, or with a performance status of 1-2, or who had received previous chemotherapy. Overall, cyclophosphamide was stopped due to nadir grade 4 neutropenia in 17/24 patients for whom this drug was planned. When mitoxantrone, 5-fluorouracil and folinic acid were used at the doses scheduled, the addition of cyclophosphamide appeared feasible in only about 25% of the patients. Furthermore, survival was identical for patients receiving or not receiving cyclophosphamide. Therefore, cyclophosphamide does not contribute substantially to this regimen. This study confirms the value of folinic acid, 5-fluorouracil and mitoxantrone in metastatic breast cancer.
authors.affiliation: GERCOD, Hôpital Saint-Antoine, Paris, France.
authors.forename: C
authors.initials: C
authors.lastname: Louvet
authors.forename: A
authors.initials: A
authors.lastname: de Gramont
authors.forename: B
authors.initials: B
authors.lastname: Demuynck
authors.forename: K
authors.initials: K
authors.lastname: Beerblock
authors.forename: C
authors.initials: C
authors.lastname: Varette
authors.forename: D
authors.initials: D
authors.lastname: Soubrane
authors.forename: L
authors.initials: L
authors.lastname: Marpeau
authors.forename: A
authors.initials: A
authors.lastname: Pigné
authors.forename: T
authors.initials: T
authors.lastname: Guillot
authors.forename: M
authors.initials: M
authors.lastname: Krulik
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000556:secondary; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage; D009362:Neoplasm Metastasis; D009503:Neutropenia / Q000139:chemically induced; D011379:Prognosis
chemical_list: D003520:Cyclophosphamide; D008942:Mitoxantrone; D002955:Leucovorin; D005472:Fluorouracil