title: Intensified dose of cyclophosphamide with G-CSF support versus standard dose combined with platinum in first-line treatment of advanced ovarian cancer a randomised study from the GINECO group.
abstract: ICON3 trial results have suggested that CAP and carboplatin-taxol regimens as first-line treatment of advanced ovarian cancer (AOC) yield similar survival. We explored the impact of increased dose of cyclophosphamide in a modified CAP regimen on the disease-free survival (DFS) and overall survival (OS) of AOC patients. From February 1994 to June 1997, 164 patients were randomised to receive six cycles every 3 weeks of either standard CEP (S) combining cyclophosphamide (C), 500 mg m(-2), epirubicin (E) 50 mg m(-2), and cisplatin (P) 75 mg m(-2) or intensive CEP (I) with E and P at the same doses, but with (C) 1800 mg m(-2) and filgrastim 5 mug kg(-1) per day x 10 days. Response was evaluated at second-look surgery. Patient characteristics were well balanced. Except for grade 3-4 neutropaenia (S: 54%, I: 38% of cycles), Arm1 presented a significantly more important toxicity: infection requiring antibiotics, grade 3-4 thrombocytopaenia, anaemia, nausea-vomiting, diarrhoea, mucositis. Median follow-up was 84 months. DFS (15.9 vs 14.8 months) and OS (33 vs 30 months) were not significantly different between S and I (P>0.05). Increasing cyclophosphamide dose by more than 3 times with filgrastim support in the modified CAP regimen CEP induces more toxicity but not better efficacy in AOC.
authors.affiliation: Centre Léon Bérard, EA 4129 sis, 28 rue Laënnec, Lyon 69008, France. ray@lyon.fnclcc.fr
authors.forename: I
authors.initials: I
authors.lastname: Ray-Coquard
authors.forename: D
authors.initials: D
authors.lastname: Paraiso
authors.forename: J-P
authors.initials: JP
authors.lastname: Guastalla
authors.forename: B
authors.initials: B
authors.lastname: Leduc
authors.forename: F
authors.initials: F
authors.lastname: Guichard
authors.forename: C
authors.initials: C
authors.lastname: Martin
authors.forename: L
authors.initials: L
authors.lastname: Chauvenet
authors.forename: Z
authors.initials: Z
authors.lastname: Haddad-Guichard
authors.forename: D
authors.initials: D
authors.lastname: Lepillé
authors.forename: H
authors.initials: H
authors.lastname: Orfeuvre
authors.forename: H
authors.initials: H
authors.lastname: Gautier
authors.forename: D
authors.initials: D
authors.lastname: Castera
authors.forename: E
authors.initials: E
authors.lastname: Pujade-Lauraine
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D018269:Carcinoma, Endometrioid / Q000188:drug therapy; D002945:Cisplatin / Q000008:administration & dosage; D003520:Cyclophosphamide / Q000008:administration & dosage; D018284:Cystadenocarcinoma, Serous / Q000188:drug therapy; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D003520:Cyclophosphamide; D016190:Carboplatin; D002945:Cisplatin