title: Bleomycin, epidoxorubicin, cyclophosphamide, vincristine and prednisone (BACOP) in patients with follicular non-Hodgkin's lymphoma: results of a prospective, multicenter study of the Gruppo Italiano Per Lo Studio Dei Linfomi (GISL).
abstract: At present we report the results of a prospective, non-randomized open trial, conducted on follicular lymphoma (FL) patients by the Gruppo Italiano per lo Studio dei Linfomi (GISL), after a median follow-up of 62.6 months. Seventy-three patients with FL were registered to the study and treated with combination chemotherapy consisting of cyclophosphamide, epidoxorubicin, vincristine, bleomycin and prednisone, weekly administered every 4 weeks. After chemotherapy, involved-field radiotherapy was delivered in case of either localized, bulky and extranodal disease at presentation or limited residual disease at the end of chemotherapy. Patient received four or eight chemotherapy courses in case of localized or advanced disease, respectively. The overall response rate at the end of the treatment program was 97.3%, with 78.1% CR and 19.2% PR. CR rate was 94.3 and 63.1% in stage I-II and III-IV, respectively (p = 0.006). Beside the stage, response rate was significantly influenced by bone marrow involvement, and the number of extranodal sites. Relapse free survival was 60.8% at 5 years in the whole series; in localized disease it was 70.3 vs. 44.8% in advanced disease (p = 0.044). Relapse free survival was significantly influenced by stage, bone marrow involvement, number of extranodal sites and International Prognostic Index (IPI) score. The overall 5-year survival rate was 90.2%; being 95.6% for patients with stage I-II and 85.1% for those III-IV (p = 0.0133). In addition, both IPI and Italian Lymphoma Intergroup (ILI) score had a significant impact on survival. The toxicity profile of the treatment was acceptable. From the results of this prospective study it is possible to conclude that this regimen and the whole treatment program is effective as first line therapy for the general population of FL. In particular the BACOP schedule is a valid anthracycline-containing regimen, and in this respect suitable to be considered as a treatment option.
authors.affiliation: Dipartimento di Oncologia, Azienda Ospedaliera Santo Spirito, Pescara, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Lombardo
authors.forename: Fortunato
authors.initials: F
authors.lastname: Morabito
authors.forename: Francesco
authors.initials: F
authors.lastname: Merli
authors.forename: Stefano
authors.initials: S
authors.lastname: Molica
authors.forename: Luigi
authors.initials: L
authors.lastname: Cavanna
authors.forename: Stefano
authors.initials: S
authors.lastname: Sacchi
authors.forename: Chiara
authors.initials: C
authors.lastname: Broglia
authors.forename: Francesco
authors.initials: F
authors.lastname: Angrilli
authors.forename: Fiorella
authors.initials: F
authors.lastname: Ilariucci
authors.forename: Caterina
authors.initials: C
authors.lastname: Stelitano
authors.forename: Dimitri
authors.initials: D
authors.lastname: Luisi
authors.forename: Raffaella
authors.initials: R
authors.lastname: Bertè
authors.forename: Stefano
authors.initials: S
authors.lastname: Luminari
authors.forename: Massimo
authors.initials: M
authors.lastname: Federico
authors.forename: Maura
authors.initials: M
authors.lastname: Brugiatelli
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000627:therapeutic use*; D001761:Bleomycin / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007558:Italy; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000627:therapeutic use*; D011379:Prognosis; D011446:Prospective Studies; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014750:Vincristine / Q000627:therapeutic use*
chemical_list: D001761:Bleomycin; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D011241:Prednisone