title: A cooperative study on ProMACE-CytaBOM in aggressive non-Hodgkin's lymphomas.
abstract: Chemotherapy using cyclophosphamide, doxorubicin, etoposide, cytarabine, bleomycin, vincristine, methotrexate with leucovorin, and prednisone (ProMACE-CytaBOM) for patients with intermediate or high grade non-Hodgkin lymphomas (G, H and K according to the Working Formulation), was tested by the Gruppo Cooperativo Lombardo to confirm the activity of the regimen and to test the feasibility and safety of administering third-generation drug regimen in a cooperative group setting. Among 64 previously untreated patients, aged between 20 and 71 years, 7 had stage IB-IIB, 12 had stage IIIA-B, 45 (67%) had stage IVA-B. There were 44 complete remissions (CRs) (69%) and 14 partial remissions (22%); the difference between patients in stage I-II-III (84% complete remissions) and those in stage IV (62% complete remissions) was statistically significant. The median length of follow up was 20 months (range 1-60 months), with 56% of patients alive at 60 months and 53% of CRs patients free of disease at 60 months. Patients in stage I-II-III have the best survival and disease free survival compared to stage IV, 87% versus 42% and 72% versus 32% respectively (both with high statistical significance). Grade 3-4 (WHO) haematological toxicity was observed in 39% of patients, with 3 septic deaths. Two more patients died with chemotherapy related toxicity (1 stroke and 1 acute renal insufficiency). Administration of ProMACE-CytaBOM is a feasible and safe regimen although it presents moderate toxicity. ProMACE-CytaBOM may represent improved treatment for aggressive lymphomas, in terms of duration of response and survival, but a longer follow up is needed.
authors.affiliation: Gruppo Cooperativo Lombardo, Istituto di Scienze Mediche, University of Milan, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Cassi
authors.forename: C
authors.initials: C
authors.lastname: Butti
authors.forename: L
authors.initials: L
authors.lastname: Baldini
authors.forename: G B
authors.initials: GB
authors.lastname: Pisoni
authors.forename: A
authors.initials: A
authors.lastname: Ceriani
authors.forename: C
authors.initials: C
authors.lastname: Confalonieri
authors.forename: L
authors.initials: L
authors.lastname: Scandolaro
authors.forename: A
authors.initials: A
authors.lastname: De Paoli
authors.forename: F
authors.initials: F
authors.lastname: Lombardi
authors.forename: L
authors.initials: L
authors.lastname: Montalbetti
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use* / Q000633:toxicity*; D001761:Bleomycin / Q000008:administration & dosage / Q000633:toxicity; D002648:Child; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000633:toxicity; D003561:Cytarabine / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage / Q000633:toxicity; D005047:Etoposide / Q000008:administration & dosage / Q000633:toxicity; D005240:Feasibility Studies; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000633:toxicity; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008727:Methotrexate / Q000008:administration & dosage / Q000633:toxicity; D008875:Middle Aged; D009367:Neoplasm Staging; D011241:Prednisone / Q000008:administration & dosage / Q000633:toxicity; D014750:Vincristine / Q000008:administration & dosage / Q000633:toxicity
chemical_list: D003561:Cytarabine; D001761:Bleomycin; D014750:Vincristine; D005047:Etoposide; D004317:Doxorubicin; D003520:Cyclophosphamide; D002955:Leucovorin; D011241:Prednisone; D008727:Methotrexate