title: Frontline therapy with early intensification and autologous stem cell transplantation versus conventional chemotherapy in unselected high-risk, aggressive non-Hodgkin's lymphoma patients: a prospective randomized GEMOH report.
abstract: This prospective multicenter randomized trial compares conventional with early intensification with high-dose sequential chemotherapy (HDS) and autologous stem cell transplantation (ASCT) as frontline therapy in high-risk non-Hodgkin lymphomas (NHL). Newly diagnosed patients with aggressive high-risk [intermediate-high (HI) and high-risk (HR)] NHL according to the international prognosis index (IPI) were randomized to receive 12-week VACOP-B (arm A, 27 patients) or 6-week VACOP-B followed by HDS and ASCT (arm B, 29 patients). Complete remission rate was 52% in arm A and 55% in B. Nine patients (16%) died early due to progression. According to intention-to-treat, with a median follow-up of 23 months, the 5-year actuarial overall survival, progression-free survival and disease-free survival in arms A and B were 47 and 40% (p = nonsignificant), 47 and 30% (p = nonsignificant), and 97 and 47% (p = 0.02), respectively. Abbreviated chemotherapy followed by intensification with HDS-ASCT does not seem to be superior to conventional chemotherapy in HI/HR aggressive NHL.
authors.affiliation: Marília Medical School, São Paulo, Brazil.
authors.forename: R C
authors.initials: RC
authors.lastname: Baldissera
authors.forename: M
authors.initials: M
authors.lastname: Nucci
authors.forename: A C
authors.initials: AC
authors.lastname: Vigorito
authors.forename: A
authors.initials: A
authors.lastname: Maiolino
authors.forename: B P
authors.initials: BP
authors.lastname: Simões
authors.forename: I
authors.initials: I
authors.lastname: Lorand-Metze
authors.forename: F J P
authors.initials: FJ
authors.lastname: Aranha
authors.forename: E C M
authors.initials: EC
authors.lastname: Miranda
authors.forename: K B B
authors.initials: KB
authors.lastname: Pagnano
authors.forename: M A
authors.initials: MA
authors.lastname: Ruiz
authors.forename: A A J G
authors.initials: AA
authors.lastname: Moraes
authors.forename: C A
authors.initials: CA
authors.lastname: De Souza
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D001761:Bleomycin / Q000008:administration & dosage; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008228:Lymphoma, Non-Hodgkin / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D036102:Peripheral Blood Stem Cell Transplantation; D011241:Prednisone / Q000008:administration & dosage; D011379:Prognosis; D012074:Remission Induction; D012307:Risk Factors; D014182:Transplantation, Autologous; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D001761:Bleomycin; D014750:Vincristine; D005047:Etoposide; D004317:Doxorubicin; D003520:Cyclophosphamide; D011241:Prednisone