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 ReportBaldissera R.C.a · Nucci M.c · Vigorito A.C.d, e · Maiolino A.c · Simões B.P.g · Lorand-Metze I.d · Aranha F.J.P.d, e · Miranda E.C.M.d · Pagnano K.B.B.d · Ruiz M.A.b · Moraes A.A.J.G.f · de Souza C.A.d
aMarília Medical School and bSão José do Rio Preto Medical School, São Paulo, cUniversidade Federal do Rio de Janeiro, Rio de Janeiro, dState University of Campinas, eVera Cruz Hospital and fCampinas Oncology Center, Campinas, and gUniversity of São Paulo, Ribeirão Preto, Brazil
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Article / Publication Details
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 was52% 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.
© 2006 S. Karger AG, Basel
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