A randomized phase 3 trial of autologous vs allogeneic transplantation as part of first-line therapy in poor-risk peripheral T-NHL

Autor: Schmitz, Norbert, Truemper, Lorenz, Bouabdallah, Krimo, Ziepert, Marita, Leclerc, Mathieu, Cartron, Guillaume, Jaccard, Arnaud, Reimer, Peter, Wagner, Eva, Wilhelm, Martin, Sanhes, Laurence, Lamy, Thierry, de Leval, Laurence, Rosenwald, Andreas, Roussel, Muriel, Kroschinsky, Frank, Lindemann, Walter, Dreger, Peter, Viardot, Andreas, Milpied, Noël, Gisselbrecht, Christian, Wulf, Gerald, Gyan, Emmanuel, Gaulard, Philippe, Bay, Jacques Olivier, Glass, Bertram, Poeschel, Viola, Damaj, Gandhi, Sibon, David, Delmer, Alain, Bilger, Karin, Banos, Anne, Haenel, Mathias, Dreyling, Martin, Metzner, Bernd, Keller, Ulrich, Braulke, Friederike, Friedrichs, Birte, Nickelsen, Maike, Altmann, Bettina, Tournilhac, Olivier
Zdroj: Blood; May 2021, Vol. 137 Issue: 19 p2646-2656, 11p
Abstrakt: First-line therapy for younger patients with peripheral T-cell non-Hodgkin lymphoma (T-NHL) consists of 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) with or without etoposide (CHOEP), consolidated by high-dose therapy and autologous stem cell transplantation (auto-SCT). We hypothesized that allogeneic stem cell transplantation (allo-SCT) could improve outcomes. 104 patients with peripheral T-cell non-Hodgkin lymphoma, except ALK+ anaplastic large cell lymphoma, 18 to 60 years, all stages, and all age adjusted International Prognostic Index scores, except 0 and stage I, were randomized to 4 cycles of CHOEP and 1 cycle of dexamethasone, cytosine-arabinoside, and platinum (DHAP) followed by high-dose therapy and auto-SCT or myeloablative conditioning and allo-SCT. The primary end point was event-free survival (EFS) at 3 years. After a median follow-up of 42 months, the 3-year EFS after allo-SCT was 43%, as compared with 38% after auto-SCT. Overall survival at 3 years was 57% vs 70% after allo- or auto-SCT, without significant differences between treatment arms. None of the 21 responding patients proceeding to allo-SCT relapsed, as opposed to 13 of 36 patients (36%) proceeding to auto-SCT. Eight of 26 patients (31%) and none of 41 patients died of transplant-related toxicity after allo- and auto-SCT, respectively. The strong graft-versus-lymphoma effect after allo-SCT was counterbalanced by transplant-related mortality. This trial is registered at www.clinicaltrials.gov as #NCT00984412.
Databáze: Supplemental Index